Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dihydrocodeine tartrate; Paracetamol
Crescent Pharma Ltd
N02AJ01
Dihydrocodeine tartrate; Paracetamol
30mg ; 500mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070100; GTIN: 5012854023826
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT REMEDEINE FORTE tablets Co-Dydramol 30/500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablet containing paracetamol 500 mg and dihydrocodeine tartrate BP 30 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, circular, flat faced tablet with a bevelled edge. The tablet is engraved PD 30 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of severe pain where there is a higher analgesic requirement (higher than tablets of 500/20 mg). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ 1 or 2 tablets every four to six hours when necessary to a maximum of 8 tablets in 24 hours. _Elderly _ One tablet every 4 - 6 hours increasing to two tablets every 4 - 6 hours if required and tolerated. Do not exceed eight tablets in any 24 - hour period. _Paediatric population_ _Children 16 to 18 years _ 1 or 2 tablets every six hours when necessary to a maximum of 8 tablets in 24 hours. _Children 12 to 15 years _ 1 tablet every six hours when necessary to a maximum of 4 tablets in 24 hours. _Children under 12 years _ Not recommended. Method of administration For oral use. This medicine should, if possible, be taken during or after meals. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Respiratory depression. Obstructive airways disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This medicine should be given with caution in patients with allergic disorders and should not be given during an attack of asthma. Caution should also be observed if there is marked impairment of liver function, advanced kidney disease and in chronic alcoholics. _Risk from concomitant use of sedative medicines such as benzodiazepines or related _ _drugs: _ Concomitant use of this medicine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of Прочитайте повний документ