Package leaflet: Information for the user

Cycloserine 250mg capsules

cycloserine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Cycloserine capsules are and what they are used for

2. What you need to know before you take Cycloserine capsules

3.    How to take Cycloserine capsules

4. Possible side effects

5. How to store Cycloserine capsules

6. Contents of the pack and other 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.

2. What you need to know before

you take Cycloserine capsules

Do not take Cycloserine capsules:

-    If you are allergic to cycloserine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

-    If you have epilepsy

-    If you suffer from depression

-    If you have severe anxiety or psychosis (abnormally thoughts)

-    If you have a severe kidney disease

-    If you are an alcoholic

Warnings and precautions

Talk to your doctor or pharmacist before

taking Cycloserine capsules

-    If you suffer from porphyria (a disorder affecting the red blood cells)

If you suffer from porphyria, tell your doctor.

Other medicines and Cycloserine capsules

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

In particular, talk to your doctor if you are taking any of the following medicines:

- Ethioamide, isoniazid (for tuberculosis [TB]) 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. Cycloserine capsules with alcohol Alcohol should be avoided whilst taking this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Cycloserine capsules contain sunset yellow (E110) and carmoisine (E122) Sunset yellow (E110) and carmoisine (E122) may cause allergic reactions.

3. How to take Cycloserine capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended 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.

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

Use in children

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

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. 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 medicine, ask your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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

5. How to store Cycloserine capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.

Store below 25°C. Keep the bottle tightly closed in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and

other information

What Cycloserine capsules contain

Each hard capsule contains 250mg of the active substance cycloserine.

The other ingredients are: Talc, Carmoisine (E122) (see section 2), Erythrosin (E127), Sunset Yellow FCF (E110) (see section 2), Titanium Dioxide (E171), Black Iron Oxide (E172) and Gelatin.

What Cycloserine capsules look 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, Ireland

Manufacturer

Dales Pharmaceuticals Ltd Snaygill Industrial Estate Keighley Road, Skipton North Yorkshire, BD23 2RW, UK

This leaflet was last revised in August 2015