Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Codeine phosphate hemihydrate; Paracetamol
UCB (Pharma) Ireland Limited
N02AJ; N02AJ06
Codeine phosphate hemihydrate; Paracetamol
30/500 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Marketed
1997-02-21
PACKAGE LEAFLET: INFORMATION FOR THE USER TYLEX® 30 MG / 500 MG HARD CAPSULES CODEINE PHOSPHATE HEMIHYDRATE, 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Tylex is and what it is used for 2. What you need to know before you take Tylex 3. How to take Tylex 4. Possible side effects 5. How to store Tylex 6. Contents of the pack and other information. 1. WHAT TYLEX IS AND WHAT IT IS USED FOR Tylex contains two different medicines called paracetamol and codeine phosphate hemihydrate. 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. Paracetamol is an analgesic which acts to relieve pain and fever. Tylex is used in adults and adolescents from 12 to 18 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYLEX DO NOT TAKE TYLEX: • if you are allergic to paracetamol or codeine phosphate hemihydrate, or any of the other ingredients of this medicine (listed in section 6). • if you are a child under 12 years old. • for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome. • if you know that you metabolise very rapidly codeine into morphine. • if you have severe asthma attacks or severe breathing problems. • if you are an alcoholic. • if you have r Read the complete document
Health Products Regulatory Authority 29 August 2022 CRN00D4DM Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tylex 30 mg / 500 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of codeine phosphate hemihydrate and 500 mg of paracetamol. Excipients: sodium metabisulfite (E223) 0.36 mg/capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Hard gelatin capsule with white opaque body and red cap, both with “C30” printed in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tylex Capsules is indicated for use in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults_: The usual dose is one or two capsules up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose should not exceed 240 mg of codeine phosphate hemihydrate (i.e. not more than eight capsules per 24 hours should be taken). _Duration of treatment:_ Codeine should be used at the lowest effective dose for the shortest period of time. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. _Elderly:_ As for adults, however a reduced dose may be required. See warnings. _Paediatric population_: _Children aged less than 12 years:_ Codeine should not be used in children below the age of 12 yearsbecau Read the complete document