Rizelium 5

Generic Name: Flunarizine

Strength: 5 mg

Dosage Form: Capsule

Manufacturer: UniMed UniHealth Pharmaceuticals Ltd.

Indication:

Rizelium is indicated for the prophylaxis of classic (with aura) or common (without aura) migraine. It is also used for the symptomatic treatment of vestibular vertigo due to diagnosed functional disorders of the vestibular system, peripheral vascular disease (PVD), motion sickness, and as an add-on therapy for refractory epilepsy resistant to conventional antiepileptic treatment.

Dosage and Administration:

The starting dose for migraine and vertigo in patients under 65 years is 10 mg at night, and 5 mg daily for those over 65. For children (>40 kg) with vertigo and motion sickness, the dose is 5 mg daily. In refractory epilepsy, the adult dose is 15-20 mg daily, and for children, it's 5-10 mg daily as an add-on therapy.

For peripheral vascular disease, the dosage is 10 mg twice daily, which can be increased up to 30 mg per day if needed.

Maintenance treatment for migraine and vertigo, if effective and well-tolerated, should be interrupted after 6 months, and re-initiated only if the patient relapses. The dose may be reduced to 5 days of treatment per week with two successive drug-free days.

Rizelium capsules should be swallowed whole and can be taken with or without food, preferably at night to minimize drowsiness.

Side Effects:

Common side effects may include drowsiness, fatigue, weight gain, and increased appetite. Other reported adverse experiences during chronic treatment include depression (especially in patients with a history of depressive illness), extrapyramidal symptoms (such as slow movement, rigidity, restlessness, tremors, and involuntary movements of the face or mouth), heartburn, nausea, stomach pain, insomnia, anxiety, milk production in non-breastfeeding women (galactorrhoea), dry mouth, muscle ache, and skin rash.

Precautions:

Rizelium may cause drowsiness, which can be aggravated by alcohol or other central nervous system depressants. Patients should exercise caution while driving or operating machinery. It is not suitable for treating an acute migraine attack. This medication may also lead to extrapyramidal and depressive symptoms, and potentially reveal Parkinsonism, especially in elderly or predisposed individuals.

It is contraindicated in patients with hypersensitivity to flunarizine, a history of depressive illness, or pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders. The safety of flunarizine during pregnancy and lactation has not been established.

Drug Interactions:

Galactorrhoea has been reported in women on oral contraceptives within the first two months of Rizelium treatment. Hepatic enzyme inducers like carbamazepine and phenytoin may increase the metabolism of Rizelium, potentially requiring a dosage increase.