Almigren tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

almotriptan (almotriptan malate)

Available from:

Chanelle Medical Unlimited Company

ATC code:

N02CC05

INN (International Name):

almotriptan (almotriptan malate)

Dosage:

12,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(2/1x2/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-07-11

Summary of Product characteristics

Almigren 12.5mg Film-coated tablets - Summary of Product
Characteristics (SmPC)
1
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9 SUMMARY OF PRODUCT CHARACTERISTICS
ALMIGREN FILM-COATED TABLETS 12.5MG
1.
NAME OF THE MEDICINAL PRODUCT
Almigren Film-coated tablets 12.5mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains 12.5 mg almotriptan as almotriptan
malate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white coloured, round, biconvex, film coated tablets.
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
Almigren 12.5mg Film-coated tablets 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.
_ 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.
_Paediatric population_
_ 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.
_EElderly (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_
Dosage adjustment is not required in patients with mild or moderate
renal impairment. Patients wi