insulin lispro protamine and insulin lispro Subcutaneous

IN-su-lin LIS-pro PROE-ta-meen, ree-KOM-bi-nant, IN-su-lin LIS-pro, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

• Humalog Mix 50/50


• Humalog Mix 75/25

Available Dosage Forms:

• Suspension

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Lispro, Recombinant

Uses For insulin lispro protamine and insulin lispro

Insulin lispro protamine and insulin lispro is a combination of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. If you have diabetes, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.

insulin lispro protamine and insulin lispro is available only with your doctor's prescription.

Before Using insulin lispro protamine and insulin lispro

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For insulin lispro protamine and insulin lispro, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to insulin lispro protamine and insulin lispro or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of insulin lispro protamine and insulin lispro in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dose in patients receiving insulin lispro protamine and insulin lispro.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking insulin lispro protamine and insulin lispro, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using insulin lispro protamine and insulin lispro with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using insulin lispro protamine and insulin lispro with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of insulin lispro protamine and insulin lispro. Make sure you tell your doctor if you have any other medical problems, especially:

• Emotional disturbances or


• Illness or


• Stress—These conditions increase blood sugar and may increase the amount of insulin you need.

• Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

• Kidney disease or


• Liver disease—Effects of insulin lispro protamine and insulin lispro combination may be increased because of the slower removal of the medicine from the body.

Proper Use of insulin lispro protamine and insulin lispro

Each package of insulin lispro protamine and insulin lispro combination contains a patient information leaflet. Read this leaflet carefully before beginning your treatment and each time you refill for any new information, and make sure you understand:

• How to prepare the medicine.


• How to inject the medicine.


• How to use disposable insulin delivery device.


• How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., under the skin of your abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

When used as a mealtime insulin, this insulin combination should be taken within 15 minutes before a meal.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should never mix insulin lispro protamine and insulin lispro combination with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.

Dosing

The dose of insulin lispro protamine and insulin lispro will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of insulin lispro protamine and insulin lispro. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For diabetes mellitus:
    
    • Adults—The dose is based on your blood sugar and must be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of insulin lispro protamine and insulin lispro, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

After a cartridge has been inserted into a pen, you may store the cartridge and pen at room temperature, not in the refrigerator, for up to 10 days.

Precautions While Using insulin lispro protamine and insulin lispro

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take insulin lispro protamine and insulin lispro. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.


• Other medicines—Do not take other medicines during the time you are taking insulin lispro protamine and insulin lispro unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.


• Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs.


• Keep some kind of quick-acting sugar handy to treat low blood sugar.


• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

insulin lispro protamine and insulin lispro may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; shortness of breath; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.

Too much insulin lispro protamine and insulin lispro combination can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; depression; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

insulin lispro protamine and insulin lispro Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Anxiety


• blurred vision


• chills


• cold sweats


• coma


• confusion


• convulsions


• cool, pale skin


• cough


• decreased urine


• depression


• difficulty swallowing


• dizziness


• dry mouth


• fast heartbeat


• flushing or redness of the skin


• headache


• hives


• increased hunger


• increased thirst


• irregular heartbeat


• itching


• loss of appetite


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• nightmares


• numbness or tingling in the hands, feet, or lips


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• seizures


• shakiness


• shortness of breath


• skin rash


• slurred speech


• sweating


• swelling


• tightness in the chest


• unusual tiredness or weakness


• unusually warm skin


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• redistribution or accumulation of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More insulin lispro protamine and insulin lispro Subcutaneous resources

• Insulin lispro protamine and insulin lispro Subcutaneous Use in Pregnancy & Breastfeeding
• Insulin lispro protamine and insulin lispro Subcutaneous Drug Interactions
• Insulin lispro protamine and insulin lispro Subcutaneous Support Group
• 1 Review for Insulin lispro protamine and insulin lispro Subcutaneous - Add your own review/rating

Compare insulin lispro protamine and insulin lispro Subcutaneous with other medications

• Diabetes, Type 1
• Diabetes, Type 2

MUSE 125 microgram, 250 micrograms, 500 micrograms or 1000 micrograms urethral stick.

MUSE (alprostadil)

Before using MUSE, please read this leaflet carefully; it contains important information for you and your partner about using MUSE. Ask your doctor or pharmacist for help if anything in this leaflet is not clear, or if you want more information.

Please keep the leaflet so that you can refer to it again.

What Is Muse?

The name of your medication is MUSE. It consists of a single use applicator for administering the active ingredient alprostadil, directly into your urethra, the pathway for urine through the penis. Alprostadil is suspended in the single excipient, macrogol, to form a urethral stick which is contained in the tip of the applicator. There are four dose strengths available containing either 125, 250, 500 or 1000 micrograms of alprostadil. Your doctor will decide with you which strength is right for you.

MUSE is supplied in packs containing either 1 or 6 foil pouches, each pouch contains one dose of MUSE.

How Does Muse Work?

Alprostadil is identical to a natural substance in your body called prostaglandin E₁. Alprostadil is absorbed from the urethra into the surrounding tissues where it increases the flow of blood into the penis, causing an erection.

Who Makes Muse?

MUSE is manufactured by

VIVUS Inc.

735/745 Airport Road

Lakewood

NJ 08701

USA

The site of batch release is

Recipharm Limited

Vale of Bardsley

Ashton-under-Lyne

Lancashire

OL7 9RR

UK

The Marketing Authorisation holder in the UK is

Meda Pharmaceuticals

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

The Product Authorisation holder in Ireland is

Meda Health Sales Ireland Limited

Office 10

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

What Is Muse Used For?

