Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate
Wockhardt UK Ltd
R05DA04
Codeine phosphate
60mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012727903071
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends • New single wing Wockhardt logo • Pharmcode placed on 8mm from the cutting edge • Added arrow to indicate pharmacode reading • Removed pre-printed India neutral code 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 painkillers such as paracetamol or ibuprofen alone. These tablets are used to relieve pain, suppress coughs and treat diarrhoea. 2. BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS • do not take for longer than directed by your prescriber • taking codeine regularly for a long time can lead to addiction, which might make you feel restless and irritable when you stop the tablets • taking a painkiller for headaches too often or for too long can make them worse Codeine Phosphate Đọc toàn bộ tài liệu
OBJECT 1 CODEINE PHOSPHATE 60MG TABLETS Summary of Product Characteristics Updated 18-Apr-2017 | Wockhardt UK Ltd 1. Name of the medicinal product Codeine Phosphate 60mg Tablets 2. Qualitative and quantitative composition Codeine phosphate 60mg 3. Pharmaceutical form Oral - tablet 4. Clinical particulars 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 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 patients 4.3 Contraindications Acute respiratory depression, hypersensitivity to codeine or other opioid analgesics or to any of the excipients, obstructive airways Đọc toàn bộ tài liệu