Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate
Clonmel Healthcare Ltd
N02AJ; N02AJ06
Paracetamol; Codeine phosphate hemihydrate
500 mg/30 milligram(s)
Capsule, hard
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Not marketed
2013-11-29
PACKAGE LEAFLET: INFORMATION FOR THE USER CO-TIPOL 500MG / 30MG HARD CAPSULES PARACETAMOL/ CODEINE PHOSPHATE HEMIHYDRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IM- PORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - 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 Co-Tipol is and what it is used for 2. What you need to know before you take Co-Tipol 3. How to take Co-Tipol 4. Possible side effects 5. How to store Co-Tipol 6. Contents of the pack and other information 1. WHAT CO-TIPOL IS AND WHAT IT IS USED FOR Co-Tipol is a pain killer (analgesic) used for the treatment of moderate to severe pain. It is a mixture of two drugs, paracetamol and codeine phosphate hemihydrate. They are part of a group of medicines known as analgesics (pain killers). Co-Tipol can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paraceta- mol. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TIPOL - This product contains paracetamol and codeine phosphate hemihydrate. Do not take Co-Tipol with any other product that contains paracetamol or codeine phosphate. - Contains paracetamol - Do not take any other paracetamol-containing products - Do not exceed the stated dose - Immediate medical advice should be sought in the event of overdosage, because of the risk of irre- versible liver damage. DO NOT TAKE Pročitajte cijeli dokument
Health Products Regulatory Authority 19 September 2022 CRN00CX41 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co‐Tipol 500 mg/30 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 500 mg paracetamol and 30 mg codeine phosphate hemihydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule Co‐Tipol are hard capsules consisting of a white and a yellowish orange section containing white powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Moderate to severe pain. Children 12‐18 years: Co‐Tipol is only suitable for use in children older than 12 years for treatment of acute moderate pain that cannot be relieved by other analgesics such as paracetamol and ibuprofen (alone). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology AGE SINGLE DOSE MAXIMUM DAILY DOSE (24 HOURS) Adults (18 years and over) 1 ‐ 2 hard capsules (equivalent to 500 ‐ 1,000 mg of paracetamol and 30 ‐ 60 mg of codeine phosphate hemihydrate) Up to 8 hard capsules (equivalent to up to 4,000 mg of paracetamol and up to 240 mg of codeine phosphate hemihydrate) The maximum daily dose must not be exceeded, and the interval between doses should be at least six hours (if any further capsules are needed). This product should not be used with other paracetamol or codeine‐containing medicines. Co‐Tipol should be used at the lowest effective dose for the shortest possible time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg. The maximum daily dose of paracetamol should not exceed 60mg/kg/day (up to a maximum of 2g per day) in the following situations, unless directed by a physician: Weight less than 50kg Chronic alcoholism Dehydration Chronic malnutrition Renal and hepatic impairment The dose should be reduced or the interval between doses should be increased in the presence of impaired liver and/or kidney function and in subje Pročitajte cijeli dokument