Country: দক্ষিণ আফ্রিকা
ভাষা: ইংরেজি
সূত্র: South African Health Products Regulatory Authority (SAHPRA)
GlaxoSmithKline South Africa (Pty) Limited
See ingredients
TABLET
EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg
Registered
2006-04-05
Page 1 of 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S2 XYZAL Levocetirizine dihydrochloride 5 mg film-coated tablets XYZAL tablets contains sugar (63,50 mg lactose monohydrate per tablet) XYZAL ORAL SOLUTION Levocetirizine dihydrochloride 0,5 mg/mL oral solution XYZAL ORAL SOLUTION contains sugar (0,4 g maltitol per mL) READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. XYZAL is available without a doctor ' s prescription, for you to treat a mild illness. Nevertheless, you still need to use XYZAL carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share XYZAL with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You or your child must see a doctor if your symptoms worsen or do not improve after 14 to 21 days. WHAT IS IN THIS LEAFLET: 1. What XYZAL is and what it is used for 2. What you need to know before you use XYZAL 3. How to take XYZAL 4. Possible side effects 5. How to store XYZAL Page 2 of 10 6. Contents of the pack and other information. 1. WHAT XYZAL IS AND WHAT IT IS USED FOR The active ingredient, levocetirizine dihydrochloride, is an antihistamine for systemic use. It is used for the treatment of signs of illness (symptoms) associated with: • allergic rhinitis (including persistent allergic rhinitis) • chronic nettle rash of unknown origin (chronic idiopathic urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL DO NOT TAKE XYZAL: • if you or your child are hypersensitive (allergic) to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any other substances with a similar chemical structure or to one of the other ingredients of XYZAL (listed in section 6 ‘What XYZAL contains’ • if you or your child have a severe impairment of kidney function. WARNINGS AND PRECAUTIONS: Take special care if you have predisposing factors of urinary retention (inability to completely empty your bladder) (e.g. spinal cord lesions, prostat সম্পূর্ণ নথি পড়ুন
Page 1 of 15 NCDS07 XYZAL ORAL SOLUTION AND TABLETS SCHEDULING STATUS: S2 1. NAME OF THE MEDICINE: XYZAL Levocetirizine dihydrochloride 5 mg film-coated tablets XYZAL ORAL SOLUTION Levocetirizine dihydrochloride 0,5 mg/mL oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: EACH FILM-COATED TABLET CONTAINS 5 MG LEVOCETIRIZINE DIHYDROCHLORIDE. _Excipient with known effect: _ Contains sugar (63,50 mg lactose monohydrate per tablet). EACH 1 ML ORAL SOLUTION CONTAINS 0,5 MG LEVOCETIRIZINE DIHYDROCHLORIDE. _Excipients with known effect: _ 0,675 mg methyl parahydroxybenzoate per mL 0,075 mg propyl parahydroxybenzoate per mL Contains sugar (0,4 g maltitol per mL). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM: XYZAL: film-coated tablets. White to off-white, oval film-coated tablet with a Y logo on one side. Page 2 of 15 NCDS07 XYZAL ORAL SOLUTION: oral solution. Clear and colourless solution. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS: XYZAL is indicated for the relief of symptoms associated with the following allergic conditions: • seasonal allergic rhinitis • perennial allergic rhinitis • chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: XYZAL FILM-COATED TABLET: The film-coated tablet must be taken orally, swallowed 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 OF AGE AND OLDER: The daily recommended dose is one 5 mg tablet. _ _ ELDERLY: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see “Patients with renal impairment below”). CHILDREN: For children aged 2 – 6 years no adjusted dosage is possible with the film-coated tablet formulation. IT IS RECOMMENDED TO USE XYZAL ORAL SOLUTION (see section 4.4). _Children aged 6 – 12 years: _ Page 3 of 15 NCDS07 The daily recommended dose is one 5 mg tablet. XYZAL ORAL SOLUTION: An oral syringe is included in the package. The appropriate volume o সম্পূর্ণ নথি পড়ুন