Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Cupal Limited
PARACETAMOL
250 MG/5ml
Oral Suspension
Product not subject to medical prescription
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER MEDINOL OVER 6 250 MG/5 ML ORAL SUSPENSION 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 this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. What this medicine is and what it is used for This Medicine contains paracetamol. This medicine has been specifically formulated for children aged 6 and over and is used for the relief of mild to moderate pain, including headache, toothache and sore throat and can relieve the symptoms of colds, flu and fever. 2. What you need to know before you take this medicine Do not take this medicine… • If you or your child are allergic to any of the ingredients in this product. See 'What this medicine contains' for the full list of ingredients. • At the same time as taking other medicines containing paracetamol. Take special care with… • Continual use of this medicine without a doctor’s supervision may be harmful. • Patients Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medinol Over 6 250mg/5ml oral suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains Paracetamol 250mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. A yellowish/off-white to light orange/brown translucent oral suspension with a taste and smell characteristic of strawberries. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of mild to moderate pain including headache, toothache and sore throat. Symptomatic relief of influenza, feverishness and colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral DOSAGE It is important to SHAKE THE BOTTLE for at least 10 seconds before use. Children aged 12 – 16 years: Two – three 5mL spoonfuls (large end) up to 4 times a day Adults and children over 16 years: Two – four 5mL spoonfuls (large end) up to 4 times a day This suspension should not be used in children under 6 years Child’s Age How Much How often (in 24 hours)* 6 – 8 years One 5 mL spoonful (large end) 4 times 8 – 10 years One 5.0 mL spoonful (large end) and One 2.5 mL spoonful (small end) 4 times 10 – 12 years Two 5 mL spoonfuls (large end) 4 times • Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist • Do not give to children under the age of 6 years IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/07/2013_ _CRN 2112534_ _page number: 1_ 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FO Läs hela dokumentet