Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, Cork, P43 FA46, Ireland
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.
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.
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.
Not recommended.
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 of acute overdosage consists of charcoal administration, if considered appropriate and supportive measures. No specific antidote is known.
2 years.
Do not store above 25°C.
The tablets are supplied in PVC/Aluminium blister packs in a carton containing 20 tablets.
No special requirements.
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