Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate; Paracetamol
UCB Pharma Ltd
N02AJ06
Codeine phosphate; Paracetamol
30mg ; 500mg
Oral capsule
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070100; GTIN: 5015366000323 5015366000330 5015366000347
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again • If you have 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 • In this leaflet Tylex 30 mg / 500 mg Capsules, hard will be called Tylex. IN THIS LEAFLET 1. What Tylex is for 2. Before you take Tylex 3. How to take Tylex 4. Possible side effects 5. How to store Tylex 6. Further information 1. WHAT TYLEX IS FOR Tylex can be used in adults and 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. 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. 2. BEFORE YOU TAKE TYLEX IMPORTANT INFORMATION ABOUT TYLEX: • Do not take for longer than directed by your prescriber • Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the capsules • Taking a painkiller for headaches too often or for too long can make them worse. DO NOT TAKE TYLEX IF: • For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome • You know that you metabolise very rapidly codeine into morphine • You are breastfeeding • You are allergic to paracetamol or codeine phosphate hemihydrate, or to any of the other ingredients in Tylex (see section 6) • You are taking other Paracetamol containing medicines • You are pregnant without first talking to your doctor • You are a child under 12 years old. If any of the above applies to you talk to your doctor. WARNINGS AND PRECAUTIONS Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance tha Lees het volledige document
OBJECT 1 TYLEX CAPSULES Summary of Product Characteristics Updated 17-Feb-2016 | UCB Pharma Limited 1. Name of the medicinal product Tylex 30 mg / 500 mg capsules, hard or Medocodene 30 mg /500 mg capsules, hard. 2. Qualitative and quantitative composition Each capsule contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate. Excipients: Sodium metabisulfite (E223) 0.36 mg/capsule. For the full list of excipients see section 6.1. 3. Pharmaceutical form Capsules, hard. Hard gelatin capsules with white body and red cap, both with 'C30' printed in black. 4. Clinical particulars 4.1 Therapeutic indications Tylex Capsules 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). 4.2 Posology and method of administration Codeine should be used at the lowest effective dose for the shortest period of time. 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. ADULTS Tylex capsules are given orally. The usual dose is one or two capsules up to 4 times a day at intervals not less than 6 hours. Maximum daily dose should not exceed 240 mg of codeine phosphate (i.e., not more than eight capsules per 24 hours should be taken) ELDERLY A reduced dose may be required. 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 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). Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it shoul Lees het volledige document