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Cycloserine

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PACKAGE LEAFLET: INFORMATION FOR THE USER


CYCLOSERINE

250mg capsules


Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are 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 Cycloserine capsules are and what they are used for

2.    Before you take Cycloserine capsules

3.    How to take Cycloserine capsules

4.    Possible side effects

5.    How to store Cycloserine capsules

6.    Further information


1. WHAT CYCLOSERINE CAPSULES ARE AND WHAT THEY ARE USED FOR

Cycloserine capsules contain the active ingredient cycloserine, which is an antibiotic.

Cycloserine is used to treat tuberculosis (TB) together with other medicines. It is also used to treat infections of the urinary tract.


medicines obtained without a prescription. In particular, talk to your doctor if you are taking any of the following medicines:

   Ethionamide, isoniazid (for tuberculosis [TB])

   Alcohol.

It may still be all right for you to be given Cycloserine capsules and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

If you are pregnant, think you might be pregnant, planning to become pregnant or breast-feeding you should not take Cycloserine capsules unless your doctor tells you to. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Cycloserine capsules have no effect on your ability to drive or use machines.


2. BEFORE YOU TAKE CYCLOSERINE CAPSULES

Do not take Cycloserine capsules if

•    You are allergic (hypersensitive) to

cycloserine or any of the other ingredients of Cycloserine capsules (see list of ingredients in Section 6).

An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    You have epilepsy

•    You suffer from depression

•    You have severe anxiety or psychosis (abnormal thoughts)

•    You have a severe kidney disease

•    You are an alcoholic.

Take special care with Cycloserine capsules if

•    You suffer from porphyria (a disorder affecting the red blood cells).

If you suffer from porphyria, tell your doctor. Taking other medicines You should tell your doctor if you are taking or have taken any medicines, including


3. HOW TO TAKE CYCLOSERINE CAPSULES

Always take Cycloserine capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose: is 500mg to 1g daily in divided doses.

Adults: the usual starting dose for adults is 250mg every twelve hours for the first two weeks.

The maximum daily dose is 1g.

Children: the usual starting dose for children is 10mg per kg of body weight per day and then adjusted depending on the response.

Elderly: elderly patients with kidney disease will need a reduced dose.

The capsules should be swallowed whole with water.



If you take more Cycloserine capsules than you should:

Go to the nearest casualty department or contact your doctor immediately. Take the tablet carton with you.

If you forget to take Cycloserine capsules:

If you miss a dose, take one as soon as you can. However, do not take a double dose to make up for a forgotten dose. If you have missed several doses, tell your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.


5. HOW TO STORE CYCLOSERINE CAPSULES

Keep out of the sight and reach of children. Store below 25°C and protect from moisture. Do not use the drug after the date indicated on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help protect the environment.


4. POSSIBLE SIDE EFFECTS

Like all medicines, Cycloserine capsules can cause side effects, although not everybody gets them.

Very serious side effects

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

In patients receiving higher doses of Cycloserine the following have been reported:

•    sudden shortness of breath (heart failure) - in patients receiving 4-6 capsules of cycloserine daily (1.0 -1.5g daily).

•    coma

•    severe headaches

•    feeling drowsy or very sleepy

•    shaking

•    dizziness

•    confusion

•    loss of memory

•    slurred speech

•    fits

•    pins and needles in your hands and/or feet

•    loss of use of your arms or legs

•    character and mood changes including feeling irritable and aggressive.

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

6. FURTHER INFORMATION

What Cycloserine capsules contain:

Each capsule contains 250mg of the active substance cycloserine.

The other ingredients are: Talc, Carmoisine (E122), Erythrosin (E127), Sunset Yellow FCF (El 10), Titanium Dioxide (E171), Black Iron Oxide (E172) and Gelatin.

What Cycloserine capsules looks like and contents of the pack

Cycloserine capsules are red and grey and come in plastic bottles containing 100 capsules.

Marketing Authorisation Holder

King Pharmaceuticals Ltd Donegal Street Ballybofey County Donegal.

Manufacturer

The product is manufactured by Dales Pharmaceuticals Ltd Snaygill Industrial Estate Keighley Road Skipton

North Yorkshire England.

This leaflet was last revised in

November 2007



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