Sibelium 5mg (5 blisters x 20 tablets/box)

Indications

Migraine prophylaxis treatment in case other treatments are not effective or poorly tolerated.

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Contraindications

Hypersensitivity to flunarizine or any of the excipients in the formulation. Preexisting symptoms of Parkinson’s disease before treatment. History of extrapyramidal symptoms. Depressive illness or a history of recurrent depression.

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Compositon/Ingredients

Flunarizin 5mg

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Dosage and administration

Adult patients ≤ 65 years and elderly patients (> 65 years): 5 mg daily taken at night, maintained in 4 to 8 weeks. The period of time for treatment is not more than 6 months. Recommendations for adult patient ≤ 65 years: If therapeutic response is inadequate, the dose may be increased up to 10 mg/day; however the patients’ tolerance should be considered. Children Children ≥ 12 years, especially in these with unidentified migraine prophylaxis: 5 mg daily taken at night. The period of time for treatment is not more than 6 months. Children < 12 years: Do not use. Hepatic impairment: Starting dose of 5 mg/day, taken in the evening

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Precaution

Sibelium 5mg should be discontinued if: During this treatment, depressive, extrapyramidal or other unacceptable symptoms occur. After 8 weeks of this initial treatment, no significant improvement is observed. Fatigue may increase progressively. The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Avoid the use of Sibelium 5mg during pregnancy. A decision on whether to discontinue breast-feeding or to continue/discontinue therapy with flunarizine should be made. Caution should be exercised during activities such as driving or operating dangerous machinery. Patients should be aware of how they react to drug before driving or operating machinery.

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Storage

Store at temperature below 30°C, protect from light.