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Active Ingredient: Clobazam

How does it work?

Clobazam belongs to a group of medicines called benzodiazepines.

The brain and nerves are made up of many nerve cells that communicate with each other through electrical signals. These signals must be carefully regulated for the brain and nerves to function properly.

When abnormally rapid and repetitive electrical signals are released in the brain, it becomes over-stimulated and normal function is disturbed. This results in fits or seizures. Anxiety may also be related to the inappropriate stimulation of nerves in the brain.

GABA is a chemical that, when released in the brain, acts as a natural calming agent and keep the nerve activity in balance. Once the brain absorbs the GABA (uptake), this chemical can no longer act on the nerves. Too little GABA, the brain may become overexcited.

Clobazam acts on receptors in the brain (GABA receptors) to increase the release of GABA. This increases the calming effects of nerve cells by GABA. By calming nerve cells, clobazam prevents excessively rapid and repetitive firing of electrical signals. Thereby electrical nerve activity in the brain is stabilised, leading to prevention and treatment of fits and maintenance of normal brain function.

As clobazam prevents fitting, it may be used (in conjunction with another anti-epileptic medicine) for the treatment of epilepsy.

Clobazam may also be used to relieve anxiety in serious or disabling anxiety related conditions. It is not recommended for the long-term treatment of anxiety due to the development of dependence (recommended maximum of 4 weeks).

What is it used for?

• Epilepsy
• Short term treatment of severe anxiety

Warning!

• This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• You should not suddenly stop taking this medicine unless your doctor tells you otherwise.

Use with caution in

• Abnormal muscle weakness (myasthenia gravis)
• Elderly people
• Kidney disease
• Liver disease
• Personality disorders
• Severe or sudden decrease in lung function (severe or acute pulmonary insufficiency)
• Shaky or unsteady voluntary movements e.g walking (cerebellar ataxia)
• Syndrome involving short spells when breathing stops during sleep (sleep apnoea syndrome)

Not to be used in

• Allergy to any medicine in the benzodiazepine family
• Children under three years of age
• Long-term psychotic illness
• Phobias or obsessional states
• Single medicine to treat depression or anxiety related to depression

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should not be used during pregnancy or breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Dry mouth
• Drowsiness
• Shaking, usually of the hands (tremor)
• Addiction to the medicine (dependence)
• Muscle weakness
• Restlessness
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
• Decreased appetite
• Dizziness

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Clobazam blood levels may be increased by cimetidine.

Clobazam may alter the blood levels of some other anti-epileptic medicines such as phenytoin and sodium valproate. Clobazam blood levels may be altered by other antiepileptic medicines such as carbamazepine, phenobarbital and phenytoin.

There may be an increase in side effects such as sedation and dizziness when clobazam is taken with:

• Alcohol
• Antipsychotic medicines such as clozapine
• Pain-relieving medicines such as morphine
• and sedating medicines such as other benzodiazepines.

Clobazam may increase the effect of:

• Muscle relaxants such as baclofen
• and pain relieving medicines such as morphine.