Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
Imbat Limited
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; levocetirizine
Authorised
2007-12-19
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XYZAL ® 5 MG FILM-COATED TABLETS For adults and children aged 6 years and above (levocetirizine dihydrochloride) Your medicine is available using the above name but will be referred to as Xyzal throughout this leaflet. 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 1. What Xyzal is and what it is used for 2. What you need to know before you take Xyzal 3. How to take Xyzal 4. Possible side effects 5. How to store Xyzal 6. Contents of the pack and other information 1. WHAT XYZAL IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Xyzal. Xyzal is an antiallergic medication. For the treatment of signs of illness (symptoms) associated with: allergic rhinitis (including persistent allergic rhinitis); nettle rash (urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL DO NOT TAKE XYZAL if you are allergic to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6). if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Xyzal. If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice. If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Xyzal Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipient(s) with known effect Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the UK & Czech Republic_ White to off-white, oval, film-coated tablet with a Y logo on one side. 4 CLINICAL PARTICULARS As per PA0891/003/001 5 PHARMACOLOGICAL PROPERTIES As per PA0891/003/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Lactose monohydrate Colloidal anhydrous silica Magnesium stearate Hypromellose (E464) Titanium dioxide (E 171) Macrogol 400 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 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_ _ _ _1_ _6_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _4_ _3_ _6_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing blister strips. Pack size: 28 or 30. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISAT Læs hele dokumentet