Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
ZOLMITRIPTAN
ASTRA ZENECA (ISRAEL) LTD
N02CC03
TABLETS SOLUBLE IN MOUTH
ZOLMITRIPTAN 2.5 MG
PER OS
Required
ASTRA ZENECA UK LIMITED
ZOLMITRIPTAN
ZOLMITRIPTAN
Acute treatment of migraine with or without aura.
2012-05-31
ZOMIG RAPIMELT approved 0509 Page of 10 1 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved 01.2012.” SUMMARY OF PRODUCT CHARACTERISTICS ZOMIG 2.5 MG SOLUBLE IN MOUTH 1. TRADENAME OF THE MEDICINAL PRODUCT ‘Zomig Rapimelt’ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets soluble in mouth containing 2.5 mg of zolmitriptan. For excipients: see Section 6.1 3. PHARMACEUTICAL FORM Tablets soluble in mouth. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Zomig Rapimelt’ is indicated for the acute treatment of migraine with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of ‘Zomig Rapimelt’ to treat a migraine attack is 2.5 mg. ‘Zomig Rapimelt’ rapidly dissolves when placed on the tongue and is swallowed with the patient’s saliva. A drink of water is not required when taking ‘Zomig Rapimelt’. ‘Zomig Rapimelt’ can be taken when water is not available thus allowing early administration of treatment for a migraine attack. This formulation may also be beneficial for patients who suffer from nausea and are unable to drink during a migraine attack, or for patients who do not like swallowing conventional tablets. If symptoms persist or return within 24 hours, a second dose of zolmitriptan has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not achieve satisfactory relief with 2.5 mg doses, subsequent attacks can be treated with 5 mg doses of ‘Zomig Rapimelt’. In those patients who respond, significant efficacy is apparent within 1 hour of dosing with zolmitriptan. Zolmitriptan is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that ‘Zomig Rapimelt’ is taken as early as possible after the onset of migraine headache. ZOMIG RAPIMELT approved 0509 Page of 10 2 In the event of recurrent attacks, it is recommended that the total intake of ‘Zomig Rap Læs hele dokumentet