Posology : מינונים

4.2     Posology and method of administration
Naramig tablets should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage.

Naramig Tablets are recommended as monotherapy for the acute treatment of a migraine attack.

Naramig Tablets should not be used prophylactically.

Posology
Adults (18-65 years of age)
The recommended dose of Naramig Tablets is a single 2.5mg tablet.

The total dose should not exceed two 2.5mg 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 Naramig Tablets a second dose should not be taken for the same attack, as it is unlikely to be of benefit. However Naramig Tablets may be used for subsequent migraine attacks.

Adolescents (12-17 years of age)
Efficacy of Naramig Tablets at single doses of 0.25, 1.0 and 2.5mg was not demonstrated to be greater than placebo in a placebo-controlled study in adolescents (12 to 17 years). Therefore, the use of Naramig Tablets 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 effectiveness of naratriptan in individuals over age 65 have not been evaluated and therefore, its use in this age group cannot be recommended. There is a moderate decrease in clearance with age (see Pharmacokinetics).

Renal Impairment
Naramig should be used with caution in patients with renal impairment. The maximum dose in any 24 hour treatment period is a single 2.5mg tablet. The use of Naramig is contraindicated in patients with severe renal impairment (creatinine clearance < 15mL/min)
(See Contraindications and Pharmacokinetics).

Hepatic Impairment
Naramig should be used with caution in patients with hepatic impairment. The maximum dose in any 24 hour treatment period is a single 2.5mg tablet. The use of Naramig is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C)
(See Contraindications and Pharmacokinetics).

Method of administration
Naramig Tablets should be swallowed whole with water.