Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Paracetamol
Teva B.V.
N02BE01
Paracetamol
Film-coated tablet
paracetamol
Not marketed
2022-04-01
Paracetamol, DE/H/6508/001, 03.03.22 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PARACETAMOL TEVA 500 MG FILM-COATED TABLETS paracetamol _RX _ 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. _OTC _ 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 or pharmacist 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - 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 PARACETAMOL TEVA is and what it is used for 2. What you need to know before you take PARACETAMOL TEVA 3. How to take PARACETAMOL TEVA 4. Possible side effects 5. How to store PARACETAMOL TEVA 6. Contents of the pack and other information 1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have a fever. PARACETAMOL TEVA is used for symptomatic treatment of mild to moderate pain and/or fever. PARACETAMOL TEVA is indicated in adults, adolescents and children aged 6 years and over. 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 PARACETAMOL TEVA DO NOT T Les hele dokumentet
Health Products Regulatory Authority 20 September 2022 CRN00CVW4 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol Teva 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg paracetamol. Excipients with known effect: Each film-coated tablet contains 12 µg of glucose and sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, oval shaped biconvex tablet, breakline on one side of the tablet and plain on the other. The tablet is approximately 7.9 x 17.1 mm in size with a height of approximately 5.0-6.5 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever. Paracetamol Teva is indicated in adults, adolescents and children aged 6 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage is in accordance with the information in the following table. Dose depends on age and body weight, generally 10 to 15 mg/kg body weight as a single dose, up to a maximum of 60 mg/kg body weight as the total daily dose. In each case, the dosing interval depends on the symptoms and maximum total daily dose. It should be no less than 4 hours. For children under the age of 6 years, more suitable formulations are available. If symptoms persist beyond 3 days, a doctor should be consulted. BODY WEIGHT (AGE) SINGLE DOSE (EQUIVALENT PARACETAMOL DOSE) (NUMBER OF TABLETS) MAX. DAILY DOSE (24 H) (EQUIVALENT PARACETAMOL DOSE) (NUMBER OF TABLETS/DOSES MINIMUM INTERVAL BETWEEN DOSES 22 kg - 30 kg (children 6 – 9 years approximately) 250 mg (1 half tablet) 1,000 – 1,500 mg (maximum of 2-3 tablets/4-6 doses) 4 - 6 hours 30 kg- 40 kg (children 9 – 12 years approximately) 500 mg (1 tablet) 1,500 – 2,000 mg (maximum of 3-4 tablets/ doses) 4 -6 hours Health Products Regulatory Authority 20 September 2022 CRN00CVW4 Page 2 of 8 40 kg - 55 kg (children 12 - 15 years approx Les hele dokumentet