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CLOBAZAM AUDEN 10MG TABLETS

Active substance(s): CLOBAZAM

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6. Storing Clobazam 10 mg Tablets
Keep the pack in a safe place, where children cannot reach or see it.
You should not take Clobazam 10 mg Tablets after the date (month and year) printed after “EXP”
on the box. If the expiry date has passed, take the tablets back to your pharmacist for safe disposal.
7. What is in Clobazam 10 mg Tablets?
The tablets are whitish and round marked with a score line on one side and ‘CB 10’ on the other.
Active substance:
Each tablet contains 10 mg of clobazam.
Other ingredients:
Lactose monohydrate
Cellulose microcrystalline
Sodium starch glycolate
Talc
Magnesium stearate.

8. Addresses
Marketing Authorisation holder
Auden Mckenzie (Pharma Division) Ltd
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK

Read this leaflet carefully before you start taking this medicine.
Keep this leaflet; you may want to read it again later.
If you have any questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you.
It should not be given to anyone else.
It may harm them, even if their symptoms are similar to 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.

1. Why do you need to use this medicine?
Clobazam is used, for short periods, to treat severe anxiety. It may also be used for longer periods
as part of a treatment for epilepsy. It may also be used for mental illness such as schizophrenia
(in combination with other treatments).
2. How does this medicine work?
Clobazam belongs to a group of medicines called ‘benzodiazepines’.
It acts by calming excitable nerve cells in the brain.

Manufacturer
TioFarma BV.
Benjamin Franklinstraat 9
3261 LW
Oud-Beijerland
The Netherlands
This leaflet was last revised in August 2014.

For information in large print, on tape, on CD or in Braille,
phone 01895 627 420.

A1000135_3 V1 Clobazam 10mg PIL.indd 1

Clobazam Auden 10mg Tablets

In this leaflet:
1 Why do you need to use this medicine?
2 How does this medicine work?
3 Before you take Clobazam 10 mg Tablets
4 How to take Clobazam 10 mg Tablets
5 Possible side effects
6 How to store Clobazam 10 mg Tablets
7 What is in Clobazam 10 mg Tablets
8 Addresses

Each pack of Clobazam 10 mg Tablets contains 30 tablets.

A1000135/3

PATIENT INFORMATION LEAFLET

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3. Before you take Clobazam 10 mg Tablets
Do not take Clobazam 10 mg Tablets:
- if you are allegic (hypersensitive) to clobazam or any other ingredients in the tablet. An allergic
reaction may include a rash, itching, difficulty in breathing or swelling of the face, lips throat or tongue
- if you have very severe form of muscle weakness namely myasthenia gravis
- if you have trouble breathing, including when you are asleep
- if your liver does not function at all well
- during the first 13 weeks of pregnancy and if you are breast feeding
- if administering to children aged between 6 months to 3 years
If any of the following apply to your, tell you doctor or nurse before taking the tablets:
- if you are, may be or planning to become pregnant
- if you have a kidney or liver condition
- if you experience muscle weakness
- if a doctor has described you as suffering the problem of ‘inappropriate behaviour’, depression,
loss of memory or chronic psychosis
- if you are over 65. This is due to the increased sensitivity to adverse reactions in the elderly such as
drowsiness, dizziness and muscle weakness. There is also an increased risk of fall that may result in
serious injury.
- if you have difficulty digesting medicines. Some patients liver may not metabolise (break down)
medicines adequately. In these patients the medicine may remain in the body for a longer period of
time. This may result in side effects. If you are known to poorly metabolise certain medicines please
speak to your doctor.
- if you have ever become dependent upon another drug or alcohol. Alcohol should not be taken
during treatment with Clobazam as there is an increased risk of experiencing side effects. Page 1 of 4

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Taking other medicines
Always tell your doctor if you are taking any other medicines because taking some
medicines together can be harmful. This includes medicines, vitamins and herbal
preparations you have bought yourself.

Children aged six years and over should be started at 5mg daily and a usual maintenance dose
of 0.3 mg to 1 mg/kg body weight daily.
There has not been enough use of Clobazam in children under six years to be able to suggest a
suitable dose. The tablets should be swallowed whole with water; do not chew them.

You are likely to feel sleepy if clobazam is taken with:
• Antipsychotics such as pimozide, (used to change behaviour and moods)
• Sedatives
• Some antidepressants (such as paroxetine)
• Strong pain killers (such as narcotic analgesics)
• Anti-epileptic medicines (such as phenytoin, carbamazepine, stiripentol and its active metabolite
N-desmethylclobazam or valproic acid)
• Anaesthetics
• Sedating antihistamines
• Alcohol
• Omeprazole - used to treat the symptoms of acid reflux such as heartburn or acid regurgitation.
• Ticlopidine - an antiplatelet medication used in patients with an increased risk of stroke
• Fluconazole - used in the treatment of fungal conditions
• Dextromethorphan - used to relieve dry, irritating coughs
• Nebivolol - medicine used to treat high blood pressure.

