Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PARACETAMOL 1000 mg/stuk
PARACETAMOL 1000 mg/stuk
Tablet
ALGINEZUUR (E 400) ; CALCIUMCARBONAAT (E 170) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551), ALGINEZUUR ; CALCIUMCARBONAAT (E 170) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551)
Oraal gebruik
2022-04-22
Paracetamol, DE/H/6508/002, 03.03.22 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PARACETALGIN 1000 MG, TABLETTEN 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 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. Whatis and what it is used for 2. What you need to know before you take Read the complete document3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT 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. is used for symptomatic treatment of mild to moderate pain and/or fever. is indicated in adults and adolescents aged 16 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 DO NOT TAKE: - if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS To avoid overdose tell your doctor if you are taking other paracetamol containing products. Your doctor will adjust the dosage, in order to avoid the risk of overdose. Do not take any other paracetamol-containing products. Talk to your doctor or pharmacist before using if you: - have liver or kidney problems - are underweight or malnourished - regularly drink alcohol - are suffering from impaired liver function (liver inflammation,
Paracetamol , DE/H/6508/001, 03.03.22 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Paracetalgin 1000 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1000 mg paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white, oval shaped biconvex tablet, breakline on both sides of the tablet. The tablet is approximately 9.2 x 22.0 mm in size with a height of approximately 7.0-8.5 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.is indicated in adults and adolescents aged 16 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. 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 > 55 kg (adults and adolescents from 16 years of age) 500 mg – 1,000 mg ( 1 / 2 -1 tablet) 3,000 mg (maximum of 3 tablets/ 3-6 doses) 4 – 6 hours The maximum daily dose (24 hours) stated in the table must not be exceeded under any circumstances. 2 The lowest dose necessary to achieve efficacy should be used. Maximum duration of continued use without medical advice: 3 days. Elderly patients Dose adjustment is not required in the elderly. However, it should be taken into account that renal and/or hepatic insufficiency is more common in the elderly (see section 4.4). Renal impairment Paracetamol should be used with caution in the presence of renal insufficiency and Read the complete document