Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate
A A H Pharmaceuticals Ltd
R05DA04
Codeine phosphate
60mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200; GTIN: 5025903001539
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used Wockhardt UK Limited Codeine Phosphate Weifa leaflet 107021/3 n-a 206 x 336mm matt.pirie-scott 1 21/04/2015 569101 404 Process Black Keylines (Does not print) Text Limit artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. UK English 9.3pt (main body) / 9.3pt (variables) PACKAGE LEAFLET: INFORMATION FOR THE USER CODEINE PHOSPHATE TABLETS Read all of this leaflet carefully before you start using this medicine. – Keep this leaflet. You may need to read it again. – If you have further questions, please ask your doctor, nurse or pharmacist. – This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Codeine Phosphate Tablets are and what they are used for 2. Before you take Codeine Phosphate Tablets 3. How Codeine Phosphate Tablets should be taken 4. Possible side effects 5. How to store Codeine Phosphate Tablets 6. Further information 1. WHAT CODEINE PHOSPHATE TABLETS ARE AND WHAT THEY ARE USED FOR 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 paracetamol. Codeine can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other p Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codeine Phosphate 60mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Codeine Phosphate BP 60 mg 3. PHARMACEUTICAL FORM Tablets 4.1. THERAPEUTIC INDICATIONS 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). As an anti-tussive. For the symptomatic treatment of chronic diarrhoea. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Dosage: _ IN ACUTE MODERATE PAIN: ADULTS: The recommended dosage range is 30 to 60 mg. Codeine should be used at the lowest effective dose for the shortest period of 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 240 mg. PAEDIATRIC POPULATION: Children aged 12 years to 18 years: The recommended codeine dose for children 12 years and older should be 30 to 60 mg_ _every 6 hours when necessary, up to a maximum dose of codeine of 240 mg daily. The dose is based on the body weight (0.5-1mg/kg). Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). AS AN ANTI-TUSSIVE: ADULTS: 15-30mg three or four times daily. CHILDREN: Not suitable for children. FOR THE SYMPTOMATIC TREATMENT OF CHRONIC DIARRHOEA: ADULTS: 15-60 mg three to four times daily. CHILDREN: Not suitable for children. There is no evidence that the dose differs in the elderly. _ _ 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._ _ _Method of Administration: _ To be taken by mouth. 4.3. CONTRAINDICATIONS Hypersensitivity to codeine or any of the tablet excipients. Acute respiratory depression and acute alcoholism where there is a risk of Lugege kogu dokumenti