Active Ingredient: Flunarizine
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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 10 milligrams flunarizine, once daily at the end of the day, over the duration of 2 months. Afterwards, oral, 10 milligrams flunarizine, divided weekly at the end of the day, 5 doses in total, over the duration of 4 months.
Treatment is started at 10 mg daily (at night) for adult patients aged 18 to 64 years. If, during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued. 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.
At night.
For:
Oral, 5 milligrams flunarizine, once daily, over the duration of 2 months. Afterwards, oral, 5 milligrams flunarizine, divided weekly, 5 doses in total, over the duration of 4 months.
Treatment is started 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. 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.
At night.
For:
Regimen A: Oral, 5 milligrams flunarizine, once daily, over the duration of 6 months.
Regimen B: In case that patient weight is ≥ 40 kg, oral, between 5 milligrams flunarizine and 10 milligrams flunarizine, once daily, over the duration of 6 months. The maximum allowed total dose is 10 milligrams flunarizine daily.
The maximum recommended treatment duration is 6 months.
At night.
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