Country: Sweden
Bahasa: Sweden
Sumber: Läkemedelsverket (Medical Products Agency)
paracetamol
Accord Healthcare B.V.
N02BE01
paracetamol
500 mg
Brustablett
sorbitol Hjälpämne; paracetamol 500 mg Aktiv substans
Receptbelagt
Förpacknings: Strip, 10 tabletter; Strip, 12 tabletter; Strip, 16 tabletter; Strip, 20 tabletter; Strip, 24 tabletter; Strip, 30 tabletter; Strip, 40 tabletter; Strip, 60 tabletter; Strip, 90 tabletter; Strip, 100 tabletter; Strip, 500 tabletter; Tub, 10 tabletter; Tub, 12 tabletter; Tub, 16 tabletter; Tub, 20 tabletter; Tub, 24 tabletter; Tub, 30 tabletter; Tub, 40 tabletter; Tub, 60 tabletter; Tub, 90 tabletter; Tub, 100 tabletter; Tub, 500 tabletter; Tub, 6 tabletter; Strip, 6 tabletter
Godkänd
2019-06-27
1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PARACETAMOL ACCORD 500 MG EFFERVESCENT TABLETS paracetamol [For medicines available only on prescription:] 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 pharmacis. - 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. [For medicines available without prescription:] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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 Baca dokumen lengkap3. 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 [For medicines available only on prescription:] contains paracetamol which belongs to the group of medicines called analgesics and antipyretics. is used to relieve mild to moderate pain and/or fever. [For medicines available without prescription:] contains paracetamol which belongs to th
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paracetamol Accord 500 mg effervescent tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg paracetamol. Excipients with known effect: Each 500 mg tablet contains 418.5 mg sodium and 100 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Effervescent tablet. White to off-white, round, flat, beveled edges tablets, plain on both sides with odour of lemon. Diameter: 25.4 mm approximately 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Maximum daily dose should not be exceeded due to risk of serious hepatic damage (see sections 4.4 and 4.9). _Adults and adolescents over 50 kg bodyweight (>15 years):_ 1 - 2 tablets (500 mg – 1 g) every 4 to 6 hours as required. It is generally not required to exceed 3 g of paracetamol per day (6 tablets per 24 hours). The maximum daily dose is 4 g (8 tablets per 24 hours). _Paediatric population:_ Paediatric dosage should be based on body weight and suitable dosage form used. Information on the age of children within the weight group given below is for guidance only. The recommended dose for children is 10-15 mg/kg body weight every 4-6 hours, 3 to 4 times per 24 hours. The maximum dose for children is 60 mg/kg/24 hours divided into 4 doses. _Children over 40 kg bodyweight (>12 years):_ 1 tablet (500 mg) every 4-6 hours. The maximum daily dose is 2.5 g (5 tablets per 24 hours). The dose interval should always be at least 4 hours. Method of administration 2 For oral administration. The tablets should be placed in a glas of water and allowed to dissolve completely before swallowing. _Special groups of patients:_ Impaired liver function, chronic alcohol consumption: In patients with impaired hepatic function or Gilbert’s syndrome, the dose must be reduced or the dosing interval prolonged (see section 4.4). Impaired kidney function: I Baca dokumen lengkap