XANAX Tablet Ref.[6145] Active ingredients: Alprazolam

Posology

Duration of treatment

Xanax should be used in the lowest possible effective dose, for the shortest possible time and for a maximum of 2-4 weeks. The need for continued treatment should be reassessed frequently. Long-term treatment is not recommended. The risk of dependence may increase with dose and duration of treatment (see section 4.4).

Anxiety

250 micrograms (0.25 mg) to 500 micrograms (0.5 mg) three times daily, increasing if required to a total of 3 mg daily.

The elderly or in the presence of debilitating disease: 250 micrograms (0.25 mg) two to three times daily to be gradually increased if needed and tolerated.

If side-effects occur, the dose should be lowered. It is advisable to review treatment regularly and to discontinue use as soon as possible. Should longer term treatment be necessary, then intermittent treatment may be considered to minimize the risk of dependence.

Paediatric population

The safety and efficacy of alprazolam in children and adolescents below the age of 18 years have not been established. No data are available.

Method of administration

For oral use.

The optimum dosage of Xanax should be based upon the severity of the symptoms and individual patient response. The lowest dose which can control symptoms should be used. Dosage should be reassessed frequently. The usual dosage is stated above; in the few patients who require higher doses, the dosage should be increased cautiously to avoid adverse effects. When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medications will require lower doses than those so treated, or those with a history of chronic alcoholism.

The dose must be gradually reduced to avoid withdrawal symptoms (see section 4.4).

Elderly patients

There is a reduced clearance of the drug and, as with other benzodiazepines, an increased sensitivity to the drug in elderly patients. See section 5.2.

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 have been taken.

Following overdose with oral benzodiazepines, vomiting may be induced (within 1 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.

3 years.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Clear PVC/aluminium foil blister strips of 10 tablets, packed 6 strips to a box.

Glass bottle with metal screw cap or HDPE bottle with LDPE tamper evident cap containing 100 or 1000 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.