If you forget a dose:
Take one as soon as you remember unless it is nearly time for the next dose.
Never take an extra dose to make up for the one missed.
If you take too many tablets:
Tell your doctor immediately or go to your nearest hospital casualty department.
Do not drive yourself, because you may start to feel sleepy.
Unless you are being treated long-term for epilepsy, your doctor will only prescribe these tablets for a
short time (2–4 weeks). Even short-term treatment may produce dependency. To stop treatment you will
be told to reduce gradually the number of tablets you take each day. In some people, stopping the tablets
produces sleeplessness, anxiety, loss of appetite and weight, tremor (the shakes), perspiration, ringing in
the ears and disturbances of perception. Tell your doctor if this happens.
Consult your doctor or the pharmacist for any clarification on the use of this product.

If you are to be given anaesthesia with nitrous oxide, tell the anaesthetist that you are using Clobazam.

Dependency on clobazam can occur, and stopping treatment may give you withdrawal symptoms
(recurrence of the initial symptoms which led to clobazam treatment, which may be accompanied
by mood changes, anxiety or sleep disturbances and restlessness)

Lithium - used for a mental illness called ‘manic-depressive illness’ (mood changes between a state of
high excitability or exaggerated emotions and depression).

5. Possible side effects
Like all medicines, Clobazam 10 mg Tablets can cause side effects, although not everybody gets them.

Cimetidine (a medicine used to treat stomach problems) may enhance Clobazam activity.

Talk to your doctor straight away if the following occur as it may mean your treatment needs to change:
• Restlessness, irritability, difficult in sleeping, anxiety, delusions, nightmares, hallucinations, suicidal
thoughts.
• Increased possibility of tripping or falling especially in elderly patients.
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like
symptoms and fever. This may be something called ‘Stevens Johnson Syndrome’ which is a severe
blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over
the body. Also a feeling of being generally unwell, fever, chills and aching muscles.
This is something called ‘Toxic epidermal necrolysis’.

Using Clobazam with other antiepileptic medicines may change the amount of medicine needed to
treat your epilepsy. Use of two or more antiepileptics may lead to increased side effects without a
corresponding decrease in convulsions (fits).
Pregnancy and breast-feeding
Taking clobazam in pregnancy should be avoided if possible.
Tell your doctor if you are pregnant or plan to become pregnant as your prescription may be
changed to something more suitable; although withdrawal from clobazam should always be gradual.
Where you need to take clobazam in late pregnancy in order to control epileptic seizures, your baby
may show some withdrawal symptoms after birth such as low temperature, floppy baby syndrome
(lack of muscle tone and breathing difficulties).
Do not breast feed while using clobazam. In this case the newborn should be closely monitored during
the postnatal period.
Driving and using machines
If you feel sleepy after taking this medicine, do not drive or use dangerous machinery.
If you have been on clobazam for epilepsy, it is wise not to drive during withdrawal of medication
and the following six months.
Do not drink alcohol.
Important information about one of the ingredients of Clobazam 10 mg Tablets
Clobazam 10 mg Tablets contain lactose. If you have been told by your doctor that you have an
intolerance to lactose or some other sugars, contact your doctor before taking this product.
4. How to take Clobazam 10 mg Tablets
Your doctor will tell you when and how to take your medicine. The usual starting dose for the treatment
of anxiety or epilepsy is 20 mg to 30 mg daily in divided doses but sometimes as a single dose at night.
Your doctor may increase the dose (up to a maximum of 60 mg daily) or decrease the dose to suit you.
In the elderly and those with kidney or liver disease, lower doses (10 mg to 20 mg daily) are used.

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The following side effects are more likely to occur at the beginning of treatment and often disappear
with continued treatment or a reduction in dose:
• Sleepiness, fatigue and sedation.
• Dizziness, dry mouth, constipation, loss of appetite, nausea, fine tremor of the fingers.
Other side effects include:
• Amnesia (loss of memory) may occur at higher doses.
• Difficulty in breathing, especially in patients with asthma.
• Skin reactions such as rash.
• Headache, confusion, muscle jerks, muscle weakness, Problems walking or other movement
problems and slower reaction times.
• Unsteadiness on your feet, double vision, difficulty in speaking, weight gain, loss of sex drive
– especially at high doses or in long term treatment.
• Rare cases of muscle weakness and restlessness have been reported when clobazam is used to
treat epilepsy.
• Being aggressive.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

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08/08/2014 11:47

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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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