Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
ELETRIPTAN HYDROBROMIDE EQV ELETRIPTAN
PFIZER PRIVATE LIMITED
N02CC06
20mg
TABLET, FILM COATED
ORAL
Prescription Only
Pfizer Manufacturing Deutschland GmbH
2002-01-14
RELPAX Eletriptan Hydrobromide 1. TRADE NAME OF THE MEDICINAL PRODUCT RELPAX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 20 mg, 40 mg or 80 mg eletriptan as eletriptan hydrobromide. 3. PHARMACEUTICAL FORM Film-coated tablets. The 20 mg tablet is a 6.25 mm orange film coated standard round convex tablets with a clear overcoat, engraved with ‘REP 20’ on one side and ‘Pfizer’ on the reverse. The 40 mg tablet is an 8.0 mm orange film coated standard round convex tablets with a clear overcoat, engraved with ‘REP 40’ on one side and ‘Pfizer’ on the reverse. The 80 mg tablet is a 10.0 mm orange film coated standard round convex tablets with a clear overcoat, engraved with ‘REP 80’ on one side and ‘Pfizer’ on the reverse. 4. 4.1 CLINICAL PARTICULARS THERAPEUTIC INDICATION Acute treatment of migraine with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Eletriptan tablets should be taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage. Eletriptan tablets should not be used prophylactically_._ _ _ The tablets should be swallowed whole with water. Adults (18-65 years of age) The recommended initial dose is 40 mg. If headache returns within 24 hours:_ _If after an initial response migraine headache recurs within 24 hours, an additional dose of the same strength of eletriptan has been shown to be effective in treating the recurrence. If a second dose is required, it should not be taken within 2 hours of the initial dose. If no response is obtained_:_ If a patient does not achieve a headache response to the first Read the complete document