国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nifedipine
Teofarma S.r.l.
C08CA05
Nifedipine
30mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200; GTIN: 5015313011723
PACKAGE LEAFLET: INFORMATION FOR THE USER CORACTEN XL 30 MG AND 60 MG CAPSULES NIFEDIPINE Read all this leaflet carefully before you start taking this medicine because it contains important information for you. − 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Coracten XL is and what it is used for 2. What you need to know before you take Coracten XL 3. How to take Coracten XL 4. Possible side effects 5. How to store Coracten XL 6. Contents of the pack and other information 1. WHAT CORACTEN XL IS AND WHAT IT IS USED FOR Coracten XL contains nifedipine, which belongs to a group of medicines called calcium-channel blockers. Used to treat: • high blood pressure in adults To prevent: • chronic stable angina pectoris (heart/chest pain) in adults. For high blood pressure: Coracten XL works by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart. For angina: Coracten XL works by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart. PLEASE NOTE: These capsules are sustained-release capsules which release the active ingredient slowly over 24 hours. Do not use to treat attacks of angina or heart attacks when they happen. See your doctor if you are unsure why you have been prescribed these capsules. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CORACTEN XL DO NOT TAKE CORACTEN XL: • if you are allergic to nifedipine or any of the othe 阅读完整的文件
OBJECT 1 Coracten XL 30 mg Capsules Summary of Product Characteristics Updated 07-Sep-2021 | UCB Pharma Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Coracten XL 30 mg 2. Qualitative and quantitative composition Each capsule contains 30mg Nifedipine. Excipients with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged release capsule, hard Opaque caramel cap and body, printed with “COR 30 mg” using black ink, containing four off-white minitablets. 4. Clinical particulars 4.1 Therapeutic indications Coracten XL capsules are indicated in adults for the treatment of hypertension and the prophylaxis of chronic stable angina pectoris. 4.2 Posology and method of administration Posology Normally treatment is initiated with one 30mg Coracten XL capsule every 24 hours. Dosage may be titrated to a higher level as clinically warranted. The dose may be adjusted to 90mg every 24 hours. Co-administration wi 阅读完整的文件