País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Flamingo Pharma (UK) Ltd
N02BE01
Paracetamol
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5060464500862 5060464500039
XXXX PHARMA CODE XXXX PHARMA CODE 285 mm 285 mm 150 mm 150 mm FONTS SIZE : Header's font size : 12 pt. Generic fonts size : 9 pt. FONTS : Arial _(GSL)_ PARACETAMOL 500MG TABLETS (FPL) LEAFLET SIZE : 285 X 150 MM MPLLPAR0500CL016FPLXXX240V02 Package leaflet: Information for the patient PARACETAMOL 500 MG TABLETS PARACETAMOL 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. • 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. 1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS 3. HOW TO TAKE PARACETAMOL TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PARACETAMOL TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT IS IN THIS LEAFLET These tablets contain the active ingredient, paracetamol. Paracetamol is an analgesic and an antipyretic which means it relieves pain and lowers temperature. Paracetamol Tablets are used for the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, rheumatic aches and pains. Also for the relief of symptoms of influenza, feverishness and feverish colds. 1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR SOME PEOPLE MUST NOT TAKE THESE TABLETS. DO NOT TAKE PARACETAMOL TABLETS: • If you are allergic to paracetamol or to any other of the other ingredients of this medicine (listed in section 6). DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Paracetamol Tablets • If you suffer from any liver or kidney prob Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500mg Tablets BP. PocketPak Paracetamol 500 mg Caplets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol 500mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. White, capsule shaped tablet with a break-line on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, aches and pains. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness, feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Adults, the elderly and children 16 years and over: One or two tablets to be taken up to four times daily. Maximum dose of 8 tablets in 24 hours. Children 10 to 15 years of age: One tablet to be taken for every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Children under 10 years of age: Not recommended. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500mg. The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24 hour period. Dosage should not be continued for more than 3 days without consulting a doctor. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Where analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen. Headache induced by overuse of analgesics (MOH medication-overuse headache) should not be treated by dose increase. In such cases, the use of analgesics should be discontinued in consultation with the doctor. Care is advised in the administration of paracetamol to patients with alcohol dependency (see section 4.9), severe renal or severe hepatic impairment. The hazards of overdose are greater Leia o documento completo