Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Acute treatment of the headache phase of migraine attacks with or without aura.
Almogran/Amignul/Almotrex should be taken with liquids as early as possible after the onset of migraine-associated headache but it is also effective when taken at a later stage.
Almotriptan should not be used for migraine prophylaxis.
The tablets can be taken with or without food.
The recommended dose is one tablet containing 12.5 mg of almotriptan. A second dose may be taken if the symptoms reappear within 24 hours. This second dose may be taken provided that there is a minimum interval of two hours between the two doses.
The efficacy of a second dose for the treatment of the same attack when an initial dose is ineffective has not been examined in controlled trials. Therefore if a patient does not respond to the first dose, a second dose should not be taken for the same attack.
The maximum recommended dose is two doses in 24 hours.
There are no data concerning the use of almotriptan in children and adolescents, therefore its use in this age group is not recommended.
No dosage adjustment is required in the elderly. The safety and effectiveness of almotriptan in patients older than 65 years has not been systematically evaluated.
Dosage adjustment is not required in patients with mild or moderate renal impairment. Patients with severe renal impairment should take no more than one 12.5 mg tablet in a 24 hour period.
There are no data concerning the use of almotriptan in patients with hepatic impairment (see Section 4.3 Contraindications and 4.4 Special warning and precautions for use).
The most frequently reported adverse event in patients receiving 150 mg (the highest dose administered to patients) was somnolence.
Overdose should be treated symptomatically and vital functions should be maintained. Since the elimination half-life is around 3.5 hours monitoring should continue for at least 12 hours or while symptoms or signs persist.
Shelf life: 5 years.
This medicinal product does not require any special storage conditions.
Boxes containing aluminium foil blisters with 2, 3, 4, 6, 7, 9, 12, 14 or 18 tablets.
Not all pack sizes may be marketed.
No special requirements.
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