Clobazam 10 mg Tablets

CLOBAZAM ADCO contains the active substance clobazam. CLOBAZAM ADCO is used to treat anxiety in neurotic patients and for pre-operative medication. CLOBAZAM ADCO can also be effective in relieving acute symptoms of alcohol withdrawal syndrome.

Do not take CLOBAZAM ADCO:

• if you are hypersensitive (allergic) to clobazam or any of the other ingredients of CLOBAZAM ADCO (listed in section 6)
• if you have a history of drug or alcohol dependence
• if you suffer from an illness that causes muscle weakness (called ‘myasthenia gravis’)
• if you have breathing problems
• if you stop breathing for short periods during sleep (called ‘sleep apnoea syndrome’)
• if you have severe liver problems
• if you are in your first trimester of pregnancy or breastfeeding your baby
• if the patient is under 3 years.

Do not share medicines prescribed for you with any other person. Always take CLOBAZAM ADCO exactly as your doctor has instructed you with an adequate amount of liquid. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose. The normal adult dose ranges between 10 – 30 mg daily. Doses of 20 mg and above should preferably be given at bedtime or as divided doses. Treatment will usually start with the lowest recommended dose and the maximum dose should not be exceeded. Use in children: The daily dose should be halved for children. Elderly people: For elderly, debilitated and light-weight patients, the daily dose should be halved. The overall duration of treatment should not be more than 8 – 12 weeks, including a tapering off process. If you doctor extends treatment beyond this period, it should not take place without re-evaluation of your status. Your doctor will tell you how long your treatment with CLOBAZAM ADCO will last. Do not stop treatment early because you may experience headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. If you have the impression that the effect of CLOBAZAM ADCO is too strong or too weak, tell your doctor or pharmacist. If you take more CLOBAZAM ADCO than you should: In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre. If you forget to take a dose of CLOBAZAM ADCO: Do not take a double dose to make up for forgotten individual doses.

CLOBAZAM ADCO can have side effects. Not all side effects reported for CLOBAZAM ADCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLOBAZAM ADCO, please consult your doctor, pharmacist or other healthcare provider for advice. If any of the following happens, stop taking CLOBAZAM ADCO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting (dizziness).

These are all very serious side effects. If you have them, you may have had a serious reaction to CLOBAZAM ADCO. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• respiratory depression (a breathing disorder characterized by slow and ineffective breathing),
• respiratory failure particularly in patients with pre-existing compromised respiratory function e.g., in patients with bronchial asthma or brain damage,
• photosensitivity reaction (an immune system reaction that is triggered by sunlight causing itchy patches or redness),
• urticaria (also known as hives, is an outbreak of swollen, pale red bumps or plaques (wheals) on the skin that appear suddenly),
• Stevens-Johnson syndrome (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters),
• toxic epidermal necrolysis (symptoms include a painful, red area that spreads quickly, the skin may peel without blistering and fever),
• hypothermia (when your body loses heat faster than it can produce heat).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent side effects
• decreased appetite,
• irritability,
• aggression,
• restlessness,
• Depression (pre-existing depression may be unmasked)
• medicine tolerance (when your body adapts to the continued presence of the medicine and doesn’t respond to the medicine as well anymore),
• agitation (a state of anxiety or nervous excitement),
• somnolence (a strong desire to sleep and a feeling of drowsiness),
• sedation,
• dizziness,
• disturbance in attention,
• slow speech/dysarthria (slurred speech)/speech disorder,
• headache,
• tremor,
• ataxia (impaired balance or coordination),
• dry mouth,
• nausea,
• constipation,
• fatigue, especially at the beginning of treatment.

Less frequent side effects

• abnormal behaviour,
• confessional state (confused thinking and reduced awareness of surroundings),
• anxiety (intense and persistent worry and fear about everyday),
• delusion (believing things that isn’t true),
• nightmare,
• loss of libido (sexual drive),
• emotional poverty,
• amnesia (memory loss that may be associated with abnormal behaviour),
• memory impairment (changes in your memory),
• anterograde amnesia (loss of the ability to recall the recent past but long-term memories are still intact),
• depression of mood and affect
• lethargy
• increased motor activity
• decreased motor activity
• paradoxical reactions (inconsistent or contradictory) such as an excess
• excitability with rage
• diplopia (double vision),
• rash
• weight increase,
• increased possibility of tripping or falling, especially in elderly patients.

Unknown frequency

• dependence (becoming dependent of CLOBAZAM ADCO),
• initial insomnia (problem falling asleep and staying asleep),
• anger,
• hallucination (seeing things that isn’t real),
• psychotic disorder (a mental disorder characterised by a disconnection from reality),
• poor sleep quality,
• suicidal ideation (to think or plan suicide),
• cognitive disorder (disorders that affect cognitive abilities including learning, memory, perception and problem solving),
• altered state of consciousness (particularly in elderly patients, may be combined with respiratory disorders),
• nystagmus (involuntary movement of the eye causing the eye to rapidly move from side to side),
• gait disturbance (change in the way you walk),
• muscle spasms,
• muscle weakness,
• slow response to stimuli (slow reaction time).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get 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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of CLOBAZAM ADCO.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Store in the original container. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).