Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
IMED Healthcare Ltd.
R06AE09
Levocetirizine dihydrochloride
0.5 milligram(s)/millilitre
Oral solution
levocetirizine
2021-08-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XYZAL 0.5 MG/ML ORAL SOLUTION For adults and children aged 2 years and above levocetirizine dihydrochloride 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 kidney disease requiring dialysis. 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 may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking Xyzal for several days before testing. This medicine may affect your Izlasiet visu dokumentu
Health Products Regulatory Authority 30 August 2021 CRN00C733 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 0.5 mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride. Excipient(s) with known effect: Methyl parahydroxybenzoate Propyl parahydroxybenzoate Maltitol liquid For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. _Product imported from Czech Republic._ Clear and colourless solution 4 CLINICAL PARTICULARS As per PA0891/003/003 5 PHARMACOLOGICAL PROPERTIES As per PA0891/003/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium acetate trihydrate Acetic acid 99% Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Glycerol 85% Maltitol liquid (E965) Saccharin sodium Tutti frutti flavor contains: Triacetin (E1518) Benzaldehyde Orange oil Vanillin Ethyl butyrate Orange oil concentrated Isoamyl acetate Allyl caproate Gamma-undecalactone Citral Geraniol Citronellol Alpha tocopherol (E307) Purified water Health Products Regulatory Authority 30 August 2021 CRN00C733 Page 2 of 2 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. After first opening: 3 months. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Amber glass bottle closed with a white polypropylene child-resistant closure in a cardboard box also containing a 10 ml oral syringe graduated at 0.25 ml. Pack size: 200 ml. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/170/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date Izlasiet visu dokumentu