Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
Acute treatment of the headache phase of migraine attacks with or without aura.
MIGARD is indicated in adults.
Frovatriptan should be taken as early as possible after the onset of a migraine attack but it is also effective when taken at a later stage. Frovatriptan should not be used prophylactically.
If a patient does not respond to the first dose of frovatriptan, a second dose should not be taken for the same attack, since no benefit has been shown.
Frovatriptan may be used for subsequent migraine attacks.
The recommended dose of frovatriptan is 2.5 mg.
If the migraine recurs after initial relief, a second dose may be taken, providing there is an interval of at least 2 hours between the two doses.
The total daily dose should not exceed 5 mg per day.
The safety and efficacy of MIGARD in children and adolescents aged below the age of 18 years have not been established. Therefore, its use in this age group is not recommended. No data are available.
Frovatriptan data in patients over 65 years remain limited. Therefore, its use in this category of patients is not recommended.
No dosage adjustment is required in patients with renal impairment (see section 5.2).
No dosage adjustment is required in patients with mild to moderate hepatic impairment (see section 5.2). Frovatriptan is contraindicated in patients with severe hepatic impairment (see section 4.3).
Oral use.
The tablets should be swallowed whole with water.
There is limited data on overdose with frovatriptan tablets. The maximum single oral dose of frovatriptan given to male and female patients with migraine was 40 mg (16 times the recommended clinical dose of 2.5 mg) and the maximum single dose given to healthy male subjects was 100 mg (40 times the recommended clinical dose). Both were not associated with side effects other than those mentioned in section 4.8. However, one post-marketing serious case of coronary vasospasm has been reported, following intake of 4 times the recommended dose of frovatriptan on three consecutive days, in a patient taking migraine prophylactic treatment with a tricyclic antidepressant. The patient recovered.
There is no specific antidote for frovatriptan. The elimination half-life of frovatriptan is approximately 26 hours (see section 5.2.).
The effects of haemodialysis or peritoneal dialysis on serum concentrations of frovatriptan are unknown.
In case of overdose with frovatriptan, the patient should be monitored closely for at least 48 hours and be given any necessary supportive therapy.
3 years.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
PVC/PE/PVDC/Aluminium blister packs with 1, 2, 3, 4, 6 and 12 tablets.
Not all pack sizes may be marketed.
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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