CLOBAZAM 10 MG TABLETS - patient leaflet, side effects, dosage

Clobazam 10 mg Tablets

clobazam

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.

• 1. What Clobazam is and what it is used for

• 2. What you need to know before you take Clobazam

• 3. How to take Clobazam

• 4. Possible side effects

• 5. How to store Clobazam

• 6. Contents of the pack and other information

  
  

1. what clobazam is and what it is used for

Clobazam tablet contains a medicine called clobazam. This belongs to a group of medicines called benzodiazepines. It works by having a calming effect on the brain.

Clobazam can be used for:

• Severe anxiety over a short time
• Epilepsy (fits) over a longer time
• Mental illness such as schizophrenia (in combination with other treatments)

2. what you need to know before you take clobazam

Do not take Clobazam

• You are allergic to clobazam, other benzodiazepine medicines or any of the other ingredients of Clobazam tablets (see section 6).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

• You are pregnant or are planning to have a baby (see below under ‚Pregnancy, breast-feeding and fertility‘ for more information).
• You are breast-feeding.
• You have ever had problems with drugs or alcohol dependence in the past.
• You suffer from an illness that causes muscle weakness (called ‚myasthenia gravis‘).
• You have liver problems.
• You have breathing problems.
• You stop breathing for short periods during sleep (called ‚sleep apnoea syndrome‘).
• The patient is under 6 years old.

Do not take if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Clobazam.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clobazam if:

• You have problems with controlling your movements (called ‚spinal or cerebellar ataxia‘).
• You have depression, irrational fears and obsessions.
• You have delusions (believing things which are not true) or hallucinations (sensing things which are not there).
• You have kidney problems.
• 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.
• 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.
• You have difficulty digesting medicines. Some patients' livers 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.

Drowsiness, difficulties breathing, coma and death may occur if Clobazam is taken together with opioids. Clobazam and opioids should only be used concomitantly, when other treatment options are inadequate. Please tell your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendations closely.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clobazam.

Other medicines and Clobazam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Clobazam can affect the way some other medicines work. Also some medicines can affect the way Clobazam works.

In particular, tell your doctor if you are taking any of the following:

• Medicines for epilepsy (such as phenytoin, carbamazepine, stiripentol or valproic acid).
• Medicines for depression (such as Monoamine Oxidase Inhibitors (MAOIs) or tricyclic anti-depressants such as trazodone, or Selective Serotonin Re-uptake Inhibitors (SSRIs) such as fluvoxamine or paroxetine).
• Medicines for severe mental illness called ‚antipsychotics‘ (such as chlorpromazine, haloperidol, clozapine and pimozide).
• Painkillers (such as medicines containing codeine, dihydrocodeine or morphine).
• Sleeping tablets (such as zolpidem).
• Tranquilisers (such as diazepam, temazepam or lorazepam).
• Muscle relaxants (such as baclofen).
• Antihistamines that make you sleepy (such as chlorphenamine, promethazine or diphenenhydramine).
• Lithium – used for a mental illness called ‚manic-depressive illness‘ (mood changes between a state of high excitability or exaggerated emotions and depression).
• Cimetidine – used to treat ulcers and heartburn.
• 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 – used to treat high blood pressure

Concomitant use of Clobazam and opioids increases the risk of drowsiness, difficulties breathing, coma and death. Follow your doctor's dosage recommendations closely.

If you are not sure if any of the above apply to you talk to your doctor or pharmacist.

Anaesthetics

If you are going to have an anaesthetic, tell your doctor or anaesthetist you are taking Clobazam. This is because your doctor may need to change the amount of anaesthetic or muscle relaxants to give you.

Clobazam with alcohol

Do not drink alcohol while taking Clobazam. This is because there is increased risk of sleepiness and other side effects.

Pregnancy, breast-feeding and fertility

Use of this medicine is not recommended during pregnancy and in women of childbearing potential not using contraception.

If you discover that you are pregnant or are planning to have a baby, consult your doctor right away to reassess the need for treatment. Do not stop taking Clobazam without talking to your doctor.

A large amount of data has not shown evidence for malformations associated with the use of benzodiazepines. However, some studies have shown a potentially increased risk of cleft lip and palate in newborn babies compared to that in the general population.

Cleft lip and palate (sometimes called ‚harelip‘) is a deformation at birth caused by incomplete fusion of the palate and upper lip. Reduced fetal movement and fetal heart rate variability may occur after taking clobazam during the second and/or third trimester of pregnancy.

If Clobazam is taken at the end of pregnancy or during childbirth, your baby may show drowsiness (sedation), muscle weakness (hypotonia or floppy infant syndrome), a drop in body temperature (hypothermia), difficulty feeding (problems suckling causing poor weight gain) and breathing problems (respiratory depression, sometimes severe).

If taken regularly in late pregnancy, your baby may get withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.

