Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Caffeine; Codeine phosphate; Paracetamol
Kent Pharma (UK) Ltd
Caffeine; Codeine phosphate; Paracetamol
30mg ; 8mg ; 500mg
Effervescent tablet
Oral
Schedule 5 (CD Inv)
Never Valid To Prescribe As A VMP
BNF: 04070100; GTIN: 5015201009627
BXP064BPC BXP064BPC PATIENT INFORMATION LEAFLET CODASOL E 8MG/500MG/30MG EFFERVESCENT TABLETS (CODEINE, PARACETAMOL AND CAFFEINE) The name of this medicine is Codasolve 8mg/500mg/30mg Effervescent Tablets. This medicine will be referred to as Codasolve Effervescent Tablets throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. • You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice. • This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it. • If you take this medicine for headaches for more than three days it can make them worse. • Keep this leaflet. You may need to read it again. IN THIS LEAFLET: 1. What Codasolve Effervescent Tablets are and what they are used for 2. Before you take Codasolve Effervescent Tablets 3. How to take Codasolve Effervescent Tablets 4. Possible side effects 5. How to store Codasolve Effervescent Tablets 6. Further information 1. WHAT CODASOLVE EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR Codasolve Effervescent Tablets contain the active ingredients codeine phosphate hemihydrate 8 mg, paracetamol 500 mg and caffeine 30 mg. This medicine can be used in patients over 12 years of age for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They are used to relieve migraine, headache, dental pain, period pain, backache, rheumatic pain, strains and sprains, and sciatica. 2. BEFORE YOU TAKE CODASOLVE EFFERVESCENT TABLETS THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION IF YOU TAKE IT CONTINUOUSLY FOR MORE THAN THREE DAYS. THIS CAN GIVE YOU WITHDRAWAL SYM Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol, Codeine and Caffeine 500mg/8mg/30mg Effervescent Tablets. Codasolve 8mg/500mg/30mg Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION E ach tablet contains paracetamol 500mg, codeine phosphate hemihydrate 8mg and caffeine 30mg. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. White to off-white coloured circular flat bevelled tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Codeine is indicated in patients older than 12 years of age for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This medicine is recommended for the relief of migraine, headache, backache, rheumatic pain, period pain, dental pain, strains and sprains and sciatica. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicine should be dissolved in at least half a tumbler of water. DOSAGE ADULTS One to two tablets dissolved in water not more frequently than every 4-6 hours when necessary to a maximum of 8 tablets in 24 hours. ELDERLY Same as adult dose. A reduced dose may be required PAEDIATRIC POPULATION: Children aged 16-18 years: One to two tablets dissolved in water every 6 hours when necessary to a maximum of 8 tablets in 24 hours. Children aged 12-15 years: One tablet dissolved in water every 6 hours when necessary to a maximum of 4 tablets in 24 hours. Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). Method of Administration This medicine is for oral administration only. Do not take for more than 3 days continuously and if no effective pain relief is achieved the patients/carers should be advised to seek medical review. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol, codeine, caffeine, opioid analgesics or any of the other c Læs hele dokumentet