MUSE is for use in men with a primarily organic (physical) cause of weak erections or impotence. Your doctor may also administer MUSE when testing your erectile function.

Who Should Not Use Muse?

You should not use MUSE if any of the following apply:

• You have previously had a bad reaction to a medicine containing alprostadil (the active medication in MUSE).


• You have an abnormally formed penis.


• You have a condition that might result in having long-lasting erections, such as sickle cell disease, leukaemia, or tumour of the bone marrow (multiple myeloma), or you have a history of long-lasting erections.


• You have been advised not to undertake sexual activity maybe because you have an unstable heart condition or have had a recent stroke.


• If your female partner is, or may be pregnant, you should use a condom barrier when you use MUSE.


• MUSE should not be used by women or children.

MUSE has not been tested in patients who have impotence primarily of psychogenic (psychological) origin.

Important Information For You And Your Partner

• 
  Pregnancy: MUSE has no contraceptive properties. Because MUSE has not been tested during human pregnancy or in couples trying to achieve pregnancy, it is recommended that adequate contraception is used if the female partner is of childbearing potential.


• 
  Sexually transmitted diseases: MUSE will not protect you or your partner from sexually transmitted diseases like chlamydia, gonorrhoea, herpes simplex virus, viral hepatitis, HIV (which causes AIDS), genital warts or syphilis. Latex condoms can protect against these diseases.

Are You Taking Other Medicines Or Do You Have A Penile Implant?

Make sure that your doctor knows about all other medicines you are taking, whether these are prescribed or bought from the chemist. If you are taking anticoagulants - medicines to thin your blood - or medicines which affect your blood pressure, tell your doctor this before starting to use MUSE. Medicines that contain decongestants such as cold remedies and some treatments for hayfever or sinus trouble may block the effects of MUSE. Appetite suppressants may have the same effect.

If you have a penile implant, or are taking other products for weak erections or impotence, discuss this with your doctor before you use MUSE.

How To Use Muse

• Your doctor will show you how to use MUSE and your dose of MUSE will be determined by you and your doctor. If MUSE does not work first time, it may be because you need a higher dose and will need to step up to the next strength. The maximum dose available is 1000 micrograms. Consult your doctor if you suspect your dose needs to be changed.


• Use one dose of MUSE as needed to achieve an erection.


• Unopened pouches of MUSE should be stored in a refrigerator (2-8°C). However, you may wish to store the product at room temperature (below 30°C for up to 14 days) before use as this may make insertion more comfortable.


• The instructions below tell you how to administer MUSE; in order for MUSE to be at its most effective, you will need to follow these carefully.

1. First wash your hands and dry them on a clean towel. Then immediately before administration, urinate and gently shake the penis several times to remove excess urine. A moist urethra makes insertion of MUSE easier and the medication has been specially designed to dissolve in the moisture that remains in the urethra after urination.

2. Open the foil pouch by tearing fully across the notched edge (Fig. 2). Let MUSE slide out of the pouch - do not remove by grasping the applicator. Save the pouch for discarding the MUSE applicator later.

3. To remove the protective cover from the applicator stem (Fig. 3), hold the body of the applicator with your thumb and forefinger. Twist the body and pull out the applicator from the cover.

Be careful not to push in or pull out the applicator button.

Avoid touching the applicator stem and tip.

Save the cover for discarding the MUSE applicator later.

4. Check that you can see the medication at the end of the stem.

5. Hold the applicator in the way which is most comfortable to you (Fig. 5a and 5b).

6. Look carefully at Fig. 6a which shows the anatomy of the penis. While sitting or standing, whichever is the more comfortable for you, take several seconds to gently and slowly stretch the penis upward to its full length, with gentle compression from top to bottom of the glans (Fig. 6b). This straightens and opens the urethra. Slowly insert the MUSE stem into the urethra, up to the collar (Fig. 6c). If you feel any discomfort or pulling sensation, withdraw the applicator slightly and then gently re-insert.

7. Gently and completely push down the button at the top of the applicator (Fig. 7) until it stops.

It is important to do this to ensure that the medication is completely released. Hold the applicator in this position for 5 seconds.

8. Gently rock the applicator from side to side. This will release the medication from the tip of the applicator (Fig. 8). Be careful not to scratch the lining of the urethra which could cause it to bleed.

9. Remove the applicator while keeping the penis upright.

10. Look at the applicator tip to check that the medication has separated from the applicator. Do not touch the stem. If you see any medication left at the end of the applicator, gently re-insert it into the urethra and repeat steps 7, 8 and 9.

11. Holding the penis upright and stretched to its full length, roll (massage) the penis firmly between your hands for at least 10 seconds (Fig. 9). This will ensure that the medication is properly distributed along the walls of the urethra. If you feel a burning sensation, it may help if you continue rolling the penis for an additional 30-60 seconds or until the burning subsides.

12. Remember, each MUSE applicator is for single administration only. After use, replace the cover on the MUSE applicator, place it in the opened foil pouch, and fold and discard it as normal household waste.

After you have administered MUSE it is important to sit, or preferably, stand or walk about for 10 minutes while the erection is developing. This will enhance your erection.

How Often Can I Use Muse?

You can use MUSE twice in any 24 hour period and up to 7 times in a 7 day period, but do not use it more often than this.

