Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
PARACETAMOL CALCIUM ASCORBATE CAFFEINE MONOHYDRATE BROMPHENIRAMINE MALEATE
Seven Seas Ltd
PARACETAMOL CALCIUM ASCORBATE CAFFEINE MONOHYDRATE BROMPHENIRAMINE MALEATE
%v/v
Tablets
Product not subject to medical prescription
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ilvico Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Coated tablet. (Tablet) Off-white, shiny, round, highly biconvex sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms associated with the common cold, influenza and upper respiratory tract infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 12 YEARS: One or two tablets taken orally with water three times daily. CHILDREN 6-12 YEARS AND THE ELDERLY: One tablet two or four times daily taken orally with water. 4.3 CONTRAINDICATIONS 1. Ilvico must not be used in the presence of narrow-angle glaucoma. 2. Hereditary glucose-6-phosphate dehydrogenase deficiency (risk of haemolytic anaemia). 3. Hypersensitivity to Paracetamol or any of the other ingredients. 4. For pregnancy and nursing mothers. 5. Use in children less than 6 years old. 6. Use in patients with tachyarrhythmias. Each tablet contains: Paracetamol 250 mg Calcium Ascorbate 36 mg (equivalent to ascorbic acid 30mg) Caffeine Monohydrate 10 mg Brompheniramine Maleate 3 mg Also Contains Sucrose 206.5 mg Lactose 63.7 mg Wheat flour 19.0 mg For a full list excipients, see section 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/12/2010_ _CRN 2060305_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION In simultaneous use with drugs which cause enzyme induction in liver, e.g. certain hypnotics and antiepileptics, liver damage may be caused with paracetamol doses which are otherwise not harmful. The same applies to alcohol abuse. When gastric emptying is slowe Lugege kogu dokumenti