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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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.

Each pack of Clobazam 10 mg Tablets contains 30 tablets.

8.    Addresses

Marketing Authorisation holder

Auden Mckenzie (Pharma Division) Ltd

Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK

Manufacturer

TioFarma BV., Benjamin Franklinstraat 9, 3261 LW, Oud-Beijerland, The Netherlands This leaflet was last revised in January 2016.

For information in large print, on tape, on CD or in Braille, phone 01271 385 257.

O

Auden Mckenzie

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

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.

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. _Pagei of 4

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.

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

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

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

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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

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.

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.

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.

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)

5.    Possible side effects

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

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’.

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.

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