Do not take Clobazam if you are breast-feeding or are planning to breast-feed. This is because it may pass into the mothers' milk

Driving and using machines

You may feel sleepy or have concentration or memory problems after taking this medicine.

You may also experience double vision or you may react more slowly to things. If this happens, do not drive or use any tools or machines.

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.

Clobazam tablets contains lactose

If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicinal product.

3. how to take clobazam

Always take Clobazam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

Swallow the tablets whole, or crushed and mixed with apple sauce. Clobazam tablets can be divided into equal doses and it can be taken with or without food.

• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
• Keep taking Clobazam tablets until your doctor tells you to stop.
• Clobazam is usually given for 2–4 weeks. After that, your doctor will decide whether you should keep taking this medicine.
• The usual dose is 20–30mg each day. This can be taken as two separate doses or as a single dose at night.
• Your doctor may increase your dose to up to 60mg each day.
• Your doctor may lower the dose to suit you.

Children (6 years and above)

• The usual dose is 5mg each day.

Elderly

• The usual dose for anxiety is 10–20mg each day.

If you take more Clobazam than you should

If you take more Clobazam than you should, tell your doctor or go to your nearest hospital casualty department straight away. Do not drive yourself, because you may start to feel sleepy. Remember to take with you any tablets that are left and the pack. This is so the doctor knows what you have taken.

110 mm

If you forget to take the Clobazam

• If you forget a dose, take it as soon as you remember it.
• However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clobazam

Keep taking this medicine until your doctor tells you to stop. Do not stop taking Clobazam just because you feel better.

• When your doctor says that you can stop taking Clobazam, you need to do this gradually.

Your doctor will help you to do this.

• Stopping the tablets can make you feel stressed (anxiety), confused or depressed. You may also lose your appetite and have difficulty sleeping. Tell your doctor if this happens.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

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

You may feel ill after taking the tablets, or notice unusual or unexpected symptoms. If this happens, tell your doctor.

Tell your doctor straight away if you have any of the following side effects:

Common (may affect up to 1 in 10 people):

• Feeling irritable or restless.

Uncommon (may affect up to 1 in 100 people):

• Poor memory while taking Clobazam (amnesia) or showing unusual behaviour.
• Nightmares.
• Feeling anxious.
• Believing things which are not true (delusions).
• Increased possibility of tripping or falling, especially in elderly patients.

Not known (frequency cannot be estimated from available data):

• Sleeping problems that get worse after taking this medicine.
• Sensing things which are not there (hallucinations).
• Being less aware of your environment, especially in the elderly.
• Feeling suicidal.
• 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‘.
• 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‘.

If you get any of the above side effects, your doctor may decide that your treatment needs to be stopped. These side-effects are more likely to happen in elderly people and children.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

Very common (may affect more than 1 in 10 people):

• Difficulty in staying awake or alert.

Common (may affect up to 1 in 10 people):

• Feeling sleepy or dizzy.
• Feeling agitated or being aggressive.
• Depression.
• Headache.
• Short attention span.
• Difficulty in speaking.
• Shaking fingers (tremor).
• Problems with walking or other movement problems.
• Clobazam having less effect than normal (especially in long term use).
• Dry mouth, constipation.
• Loss of appetite, feeling sick (nausea).

Uncommon (may affect up to 1 in 100 people):

• Loss of sexual drive.
• Memory difficulties, confusion.
• Double vision.
• Skin rash.
• Weight gain.

Not known (frequency cannot be estimated from available data):

• Becoming dependent on Clobazam (‚physical or mental dependence‘) (especially in long term use).
• Afeeling of being out of touch with reality and being unable to think or judge clearly (psychosis).
• Feeling angry.
• Changes in the way you walk.
• Breathing problems.
• Sensitivity to sunlight.
• Itchy, lumpy rash (urticaria).
• Muscle spasms or muscle weakness.
• Reacting to things more slowly than usual.
• Rapid uncontrollable movement of the eyes.
• Learning problems.
• Abnormally low body temperature.

What clobazam tablets look like and contents of the pack

Clobazam 10 mg tablets:

White to off-white, oval shaped tablets with a functional score line on one face and “1” and “0” debossed on the other face.

The tablet can be divided into equal doses.

Clobazam 20 mg tablets:

White to off-white, oval shaped tablets with a functional score line on one face and “2” and “0” debossed on the other face.

The tablet can be divided into equal doses.

Clobazam tablets are available in blister packs.

Pack sizes: 10, 20,28,30,50 and 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Brown & Burk UK Ltd

5 Marryat Close, Hounslow West, Middlesex TW4 5DQ United Kingdom

Manufacturer

Brown & Burk UK Ltd

5 Marryat Close Hounslow West

Middlesex TW4 5DQ

United Kingdom

This leaflet was last revised in 10/2020.

5. How to store Clobazam

Size: 260(L) x 360(W) mm

Back Side