Source: Web Search Revision Year: 2017 Publisher: BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
SEDOXIL is indicated for the management of anxiety disorder associated or not to psychoneurotic conditions.
Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Dosage should be individualised according to the age of patient and severity of symptoms.
Adults: average dose is 1–3 mg daily, preferably divided in three doses.
Elderly patients: do not exceed 1,5 mg daily.
Children: Not for paediatric use.
Treatment of anxiety should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free.
The overall duration of treatment generally should not be more than 8-12 weeks including the tapering off process. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without revaluation of the patient’s status with special expertise.
In any case treatment should be started with the lowest recommended dose.
In case of a missing dose after more than 1 hour as scheduled do not take it. Do not double the dose.
The patient should be checked regularly observed 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, including alcohol.
In the management of overdose it should be borne in mind that multiple agents might have been taken. Following overdose with SEDOXIL vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken (if an endotracheal tube is in place) if the patient is unconscious, to prevent aspiration of vomiting. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce SEDOXIL absorption. Special attention should be paid to respiratory and cardiac functions and the patient should be closely observed in an intensive care unit.
Overdose of benzodiazepines is usually manifested by central nervous system depression, ranging from drowsiness to coma. In mild cases symptoms include drowsiness, mental confusion and lethargy, and in more serious cases, symptoms include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Flumazenil, a specific benzodiazepine receptor antagonist, may be useful as an antidote.
Blister PVC/Alu: 5 years.
Blister Alu/Alu: 4 years.
Store in the original container.
Blisters of Alu/Alu or PVC/Alu. Packs of 10, 20, 30, 40 and 60 tablets.
Not all pack sizes may be marketed.
No special requirements.
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