Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PARACETAMOL CODEINE PHOSPHATE DOXYLAMINE SUCCINATE CAFFEINE
SSL International plc
450mg,10mg Milligram
Tablets
2009-09-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol, Codeine, Caffeine and Doxylamine Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Film-coated Tablet Yellow, capsule shaped tablet, embossed ‘SYNDOL’ on one side with a single breakline on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief in tension headache and other pains of a similar tension state origin. For the symptomatic relief of pain following surgical and dental operations and procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years Take 1 or 2 tablets every four or six hours as need for relief. Do not exceed 8 tablets per day. Not recommended for children under 12 years. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product should not be administered to children under the age of 12 years unless prescribed specifically by the physician. The use of this product may induce drowsiness. Persons should not drive or operate machinery unless this effect has been shown not to occur. Do not exceed the stated dose. PROLONGED REGULAR USE, EXCEPT UNDER MEDICAL SUPERVISION, MAY LEAD TO PHYSICAL AND PSYCHOLOGICAL DEPENDENCE (ADDICTION) AND RESULT IN WITHDRAWAL SYMPTOMS, SUCH AS RESTLESSNESS AND IRRITABILITY ONCE THE DRUG IS STOPPED This product should only be used when clearly necessary. Paracetamol 450.00 mg Codeine Phosphate 10.00 mg Doxylamine Succinate 5.00 mg Caffeine 30.00 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/04/2010_ _CRN 2080967_ _page number: 1_ If symptoms persist or become worse, consult your d Citiți documentul complet