Flunarizine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 22, 2025🚩 Report this page

Flunarizine

Antivertigo Preparations

CA Health Canada

Drug class: Antivertigo Preparations
Availability: See label
Routes: Oral
Markets covered: 1
Products on record: 1

Overview

Flunarizine is an active pharmaceutical ingredient in the Antivertigo Preparations group (N07CA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	March 22, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

FLUNARIZINE (flunarizine hydrochloride) is indicated for:  Prophylaxis of migraine (with and without aura) in patients with frequent and severe attacks, who have not responded satisfactorily to other treatment and/or in whom other therapy has resulted in unacceptable side effects.
FLUNARIZINE is not indicated for the treatment of acute attacks. 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of FLUNARIZINE in pediatric patients has not been established.
3 Pediatrics. 2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of FLUNARIZINE in the prophylaxis of migraine has not been established in elderly subjects. 3 Pharmacokinetics, Geriatrics.

Sources & citations

[1]Health Canada (DPD) · 02246082 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In clinical trials with FLUNARIZINE in migraine patients, drowsiness (also described as sedation or fatigue) as well as weight gain (and/or increased appetite) occurred fairly frequently, in the order of 20 and 15%, respectively.
1%) required withdrawal from FLUNARIZINE therapy due to drowsiness and weight gain, respectively. The most serious side effect encountered in migraineurs during clinical trials was depression. 3%) were withdrawn due to depression. Clinical experience in other indications and epidemiologic surveys suggest that extrapyramidal symptoms may develop during FLUNARIZINE therapy.
Elderly patients are particularly at risk. See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Extrapyramidal Symptoms. Other side effects encountered in clinical trials for migraine prophylaxis included the following: FLUNARIZINE (flunarizine hydrochloride) Page 8 of 23 Central Nervous System Disorders: Anxiety, dizziness/vertigo insomnia and sleep change; Gastrointestinal Disorders: Emesis, gastralgia, heartburn, nausea; Miscellaneous: Asthenia, dry mouth, muscle aches, skin rash.
5 Post-Market Adverse Reactions International post-marketing experience suggests that patients between 20 and 54 years of age with a personal or familial history of depression are particularly at risk. See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Depression.

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

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.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

Drugs in the same class

Sources & citations