País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate
Sandoz Ltd
R05DA04
Codeine phosphate
60mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200
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 Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codeine Phosphate Tablets 60mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains codeine phosphate BP 60mg. 3. PHARMACEUTICAL FORM Tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an analgesic in mild to moderate pain, as an anti-tussive, and for the symptomatic treatment of chronic diarrhoea. Codeine is indicated 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 Codeine Phosphate Tablets 60 mg are not indicated for children 0-18 years old. 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. In mild to moderate pain: Adults and the elderly: 30 mg to 60 mg every 6 hours when necessary, to a maximum of 180 mg daily. As an anti-tussive: Adults and the elderly: 15 mg to 30 mg, 3 or 4 times daily. For the symptomatic treatment of chronic diarrhoea: Adults and the elderly: 15 mg to 60 mg every 6 hours, to a maximum of 180 mg daily. 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: Oral. 4.3 CONTRAINDICATIONS • Respiratory depression and liver failure. • In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life- threatening adverse reactions (see section 4.4). • In women during breastfeeding (see section 4.6). • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use of high doses has produced morphine-like dependency. Avoid when there is a history of asthma, hepatic or Leer el documento completo