Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Codeine phosphate hemihydrate; PARACETAMOL
Bristol Laboratories Limited
N02AJ; N02AJ06
Codeine phosphate hemihydrate; PARACETAMOL
500/30 milligram(s)
Effervescent tablet
Product subject to prescription which may not be renewed (A)
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Not marketed
2014-12-05
Package Leaflet: Information for the User Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets Paracetamol/Codeine Phosphate Hemihydrate 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 Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets are and what they are used for 2. What you need to know before you take Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets 3. How to take Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets 4. Possible side effects 5. How to store Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets 6. Contents of the pack and other information 1. What Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets are and what they are used for This medicine contain Paracetamol/Codeine. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. This medicine can be used in patients over 16 years 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 Paracetamol/Codeine 500 mg / 30 mg Effervescent Tablets Do not take this medicine if: • you are allergic to paracetamol or codeine, or any of the other ingredients of this medicine (listed in section 6) • you suffer from breathing problems, for example chronic bronchitis or emphysema or are suffering an asthma attack • you are taking monoamine oxidase inhibitors (MAOIs) or ha Read the complete document
Health Products Regulatory Authority 16 November 2018 CRN008L7G Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol/Codeine 500 mg/30 mg, effervescent tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500mg and Codeine Phosphate hemihydrate 30mg. Excipients with known effect: Each tablet also contains 487 mg of sorbitol and 413 mg of sodium. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet Bevelled, flat, round, white tablet with a scoreline on one face. Although the tablets have a score line, they are not to be halved as they do not divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PARACETAMOL CODEINE 500 mg / 30 mg, effervescent tablets is indicated in the relief of severe pain in adults. Codeine is indicated 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 tablets every four hours as required. The total daily dose should not exceed 4 g paracetamol and 240 mg of codeine (8 tablets in a day). Elderly: As for adults, however a reduced dose may be required (see section 4.4) Health Products Regulatory Authority 16 November 2018 CRN008L7G Page 2 of 16 Paediatric population: _Adolescents 16-18 years old (body weight >35 kg)_ The dose should primarily be calculated based on the codeine component and body weight. The recommended dose for codeine is 0.5-1 mg / kg body weight / dose with a maximum dose of codeine of 60mg, every 6 hours when necessary up to maximum dose of 240 mg daily. The maximum doses of 15 mg / kg body weight / dose (60 mg / kg body weight / day) of paracetamol and 1 mg / kg body weight / dose (4 mg / kg body weight / day) of codeine must not be exceeded. Do not take more that 8 tablets in a 24 hour period. _Children aged 12- 15 years:_ This com Read the complete document