SUMATRAN Tablet Ref.[49831] Active ingredients: Sumatriptan

General recommendations with regard to use and administration

Sumatriptan should not be used prophylactically.

Sumatriptan is recommended as monotherapy for the acute treatment of a migraine attack and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3).

It is advisable that sumatriptan be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.

Posology

The following recommended doses of sumatriptan should not be exceeded.

Adults

The recommended dose for adults is 50 mg sumatriptan. Some patients may require 100 mg sumatriptan.

Although the recommended oral dose of sumatriptan is 50 mg, it must be taken into account that the severity of migraine attacks varies both within and between patients. Doses of 25 mg – 100 mg have shown to be more effective than placebo in clinical trials but 25 mg is statistically significantly less effective than 50 mg and 100 mg.

If a patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Sumatriptan tablets may be taken for subsequent attacks.

If the patient has responded to the first dose, but the symptoms recur a second dose may be given in the next 24 hours, provided that there is a minimum interval of 2 hours between the two doses. No more than 300 mg should be taken in any 24-hour period.

Paediatric population

The efficacy and safety of sumatriptan tablets in children aged less than 10 years have not been established. No clinical data are available in this age group.

The efficacy and safety of sumatriptan tablets in children 10 to 17 years of age have not been demonstrated in the clinical trials performed in this age group. Therefore, the use of sumatriptan tablets in children 10 to 17 years of age is not recommended (see section 5.1).

Elderly (over 65 years of age)

Experience of the use of sumatriptan tablets in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of sumatriptan in patients aged over 65 years is not recommended.

Hepatic impairment

In patients with mild to moderate hepatic insufficiency low doses of 25-50 mg sumatriptan should be considered.

Method of administration

The tablets must be taken with water. The sumatriptan substance has a bitter taste. The bitter taste is masked with the aid of a grapefruit flavour

Symptoms and signs

Doses in excess of 400 mg orally and 16 mg subcutaneously were not associated with adverse reactions other than those mentioned. Patients have received single injections of up to 12 mg subcutaneously without significant adverse reactions.

Treatment

If overdose occurs, the patient should be monitored for at least 10 hours and standard supportive treatment applied as required. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.

5 years.

This medicine does not require any special storage conditions.

The tablets are packed in aluminium/aluminium blister strips and inserted in a cardboard carton.

2, 3, 4, 6, 8, 12, 18, 20, 24, 30, 50, 100 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.