Questions Commonly Asked About Muse

Will the use of MUSE hurt?

You may feel some discomfort from insertion, although with repeated use, administration will become easier.

Urinating before administration and making sure you stretch your penis to its full length will reduce the chance of discomfort. In addition, the medication in MUSE may cause some burning and aching, which should go away in a short period of time.

How long will the effect of MUSE last?

An erection should begin within 5 to 10 minutes after administering MUSE. The duration of effect is about 30 to 60 minutes. However, the actual duration will vary from patient to patient.

What will the erection be like?

How will it compare with the erections in the past?

An effective dose of MUSE should produce an erection sufficient for sexual intercourse. MUSE may not create an erection such as those you experienced in the past; there may be some mild pain and aching in the penis or groin and your erection may continue after orgasm.

Because MUSE increases local blood flow, your penis may feel warm and become red.

How do I know if I have the correct dose of MUSE?

You and your doctor will determine the appropriate dose of MUSE. If your erection cannot be maintained for the time you need to have foreplay and sexual intercourse, you may need to have the dose increased. Alternatively, if your erection lasts too long, you may require a dose decrease. Consult your doctor if you suspect your dose needs to be changed.

After my erection is over, will my penis feel sensitive?

Your penis may feel warm, full and sensitive to the touch for a few hours. This is normal.

Additional Information And Practical Tips

Factors which may enhance your erection:

• Being well rested and relaxed.


• Sexual foreplay with your partner or self-stimulation while sitting or standing.


• Pelvic exercises, e.g. tightening and releasing your pelvic and buttock muscles (the muscles you use to stop urination).

Factors which may reduce your erection:

• Anxiety, fatigue, tension or too much alcohol.


• Lying on your back too soon after administration of MUSE may decrease blood flow to the penis and result in loss of erection. It is important to sit, stand or walk about for 10 minutes before you assume positions for sexual intercourse.


• Urination or dribbling immediately following administration may result in loss of medication from the urethra.


• Using medications that contain decongestants, such as over-the-counter cold remedies, allergy, sinus medications and appetite suppressants, may block the effect of MUSE.

Your doctor may review your treatment from time to time.

What Are The Possible Side-Effects Of Muse?

The most common side-effects that have been observed by men using MUSE are:

• Aching in the penis, testicles, legs and perineum (the area between the penis and the rectum).


• Warmth or a burning sensation in the urethra.


• Minor urethral bleeding due to incorrect administration.

The following side-effects may also occur but they are less common:

• Swelling of the leg veins.


• Headache.


• Light-headedness/dizziness.


• Fainting.


• Rapid pulse.


• Rarely, prolonged erection, changes to your penis (e.g. curvature of the penis), or urinary tract infection may occur.


• Very rarely, rash and allergic skin reactions may occur.

Please note: if your erection is rigid for 4 hours or more, call your doctor promptly.

After using MUSE you should avoid activities, such as driving or hazardous tasks, where injury could result if dizziness or fainting were to occur. In men experiencing these symptoms, the symptoms have usually occurred during the initiation of treatment and within one hour of MUSE administration.

If you notice any other symptoms or changes while you are using MUSE, or you are at all concerned, speak to your doctor or chemist.

What Are The Possible Side-Effects Of Muse For Your Partner?

The most common side-effects in women whose partners use MUSE are vaginal itching or burning. Using a water-based lubricant can help to make vaginal penetration easier.

What To Do If Your Erection Lasts Longer Than Desired

Application of ice packs to the inner thigh may shorten the duration of the erection since the cold will restrict the flow of blood to the penis. If used, ice packs should be applied alternately to each inner thigh for no longer than 10 minutes. If the dose is too high, you may also notice that your pulse rate increases or you feel dizzy or faint. If this happens, immediately lie down and raise your legs. If symptoms persist, call your doctor.

If you have a rigid erection that lasts longer than four hours, you should speak to the doctor who prescribed MUSE to you straight away. If you cannot contact this doctor or any other doctor in his practice or clinic, then go to the hospital casualty department.

How Should I Store Muse?

Do not use MUSE after the expiry date shown on the pack.

MUSE should not be exposed to high temperatures (i.e. above 30°C) or to direct sunlight since it will become ineffective. Store unopened pouches in a refrigerator (2-8°C) and only keep at room temperature (below 30°C) for up to 14 days before use. If travelling, do not leave MUSE in a car or anywhere else where it may be exposed to high temperatures.

Remember

This medicine is for YOU. Only a doctor can prescribe it for you. Never give it to others, even if their symptoms are the same as yours as it may not be suitable for them.

The information in this leaflet applies only to MUSE and is a summary of the information available. If you require further information or you have any questions, speak to your doctor or chemist.

Sexual Dysfunction Helpline

If you would like more information on impotence or any aspects of treatment, you can call:

The Sexual Dysfunction Association (formerly the Impotence Association Helpline),

Windmill Place Business Centre

2-4 Windmill Lane

Southall

Middlesex

UB2 4NJ

UK

Tel:0870 7743571

The Helpline is open on weekdays from 9a.m. to 5p.m. All calls are answered in the strictest confidence.

This leaflet was revised in January 2007

Copyright © Meda Pharmaceuticals

MUSE is a registered trademark of VIVUS Inc.

Meda Pharmaceuticals

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

Meda Health Sales Ireland Limited

Office 10

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

Vancocin Matrigel Capsules 125mg

1. Name Of The Medicinal Product

Vancocin Matrigel 125 mg Hard capsules.

