FRISIUM 10 TABLET 10 MG [SIN01591P]

Product Info

FRISIUM 10 TABLET 10 MG

[SIN01591P]

4.1 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 gastro-intestinal area), and emotional instability.
In cases of psychovegetative and psychosomatic disorders, the doctor should investigate the possibility of an organic cause.
Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjuvant of different treatment.

• As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant mono-therapy.

4.2 Posology and method of administration
Dosage
Pharmaceutical presentation, dosage, and duration of treatment must be adjusted to the individual clinical response, the indication, and the severity of the condition. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
When treatment with Frisium10 is to be discontinued after prolonged administration, the dosage should normally be tapered off over a period of time.

Treatment of anxiety states:
Adults and adolescents over 15 years of age: The initial dose is usually 20mg Frisium10 daily. If necessary, the daily dose may be increase to 30mg. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.

Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A total daily dose of 10–15mg is often enough.

Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5–10 mg is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.

Secondary dosage adjustment: After improvement of the symptoms, the dose may be reduced.

Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.

Duration of treatment: The duration of treatment must be as short as possible. The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-off process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a 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.

Discontinuation of treatment: After improvement of the symptoms, the dose may be reduced. After prolonged treatment, Frisium10 should not be withdrawn suddenly. The dose should be reduced gradually under medical supervision, otherwise symptoms such as restlessness, anxiety, and insomnia may occur.

Treatment of epilepsy in combination with one or more other antiepileptics:
Adults and adolescents over 15 years of age: Small doses (5–15mg/day as the initial dose), gradually increasing to a maximum daily dose of about 80mg. Furthermore, constant doses (e.g. 20mg/day) and intermitted therapy (discontinuing Frisium10 and subsequently prescribing it again) have proven effective.

Children from 3 to 15 years of age: Treatment should normally be started with 5mg, and a maintenance dose of 0.3–1.0 mg/kg body weight daily is usually enough. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.

Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.

Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.

Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.

Discontinuation of treatment: At the end of treatment – also in cases where there has been a poor response to therapy – the dose should be gradually reduced, because otherwise and increased proneness to seizures as well as other withdrawal symptoms cannot be excluded.

Administration
The tablets should not be swallowed whole with some liquid. If the dose is to be distributed over the day, the larger portion should be taken in the evening. Doses of up to 30mg Frisium10 can also be administered as a single evening dose.
The duration of treatment is determined by the doctors. After a period not exceeding 4 weeks, the doctor should decide whether continuation of treatment is necessary. Prolonged spells of uninterrupted treatment should be avoided, since they may lead to dependence.

4.3 Contraindications

Frisium must not be used in any of the following circumstances:

• hypersensitivity to the active substance, other benzodiazepines or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• myasthenia gravis

• severe respiratory insufficiency

• sleep apnoea syndrome

• severe liver dysfunction

• acute intoxication with alcohol or other centrally acting substances

• history of dependence on alcohol, medicinal products or drugs

• lactation