Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland
Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
In patients with depression or anxiety associated with depression, Frisium must be used only in conjunction with adequate concomitant treatment.
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.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazipines is recommended only for adjunctive, i.e. not for primary treatment.
Treatment should 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; if so it should not take place without re-evaluation of the patient’s status with special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependance.
Adults: The usual anxiolytic dose for adults is 20-30 mg daily in divided doses or as a single dose given at night. Doses of up to 60 mg 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 symptoms the dose may be reduced. It should not be used for longer than 4 weeks.
Due regard must be paid to the possibility of interference with alertness and reaction time.
Long term chronic use as an anxiolytic is not recommended. Treatment should always be withdrawn gradually. Patients who have taken Frisium for a long time may require a longer period during which doses are reduced.
Elderly: Doses of 10-20 mg daily in anxiety may be used in the elderly and debilitated who are usually more sensitive to the effects of psychoactive agents. Treatment requires low initial doses and gradual dose increments under careful observation.
Adults: In epilepsy a starting dose of 10-20 mg daily with increases of 10mg increments, as necessary up to a maximum of 60mg daily.
Children aged 6 years and above: When prescribed for treatment requires low initial doses and gradual dose increments under careful observation. It is recommended that normally treatment should be started at 5 mg daily. A maintenance dose of 0.3 to 1 mg/kg body weight daily is usually sufficient. As there is no age appropriate formulation to enable safe and accurate dosing, no dosage recommendations can be made in children under 6 years of age.
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. 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 tablets can be administered whole, or crushed and mixed in applesauce and used immediately (please refer to section 5.2). The 10mg tablets can be divided into equal halves of 5mg. Clobazam can be given with or without food.
Increased responsiveness and higher susceptibility to adverse effects may be present in these patients and require low initial doses and gradual dose increments under careful observation. The maximum dose should not be exceeded.
The patient should be checked regularly at the start of the treatment in order to decrease if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants. The risk of a fatal outcome is increased in cases of combined poisoning with other CNS depressants, including alcohol.
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents have been taken.
Vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Secondary elimination of clobazam (by forced diuresis or haemodialysis) is ineffective.
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
3 years.
Do not store above 25°C. Store in the original package.
PVC/Aluminium foil blister packs of 100 tablets.
No special requirements.
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