GAMANIL Film-coated tablet Ref.[49943] Active ingredients: Lofepramine

Posology

Adults

The usual dose is 70mg twice daily (140mg) or three times daily (210mg) depending on the patient’s response. The daily dose should always be given in divided doses not exceeding 70mg per dose.

In the treatment of depression/anxiety states associated with panic disorder features, the initial dosage should be 70mg daily for the first week.

Elderly patients

Elderly patients may respond to lower doses in some cases.

Paediatric population

The safety and efficacy of Gamanil in children under 18 years of age have not been established. No data are available. The use of Gamanil is not recommended in children and adolescents under the age of 18.

Method of administration

Gamanil 70mg film-coated tablets are for oral use.

Symptoms

Overdose may be characterised by central nervous system depression or excitation, severe anticholinergic effects or cardiotoxicity. In particular, depending on the amount taken, overdose with Gamanil may lead to epileptiform seizures or cardiac events, such as conduction disorders, QT- prolongation, arrhythmias including Torsades de Pointes.

Management

The treatment of overdose is directed to symptoms. It should include immediate gastric lavage and routine close monitoring of cardiac function. Reports of overdosage with 0.7–6.72 g have shown no serious sequelae directly attributable to lofepramine.

2 years.

Store below 25°C. Store in the original package/container in order to protect from light and moisture.

Gamanil comes in 3 different types of containers:

1. PVDC/AL foil blister packs containing 56 tablets
2. Polypropylene containers of 250 tablets
3. Amber glass bottles containing 56 tablets

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.