Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Ranbaxy Ireland Limited
PARACETAMOL
500 Milligram
Tablets
Product not subject to medical prescription
Withdrawn
2010-09-10
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/004/001 Case No: 2051264 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RIMADOL PARACETAMOL TABLETS BP 500MG The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 29/05/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/05/2008_ _CRN 2051264_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimadol Paracetamol Tablets BP 500 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of Paracetamol. Excipients: Each tablet contains 16.67mg lactose monohydrate. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet White, capsule shaped tablet, embossed with 'RIMADOL' on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of the symptoms of headache, toothache, common cold, influenza, menstrual pain, musculoskeletal disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults (including the elderly): The usual dose is 2 tabl Read the complete document