Страна: Мальта
Язык: английский
Источник: Medicines Authority
LEVOCETIRIZINE DIHYDROCHLORIDE
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
FILM-COATED TABLET
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2005-10-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XYZAL 5 MG FILM-COATED TABLETS For adults and children aged 6 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 allergy tes Прочитать полный документ
PAGE 1 OF 12 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 63.50 mg lactose monohydrate/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval, film-coated tablet with a Y logo on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xyzal 5 mg film-coated tablets are indicated in the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (1 film-coated tablet). _Elderly _ Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below). _ _ _Renal impairment_ The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate). Refer to the following table and adjust the dose as indicated. PAGE 2 OF 12 Dosing adjustments for patients with impaired renal function: Group eGFR (ml/min) Dosage and frequency Normal renal function 90 1 tablet once daily Mildly decreased renal function 60 – < 90 1 tablet once daily Moderately decreased renal function 30 – < 60 1 tablet once every 2 days Severely decreased renal function 15 – < 30 (not requiring dialysis) 1 tablet once every 3 days End stage renal disease (ESRD) < 15 (requiring dialysis treatment) Contra-indicated In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment. _Hepatic impairment_ No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and rena Прочитать полный документ