Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Nalion is indicated for the short term treatment of moderate or severe anxiety states and anxiety associated with depression.
It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Nalion should not be used to treat short- term mild anxiety, such as anxiety or tension associated with the stress of everyday life.
As the efficacy of alprazolam in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered.
Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks' treatment and the need for continued treatment established, especially in case the patient is symptom free. The overall duration of treatment should not be more than 8-12 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. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients.
The optimum dosage of Nalion 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 at intervals of no more than 4 weeks. The usual dosage is stated below; 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.
Treatment should always be tapered off gradually. During discontinuation of alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction (See section 4.4).
There is a reduced clearance of the drug and, as with other benzodiazepines, an increased sensitivity to the drug in elderly patients.
Anxiety: 0.25 mg to 0.5 mg three times daily, increasing if required to a total of 3 mg daily.
0.25 mg two to three times daily to be gradually increased if needed and tolerated.
Safety and efficacy of alprazolam have not been established in children and adolescents below the age of 18 years; therefore use of alprazolam is not recommended.
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.
Tablets are 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 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.
60 months.
Store below 25°C in the original package, in order to protect from light and moisture.
Tablets are packaged in aluminium foil-polyvinylchloride blisters, with a patient information leaflet in a carton of 30 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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