Patient leaflet - Clobazam Zydus 10 mg tablets
1. What Clobazam is and what it is used for
This medicine has been prescribed for you for:
- Severe anxiety over a short time
- Epilepsy (fits) over a longer time
- Mental illness such as schizophrenia (in combination with other treatments)
It contains Clobazam which belongs to a class of medicines called benzodiazepines.
This medicine has been <prescribed> to you and should not be given to anyone else.
Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
2. What you need to know before you use Clobazam
Do not take Clobazam if:
- You are allergic (hypersensitive) to clobazam, other benzodiazepine medicines or any of the other ingredients of Clobazam (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, breastfeeding 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.
- You are taking any medicinal or nonmedicinal products containing cannabidiol, as it may increase the side effects of clobazam.
- You are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
- You have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
- You feel you need to take more of to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:
- Benzodiazepines: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body). Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
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.
Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice (see section 4).
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 stomach conditions.
- Ticlopidine – an antiplatelet medication used to prevent blood clots.
- Fluconazole – used in the treatment of fungal conditions.
- Dextromethorphan – used to relieve dry, irritating coughs.
- Nebivolol – used to treat high blood pressure.
- Cannabidiol-containing products (medicinal or non-medicinal products).
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 contains lactose
If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
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. Your prescriber should have discussed with you how long the course of will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Taking this medicine
Swallow the tablets whole or crushed and mixed with apple sauce.
For 10 mg tablets: The tablets can be divided into equal halves of 5mg.
For 20 mg tablets: The score lines on the 20 mg tablets are only there to help you break the tablet if you have difficulty swallowing it whole.
Clobazam 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 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. Adults
- 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.
If you forget to take 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.
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Withdrawal symptoms such as:
- Benzodiazepines: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
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 side effects (may affect up to 1 in 10 people):
- Feeling irritable or restless
Uncommon side effects (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 side effects (may affect more than 1 in 10 people):
- Difficulty in staying awake or alert
Common side effects (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 side effects (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):
- Dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
- Becoming dependent on Clobazam (‘physical or mental dependence’) (especially in long term use)
- A feeling 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
The following side effects are more likely to happen at the start of treatment. They usually last for a short time: feeling tired, dry mouth, constipation, loss of appetite, feeling sick, shaking fingers.
If you take this medicine for a long time, you are more likely to get the following side effects: anxiety, confusion, depression, loss of appetite and difficulty sleeping.
Drug Withdrawal
When you stop taking Clobazam, you may experience drug withdrawal symptoms, which include:
- Benzodiazepines: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Clobazam, it could be a sign that you have become addicted.
- You may feel the need to keep taking the medication for longer than your doctor recommended
- You feel you need to use more than the recommended dose - You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again If you notice any of these signs, it is important you talk to your prescriber.
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 Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Clobazam
Keep out of the sight and reach of children. Do not use Clobazam after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Clobazam Zydus contains
- Each 10 mg tablet contains 10 mg clobazam as active ingredient.
- Each 20 mg tablet contains 20 mg clobazam as active ingredient.
They also contain the following ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Maize starch B, Starch 1500
Partially Pregelatinized maize starch, Colloidal Anhydrous Silica, Magnesium Stearate.
What Clobazam Zydus tablets looks like and contents of the pack
10 mg: The tablets are white to off white round tablets with break line and debossed with 'C' & '1' on one side and plain on other side. Clobazam is presented in a blister pack of 30 tablets.
20 mg: The tablets are white to off white oblong tablets with three break line on each side and debossed with ‘C’, ‘L’, ‘2’, ‘0’ on one side. Clobazam is presented in a blister pack of 30 tablets.
Marketing Authorisation Holder and Manufacturer
Zydus Pharmaceuticals UK Ltd
Sandretto Building Weedon
Northampton NN7 4PP UK
This leaflet was last revised in Mar-2026.
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 0800 9956034 / email: DrugSafety@ZydusUK.com
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