Hagizin

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Symptomatic treatment of dizziness, tinnitus,... caused by vestibular disorder
Barcode: 8935206008326
Description

HAGIZIN

COMPOSITION:

Flunarizine (as flunarizine dihydrochloride) ............................ 5 mg

Excipients q.s ..................................................................... 1 capsule

(Lactose, PVP K30, talc, magnesium stearate, sodium starch glycolate).

DOSAGE FORM: Hard capsule.

PRESENTATION: Box of 10 blisters x 10 capsules.

PHARMACODYNAMICS:

Flunarizine has antihistamine, sedative, and calcium-channel blocking activity. It is used for migraine prophylaxis, for vertigo and vestibular disorders, and for peripheral and cerebral vascular disorders.

PHARMACOKINETICS: Hagizin is well absorbed from the gastrointestinal tract and is about 90% bound to plasma proteins. Peak concentrations occur 2 to 4 hours after oral doses and steady state appearing at the fifth or sixth week. Hagizin is metabolized in the liver and excreted in the feces through the biliary tract. Flunarizine has a terminal elimination half-life of about 18 days.

INDICATIONS:

Prophylaxis of migraine attacks if other treatment measures are not effective or poorly tolerated.

CONTRAINDICATIONS:

Hypersensitivity to flunarizine or any excipients of the drug.

Pre-existing symptoms of Parkinson's disease.

A history of extrapyramidal symptoms.

Depression or a history of recurrently depressive syndrome.

PRECAUTIONS AND WARNINGS FOR USE:

- Impaired hepatic function.

- If symptoms, including depression, extrapyramidal disorders, increased fatigue occur, the therapy should be discontinued.

- 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.

- Fatigue may increase progressively during flunarizine therapy; in this event therapy should be discontinued.

PREGNANCY AND LACTATION:

Cautions should be taken in pregnant women and breast-feeding mothers.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Cautions should be taken when driving and using machines because the drug may induce drowsiness.

INTERACTIONS: Excessive effect of flunarizine may occur when flunarizine is taken concomitantly with hypnotics, tranquilizers, alcohol, or alcoholic drinks. Hepatic enzyme inducers such as carbamazepine, phenytoin, and valproate may interact with flunarizine by increasing its metabolism; an increase in dosage of flunarizine may be required.

ADVERSE EFFECTS: Drowsiness, weight gain, nausea, heartburn, dry mouth, anxiety may occur.

Conditions of rash, myalgia, extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, dyskinesia, tremor) rarely occur.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE: Symptoms: Drowsiness and asthenia may occur. A few cases of acute overdose (a single oral dose of 600 mg) have been reported associated with symptoms such as drowsiness, tachycardia, irritability.

Treatment: No specific antidote is known. Gastric lavage should be practiced within an hour of ingestion of overdose. Activated charcoal may be used if possible.

DOSAGE & ADMINISTRATION:

Adults ≤ 65 years of age and the elderly (> 65 years of age):

- 5 mg/ day, given at night for 4 to 8 weeks.

- If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued (See Precautions and warnings 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 therapy should not exceed 6 months.

- Recommendations only for patient £ 65 years of age: If clinical manifestations of the patient showed an inadequate therapeutic response, the dose may be increased up to 10 mg daily, but should be considered the patient's drug tolerability.

Children:

- Children ≥ 12 years of age, especially in migraine which has not been identified: 5 mg/ day, given at night. The therapy should not exceed 6 months.

- Children < 12 years of age: No sufficient evidence on efficacy and safety of flunarizine has been recorded. Flunarizine should not be given to children less than 12 years of age.

Or as directed by the physician.

Read the directions carefully before use.                      

Consult the physician for more information.                

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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