COMPOSITIONS :
Flunarizine HCl Tablet 5 mg, each tablet contains : Flunarizine hydrochloride equivalent to Flunarizine 5 mg.
DESCRIPTIONS :
Flunarizine HCl containing Flunarizine hydrochloride (equivalent to Flunarizine) is available in tablet 5 mg and 10 mg.
INDICATIONS :
Migraine prophylaxis.
Treatment and prophylaxis of vestibular and cerebral and peripheral disorders :
Dizziness, tinnitus, vertigo.
Lack of concentration and confusion.
Memory and sleep rhythm disorders, irritability.
Cramps when walking or when lying down, paraesthesia, cold extremities and tropic disorders.
When necessary, diet, non-smoking and appropriate walking exercise will be prescribed with Flunarizine.
DOSAGE AND ADMINISTRATIONS :
The maximum recommended dose is 10 mg/day. Decreasing the dose up to 5 mg daily can minimize the occurrence of adverse reactions.
Migraine prophylaxis :
Initial dose :
10 mg daily (at night) in patients < 65 years and 5 mg daily in patients > 65 years.
If during this treatment, depression, 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 also be discontinued.
Maintenance dose :
If patient is responding satisfactorily and if maintenance treatment is needed, the dose should be decreased to 5 day treatment a week (2 days a week without the drug). Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and should be re-initiated only if the patient relapses.
Treatment and prophylaxis of vestibular and cerebral and peripheral disorder :
The same daily dose should be used as for migraine, but the starting treatment should not be given longer than needed for symptom control, which generally takes < 2 months. However, if after 1 month for chronic vertigo or after 2 months for paroxysmal vertigo, no significant improvement is observed, the patient should be considered a non responder and administration should be discontinued.
To avoid sedative effect, it would be better to take at one time daily in the evening.
OVERDOSAGE :
On the basis of the pharmacological properties of the drug, sedation and asthenia can occur.
A few cases of acute over dosage have been reported and the observed symptoms were sedation, agitation and tachycardia. Excessive doses can be handle with administration of active charcoal, gastric lavage and supportive measures. No specific antidote is known.
Extrapyramidal symptoms and depression have been reported in patients who have taken 10 – 40 mg daily for 3 weeks and 15 months.
CONTRAINDICATIONS :
Patients with a history of depressive illness or with pre-existing symptoms of Parkinson’s disease and other extrapyramidal disorders.
Patients treated with β-Blocker.
WARNINGS AND PRECAUTIONS :
During consume this drug, do not driving and operating machinery.
Safety use in children, pregnant women and lactating women has not been established. Breast feeding should therefore be discouraged in women taking Flunarizine.
In rare cases, fatigue may increase progressively during therapy with Flunarizine; in this event, the therapy should be discontinued.
The recommended maximum dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. If during maintenance treatment the therapeutic effects wane, treatment should also be discontinued.
Treatment with the drug may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients e.g., elderly. Therefore, it should be used with caution in such patients.
Caution should be taken in hypotensive patient.
DRUG INTERACTIONS :
Galactorrhea will occur when concomitantly used with oral contraceptives for the first two months of treatment with Flunarizine.
Excessive sedation can occur when alcohol, hypnotics or tranquilizers are taken simultaneously with Flunarizine.
ADVERSE REACTIONS :
Drowsiness and fatigue that are temporary and their weight gain or increased appetite.
Side effects that need to be considered during chronic treatment :
Depression which occurs in women with a history of depression.
Extrapyramidal symptoms such as bradykinesia, rigidity, akathisia, urofacial dyskinesia, tremor, especially in elderly patients.
Infrequently reported adverse reactions experienced :
Gastrointestinal : Heartburn, nausea, gastralgia.
Central nervous system : Insomnia, anxiety.
Others : Galactorrhea, dry mouth, muscle ache, skin rash.
PRESENTATIONS :
Flunarizine HCl Tablet 5 mg Box, 10 blisters @ 10 tablets
Reg. No. GKL0402336610A2
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
