Almogran 12.5 mg film-coated tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Almotriptan

Available from:

Almirall, S.A.

ATC code:

N02CC; N02CC05

INN (International Name):

Almotriptan

Dosage:

12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective serotonin (5HT1) agonists; almotriptan

Authorization status:

Marketed

Authorization date:

2000-10-27

Patient Information leaflet

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Summary of Product characteristics

Health Products Regulatory Authority
25 January 2021
CRN009ZSQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Almogran 12.5 mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains almotriptan 12.5 mg as almotriptan D,L-hydrogen
malate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, biconvex film-coated tablet with an “A” engraved
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Almogran 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.
Almogran should not be used for migraine prophylaxis.
The tablets can be taken with or without food.
Adults (18-65 years of age)
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.
Children and adolescents (under 18 years of age)
There are no data concerning the use of almotriptan in children and
adolescents, therefore its use in this age group is not
recommended.
Elderly (over 65 years of age)
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.
Renal Impairment
Health Products Regulatory Authority
25 January 2021
CRN009ZSQ
Page 2 of 7
Dosage adjustment is not required in patients with mildor moderate
renal imp