Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
LEVOCETIRIZINE DIHYDROCHLORIDE
B & S Healthcare
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives
Authorised
2009-08-07
PACKAGE LEAFLET: INFORMATION FOR THE USER XYZAL ® 5MG FILM-COATED TABLETS (levocetirizine dihydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Xyzal is and what it is used for 2. Before you take Xyzal 3. How to take Xyzal 4. Possible side effects 5. How to store Xyzal 6. Further 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. BEFORE YOU TAKE XYZAL DO NOT TAKE XYZAL if you are ALLERGIC (HYPERSENSITIVE) to levocetirizine dihydrochloride or to an antihistamine or any of the other ingredients of Xyzal (see ‘What Xyzal contains’) if you have A SEVERE IMPAIRMENT OF KIDNEY FUNCTION (severe renal failure with creatinine clearance below 10ml/min). TAKE SPECIAL CARE WITH XYZAL The use of Xyzal is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation. 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. TAKING OTHER MEDICINES Please tell your Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipients: lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) _Product imported from the UK_ 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/02/2015_ _CRN 2157661_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium – OPA/aluminium/PVC blister Carton containing 30 tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER B & S Healthcare Unit 4, Bradfield Road Ruislip Middlesex HA4 0NU United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1328/114/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 th August 2009 10 DATE OF REVISION Soma hati kamili