Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Dosage and Administration** IMIGRAN should not be used prophylactically. The recommended dose of IMIGRAN should not be exceeded. 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. **Populations** - **Adults** The recommended dose of oral IMIGRAN is a single 50 mg tablet. Some patients may require 100 mg. If a patient does not respond to the first dose of IMIGRAN, a second dose should not be taken for the same attack. IMIGRAN 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, provided that there is a minimum interval of two hours between doses and not more than 300 mg is taken in any 24-hour period. The tablets should be swallowed whole with water. - **Children and Adolescents (under 18 years of age)** The safety and efficacy of sumatriptan tablets in this population has not been demonstrated. - **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 IMIGRAN in patients aged over 65 years is not recommended.
ORAL
Medical Information
**Indications** IMIGRAN tablets are indicated for the acute relief of migraine attacks with or without aura, including the acute treatment of migraine attacks associated with the menstrual period in women.
**Contraindications** - Hypersensitivity to any component of the preparation. - IMIGRAN should not be given to patients who have had myocardial infarction or have ischaemic heart disease (IHD), Prinzmetal's angina/coronary vasospasm, peripheral vascular disease or patients who have symptoms or signs consistent with IHD. - IMIGRAN should not be administered to patients with a history of previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). - The use of IMIGRAN in patients with uncontrolled hypertension is contraindicated. - IMIGRAN should not be administered to patients with severe hepatic impairment. - The concomitant use of ergotamine or derivatives of ergotamine (including methysergide) is contraindicated ( _see Interactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Concurrent administration of monoamine oxidase inhibitors (MAOIs) and IMIGRAN is contraindicated. IMIGRAN must not be used within two weeks of discontinuation of therapy with MAOIs.
N02CC01
sumatriptan
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
Delpharm Poznań S.A.
Active Ingredients
Documents
Package Inserts
Imigran 50mg_PI.pdf
Approved: February 28, 2023