CLOBAZAM WOCKHARDT

4). Treatment should be given for the shortest possible duration. If this medicine is being used for the treatment of epilepsy this medicine should be used for as long as the prescriber considers it necessary. Treatment of anxiety The usual anxiolytic dose for adults is 20-30 mg daily in divided doses or as a single dose given at night.

Doses up to 60mg daily have been used in the treatment of adult in-patients with severe anxiety. The lowest dose that can control symptoms should be used. After improvement of the symptoms, the dose may be reduced. It should not be used for longer than 4 weeks.

Long term chronic use as an anxiolytic is not recommended. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without re evaluation of the patient's status using special expertise.

It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence. Treatment should always be withdrawn gradually. Patients who have taken Clobazam for a long time may require a longer period during which doses are reduced.

Special populations Elderly:

Doses of 10-20 mg daily in anxiety may be used in the elderly who are more sensitive to the effects of psychoactive agents. Treatment requires low initial doses and gradual dose increments under careful observation.

Hepatic and renal impairment:

Treatment requires low initial doses and gradual dose increments under careful observation, regardless of the age group of the patient. Treatment of epilepsy in association with one or more other anticonvulsants Adults: In epilepsy a starting dose of 5-15 mg/day is recommended, increasing as necessary up to a maximum of 60 mg daily.

Special populations Elderly:

Treatment requires low initial doses and gradual dose increments under careful observation.

Hepatic and renal impairment:

Treatment requires low initial doses and gradual dose increments under careful observation, regardless of the age group of the patient.

Paediatric patients aged 2 years and above:

Clobazam doses should be adapted individually. Doses can be taken once a day or divided in 2 – 3 times a day, keeping the same total dose. When prescribed for children treatment requires low initial doses and gradual dose increments under careful observation.

2 mg/kg/day at 7 days intervals, until a minimum effective dose is reached or side effects occur. Studies have suggested that slow titration may help avoid adverse effects and that when present, side effects may be reduced or eliminated with dose reduction.

2 mg/kg every week up to the targeted dose. 3 to 1mg/kg body weight daily is usually sufficient. The patient must be re-assessed after a period not exceeding 4 weeks and every 4 weeks thereafter in order to evaluate the need for continued treatment.

A break in therapy may be beneficial if drug exhaustion develops, recommencing therapy at a low dose. At the end of treatment (including in poor-responding patients), since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended to gradually decrease the dosage.

The oral suspension is particularly recommended for children and adults with swallowing difficulties, as it allows a secure and precise dosage. Clobazam should not be used as an anticonvulsivant treatment in children from 6 months to 2 years old, unless under exceptional situations, when there is a clear epilepsy indication.

1 mg/kg/day as in this population the metabolic pathways for clobazam may not be fully mature. Up-to-date, no precise dosage recommendation can be made in this population. Available products • Clobazam Wockhardt 1 mg/ml Oral Suspension • Clobazam Wockhardt 2mg/ml Oral Suspension If low doses are required, the 1 mg/ml strength product is the most suitable presentation.

If high doses are required, the 2 mg/ml strength product is the most suitable presentation. In all cases, treatment should be initiated at the lowest effective dose with gradual dose increments under careful observation. Clobazam Wockhardt 2mg/ml Oral Suspension is recommended for doses over 20mg.

Method of administration For oral use only. Shake the bottle thoroughly before use

The following CIOMS frequency rating is used, when applicable:

Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥1/10,000, < 1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). 4 Special warnings and precautions). Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.

These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.

Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. g. 4 Warnings and Precautions) Gastrointestinal disorders Common: dry mouth, nausea, constipation Skin and subcutaneous tissue disorders Uncommon: rash Not known: photosensitivity reaction; urticaria; Stevens-Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome) Musculoskeletal and connective tissue disorders Not known: muscle spasms, muscle weakness General disorders and administration site conditions Very common: fatigue, especially at the beginning of treatment and when higher doses are used Not known: slow response to stimuli, hypothermia Investigations Uncommon: weight increased (particularly with high doses or in long-term treatment), which is reversible.

Injury poisoning and procedural complications Uncommon: fall Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Switching between formulations In some individuals taking Clobazam Oral Suspension, the drug reaches higher plasma levels than the same dose taken as a tablet. This may lead to an increased risk of respiratory depression and sedation which may be most noticeable when switching to this medicine from tablets.

Therefore, caution must be taken when switching between clobazam products as the mean Cmax on single dose administration for the suspension is higher than that observed for the tablet formulation. Children There is a lack of data regarding the use of the product in patients under 2 years old.

For this reason, careful assessment and monitoring is required by the treating physician for use in children under 2 years for anticonvulsant treatment. Amnesia Amnesia may occur with benzodiazepines. In case of loss or bereavement psychological adjustment may be inhibited by benzodiazepines.

Muscle weakness Clobazam can cause muscle weakness. Therefore, in patients with pre-existing muscle weakness or spinal or cerebellar ataxia or sleep apnoea, special observation is required and a dose reduction may be necessary. Clobazam is contraindicated in patients with myasthenia gravis.

Patients with schizophrenic or other psychotic illnesses Benzodiazepines are not recommended for the primary treatment of patients with schizophrenic or other psychotic illnesses. 8). Should this occur, use of the medicinal product should be discontinued.

They are more likely to occur in children and the elderly. Suicidal Ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for clobazam. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Depression and personality disorders Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients who are depressed and aggressive behaviour towards self and others may be precipitated.

Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.

Indeed, in patients with anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepine (such as Clobazam) alone, can precipitate suicide in such patients. , driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedative hypnotics.

These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons. Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with sedative- hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum recommended dose.

Dependence Use of benzodiazepines - including clobazam - may lead to the development of physical and psychic dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.

Therefore the duration of treatment should be as short as possible (see Posology). Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms (or rebound phenomena). Rebound phenomena are characterised by a recurrence in enhanced form of the symptoms wihich originally led to clobazam treatment.

This may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. A withdrawal syndrome may also occur when abruptly changing over from a benzodiazepine with a long duration of action (for example, Clobazam) to one with a short duration of action.

Serious Skin Reaction Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions.

SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected.

8). Respiratory Depression Respiratory function should be monitored in patients with chronic or acute severe respiratory insufficiency and a dose reduction of clobazam may be necessary. 3 Contraindications). Renal and hepatic impairment In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to […]

1 • In patients with any history of drug or alcohol dependence (increased risk of development of dependence). • In patients with myasthenia gravis (risk of aggravation of muscle weakness). • In patients with severe respiratory insufficiency (risk of deterioration).

• In patients with sleep apnoea syndrome (risk of deterioration). • In patients with severe hepatic insufficiencies (risk of precipitating encephalopathy). 6 Pregnancy and Lactation). • In breast-feeding women. • During acute intoxication with alcohol or CNS-active substances Benzodiazepines must not be given to children without careful assessment of the need for their use.

Clobazam should not be used in children from 6 months to 2 years old, unless under exceptional situations as an anticonvulsant treatment, when there is a clear epilepsy indication.