2. Qualitative And Quantitative Composition

Each capsule contains 125 mg vancomycin (as hydrochloride)

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Capsules, hard

125 mg capsules : Dark blue and peach hard capsules, imprinted with 3125 in red ink

4. Clinical Particulars

4.1 Therapeutic Indications

Vancomycin may be used orally for the treatment of staphylococcai enterocolitis and pseudomembranous colitis due to Clostridium difficile.

Vancomycin is not significantly absorbed from the normal gastro-intestinal tract and is therefore not effective by the oral route for other types of infection. Intravenous administration may be used concomitantly if required.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

For oral administration

Either the Matrigel capsules or the contents of the 500 mg vial for the parenteral administration may be used.

Adults and the elderly: The usual daily dose is 500 mg in divided doses for 7 to 10 days, although up to 2 g/day, in three or four divided doses, have been used in severe cases. The total daily dosage should not exceed 2 g.

Children: The usual daily dose is 40 mg/kg in three or four divided doses, for 7 to 10 days. The total daily dosage should not exceed 2 g.

Oral solution: The contents of the 500 mg vial for parenteral administration may be used and either given to the patient to drink, or administered by nasogastric tube. Mix thoroughly to dissolve. Common flavouring syrups may be added to the solution at the time of administration to improve the taste.

4.3 Contraindications

Hypersensitivity to vancomycin.

4.4 Special Warnings And Precautions For Use

Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active C. difficile-induced pseudomembranous colitis. Therefore, monitoring of serum concentrations may be appropriate in these patients.

Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of vancomycin and, therefore, may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. The risk is greater in patients with renal impairment. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly.

Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, have an underlying hearing loss, or are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity.

When treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside, serial monitoring of renal function should be performed.

Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent and/or sequential systemic or topical use of other potentially ototoxic and/or nephrotoxic drugs requires careful monitoring.

4.6 Pregnancy And Lactation

Usage in pregnancy: Teratology studies have been performed at 5 times the human dose in rats and 3 times the human dose in rabbits, and have revealed no evidence of harm to the foetus due to vancomycin. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin hydrochloride was found in cord blood.

No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant, whose mother received vancomycin in the third trimester, experienced conductive hearing loss that was not attributable to vancomycin. Because vancomycin was administered only in the second and third trimesters, it is not known whether it causes foetal harm. Therefore vancomycin should be given to a pregnant woman only if clearly needed.

Usage in nursing mothers: Vancomycin hydrochloride is excreted in human milk. Caution should be exercised when vancomycin is administered to a nursing woman.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Since vancomycin is not usually significantly absorbed from the gastro-intestinal tract, the toxicity encountered with parenteral therapy is unlikely to occur after oral administration (but see 'Precautions').

Nephrotoxicity: Rarely, renal failure, principally manifested by increased serum creatinine or blood urea concentrations, have been observed, especially in patients given large doses of intravenously administered vancomycin. Rare cases of interstitial nephritis have been reported. Most occurred in patients who were given aminoglycosides concomitantly or who had pre-existing kidney dysfunction. When vancomycin was discontinued, azotaemia resolved in most patients.

Ototoxicity: Hearing loss associated with intravenously administered vancomycin has been reported. Most of these patients had kidney dysfunction, pre-existing hearing loss, or concomitant treatment with an ototoxic drug. Vertigo, dizziness and tinnitus have been reported rarely.

Haematological: Reversible neutropenia, usually starting one week or more after onset of intravenous therapy or after a total dose of more than 25g, Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia and reversible agranulocytosis (granulocyte count less than 5oo/mm³) have been reported rarely. Eosinophilia has been reported rarely.

Miscellaneous: Hypersensitivity reactions, anaphylaxis, chills, drug fever, hypotension, wheezing, dyspnoea, urticaria, pruritus, flushing of the upper body ('red neck syndrome'), pain, muscle spasm of the chest and back, nausea and rashes, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and rare cases of vasculitis.

4.9 Overdose

Treatment of Overdosage

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Haemofiltration and haemoperfusion with Amberlite resin XAD-4 have been reported to be of limited benefit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis. The bacterial action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin may alter bacterial cell membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other classes of antibiotics.

Orally administered vancomycin is active against C. difficile (e.g. toxigenic strains implicated in pseudomembranous enterocolitis). It is also active against staphylococci, including Staphylococcus aureus. Vancomycin is not active in vitro against Gram-negative bacilli, mycobacteria or fungi.

5.2 Pharmacokinetic Properties

Vancomycin is poorly absorbed from the gastro-intestinal tract. During multiple dosing of 250 mg every 8 hours for 7 doses, faecal concentrations of vancomycin, in volunteers, exceeded 100mg/kg in the majority of samples.

No blood concentrations were detected and urinary recovery did not exceed 0.76%

Orally administered vancomycin does not usually enter the systemic circulation even when inflammatory lesions are present. Measurable serum concentrations may occur infrequently in patients with active C. difficile-induced pseudomembranous colitis and, in the presence of renal impairment, the possibility of accumulation exists.

