Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Paracetamol
Ricesteele Manufacturing Ltd
N02BE; N02BE01
Paracetamol
120.0 mg/5ml
Oral solution
Product not subject to medical prescription
Anilides; paracetamol
Marketed
1984-03-01
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE OR GIVE IT TO A CHILD. • Keep this leaflet. You may need to read it again • If you need more information or advice, please ask your doctor or pharmacist • You must contact your doctor if your child’s symptoms get worse or do not improve • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. . 2. BEFORE YOU GIVE PARALINK PARACETAMOL ORAL SOLUTION TO YOUR CHILD PARACETAMOL ORAL SOLUTION 120MG/5ML IN THIS LEAFLET: 1. What Paralink Paracetamol Oral Solution is and what is it used for 2. Before you give Paralink Paracetamol Oral Solution to your child 3. How to give Paralink Paracetamol Oral Solution 4. Possible side effects 5. How to store Paralink Paracetamol Oral Solution 6. Further information. 1. WHAT PARALINK PARACETAMOL ORAL SOLUTION IS AND WHAT IT IS USED FOR Paralink Paracetamol Oral Solution 120mg/5ml is a strawberry flavoured, colourless, sugar-free solution which contains paracetamol as the active ingredient. Paralink Paracetamol Oral Solution 120mg/5ml is used for the treatment of mild to moderate pain and to relieve symptoms of colds and flu. It is also used to lower a high temperature (fever), including fever following a child’s immunisation. It is suitable for children aged from 2 months. DO NOT GIVE PARALINK PARACETAMOL ORAL SOLUTION TO YOUR CHILD IF: • Your child is allergic to paracetamol or to any of the other ingredients listed (see ingredients list in section 6) • Your child has a ‘hereditary fructose intolerance’, a condition where some sugars can’t be broken down • Your child is taking any other paracetamol containing medicines. TAKE SPECIAL CARE, SPEAK TO YOUR DOCTOR OR PHARMACIST BEFORE USING PARALINK PARACETAMOL ORAL SOLUTION IF: • Your child has kidney or liver problems. TAKING OTHER MEDICINES: Paralink Paracetamol Oral Solution can affect some other medicines your child may be taking. Always tell your docto Прочетете целия документ
Health Products Regulatory Authority 17 February 2020 CRN0095YK Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paralink Paracetamol Oral Solution 120mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains Paracetamol 120mg. Each 5ml also contains: Sorbitol 70% (E420) 1.5 g Propylene Glycol 0.5 g Liquid Maltitol 0.3 g Nipasept 5.0 mg Nipasept contains a mixture of methyl, ethyl and propyl parahydroxybenzoate (E218, E216, E214). _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Oral Solution. Colourless liquid with strawberry odour and taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paralink Paracetamol Solution is indicated as an analgesic and antipyretic. It is used in the treatment of mild to moderate pain, for the relief of symptoms of colds and influenza and to reduce fever, including post-vaccination fever in childhood. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION AGE DOSE For post-vaccination fever for babies aged between 2 – 3 months 2.5mL If necessary, after 4 – 6 hours, give a second 2.5mL dose. o Do not give to babies less than 2 months of age o Do not give more than 2 doses o Leave at least 4 hours between doses o If further doses are needed, talk to your doctor or pharmacist Health Products Regulatory Authority 17 February 2020 CRN0095YK Page 2 of 5 CHILD’S AGE HOW MUCH HOW OFTEN (IN 24 HOURS) 3 – 6 months 2.5mL 4 times 6 – 24 months 5mL 4 times 2 – 4 years 7.5mL 4 times 4 – 6 years 10mL 4 times o Do not give more than 4 doses in any 24 hour period o Leave at least 4 hours between doses o Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist 4.3 CONTRAINDICATIONS Patients with rare hereditary problems of fructose intolerance should not take this medicine. Hypersensitivity to paracetamol or to any of the other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Never give more medicine than shown in the table. Always use the syringe supplied with the pack. Do Прочетете целия документ