SIBELIUM Tablet Ref.[7536] Active ingredients: Flunarizine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, Cork, P43 FA46, Ireland

Therapeutic indications

In the prophylaxis of migraine. The limited information available for periods longer than 12 months has shown flunarizine to continue to be effective. Patients should be regularly reviewed to assess their response to treatment, and if a sustained attack-free period is established, interrupted flunarizine treatment should be considered.

Posology and method of administration

Adults and elderly (18 years of age and older)

Starting Dose

Treatment is started at 10 mg daily (at night) for adult patients aged 18 to 64 years and at 5 mg daily (at night) for elderly patients aged 65 years and older. If, during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued (see Sections 4.4 and 4.8). If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.

Maintenance Treatment

If the patient is responding satisfactorily and a maintenance treatment is needed, the same daily dose should be used, but this time interrupted by two successive drug-free days every week, eg Saturday and Sunday.

Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.

Children, Infants and Neonates

Not recommended.

Overdose

Symptoms and signs

On the basis of the pharmacological properties of the drug, sedation and asthenia may be expected to occur. Cases of acute overdosage (up to 600 mg in one intake) have been reported and the observed symptoms were sedation, agitation and tachycardia.

Treatment

Treatment of acute overdosage consists of charcoal administration, if considered appropriate and supportive measures. No specific antidote is known.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

The tablets are supplied in PVC/Aluminium blister packs in a carton containing 20 tablets.

Special precautions for disposal and other handling

No special requirements.

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