Administration of vancomycin oral solution, 2 g daily for 16 days to anephric patients with no inflammatory bowel disease, gave serum levels of <0.66 μg/ml. With doses of 2 g daily, concentration of 3,100 mg/kg can be found in the faeces and levels of <1 μg/ml can be found in the serum of patients with normal renal function who have pseudomembranous colitis.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber in addition to that summarised in other sections of the Summary of Product Characteristics

6. Pharmaceutical Particulars

6.1 List Of Excipients

Capsule contents

Macrogol 6000

Capsule shell

Gelatin

Indigo carmine (E132)

Red iron oxide (E172

Yellow iron oxide (E172)

Titanium dioxide (E171)

Printing ink

Shellac

Soya lecithin

Dimeticone

Iron oxide red (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

AL/UPVC/Aclar blister packs of 20 capsules (2 strips of 10 capsules) or 28 capsules (4 strips of 7 capsules). Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Flynn Pharma Limited

Alton House

4 Herbert Street

Dublin 2

Republic of Ireland

8. Marketing Authorisation Number(S)

PL 13621/0030

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 25 September 1985

Date of last renewal of authorisation: 15^th October 2005

10. Date Of Revision Of The Text

Approved July 2008

Yervoy

Pronunciation: IP-i-LIM-ue-mab
Generic Name: Ipilimumab
Brand Name: Yervoy

Yervoy may cause severe and sometimes fatal reactions. In instances when these reactions occur, they most commonly involve intestinal inflammation, liver problems, severe skin problems, nerve problems, or endocrine problems. Most of these reactions occurred during treatment with Yervoy. However, some occurred weeks or months after treatment was stopped.

Medical assessments and lab tests, including liver and thyroid function, should be performed before you start to take Yervoy and before each dose. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Tell your doctor right away if you develop any of the following:

• Fever; stomach pain or tenderness; increased stool frequency; diarrhea; blood or mucus in the stool; black, tarry stools


• Yellowing of the skin or eyes, persistent nausea or stomach pain, loss of appetite, dark urine, pale stools


• Red, swollen, blistered, or peeling skin; mouth sores or inflammation


• Burning, tingling, or numbness; unusual muscle weakness


• Feeling of being unusually cold or hot, inability to concentrate, mental or mood changes (eg, forgetfulness, irritability), dizziness, fainting, persistent or unusual headache, unusual fatigue, change in bowel habits, unexplained weight changes


• Vision changes (eg, blurred vision, double vision), eye pain or redness

Yervoy is used for:

Treating certain types of melanoma (a kind of skin cancer). It may also be used for other conditions as determined by your doctor.

Yervoy is a monoclonal antibody. It works by helping the immune system to recognize and kill the cancer cells.

Do NOT use Yervoy if:

• you are allergic to any ingredient in Yervoy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Yervoy:

Some medical conditions may interact with Yervoy. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have an autoimmune disease (eg, ulcerative colitis, Crohn disease, rheumatoid arthritis, lupus, sarcoidosis)


• if you have liver problems


• if you have had an organ transplant

Some MEDICINES MAY INTERACT with Yervoy. However, no specific interactions with Yervoy are known at this time.

Ask your health care provider if Yervoy may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Yervoy:

Use Yervoy as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Yervoy comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Yervoy refilled.


• Yervoy is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not shake Yervoy.


• Do not use Yervoy if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Yervoy, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Yervoy.

Important safety information:

• Diarrhea may be a sign of a serious side effect that may be caused by Yervoy. Contact your doctor if you develop diarrhea or increased stool frequency. Do not treat diarrhea without first checking with your doctor.


• Tell your doctor or dentist that you take Yervoy before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver and thyroid function, may be performed while you use Yervoy. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Yervoy should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Yervoy may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Yervoy while you are pregnant. It is not known if Yervoy is found in breast milk. Do not breast-feed while you are taking Yervoy.

Possible side effects of Yervoy:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or mucus in the stool; burning, tingling, or numbness; chest pain; decreased sexual desire; decreased urination; diarrhea or increased stool frequency; dizziness; eye pain or redness; fainting; mental or mood changes (eg, forgetfulness, irritability); mouth sores or inflammation; muscle pain or weakness; persistent or unusual headache; red, swollen, blistered, or peeling skin; shortness of breath or trouble breathing; stiff neck; stomach pain or tenderness; symptoms of liver problems (eg, yellowing of the skin or eyes, persistent nausea or stomach pain, loss of appetite, dark urine, pale stools); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unusual fatigue, change in bowel habits, unexplained weight changes); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Yervoy side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Yervoy:

Yervoy is usually handled and stored by a health care provider. If you are using Yervoy at home, store Yervoy as directed by your pharmacist or health care provider. Keep Yervoy out of the reach of children and away from pets.

General information:

• If you have any questions about Yervoy, please talk with your doctor, pharmacist, or other health care provider.


• Yervoy is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Yervoy. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Yervoy resources

• Yervoy Side Effects (in more detail)
• Yervoy Use in Pregnancy & Breastfeeding
• Yervoy Drug Interactions
• Yervoy Support Group
• 0 Reviews for Yervoy - Add your own review/rating

• Yervoy Prescribing Information (FDA)


• Yervoy Advanced Consumer (Micromedex) - Includes Dosage Information


• Yervoy Consumer Overview


• Ipilimumab Professional Patient Advice (Wolters Kluwer)

Compare Yervoy with other medications

• Melanoma
• Melanoma, Metastatic

Actimmune

Pronunciation: IN-ter-FEER-on GAM-uh
Generic Name: Interferon Gamma-1B
Brand Name: Actimmune

Actimmune is used for:

Reducing the number and severity of infections associated with chronic granulomatous disease. It is also used to delay the progression of severe, life-threatening bone density disease. It may also be used for other conditions as determined by your doctor.

