Fluzinstad 5

Rx

Indications

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

Dosage

Adult patients ≤ 65 years and elderly patients (> 65 years)

• 5 mg daily taken at night, maintained in 4 to 8 weeks.
• If during this treatment, depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued (See section 8. Special warnings and precautions for use).
• If, after 8 weeks of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
• The period of time for treatment is not more than 6 months.
• Recommendations for adult patients ≤ 65 years: If the clinical symptoms of the patients showed an inadequate therapeutic response, 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:
  There is no evidence for the efficacy and safety of flunarizine in these people. Flunarizine is not recommended for children < 12 years.

Dosage in patients with hepatic impairment

• Because the drug is metabolized in the liver with a large extent, it is necessary to adjust the dose in these patients.
• The starting dose of 5 mg/day, taken in the evening.

Usage

Fluzinstad 5 is orally administered.

• 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.

Common

• Drowsiness, fatigue.
• Increased appetite, weight gain.

Less common

• Extrapyramidal symptoms (bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), depression;
• Dry mouth.

• Fluzinstad 5 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 Fluzinstad 5 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.