国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
LEVOCETIRIZINE DIHYDROCHLORIDE
Clear Pharmacy
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives
Authorised
2010-10-08
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 10 ml/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. 完全なドキュメントを読む
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: 63.50 mg lactose monohydrate / tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from UK:_ White to off-white, oval, film-coated tablet with a Y logo on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake. For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocetirizine. _Children aged 6 to 12 years:_ The daily recommended dose is 5 mg (1 film-coated tablet). _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 Patients with renal impairment below). Due to the lack of data in this population, the administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended. _Adult patients with renal impairment:_ The dosing intervals must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated fr 完全なドキュメントを読む