Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FELODIPINE
Rowex Ltd
2.5 Milligram
Tablet Prolonged Release
2008-08-22
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/135/001 Case No: 2037713 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product FELODIPINE 2.5 MG PROLONGED RELEASE TABLETS 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 22/08/2008 until 21/08/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2037713_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Felodipine 2.5 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged release tablet contains 2.5 mg felodipine. Excipient: lactose monohydrate 48.77 mg/prolonged release tablet For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet Round, biconvex film-coated-tablets, pale yellow; embossment “2.5” on one side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration The dose should be adjusted to the individual requirements of the patient. Felodipine should usually be Read the complete document