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Sedatives

Fluzinstad


Pack size:

Box of 10 blisters x 10 capsules.


Composition:

Each capsule contains flunarizine 5 mg (as flunarizine dihydrochloride).


Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.

 


  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Migraine prophylaxis treatment in case other treatments are not effective or poorly tolerated.
     
  • Fluzinstad is administered orally.

    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 Precautions).
  • 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.


Or as prescribed by physicians.
 

  • Hypersensitivity to flunarizine or to any ingrdient of the drug.
  • 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.

Rarely:

  • Nausea, stomach pain.
  • Galactorrhoea.

Unknown

  • Anxiety.
  • Rash.
  • Muscle ache.

     

  • 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.
  • In rare cases fatigue may increase progressively during flunarizine therapy. In this event, the therapy should be discontinued.
  • If during maintenance treatment, the therapeutic effects are subside, treatment should also be discontinued.
  • Accumulation may occur if given at dose levels higher than recommended, with an increased incidence of side effects.
  • Fluzinstad contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicine.
  • Pregnancy: There are no data from the use of flunarizine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of flunarizine during pregnancy.
  • Lactation: Animal studies have shown excretion of flunarizine in breast milk. It is unknown whether flunarizine is excreted in human milk. A decision on whether to discontinue breast-feeding or to continue/discontinue therapy with flunarizine should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
  • Effects on ability to drive and use machines: Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities such as driving or operating dangerous machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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