Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
levocetirizine dihydrochloride
Cipla (EU) Limited
R06AE09
levocetirizine dihydrochloride
5mg
Film-coated tablet
oral use
Pack sizes of 7, 10, 14, 20, 28, 30, 50, 56, 84, and 100 tablets.
Product subject to prescription which may be renewed (B)
Cipla (EU) Limited
antihistamine for systemic use, piperazine derivative,
Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria
Authorised
2015-03-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS 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. The name of this medicine is Levocetirizine Dihydrochloride 5mg film-coated tablets, which will be referred to as Levocetirizine tablets WHAT IS IN THIS LEAFLET 1. What Levocetirizine tablet is and what it is used for 2. What you need to know before you take Levocetirizine tablets 3. How to take Levocetirizine tablets 4. Possible side effects 5. How to store Levocetirizine tablets 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE TABLET IS AND WHAT IT IS USED FOR This medicine contains levocetirizine dihydrochloride as the active ingredient It is an antiallergic medication. This medicine is used for 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 LEVOCETIRIZINE TABLETS DO NOT TAKE LEVOCETIRIZINE TABLETS • if you are allergic (hypersensitive) to levocetirizine dihydrochloride, an antihistamine or any of the other ingredients of this medicine (listed in section 6). • if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Levocetirizine tablets. If you are likely to be unable to empty you Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine dihydrochloride 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipients with known effects: Each film-coated tablets contains 16.50mg Lactose monohydrate and 49.00mg anhydrous lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oval shaped, biconvex, film coated tablets debossed with ‘C5’ on one side and plain on other 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. 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). Paediatric population: The daily recommended dose is 5 mg (1 film-coated tablet) in children aged 6 to 12 years. 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. 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. Patients with renal impairment: The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an Lestu allt skjalið