NARAMIG Tablet Ref.[9706] Active ingredients: Naratriptan

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 can not 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.

Administration of a high dose of 25 mg naratriptan in one healthy male subject increased blood pressure by up to 71 mmHg and resulted in adverse events including light-headedness, tension in the neck, tiredness and a loss of co-ordination. Blood pressure returned to baseline by 8 hours after dosing without other pharmacological intervention.

It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of naratriptan.

Treatment

If overdosage with naratriptan occurs, the patient should be monitored for at least 24 hours and standard supportive treatment applied as required.

36 months.

Store below 30°C.

2, 4, 6 or 12 tablets in a double foil blister pack or child-resistant foil blister pack.

Not all pack sizes may be marketed.

No special requirements for disposal.