Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24
Anxiety.
Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Treatment 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 4-6 weeks, including a tapering off process.
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.
The usual dose is 30 mg daily in single or divided doses. The dose should be adjusted within the range 10 mg to 60 mg daily in accordance with response of the patient.
The lowest dose which can control symptoms should be used. It should not be usually continued beyond four weeks.
In elderly or debilitated patients, including those with impaired liver and/or renal function, the initial dose should be small, and increments should be made gradually, in accordance with the response of the patient, to preclude ataxia or excessive sedation. Half the normal adult dose is generally sufficient for a therapeutic response in the elderly or debilitated.
The patient should be checked regularly at the start of the treatment and then regularly thereafter, in order to decrease if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
See section 4.4.
Not recommended for use in children and adolescents under 18 years old.
For oral administration.
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 with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Following overdose with any medicinal product, 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.
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.
Flumazenil may be useful as an antidote. Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines, and may be used when an overdose with a benzodiazepine is known or suspected. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Consult the complete flumazenil package insert prior to use.
3 years.
No special storage precautions are required.
PVC/Aluminium blister pack of 60 tablets.
No special requirements.
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