Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
PARACETAMOL CODEINE PHOSPHATE HEMIHYDRATE DOXYLAMINE SUCCINATE CAFFEINE
Seton Products Ltd
Tablets
1994-04-17
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Syndol Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM 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 to 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. It is dangerous to exceed the recommended 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. If symptoms persist or become worse, consult your doctor. Paracetamol 450 mg Codeine phosphate hemihydrate 10 mg Doxylamine succinate 5 mg Caffeine 30 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/05/2010_ _CRN 2083312_ _pa Läs hela dokumentet