Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
Glenmark Arzneimittel GmbH
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Piperazine derivatives; levocetirizine
Not marketed
2010-05-28
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Levocetirizine Glenmark 5mg Film-coated tablets Levocetirizine dihydrochloride For adults and children aged 6 years and above 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 Levocetirizine Glenmark is and what it is used for 2. What you need to know before you take Levocetirizine Glenmark 3. How to take Levocetirizine Glenmark 4. Possible side effects 5. How to store Levocetirizine Glenmark 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Levocetirizine Glenmark 5mg film-coated tablets. Levocetirizine Glenmark 5mg Film-coated tablets is an antiallergic medication. For the treatment signs of illness (symptoms) associated with: • allergic rhinitis (including persistent allergic rhinitis); • nettle rash (urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS DO NOT TAKE LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS: • if you are allergic to levocetirizine dihydrochloride, to cetirizine, to hydroxuzine 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 Levocetirizine Glenmark 5 mg Film-coated tablets. If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prosta Przeczytaj cały dokument
Health Products Regulatory Authority 19 October 2023 CRN00DJNV Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine Glenmark 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipients: 60.27 mg lactose per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White oval film coated biconvex tablets, one side embossed with G breakline G and the other side plain. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levocetirizine Glenmark 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. 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 chi Przeczytaj cały dokument