Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate
Alliance Healthcare (Distribution) Ltd
R05DA04
Codeine phosphate
15mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200
Patient Information Leaflet SOVEREIGN MEDICAL CODEINE PHOSPHATE 15 mg, 30 mg and 60 mg Tablets READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE Please keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets are and what they are used for 2. Before you take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets 3. How to take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets 4. Possible side effects 5. How to store Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets 6. Further information 1. WHAT CODEINE PHOSPHATE TABLETS 15 MG, 30 MG, AND 60 MG TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Codeine Phosphate 15mg, 30mg or 60mg Tablets. The active ingredient is codeine phosphate. 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 painkillers 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 painkillers such as paracetamol or ibuprofen alone. It can also be used to prevent coughs and to treat the symptoms of chronic diarrhoea. 2. BEFORE YOU TAKE CODEINE PHOSPHATE 15 MG, 30 MG AND 60 MG TABLETS DO NOT TAKE THIS MEDICATION: if you have ever had an allergic reaction to any of the ingredients of Codeine Phosphate 15 mg, 30 mg and 60 mg tablets or any other medicines that you may have taken to relieve pain. (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue an Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codeine Phosphate 15mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Codeine Phosphate BP 15 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 Прочитать полный документ