Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PARACETAMOL 1000 mg/stuk
Neogen N.V. Marie Curie Square 1070 ANDERLECHT (BELGIË)
N02BE01
PARACETAMOL 1000 mg/stuk
Filmomhulde tablet
HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Paracetamol
Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; POVIDON K 30 (E 1201); STEARINEZUUR (E 570); TALK (E 553 B); TITAANDIOXIDE (E 171);
2016-04-26
1 PACKAGE LEAFLET - 1000 MG 2 PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL NEOGEN 1000 MG FILMOMHUDE TABLETTEN Paracetamol 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. WHAT IS IN THIS LEAFLET 1. What /.../ is and what it is used for 2. What you need to know before you use /.../ 3. 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 /…/ contains active substance paracetamol which belongs to a group of medicines called analgesics (painkillers). /.../ may be used in adults and children weighing more than 55 kg (i.e. about 15 years). This medicinal product is not considered suitable for children weighing less than 55 kg. Ask your pharmacist or doctor for advice. /.../ is used to relieve pain and help reduce fever. The tablets can treat mild to moderate pain and/or fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE /.../ DO NOT TAKE /.../: - if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). - if you are below 6 years of age. WARNINGS AND PRECAUTIONS Talk to your doctor before taking /.../: - if you are taking other paracetamol containing medicines, as it may severely damage the liver. - if you have liver problems (including Gilbert’s syndrome or acute hepatitis). - If you have impaired kidney function. - if you have a deficiency of a certain enzyme called glucose-6-phosphatase. - if you have haemolytic anaemia (abnormal breakdown of red blood cells). - if you have a Läs hela dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Paracetamol Neogen 500 mg filmomhulde tabletten Paracetamol Neogen 1000 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 500 mg: Each film-coated tablet contains 500 mg paracetamol 1000 mg: Each film-coated tablet contains 1000 mg paracetamol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 500 mg: White, film-coated, oval tablet, scored and marked "P 500" on one side. 1000 mg: White, film-coated, oval tablet that has a break line on one side and is 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/or fever. _FOR THE 500 MG STRENGTH_ This product is indicated in adults and children weighing more than 30 kg (i.e. about 9 years). _FOR THE 1000 MG STRENGTH_ This product is indicated in adults and children weighing more than 55 kg (i.e. about 15 years). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ _ _FOR THE 500 MG STRENGTH: _ _ _ _Adults and children over 15 years (> 55 kg body weight) _ 1 to 2 tablets of 500 mg at a time, up to 6 tablets (3000 mg) per 24 hours. The dosing interval should be at least 4 hours. _Paediatric population_ Children from 9 to 15 years This pharmaceutical form is not considered suitable for children below the age of 6. The posology depends on the child’s bodyweight. The recommended dose is 60 mg/kg/day, not more than 3000 mg (3 g) per day: 3 - 30-40 kg (about 9-12 years): 1 tablet at a time (i.e. 500 mg), up to 3-4 times in 24 hours, with a dosing interval of 6-8 hours. - 40-55 kg (about 12-15 years): 1 tablet at time (i.e. 500 mg), up to 4-6 times per 24 hours, with a dosing interval of 4-6 hours. The lower frequency of administration is intended for children in the lower limit of the relevant weight group. Systematic administration, including during the night, helps to avoid pain and fever oscillations. _ _ _FOR THE 1000 MG ST Läs hela dokumentet