Flunarizine

2 Recommended Dose and Dosage Adjustment  Adults The recommended dose is 10 mg daily (at night) for patients younger than 65 years of age. If, during this treatment, depressive, extrapyramidal or other unacceptable adverse experiences occur, administration should be discontinued.

If, after 3 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should also be discontinued. If treatment goes beyond 6 months, patients should continue to be closely monitored for side effects, in particular CNS related events and therapy should be discontinued at the first sign of adverse reactions.

See 7 WARNINGS AND PRECAUTIONS, Extrapyramidal Symptoms. FLUNARIZINE (flunarizine hydrochloride) Page 5 of 23 Although there are no long-term controlled clinical trials with FLUNARIZINE, clinical experience suggests that two successive drug-free days per week may decrease the potential for adverse reactions.

However, it should be noted that a brief interruption in therapy will not significantly reduce the exposure to FLUNARIZINE, given its long half-life (19 days).  Pediatrics Health Canada has not authorized an indication for pediatric use.

5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.

5 OVERDOSAGE Symptoms On the basis of the pharmacological properties of the drug, sedation and asthenia may be expected to occur. g. g. tachycardia). Treatment There is no specific antidote. Activated charcoal may be given if considered appropriate.

For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Each grey opaque body, red opaque cap, hard gelatin capsule, imprinted "5", with a white powder fill, contains flunarizine hydrochloride equivalent to 5 mg flunarizine.

Available in bottles of 60 and 100, and unit dose packages of 60 capsules. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral capsule 5 mg of flunarizine hydrochloride cornstarch, lactose monohydrate, stearic acid, and talc.

The capsule shell, imprinted with edible black ink, contains the non-medicinal ingredients black iron oxide, D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. The edible black ink contains the non-medicinal ingredients black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

FLUNARIZINE (flunarizine hydrochloride) Page 6 of 23 7 WARNINGS AND PRECAUTIONS General  Fatigue: In rare cases, fatigue may increase progressively during FLUNARIZINE treatment: in this event, therapy should be discontinued. Monitor patients closely and at regular intervals for fatigue.

g. operating potentially dangerous machinery or a vehicle) until the response to the drug has been determined.

Endocrine and Metabolism  Galactorrhea:

Galactorrhea has been reported in a few female patients, some of whom were also on oral contraceptives, within the first two months of FLUNARIZINE treatment. Discontinuation of FLUNARIZINE therapy resolved the galactorrhea in most cases.

FLUNARIZINE therapy caused a mild but significant elevation of serum prolactin levels while Growth Hormone (GH), Luteinizing Hormone (LH), Follicle-Stimulating Hormone (FSH) and Thyroid-Stimulating Hormone (TSH) levels did not show significant variation.

Two cases of menstrual irregularities have been reported.  Lactose: FLUNARIZINE capsules contain lactose monohydrate. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this product.

Hepatic/Biliary/Pancreatic FLUNARIZINE is metabolised by the liver, therefore care should be exercised when FLUNARIZINE is given to patients with compromised liver function Monitoring and Laboratory Tests Patients should be followed closely and monitored at regular intervals for:  extrapyramidal symptoms  depressive symptoms  fatigue This is to facilitate early detection and treatment discontinuation.

If the therapeutic effects diminish during treatment, FLUNARIZINE should be discontinued. 2 Recommended Dose and Dosage Adjustment.

Neurologic  Extrapyramidal Symptoms:

FLUNARIZINE is contraindicated in patients with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders (see 2 CONTRAINDICATIONS). Clinical studies indicate that FLUNARIZINE treatment, even at recommended doses, can produce motor disturbances in subjects who did not show previous neurological deficits.

Elderly patients appear to be particularly at risk. The clinical symptoms resemble Parkinson's disease, however, they do not improve with antiparkinson medication. Experience to date suggests that in most instances the extrapyramidal symptoms tend to be reversible following discontinuation of FLUNARIZINE treatment.

Monitor patients closely and at regular intervals for extrapyramidal symptoms.

FLUNARIZINE (flunarizine hydrochloride) Page 7 of 23 Psychiatric  Depression:

FLUNARIZINE is contraindicated in patients with depression (see 2 […]