Country: নেদারল্যান্ডস
ভাষা: ডাচ
সূত্র: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PARACETAMOL
Olvos Science S.A.
N02BE01
PARACETAMOL
Orodispergeerbare tablet
AARDBEIENSMAAKSTOF ; ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ETHYLCELLULOSE (E 462) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421),
Oraal gebruik
Paracetamol
Hulpstoffen: AARDBEIENSMAAKSTOF; ARABISCHE GOM (E 414); ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); ETHYLCELLULOSE (E 462); MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421);
2013-04-10
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER PREST 500 MG ORODISPERGEERBARE 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 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. What Prest is and what it is used for 2. What you need to know before you take Prest 3. How to take Prest 4. Possible side effects 5. How to store Prest 6. Contents of the pack and other information 1. WHAT PREST IS AND WHAT IT IS USED FOR Prest contains the active substance paracetamol which belongs to a group of medicines called analgesics (painkillers). Prest is used for symptomatic treatment of mild to moderate pain and/or fever. Prest 500 mg orodispergeerbare tabletten may be used in adults and adolescents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREST DO NOT TAKE PREST - if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Prest: - 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 drink alcohol. - if you have a poor nutritional status, for example as a result of alcohol abuse, loss of appetite (anorexia), or malnutrition. You may have to take a lower dose, সম্পূর্ণ নথি পড়ুন
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prest 500 mg, orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 500 mg paracetamol. Excipient with known effect Each tablet contains 22.4 mg aspartame (E951). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet White to off-white round, flat face radius edge tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prest 500 mg orodispersible tablet is indicated in adults and adolescents only. Symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Doses depend on body weight and age; a single dose ranges from 10 to 15 mg/kg body weight (= b.w.) to a maximum of 60 mg/kg b.w. for total daily dose (see also section 4.4). Adolescents: 500 mg, max 3000 mg per 24 hours. Adults: 500-1000 mg, max 3000 mg per 24 hours. Prest 500 mg orodispersible tablet is not recommended in children below 12 years of age (43 kg). _Direction for use: _ - The specific dose interval depends on the symptoms and the maximum daily dose. Depending on the reoccurrence of symptoms (fever and/or pain), repeated administration is allowed. It should, however, preferably never fall below 6 hours and in no case fall below 4 hours. - Not to be used in combination with other paracetamol-containing products. Page 2 of 10 - The indicated dose must not be exceeded due to risk of serious damage to the liver (see section 4.4 and 4.9). - If the patient does not feel better or he/she feels worse after 3 days or if other symptoms occur, treatment should be discontinued and a physician should be consulted. - The ingestion of paracetamol with food and drink does not affect the efficacy of the medicinal product. _Renal impairment _ In case of renal insufficiency (renal failure), the dose should be reduced. For adults: Glomerular filtration rate Dose 10 – 50 ml/min, 500 mg every 6 hours < 10 ml/min, 500 mg every 8 hours _H সম্পূর্ণ নথি পড়ুন