Actimmune is a protein identical to one found in the body. How Actimmune works is not fully understood. It is thought to enhance the action of cells the body uses in defense against certain diseases.

Do NOT use Actimmune if:

• you are allergic to any ingredient in Actimmune or to any medicine derived from Escherichia coli

Contact your doctor or health care provider right away if any of these apply to you.

Before using Actimmune:

Some medical conditions may interact with Actimmune. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of bone marrow depression, blood problems (eg, anemia), liver problems, seizures or epilepsy, or suicidal thoughts or behaviors


• if you have a history of irregular heartbeat, congestive heart failure, or other heart problems

Some MEDICINES MAY INTERACT with Actimmune. However, no specific interactions with Actimmune are known at this time.

Ask your health care provider if Actimmune may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Actimmune:

Use Actimmune as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Actimmune. Talk to your pharmacist if you have questions about this information.


• Actimmune is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Actimmune at home, carefully follow the injection procedures taught to you by your health care provider.


• Do not shake Actimmune.


• The medicine vial is for a single dose only. Any unused portion of Actimmune should be thrown away.


• Do not use Actimmune if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not inject into an area of the body where the skin is irritated, red, bruised, infected, or scarred in any way. If you experience a break in the skin, a blue-black discoloration of the skin, or fluid drainage from the injection site, contact your heath care provider at once before continuing Actimmune.


• To decrease side effects, use Actimmune at bedtime unless directed otherwise by your doctor.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Actimmune, use it as soon as possible. However, your next injection should be scheduled about 48 hours later. Do not use 2 doses at once. Do not use Actimmune on 2 consecutive days.

Ask your health care provider any questions you may have about how to use Actimmune.

Important safety information:

• Flu-like symptoms caused by this drug can be lessened by taking Actimmune at bedtime. Use a nonprescription medicine to prevent or lessen fever and headache.


• Actimmune may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• Actimmune may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Lab tests, including blood cell counts, kidney and liver function tests, and urine tests, may be performed while you use Actimmune. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Actimmune in CHILDREN; they may be more sensitive to its effects, especially elevated liver enzyme levels.


• PREGNANCY and BREAST-FEEDING: It is not known if Actimmune can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actimmune during while you are pregnant. It is not known if Actimmune is found in breast milk. Do not breast-feed while taking Actimmune.

Possible side effects of Actimmune:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; fatigue; flu-like symptoms (eg, low-grade fever, chills, general body discomfort); headache; joint pain; muscle pain; nausea; pain, redness, or swelling at the injection site; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dizziness; fainting; fast or irregular heartbeat; high or persistent fever; mood or mental changes; seizures; signs of infection (eg, chills, persistent sore throat); stomach pain; trouble walking; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Actimmune side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; mental changes; trouble walking; unusual bruising or bleeding.

Proper storage of Actimmune:

Store Actimmune in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Actimmune should not be left at room temperature for longer than 12 hours. Any vials of Actimmune left out of the refrigerator for longer than 12 hours should not be used and should be thrown away. Keep Actimmune out of the reach of children and away from pets.

General information:

• If you have any questions about Actimmune, please talk with your doctor, pharmacist, or other health care provider.


• Actimmune is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Actimmune. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Actimmune resources

• Actimmune Side Effects (in more detail)
• Actimmune Use in Pregnancy & Breastfeeding
• Actimmune Drug Interactions
• Actimmune Support Group
• 0 Reviews for Actimmune - Add your own review/rating

• Actimmune Prescribing Information (FDA)


• Actimmune Advanced Consumer (Micromedex) - Includes Dosage Information


• Actimmune Concise Consumer Information (Cerner Multum)


• Actimmune Monograph (AHFS DI)


• Interferon Gamma-1b Professional Patient Advice (Wolters Kluwer)

Compare Actimmune with other medications

• Chronic Granulomatous Disease
• Cutaneous T-cell Lymphoma
• Idiopathic Pulmonary Fibrosis
• Osteopetrosis

Tegretol Suppositories

Geigy

TEGRETOL 125 and 250 mg Suppositories

(carbamazepine)

What you need to know about Tegretol Suppositories

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to use the suppositories. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Tegretol Suppositories are and what they are used for


• 2. Things to consider before you are treated with Tegretol Suppositories


• 3. How to use Tegretol Suppositories


• 4. Possible side effects


• 5. How to store Tegretol Suppositories


• 6. Further information

What Tegretol Suppositories are and what they are used for

Carbamazepine, the active ingredient in Tegretol Suppositories is an anti-convulsant medicine (prevents fits).

Tegretol Suppositories are used to treat some forms of epilepsy. They are useful in the short term, (maximum 7 days), for patients who cannot take medicines by mouth, e.g. after surgery or if unconscious.

Things to consider before you are treated with Tegretol Suppositories

Some people MUST NOT have Tegretol Suppositories. Make sure your doctor knows if:

• you think you may be hypersensitive (allergic) to carbamazepine or similar drugs such as oxcarbazepine (Trileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to oxcarbazepine.


• you think you may be allergic to any of the other ingredients of Tegretol Suppositories (these are listed at the end of the leaflet). Signs of a hypersensitivity reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling.


• you have any heart problems,


• you have ever had problems with your bone marrow,


• you have a blood disorder called porphyria,


• you have taken drugs called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.

A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious skin side effects can rarely occur during treatment with carbamazepine. This risk can be predicted with a blood sample in people of Chinese and Thai origin. Discuss this with your doctor before taking carbamazepine if you are of such origin.

