Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levocetirizine dihydrochloride
Viatris UK Healthcare Ltd
R06AE09
Levocetirizine dihydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5016695004327
340 mm Levocetirizine dihydrochloride For adults and children aged 6 years and above SAME SIZE ARTWORK SIZE: 170 mm x 340 mm 170 mm PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOCETIRIZINE 5 MG FILM-COATED TABLETS FONT TYPE: TIMES NEW ROMAN FONT SIZE: 9 PT DATE: 26-02-2019 VERSION: 01 (UK) VARIATION NO. : PT/H/0250/001/IB/015 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 5 mg film-coated tablets are and what they are used for 2. What you need to know before you take Levocetirizine 5 mg film-coated tablets 3. How to take Levocetirizine 5 mg film-coated tablets 4. Possible side effects 5. How to store Levocetirizine 5 mg film-coated tablets 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE 5 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Levocetirizine is a type of medicine called a non-sedating antihistamine. It is used to treat signs and symptoms of an allergic reaction such as: ● an itchy rash similar to nettle rash which lasts a long time (urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE 5 MG FILM-COATED TABLETS DO NOT TAKE LEVOCETIRIZINE 5 MG FILM-COATED TABLETS ● if you are allergic to l e v o c e t i r i z i n e dihydrochloride, to cetirizine, to hydroxyzine 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 Levocet Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine 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 halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of chronic idiopathic urticaria 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _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). _Children aged 6 to 12 years: _ The daily recommended dose is 5 mg (1 film-coated tablet). _Children aged 2 to 6 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 _Infants and toddlers aged less than 2 years_ : The administration of levocetirizine 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 from serum creatinine (mg/dl) determination using the following formula: Dosing Adjustments for Patients with Impaired Renal Function: Group Creatinine clearance (ml/min) Dosage and frequency Normal 80 5 mg once daily Mild 50 Read the complete document