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CYCLOSERINE

Active substance(s): CYCLOSERINE

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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.

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

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.

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

Artwork for:
King Pharmaceuticals Limited
Product name:
Cycloserine 250mg
PL/PA no:
PL 14385/0005
Type: Leaflet
Artwork dimensions: 200mm x170mm
Profile supplied: Yes
Date of first artwork: 12 August 2015
Reason for request:
Artwork in originatior style with text revisions
Version no: 2DB
Date of revision:
12 August 2015
Colours:
As swatch(es)
Font(s):
8pt Helvetica
Artwork software:
InDesign CS6
Proof software: PDF
BAC ref: S831

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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