You should also ask yourself these questions before you have Tegretol Suppositories. If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Tegretol Suppositories might not be the right medicine for you.

• Are you pregnant or planning to become pregnant?


• Are you breast feeding?


• Do you suffer from the sort of epilepsy where you get mixed seizures which include absences?


• Do you have any mental illness?


• Are you allergic to an epilepsy medicine called phenytoin?


• Do you have liver problems?


• Are you elderly?


• Do you have any eye problems such as glaucoma (increased pressure in the eye)?

Are you taking other medicines?

Because of the way that Tegretol works, it can affect, and be affected by, lots of other things that you might be eating or medicines that you are taking. It is very important to make sure that your doctor knows all about what else you are taking, including anything that you have bought from a chemist or health food shop. It may be necessary to change the dose of some medicines, or stop taking something altogether.

Tell the doctor if you are taking:

• Hormone contraceptives, e.g. pills, patches, injections or implants. Tegretol affects the way the contraceptive works in your body, and you may get breakthrough bleeding or spotting. It may also make the contraceptive less effective and there will be a risk of getting pregnant. Your doctor will be able to advise you about this, and you should think about using other contraceptives.


• Hormone Replacement Therapy (HRT). Tegretol can make HRT less effective.


• Any medicines for depression or anxiety.


• Corticosteroids (‘steroids’). You might be taking these for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains.


• Anticoagulants to stop your blood clotting.


• Antibiotics to treat infections including skin infections and TB.


• Antifungals to treat fungal infections.


• Painkillers containing paracetamol, dextropropoxyphene, tramadol, methadone or buprenorphine.


• Other medicines to treat epilepsy.


• Medicines for high blood pressure or heart problems.


• Antihistamines (medicines to treat allergy such as hayfever, itch, etc).


• Diuretics (water tablets).


• Cimetidine or omeprazole (medicines to treat gastric ulcers).


• Isotretinoin (a medicine for the treatment of acne).


• Metoclopramide (an anti-sickness medication).


• Acetazolamide (a medicine to treat glaucoma - increased pressure in the eye).


• Danazol or gestrinone (treatments for endometriosis).


• Theophylline or aminophylline (used in the treatment of asthma).


• Ciclosporin (an immunosuppressant, used after transplant operations, but also sometimes in the treatment of arthritis or psoriasis).


• Drugs to treat schizophrenia.


• Cancer drugs.


• The anti-malarial drug, mefloquine.


• Drugs to treat HIV.


• Levothyroxine (used to treat hypothyroidism).


• Muscle relaxant drugs.


• Bupropion (used to help stop smoking).


• A herbal remedy called St John’s Wort or Hypericum.


• Drugs or supplements containing Vitamin B (nicotinamide).

Pregnancy and breastfeeding

You must discuss your epilepsy treatment with your doctor well before you become pregnant. If you do get pregnant you must tell the doctor straightaway. It is important that your epilepsy remains well controlled, but, as with other anti-epilepsy treatments, there is a risk of harm to the foetus. Make sure you are very clear about the risks and the benefits of being treated with Tegretol Suppositories.

Mothers being treated with Tegretol Suppositories can breastfeed their babies, but you must tell the doctor as soon as possible if you think that the baby is suffering side effects such as excessive sleepiness or skin reactions because you are being treated with Tegretol Suppositories.

Will there be any problems with driving or using machinery?

Tegretol Suppositories can make you feel dizzy or drowsy, especially at the start of treatment or when the dose is changed. If you are affected in this way, or if your eyesight is affected, you should not drive or operate machinery.

Other special warnings

• Drinking alcohol may affect you more than usual. Discuss whether you should stop drinking with your doctor.


• Eating grapefruit, or drinking grapefruit juice, may increase your chance of experiencing side effects.


• Your doctor may want you to have a number of blood tests before you are treated with Tegretol and sometimes during your treatment. This is quite usual and nothing to worry about.

How to use Tegretol Suppositories

The doctor will tell you the dose you need. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. It is important to use the suppositories at the right times. If you are not sure, ask your doctor or pharmacist. Keep using the suppositories for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Suppositories are designed to be inserted into the back passage (rectum). Never take them by mouth.

For how to insert the suppositories see the end of the leaflet.

Your doctor will work out the dose that you need. It varies from person to person.

The maximum dose is 1,000 mg per day. Elderly people might need a lower dose.

What if you forget a dose?

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, though, just take the next dose and forget about the one you missed.

Using too many suppositories

If you accidentally insert too many suppositories, or if anyone swallows any suppositories, tell your doctor or your nearest hospital casualty department. Take your pack with you so that people can see what medicine you are having.

Tegretol Suppositories Side Effects

Tegretol Suppositories do not usually cause problems, but like all medicines, they can sometimes cause side effects.

Some side effects can be serious

Stop using the suppositories and tell your doctor straight away if you notice:

• Serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, or skin peeling accompanied by fever. These reactions may be more frequent in patients of Chinese or Thai origin


• Mouth ulcers or unexplained bruising or bleeding


• Sore throat or high temperature, or both


• Yellowing of your skin or the whites of your eyes


• Swollen ankles, feet or lower legs


• Any signs of nervous illness or confusion


• Pain in your joints and muscles, a rash across the bridge of the nose and cheeks and problems with breathing (these may be the signs of a rare reaction known as lupus erythematosus)


• Fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be the signs of a multi-organ sensitivity disorder)


• Bronchospasm with wheezing and coughing, difficulty in breathing, feeling faint, rash, itching or facial swelling (these may be the signs of a severe allergic reaction)


• Pain in the area near the stomach.

