IMIGRAN Tablet Ref.[7802] Active ingredients: Sumatriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Glaxo Wellcome UK Ltd. trading as GlaxoSmithKline UK., 980 Great West Road, Brentford, Middlesex, TW8 9GS

Therapeutic indications

Imigran tablets are indicated for the acute relief of migraine attacks, with or without aura. Imigran should only be used where there is a clear diagnosis of migraine.

Posology and method of administration

Adults

Imigran is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of Imigran should not be exceeded.

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

The recommended dose of oral Imigran is a 50mg tablet. Some patients may require 100mg.

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

Patients who do not respond to the prescribed dose of Imigran should not take a second dose for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Imigran may be taken for subsequent attacks.

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

The tablets should be swallowed whole with water.

Paediatric population

The efficacy and safety of Imigran 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 Imigran 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 Imigran 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 Imigran 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 Imigran in patients aged over 65 years is not recommended.

Overdose

Doses in excess of 400mg orally were not associated with side effects other than those mentioned.

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

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

Shelf life

36 months.

Special precautions for storage

Store below 30°C.

Nature and contents of container

Aluminium double foil blister pack or child-resistant foil blister pack in a cardboard carton, containing either 2, 3, 6, 12, 18 or 24 tablets.

Special precautions for disposal and other handling

None stated.

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