Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
zolmitriptan
Orifarm AB
N02CC03
zolmitriptan
2,5 mg
Filmdragerad tablett
laktos (vattenfri) Hjälpämne; zolmitriptan 2,5 mg Aktiv substans
Receptbelagt
Zolmitriptan
Avregistrerad
2006-02-23
1. NAME OF THE MEDICINAL PRODUCT Zomig 2.5 mg film-coated tablets Zomig 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg film-coated tablet contains 2.5 mg zolmitriptan. Each 5 mg film-coated tablet contains 5 mg zolmitriptan. Excipients with known effect Each 2.5 mg film-coated tablet contains 100 mg lactose. Each 5 mg film-coated tablet contains 200 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Round, biconvex, yellow or pink film-coated tablets containing 2.5 mg and 5 mg of zolmitriptan respectively. The tablets are intagliated with the letter ‘Z’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zomig is indicated in adults aged 18 years and older for acute treatment of migraine headache with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Zomig tablets to treat a migraine attack is 2.5 mg. It is advisable that Zomig tablets are taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack. If a patient does not achieve satisfactory relief with 2.5 mg doses, for subsequent attacks 5 mg doses of Zomig could be considered. The total daily intake should not exceed 10 mg. Not more than 2 doses of Zomig should be taken in any 24-hour period. Zomig is not indicated for prophylaxis of migraine. Zolmitriptan 2,5 mg; 5 mg Film-coated tablet _Paediatric population_ _Use in Children (under 12 years of age) _ The safety and efficacy of zolmitriptan tablets in children aged birth to < 12 years have not been established. No data are available. Use of Zomig in children is therefore not recommended. _Ad Läs hela dokumentet