Naratriptan

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

naratriptan (naratriptan hydrochloride)

Доступна с:

Chanelle Medical

ИНН (Международная Имя):

naratriptan (naratriptan hydrochloride)

дозировка:

2,5mg

Фармацевтическая форма:

tablets film-coated

Тип рецепта:

Prescription

Характеристики продукта

ID: S161M -
UK/H/2484/01/DC & UK/H/4354/01/DC
& UK/H/4416/01/DC
VERSION: 01
REVIEWED DATE: 01/04/11
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Naratriptan 2.5 mg film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of naratriptan (as naratriptan
hydrochloride).
_Excipient(s):_
Contains lactose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Green, oblong shaped, film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naratriptan is indicated for the acute treatment of migraine attacks
with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Naratriptan is recommended as monotherapy for the acute treatment of a
migraine attack.
Naratriptan should not be used prophylactically.
Naratriptan should be swallowed whole with water.
Adults (18-65 years of age)
The recommended dose of Naratriptan is a single 2.5 mg tablet.
The total dose should not exceed two 2.5 mg tablets in any 24-hour
period.
If symptoms of migraine should recur, following an initial response, a
second dose may be
taken provided that there is a minimum interval of four hours between
the two doses.
If a patient does not respond to a first dose of Naratriptan a second
dose should not be taken
for the same attack, as it is unlikely to be of benefit. However
Naratriptan may be used for
subsequent migraine attacks.
Adolescents (12-17 years of age)
Efficacy of Naratriptan at single doses of 0.25, 1.0 and 2.5 mg was
not demonstrated to be
greater than placebo in a placebo-controlled study in adolescents (12
to 17 years). Therefore,
the use of Naratriptan in patients under 18 years of age is not
recommended.
Children (under 12 years of age)
There are no data available on the use of naratriptan in children
under 12 years of age
therefore its use in this age group is not recommended.
Elderly (over 65 years of age)
The safety and efficacy of naratriptan in individuals over age 65 has
not yet been established
and the