Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
paracetamol
Galpharm Healthcare Limited
N02BE01
paracetamol
1 g
Tablett
paracetamol 1 g Aktiv substans
Receptbelagt
Avregistrerad
2016-12-22
VERSION 7 PATIENT LEAFLET: INFORMATION FOR THE USER PARACETAMOL GALPHARM 500MG 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 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, pharmacist or nurse. 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. 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 with fever and 5 days with pain. WHAT IS IN THIS LEAFLET 1. What Paracetamol Galpharm is and what it is used for 2. What you need to know before you take Paracetamol Galpharm 3. How to take Paracetamol Galpharm 4. Possible side effects 5. How to store Paracetamol Galpharm 6. Contents of the pack and other information 1. WHAT PARACETAMOL GALPHARM IS AND WHAT IT IS USED FOR Paracetamol Galpharm contains paracetamol which belongs to the group of medicines called analgesics and antipyretics. Paracetamol Galpharm is used to relieve mild to moderate pain and/or fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL GALPHARM DO NOT TAKE PARACETAMOL GALPHARM If you are allergic to paracetamol Läs hela dokumentet
S UMMARY OF P RODUCT C HARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Paracetamol Galpharm 500mg tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION 1 tablet contains 500 mg of paracetamol. For the full list of excipients, see section 6.1 3 P HARMACEUTICAL F ORM Tablet White, 16.5 x 8.2 mm, oblong tablet with score line on one side. The tablet can be divided into equal doses. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including elderly) and children 12 years and older (minimum 40kg):_ Tablets 500 mg: 1-2 tablets every 4-6 hours,, The maximum daily dose is 4g (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 each weight group given below is for guidance only. 50 mg /kg/day divided into 3 to 4 doses. Maximum treatment time without consulting a doctor is 3 days for fever and 5 days for pain. Tablets 500 mg: Weight Age Dose 17-25 kg 4 - 7 years ½ tablet every 4-6 hours, max. 4 times per 24 hours. 25-40 kg 7-12 years ½-1 tablet every 4-6 hours, max. 4 times per 24 hours. >40 kg >12 years 1-2 tablets every 4-6 hours, max. 8 tablets per 24 hours. The dose interval should always be at least 4 hours. Maximum daily dose should not be execeeded due to risk of serious hepatic damage (see sections 4.4 and 4.9) Method of administration For oral administration. _Special groups of patients:_ Impaired liver function: In patients with impaired hepatic function or Gilbert’s syndrome, the dose must be reduced or the dosing interval prolonged. Impaired kidney function: In patients with renal insufficiency, the dose should be reduced: Glomerular filtration rate Dose 10–50 ml/min 500 mg every 6 hours < 10 ml/min 500 mg every 8 hours Elderly patients: Dose adjustment is not required in the elderly. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the ex Läs hela dokumentet