Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CODEINE PHOSPHATE HEMIHYDRATE PARACETAMOL
PCO Manufacturing
CODEINE PHOSPHATE HEMIHYDRATE PARACETAMOL
30/500 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-11-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tylex 30 mg / 500 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate. Excipients: Sodium metabisulphite (E223) and Soya lecithin For full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. _Product imported from the UK_ Hard gelatin capsules with white body and red cap, both with ‘C30’ printed in black 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _The capsules are given orally. The usual dose is one or two capsules every four hours as required. The total daily dose should not exceed 240 mg of codeine phosphate hemihydrate (i.e. not more than four doses per 24 hours should be taken). _Elderly: _A reduced dose may be required. _Children: _Use in children under 12 years of age is not recommended. Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. 4.3 CONTRAINDICATIONS Tylex Capsules should not be administered to patients who have previously exhibited hypersensitivity to either paracetamol or codeine, or to any of its excipients. Tylex Capsules are not recommended for children under the age of 12 years. Use of codeine containing products is contraindicated in mothers who are breastfeeding unless pr Belgenin tamamını okuyun