Country: Малта
Језик: Енглески
Извор: Medicines Authority
PARACETAMOL
Rosemont Pharmaceuticals Limited Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds LS11 9XE, United Kingdom
N02BE01
PARACETAMOL 120 mg/5ml
ORAL SUSPENSION
PARACETAMOL 120 mg/5ml
OTC
ANALGESICS
Withdrawn
2006-08-28
PARACETAMOL 120MG/5ML ORAL SUSPENSION MODULE 1.3.1 LEAFLET VERSION: APRIL 2018 PAGE 1 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 have 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. WHAT IS IN THIS LEAFLET 1. What Paracetamol Oral Suspension is and what it is used for 2. What you need to know before you take Paracetamol Oral Suspension 3. How to take Paracetamol Oral Suspension 4. Possible side effects 5. How to store Paracetamol Oral Suspension 6. Contents of the pack and other information Paracetamol belongs to a group of medicines called pain-killers or analgesics. It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains. It is also used to relieve the symptoms of cold and flu. It is also used to help reduce a fever (high temperature). DO NOT TAKE PARACETAMOL: If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath If you have a liver disorder. Speak to your doctor or pharmacist if any of these apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Paracetamol if you have: kidney problems liver problems, including those due to drinking too much alcohol. 1. WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR PARACETAMOL 120MG/5ML ORAL SUSPENSION 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL ORAL SUSPENSION PARACETA Прочитајте комплетан документ
PARACETAMOL 120MG/5ML ORAL SUSPENSION PAGE 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paracetamol 120mg/5ml Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol 120mg/5ml Excipients with known effect: Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Sucrose 3g/5ml Sorbitol (E420) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Suspension Off-white cream suspension 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains. For the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology FOR THE RELIEF OF FEVER AFTER VACCINATIONS AT 2, 3 AND 4 MONTHS One 2.5 mL spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist. AGE: 2 – 3 MONTHS DOSE PAIN AND OTHER CAUSES OF FEVER - if your One 2.5 mL spoonful (small end). PARACETAMOL 120MG/5ML ORAL SUSPENSION PAGE 2 baby weighs over 4 kg and was born after 37 weeks If necessary, after 4-6 hours, give a second 2.5 mL dose Do not give to babies less than 2 months of age Leave at least 4 hours between doses Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. CHILD’S AGE HOW MUCH HOW OFTEN (IN 24 HOURS) 3 – 6 months One 2.5 mL spoonful (small end) 4 times 6 – 24 months One 5 mL spoonful (large end) 4 times 2 – 4 years One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end) 4 times 4 – 8 years Two 5 mL spoonfuls (large end) 4 times 8 – 10 yea Прочитајте комплетан документ