Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Paracetamol
Alter Pharma
N02BE; N02BE01
Paracetamol
500 milligram(s)
Film-coated tablet
Anilides; paracetamol
Not marketed
2014-10-03
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER PADOLIEVE 500 MG FILM-COATED TABLETS paracetamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Padolieve is and what it is used for 2. What you need to know before you take Padolieve 3. How to take Padolieve 4. Possible side effects 5. How to store Padolieve 6. Contents of the pack and other information 1. WHAT PADOLIEVE IS AND WHAT IT IS USED FOR PADOLIEVE CONTAINS PARACETAMOL. Paracetamol is a pain relieving, fever reducing medicinal product (analgesic and antipyretic). Paracetamol is used for symptomatic treatment of mild to moderate pain and/or fever. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PADOLIEVE DO NOT TAKE PADOLIEVE: - if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). - If you are taking any other paracetamol containing products. WARNINGS AND PRECAUTIONS Talk to your doctor,pharmacist or nurse before taking Padolieve if; - you have kidney or liver disease - you regularly consume excess amounts of alcohol - you suffer from a condition known as Gilberts syndrome - you are in a poor nutritional state e.g. due to eating disorders, cystic fibrosis, HIV infection, starvation - you have severe haemolytic anaemia (abnormal breakdown of red blood cells). Never take more paracetamol than recommended. A higher dose does not increase pain relief; inste Lugege kogu dokumenti
Health Products Regulatory Authority 04 January 2023 CRN00CY53 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Padolieve 500mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, caplet shaped, film-coated tablets with ‘P’, a bisect breakline and ‘500’ on one side and plain on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly)_ The usual dose is 500 mg to 1,000 mg every 4 to 6 hours as needed, to a maximum of 3 g daily. Maximum single dose is 1,000 mg. The maximum daily dose must not be exceeded due to risk of serious hepatic damage (see sections 4.4 and 4.9). _Paediatric population (weighing 25‑50 kg)_ The recommended total daily dose of paracetamol is approximately 60 mg/kg divided in 4 or 6 separate doses, or approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours. Maximum daily dose must not be exceeded due to risk of serious hepatic damage (see sections 4.4 and 4.9). Paediatric dosage should be based on body weight and a suitable dosage should be used. Information on the age of children within each weight group given below is for guidance only. Care must be taken not to exceed the maximum number of doses in a 24 hour period i.e. not more than 4 doses in a 24 hour period. Paracetamol should only be administered when clearly necessary and at the lowest efficacious dose. _Children and adolescents weighing 43‑50 kg (about 12‑15 years)_ The usual dose is 500 mg every 4 hours as needed, up to a maximum of 4 tablets daily. _Children weighing 34‑43 kg (about 11‑12 years)_ The usual dose is 500 mg every 6 hours as needed, up to a maximum of 4 tablets daily. _Children weighing 26‑34 kg (about 8‑11 years Lugege kogu dokumenti