Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
FROVATRIPTAN
LTT Pharma Limited
N02CC; N02CC07
FROVATRIPTAN
2.5 milligram(s)
Film-coated tablet
Oral use
Blister packs with 6 tablets
Product subject to prescription which may be renewed (B)
Almac Pharma Services Limited, Berlin-Chemie AG, A.Menarini Manufacturing Logistics and Services S.r.l, Laboratories Menarini
Selective 5-HT1 receptor agonists
Selective serotonin (5HT1) agonists; frovatriptan
Acute treatment of the headache phase of migraine attacks with or without aura
Authorised
2015-04-17
FROVEX 2.5 MG FILM-COATED TABLETS (frovatriptan) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor or pharmacist. * This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. * If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: What Frovex is and what it is used for What you need to know before you take Frovex How to take Frovex Possible side effects How to store Frovex Contents of the pack and other information WHAT FROVEX IS AND WHAT IT IS USED FOR Frovex 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Frovex 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing). Frovex 2.5 mg tablets should not be used to prevent a migraine attack. Frovex is used to treat migraine attacks in adults. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROVEX The diagnosis of migraine must have been clearly established by your doctor DO NOT TAKE FROVEX * If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1). * if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes), * if you have had a stroke or a transient ischaemic attack (TIA), * if you have severely or moderately high blood pressure Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FROVEX 2.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg of frovatriptan (as succinate monohydrate). Excipient(s) with known effect(s): lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). _Product imported from Greece_ Round biconvex white film-coated tablet, debossed with “m” on one side and “2.5” on the other. 4 CLINICAL PARTICULARS As per PA0865/009/001 5 PHARMACOLOGICAL PROPERTIES As per PA0865/009/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Tablet core_ Anhydrous lactose, Microcrystalline cellulose Magnesium stearate Sodium starch glycollate_ (_Type A) Silica, colloidal anhydrous _Tablet Coat_ Opadry white: Titanium dioxide (E 171) Anhydrous lactose, Hypromellose (E 464) Macrogol 3000 Triacetin 6.2 INCOMPATIBILITIES Not applicable. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _1_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _9_ _8_ _9_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER PVC/PE/ACLAR/Aluminium blister Lugege kogu dokumenti