Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SUMATRIPTAN SUCCINATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
SUMATRIPTAN SUCCINATE
2Tablet Tablets
GLAXOSMITHKLINE PHARMACEUTICALS SA
_Consumer Medication Information Leaflet (RiMUP) _ 1 IMIGRAN ® FD TABLET 50 MG Sumatriptan (50 mg) WHAT IS IN THIS LEAFLET 1. What IMIGRAN FD is used for 2. How IMIGRAN FD works 3. Before you use IMIGRAN FD 4. How to use IMIGRAN FD 5. While you are using it 6. Side Effects 7. Storage and Disposal of IMIGRAN FD 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IMIGRAN FD IS USED FOR Imigran FD tablets are used to relieve migraine attacks, including the acute treatment of migraine attacks associated with the menstrual period in women. Imigran FD tablets should only be used when you first experience signs and symptoms of a migraine attack, not to try and prevent an attack from occurring. HOW IMIGRAN FD WORKS Each Imigran capsule-shaped tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans _(also known as 5-HT1 _ _receptor agonists). _ Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Imigran is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound. BEFORE YOU USE IMIGRAN FD - _When you must not use it _ _ _ Do not use your medicine: If you are hypersensitive (allergic) to sumatriptan or to any of the ingredients of Imigran FD. - _Before you start to use it _ _ _ If you answer ‘Yes’ to any of the following questions tell your doctor about this before using your medicine as it may not be suitable for you. • Are you pregnant or trying to become pregnant? • Are you breast-feeding? − to minimise infant exposure, mothers should not breastfeed for 12 hours after using Imigran FD. • Is this headache any different from your usual migraine attacks? • Have you been told that you are allergic to Imigran FD, sumatriptan, or any of the other ingredients in Imigran FD? • Are you taking any medicines for you Read the complete document
CONFIDENTIAL IMIGRAN ® FDT SUMATRIPTAN FAST DISINTEGRATING TABLETS _(FDT) _ QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 50 of sumatriptan base as the succinate salt. PHARMACEUTICAL FORM Fast disintegrating tablets are triangular in shape. _IMIGRAN_ FDT 50 mg are pink film coated and debossed with 'GS 1YM' on one face and '50' on the other. CLINICAL PARTICULARS INDICATIONS _IMIGRAN _FDT_ _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. DOSAGE AND ADMINISTRATION _IMIGRAN_ 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 a migraine headache. It is equally effective at whatever stage of the attack it is administered. POPULATIONS ADULTS The recommended dose of oral _IMIGRAN _FDT is asingle 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 _FDT 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. CONFIDENTIAL The tablets should be swallowed whole with water. Patients with swallowing difficulties may choose to disperse a tablet in a small amount of water before administration. _IMIGRAN _FDT dispersed in water have a bitter taste. CHILDREN AND ADOLESCENTS (UNDER 18 YEARS OF AGE) _IMIGRAN _FDT have not been studied in adolescents or children (_see Clinical Studies_). ELDERLY (OVER 65 YEARS OF AGE) Experience of the use of standard 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 _ Read the complete document