Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Accord-UK Ltd
N02BE01
Paracetamol
500mg
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5055565702246 5055565712122 5055565712160 5055565712115 5055565702253 5055565747810
PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL 500 MG EFFERVESCENT TABLETS 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, pharmacist or nurse. • 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. WHAT IS IN THIS LEAFLET: 1. What Paracetamol Effervescent Tablets is and what it is used for 2. What you need to know before you take Paracetamol Effervescent Tablets 3. How to take Paracetamol Effervescent Tablets 4. Possible side effects 5. How to store Paracetamol Effervescent Tablets 6. Contents of the pack and other information 1. WHAT PARACETAMOL EFFERVESCENT TABLETS IS AND WHAT IT IS USED FOR Paracetamol Effervescent Tablets contain Paracetamol, which is a mild pain killer and reduces the body temperature in fever. The tablets are recommended for use in treatment of mild to moderate pain and/or fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL EFFERVESCENT TABLETS DO NOT TAKE PARACETAMOL EFFERVESCENT TABLETS • If you are allergic to Paracetamol, or any of the ingredients of this medicine (listed in section 6).. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Paracetamol Effervescent Tablets if you: • Are suffering from liver problems including liver problems due to excessive alcohol consumption. • Gilbert’s syndrome (mild jaundice) • Are suffering from kidney problems • Are suffering from dehydration and chronic malnutrition • Are on long-term treatment with higher doses of Paracetamol. • Are asthmatics sensitive to Aspirin. • Are on other Paracetamol containing drugs • Have fever even after Paracetamol t Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500 mg Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains 500 mg of Paracetamol. Excipients with known effect: Sodium content approximately 418.5 mg/tablet. Also contains sorbitol (E420) 100 mg /tablet. For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Effervescent Tablet White to off white round, flat, beveled edged plain on both side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology This presentation is reserved for use only in adults and in adolescents aged 12 years and above. 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. Pediatric Patients: Children below 12 years of age: Paracetamol effervescent Tablet is not recommended in children aged less than 12 years. • Adolescents of 12 to 15 years and weighing 41 to 50 kg the posology is one tablet per dose, repeated if necessary 6-4 hours later, without exceeding 4 tablets daily. • Adolescents of 16 to 18 years and weighing more than 50 kg: as adults. Adults: The usual adults dose is one to two tablets of 500mg, repeated if necessary 4 hours later, without exceeding 3g of Paracetamol a day (i.e. 6 tablets). Maximum daily dose: The maximum daily dose of Paracetamol must not exceed 3g. Maximum single dose is 1g (2 effervescent tablets) Frequency of administration: The specific dose interval depends on the symptoms and the maximum daily dose. Systematic administration enables to avoid pain or fever oscillation. 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. In adolescents administration should be regularly spaced, including nighttime, preferably at 6 hour intervals, otherwise at Прочитать полный документ