The side effects listed below have also been reported.

More than 1 in 10 people have experienced:

Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections); dizziness and tiredness; feeling unsteady or finding it difficult to control movements; feeling or being sick; changes in liver enzyme levels (usually without any symptoms); skin reactions which may be severe.

Up to 1 in 10 people have experienced:

Changes in the blood including an increased tendency to bruise or bleed; fluid retention and swelling; weight increase; low sodium in the blood which might result in confusion; headache; double or blurred vision; dry mouth; rectal irritation.

Up to 1 in 100 people have reported:

Abnormal involuntary movements including tremor or tics; abnormal eye movements; diarrhoea;
constipation.

Up to 1 in 1,000 people have reported:

Disease of the lymph glands; folic acid deficiency; a generalised allergic reaction including rash, joint pain, fever, problems with the liver, kidneys and other organs; hallucinations; depression; loss of appetite; restlessness; aggression; agitation; confusion; speech disorders; numbness or tingling in the hands and feet; muscle weakness; high blood pressure (which may make you feel dizzy, with a flushed face, headache, fatigue and nervousness); low blood pressure (the symptoms of which are feeling faint, light headed, dizzy, confused, having blurred vision); changes to heart beat; stomach pain; liver problems including jaundice; symptoms of lupus.

Up to 1 in 10,000 people have reported:

Changes to the composition of the blood including anaemia; porphyria; meningitis; swelling of the breasts and discharge of milk which may occur in both male and females; abnormal thyroid function tests; osteomalacia (which may be noticed as pain on walking and bowing of the long bones in the legs); osteoporosis; increased blood fat levels; taste disturbances; conjunctivitis; glaucoma; cataracts; hearing disorders; heart and circulatory problems including deep vein thrombosis (DVT), the symptoms of which could include tenderness, pain, swelling, warmth, skin discoloration and prominent superficial veins; lung or breathing problems; severe skin reactions including Stevens-Johnson syndrome (These reactions may be more frequent in patients of Chinese or Thai origin); sore mouth or tongue; liver failure; increased sensitivity of the skin to sunlight; alterations in skin pigmentation; acne; excessive sweating; hair loss; increased hair growth on the body and face; muscle pain or spasm; sexual difficulties which may include reduced male fertility, loss of libido or impotence; kidney failure; blood spots in the urine; increased or decreased desire to pass urine or difficulty in passing urine.

Do not be alarmed by this list. Most people use Tegretol Suppositories without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Tegretol Suppositories

Tegretol Suppositories must be stored below 30ºC.

Keep out of the reach and sight of children.

Do not use the suppositories after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop using the suppositories, please take any left over back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste.

This will help to protect the environment.

Further information

The suppositories are white or off-white in colour and come in two strengths. The active ingredient is carbamazepine, and they also contain the inactive ingredients hydroxypropyl methylcellulose and suppository mass 15. The lower dose contains 125 mg of carbamazepine and the suppository weighs about 1 gram. The higher dose contains 250 mg of carbamazepine and the suppository weighs about 2 grams.

There are 5 suppositories in each pack.

The Product licence holder is

Novartis Pharmaceuticals UK Limited

trading as Geigy Pharmaceuticals

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

England

The suppositories are made by

Novartis Pharma SAS

Site Industriel de Huningue

26 Rue de la Chapelle

F-68330 Huningue

France

How to insert the suppositories

• Empty your bowels before inserting a suppository.


• Wash your hands.


• Take out the strip of suppositories and tear off one along the perforation.


• Tear the foil wrapping apart at the notch and take out the suppository.

• Lie on one side with your knees pulled up towards your chest.


• Gently push the suppository pointed end first into your back passage (rectum) with your finger. Push the suppository in as far as possible as shown in the diagram.

• Lower your legs and, if possible, stay still for a few minutes.


• If you feel as if you need to push the suppository out, try to resist this by lying still with your buttocks pressed together. It is important to keep the suppository in the rectum to allow it to melt and the medicine to be absorbed. Pushing the suppository high into the rectum with your finger will help to reduce this feeling.


• Wash your hands.

The procedure is the same for a child. Once they have emptied their bowels, get them to lie down on their front or side. Gently push the suppository into the child’s back passage until it disappears. Try and stop the child moving around for a few minutes to reduce the risk of the suppository coming out.

If a doctor or nurse is giving the suppository to an unconscious patient, the procedure will be similar to that
described above.

This leaflet was revised in November 2009.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

TEGRETOL is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited

Histade

Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion

What is Histade (chlorpheniramine and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Histade (chlorpheniramine and pseudoephedrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Histade (chlorpheniramine and pseudoephedrine)?

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Histade (chlorpheniramine and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking Histade (chlorpheniramine and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Histade (chlorpheniramine and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

What other drugs will affect Histade (chlorpheniramine and pseudoephedrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medications you use, especially:

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with chlorpheniramine and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Histade resources

• Histade Side Effects (in more detail)
• Histade Use in Pregnancy & Breastfeeding
• Drug Images
• Histade Drug Interactions
• Histade Support Group
• 11 Reviews for Histade - Add your own review/rating

Compare Histade with other medications

• Hay Fever
• Sinusitis

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and pseudoephedrine.

See also: Histade side effects (in more detail)