Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Ethypharm
500 Milligram
Orodispersible Tablet
2003-03-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dolflash 500 mg orodispersible tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet cotains 500 mg paracetamol (as coated paracetamol cystals) Excipients: each tablet also includes 40 mg aspartame (E951). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. White, round, bi-convex tablet with central concave depression with a characteristic odour of blackcurrant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment for mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY_ This medicinal product is for ADULT USE ONLY_._ The maximum recommended posology is 3000mg of paracetamol per day, corresponding to 6 tablets daily. The usual posology is 1 tablet of 500mg, to be repeated if necessary after a minimum of 4 hours. In the event of intense pain or intense fever, 2 tablets of 500mg, to be repeated if necessary after a minimum interval of 4 hours. Do not exceed 6 tablets of 500mg over a period of 24 hours. _Maximum recommended posology_: The total dose of paracetamol should not exceed 3g daily for adults _(See Section_ _4.9, Overdose)._ _Frequency of administration_ In adults, administration should take place at intervals of a minimum of four hours. _Renal insufficiency_ In the case of severe renal insufficiency the minimum interval between 2 administrations should be 8 hours. _METHOD OF ADMINISTRATION_ Oral route. The tablet should be sucked but not chewed. The tablet may also be dispersed in a half glass of water. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/04/2012_ _CRN 2105529_ _page number: 1_ 4.3 Baca dokumen lengkap