Kraj: Malta
Język: angielski
Źródło: Medicines Authority
LEVOCETIRIZINE DIHYDROCHLORIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
COATED TABLET
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2009-12-15
dimensions: pharmacode: date sent: TECHNICAL APPROVAL min pt size: awstudio@actavis.co.uk print proof no: origination date: originated by: revision date: supplier: technically app. date*: * Please note the technical approval is provided by the supplier and is valid on the date indicated. Any technical changes made by the supplier after approval are not the responsibility of the Artwork Studio. Non Printing Colours colours/plates revised by: approved for print/date 1. 2. 3. 4. 5. 6. black 1 10pt 160x440 24.09.2012 24.09.2012 05.10.2012 K. Mutafchieva Synthon Spain AAAE3520 Levocetirizine, 5mg, PIL (MARCHESINI), Malta 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 L-Histasin is and what it is used for 2. Before you take L-Histasin 3. How to take L-Histasin 4. Possible side effects 5. How to store L-Histasin 6. Further information 1. WHAT L-HISTASIN IS AND WHAT IT IS USED FOR Levocetirizine is an anti-allergic agent. It is used to treat symptoms associated with aller- gic conditions, such as: • hay fever • (persistent) runny nose • chronic nettle rash 2. BEFORE YOU TAKE L-HISTASIN DO NOT TAKE L-HISTASIN IF: • you are ALLERGIC (HYPERSENSITIVE) TO LEVOCE- TIRIZINE, ANY RELATED SUBSTANCE, OR ANY OF THE OTHER INGREDIENTS of L-Histasin (see sec- tion 6 ‘What L-Histasin contains’). • you suffer from SEVERE KIDNEY FAILURE • you have been told by your doctor that you have an INTOLERANCE TO SOME SUGARS (since the tablets contain lactose) TAK Przeczytaj cały dokument
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT L-Histasin 5mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levocetirizine dihydrochloride Each film-coated tablet contains 5mg levocetirizine dihydrochloride (equivalent to 4.2 mg of levocetirizine). Excipient: each film-coated tablet contains 64.0 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are white to off-white, oval, biconvex tablets, debossed with ‘L9CZ’ on one side and ‘5’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic 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). Children aged 6 to 12 years The daily recommended dose is 5 mg (1 film-coated tablet). Page 2 of 8 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. The administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended due to the lack of data in this population (see also section 4.4). 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 us Przeczytaj cały dokument