Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Zentiva Pharma UK Ltd
N02BE01
Paracetamol
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5000283607083 0000050283200 5000283653745
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What paracetamol is and what it is used for 4. Possible side effects 2. What you need to know before you take paracetamol 5. How to store paracetamol 3. How to take paracetamol 6. Contents of the pack and other information FRONT BACK [554778] [1065033083] ZEN-01180422-9TT-UK-EX PARACETAMOL CAPSULES -100'S PACK- DO NOT TAKE PARACETAMOL AND TELL YOUR DOCTOR IF: • You are allergic to the active substance or any of the other ingredients in your medicine (listed in section 6) Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue CHILDREN Paracetamol 500mg Capsules must not be given to children under 10 years of age Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE AND CHECK WITH YOUR DOCTOR BEFORE TAKING PARACETAMOL IF: • You have severe kidney or liver problems • You have a liver problem caused by alcohol If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. OTHER MEDICINES AND PARACETAMOL Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also, some other medicines Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500mg of paracetamol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Size 0 capsule marked ‘S174’ with blue cap and white body containing a white granular powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol capsules are recommended for the treatment of headaches, including migraine and tension headaches; also for backache, rheumatic and muscle pains, ‘nerve pains’, toothache, dysmenorrhoea, sore throat and for relieving the fever, aches and pains of colds and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults, Elderly and Children over 16 years Two capsules up to 4 times a day. Do not take for more than 3 days without consulting your doctor. These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period. PAEDIATRIC POPULATION Not recommended for children under 10 years of age . Children aged 10 to 15 years One capsule every four to six hours when necessary to a maximum of four doses in 24 hours. Do not take for more than 3 days without consulting your doctor. METHOD OF ADMINISTRATION For oral administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE PAEDIATRIC POPULATION Not recommended for children under the age of 10 years. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. Do not exceed the recommended dose Do not take with any other paracetamol-containing products. If symptoms persist consult your doctor. Keep out of the reach of children. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of Perskaitykite visą dokumentą