Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Actavis UK Ltd
N02BE01
Paracetamol
500mg
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5012617017079 5012617017086
Seite 3 Seite 1 PACKAGE LEAFLET – INFORMATION FOR THE USER PARACETAMOL 500MG SOLUBLE TABLETS 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 pharmacist • Do not pass this medicine 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. WHAT IS IN THIS LEAFLET: 1. What paracetamol is and what it is used for 2. What you need to know before you take paracetamol 3. How to take paracetamol 4. Possible side effects 5. How to store paracetamol 6. Contents of the pack and other information 1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR The name of your medicine is Paracetamol 500mg Soluble Tablets (called paracetamol throughout this leaflet). This medicine contains paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used to treat pain (including headache, toothache and period pain) and cold or flu symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL DO NOT TAKE PARACETAMOL AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) 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 Soluble Tablets 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 Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500mg Soluble Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. Flat white tablets scored on one side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol Soluble is a mild analgesic and antipyretic. The tablets are recommended for the treatment of most painful conditions for example, headache, including migraine, toothache, sore throat, dysmenorrhoea, rheumatic pains and the symptomatic relief of colds and influenza. 4.2 Posology and method of administration POSOLOGY Adults, Elderly and Children over 16 years: Two tablets in at least half a tumbler full of water, up to 4 times daily as required. Do not take for more than 3 days without consulting your doctor. These doses should not be given 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 the age of 10 years. Children aged 10 to 15 years One tablet 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 The tablets should be dissolved in water and are for oral administration only. 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. Immediate medical Citiți documentul complet