Clobazam Celix 10 mg Tablets

• 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 tablets are and what are they used for
2. What you need to know before you take clobazam tablets
3. How to take clobazam tablets
4. Possible side effects
5. How to store clobazam tablets
6. Contents of the pack and other information

• you are allergic (hypersensitive) 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 ‘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 tablets.

Talk to your doctor or pharmacist before taking clobazam tablets 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 clobazam tablets 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:

• 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 tablets is taken together with opioids (such as codeine, dihydrocodeine or morphine) and should only be used together, 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 thoughts of suicide, 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 tablets.

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 tablets can affect the way some other medicines work. Also, some medicines can affect the way clobazam tablets 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).
• opioid painkillers (such as medicines containing codeine, dihydrocodeine or morphine). Use of clobazam tablets and opioids increases the risk of drowsiness, difficulties breathing, coma and death. Follow your doctor’s dosage recommendations closely.
• 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).

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

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

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

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 tablets 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 last six months of pregnancy.

If clobazam tablets 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 tablets if you are breast-feeding or are planning to breast-feed. This is because it may pass into the mothers’ milk.

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.

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

Swallow the tablets whole with water, with or without food. The tablets can also be crushed and mixed with apple sauce. The 10 mg tablets can be divided into equal halves. The score lines on the 20 mg tablets are only there to help you break the tablet if you have difficulty swallowing it whole.

• 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 tablets is usually given for 2-4 weeks. After that, your doctor will decide whether you should keep taking this medicine.

Your prescriber should have discussed with you how long the course of tablets 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.

Adults

• The usual dose is 20-30 mg 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 60 mg each day.
• Your doctor may lower the dose to suit you.

Children (6 years and above)

• The usual dose is 5 mg each day.

Elderly

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

If you take more clobazam tablets 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 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.

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:

• 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).

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.

Frequency not known (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.

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 on clobazam (see section “How do I know if I am tolerant or addicted?”)
• 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

Drug Withdrawal

When you stop taking clobazam tablets, you may experience drug withdrawal symptoms, which include:

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 tablets, 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.

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.

If you get any side effects, talk to your doctor or pharmacist. 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 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.

• The active substance is clobazam.
  Clobazam Celix 10 mg Tablets: Each tablet contains 10 mg of clobazam as the active ingredient.
  Clobazam Celix 20 mg Tablets: Each tablet contains 20 mg of clobazam as the active ingredient.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, pregelatinized starch, colloidal anhydrous silica, and magnesium stearate.

Clobazam Celix 10 mg Tablets are “white to off white round tablets with break line and debossed with ‘C’ & ‘1’ on one side and plain on other side”. The tablets are 7.0 mm in diameter.

Clobazam Celix 10 mg Tablets are presented in a blister pack (aluminium-PVC) of 30 tablets.

Clobazam Celix 20 mg Tablets are “white to off white oblong tablets with three break lines on each side and debossed with ‘C’, ‘L’, ‘2’, ‘0’ on one side”. The tablets are 14.5 mm in length and 5.0 mm in breadth.

Clobazam Celix 20 mg Tablets are presented in a blister pack (aluminium-PVC) of 30 tablets.

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