THERAPEUTIC INDICATIONS

Acute and chronic anxiety states, which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area) and emotional instability. In cases of psychovegetative and psychosomatic disorders, the possibility of an organic cause must be investigated. In patients with depression or anxiety associated with depression, Frisium must only be used conjunction with adequate concomitant treatment, since the use of benzodiazepines (e.g. Frisium) alone can precipitate suicide. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive of different treatment. As adjunctive therapy in patients with epilepsy not adequately stabilized with their basic medication.

POSOLOGY AND METHOD OF ADMINISTRATION

Hepatic or renal impairment: initial doses must be low and the doses increased gradually under careful observation. Treatment of anxiety states: Initial dose for >15 years of age: 2 tablets Frisium 10 daily. If necessary, the dose may be increased, a total daily dose of 30 mg should not be exceeded. Elderly and children: initial doses must be low and the doses increased gradually under careful observation. Elderly: a maintenance dose of 10-15 mg. Children 3-15 years: a daily dose of 5-10 mg is frequently sufficient. The dose may be reduced after improvement of the symptoms. Duration of treatment: as short as possible up to 1 month. A reassessment must be conducted after a period not exceeding 4 weeks and regularly thereafter to decide whether to continue treatment, especially if the symptoms have disappeared. The overall duration of treatment (i.e. including tapering off process) must not exceed 8 to 12 weeks. An individualist withdrawal time table needs to be planned for each patient in whom dependence is known or suspected. Avoid prolonged periods of uninterrupted treatment, they may lead to dependence. Treatment of epilepsy as adjunctive therapy with other medicines to prevent or arrest convulsions. The initial dose for >15 years of age should be low (5-15 mg daily), and if necessary, increased gradually to a maximum daily dose of about 80 mg. Doses of up to 30 mg may be taken as a single dose in the evening. The initial dose in children 3- 15 years: 5 mg. A maintenance dose of 0.3-1.0 mg/kg body weight daily is usually sufficient. Discontinuation of treatment: After prolonged treatment to avoid the occurrence of withdrawn symptoms it is strongly recommended not to withdrawn dose suddenly but reduced gradually under medical supervision.

CONTRA-INDICATIONS

Hypersensitivity to clobazam or any of the excipients, history of drug or alcohol dependence (increased risk of developing dependence), chronic progressive muscle disease/myasthenia gravis (risk of aggravation of muscle weakness), severe respiratory insufficiency (risk of deterioration), Temporary cessation of breathing during sleep or sleep apnoea syndrome or (risk of deterioration), severe impairment of liver function (risk of precipitating a certain disease of the brain (encephalopathy)). Drinking alcohol during treatment (increased risk of sedation and other adverse effects). Phobic and obsessional states or for the treatment of chronic phychosis. In children ages of between 6 months and 3 years, Frisium must not be used except in the presence of compelling indications or as adjunctive therapy for treatment of epilepsy.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Risk of respiratory depression (high doses). Muscle weakness. Memory lapses for events occurring after lapse-causing event. A dose reduction may be necessary in patient with hepatic & renal impairment. Frisium may lead to physical and psychological dependence (increases with the dose and treatment duration, and history of alcohol or drug abuse). The therapeutic benefit must be balanced against the risk of dependence during prolonged use. On withdrawal of benzodiazepines, especially if abrupt, a rebound phenomenon or a withdrawal syndrome may occur. Abrupt termination of treatment will lead to withdrawal symptoms.In the treatment of epilepsy with benzodiazepines including Frisium, consideration must be given to the possibility of a decrease in effectiveness (development of tolerance) in the course of treatment. Frisium may cause sedation and similar adverse effects as well as muscle weakness (may impair the ability to concentrate and react).

INTERACTIONS

Potentiating effect in coadministration with other central nervous system depressant medicines (antipsychotics, anxiolytics, antidepressants, anticonvulsants, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives), lithium, and alcohol. Possible euphoria may be enhanced with narcotic analgesics. Use in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring). Increased blood levels of valproic acid or phenytoin. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethylclobazam.

PREGNANCY AND LACTATION

Do not use in the first three months of pregnancy, and in the later stages must only be used if there are compelling indications (see full PI). Clobazam passes into breast milk, it must not be taken by breastfeeding women.

UNDESIRABLE EFFECTS

Sedation, leading to tiredness and sleepiness (especially at the start of treatment and higher doses). Slowing of reaction time, drowsiness, numbed emotions, confusion, headaches, dryness of the mouth, constipation, loss of appetite, nausea dizziness, muscle weakness, ataxia, or a fine tremor of the fingers. Disorders of articulation, unsteadiness of gait and of other motor functions, visual disorders, weight gain, or loss of libido (particularly in high doses or long-term treatment), such reactions are reversible. After prolonged use, impairment of consciousness, sometimes combined with respiratory disorders, may occur in very rare cases, particularly in elderly patients; these effects sometimes persist over longer periods. Skin reactions (rare). Paradoxical reactions (especially in the elderly and in children), in the event of such reactions, discontinue treatment. Tolerance and dependence (especially during prolonged use). Anterograde amnesia. Respiratory depression. Preexisting depression may be unmasked during treatment.

OVERDOSE

Overdose and intoxication with benzodiazepines may lead to central nervous depression, associated with drowsiness, confusion and lethargy, possibly progressing to ataxia, respiratory depression, hypotension and, rarely, coma. The risk of a fatal outcome is increased in cases of combined poisoning with other central nervous system depressants, including alcohol. In treatment for intoxication, the possible involvement of multiple agents should be taken into consideration. Gastric lavage, intravenous fluid replenishment and general supportive measures may be indicated in addition to monitoring of consciousness, respiration, pulse rate and blood pressure. Facilities for the management of complications such as airways obstruction or respiratory insufficiency must be available. Hypotension can be treated by replenishment with plasma substitutes and if necessary with sympathomimetic agents. Secondary elimination of clobazam (by forced diuresis or haemodialysis) is ineffective. The efficacy of supplementary administration of physostigmine (a cholinergic agent) or of flumazenil (a benzodiazepine antagonist) cannot be assessed because insufficient experience is available.

PHARMACODYNAMIC PROPERTIES

ATC Code : N05BA09. Pharmacological class: Benzodiazepine derivatives.

Presentation

Box, 10 blisters x 10 tablet (DPL0121203810A1)

Manufactured by

PT Aventis Pharma, Jakarta, Indonesia.

More detailed Information on request

PT Aventis Pharma Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210 (021) 4892208 - 4895608

Date of revision: 27-Mar-18 (based on BPOM approval 18-May-2017)

This information is intended for Health Care Professional only. See local product information for full details information

FRISIUM