Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate
Sandoz Ltd
R05DA04
Codeine phosphate
30mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CODEINE PHOSPHATE TABLETS 15 MG, 30 MG AND 60 MG READ ALL OF THE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE 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. 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 gets 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 Tablets are and what they are used for 2. Before you take Codeine Phosphate Tablets 3. How to take Codeine Phosphate Tablets 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 The name of your medicine is Codeine Phosphate Tablets 15 mg, 30 mg or 60 mg. The active ingredient, codeine phosphate, is an analgesic or painkilling medicine. It also has cough-suppressant properties and can be useful for stopping chronic diarrhoea. Codeine Phosphate Tablets are used in adults for: • the relief of mild to moderate pain • to relieve coughing • to treat the symptoms of chronic diarrhoea by making the stools more solid and less frequent. Codeine can be used for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. 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. 2. BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS DO NOT TAKE THIS MEDICINE BEFORE TELLING YOUR DOCTOR: • if you are allergic or have previously been allergic to codeine, codeine phosphate, or any of the other ingredients in Codeine Phosphate Tablets 2 • if you are, or might be pregnant, or are breast-feeding • if you have hav Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codeine Phosphate 30mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Codeine phosphate 30mg For excipients see 6.1 3 PHARMACEUTICAL FORM Oral - tablet 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). Dry or painful cough Diarrhoea 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with codeine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). FOR MILD TO MODERATE PAIN ADULTS: 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. 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. PAEDIATRIC POPULATION: CHILDREN_ _AGED 12 YEARS TO 18 YEARS:_ _ The recommended codeine dose for children 12 years and older should be 30- 60mg 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). ELDERLY: Dosage should be reduced in elderly patients. FOR DRY OR PAINFUL COUGH ADULTS: 15-30mg, 3-4 times daily CHILDREN: Not recommended ELDERLY: Dosage should be reduced in elderly patients DIARRHOEA ADULTS: 30mg three to four times daily (range 15-60mg) CHILDREN: Not recommended ELDERLY: Dosage should be reduced in elderly patient Baca dokumen lengkapnya