Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nifedipine
Genus Pharmaceuticals Ltd
C08CA05
Nifedipine
20mg
Modified-release tablet
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 02060200; GTIN: 5030451000118
WHAT IS IN THIS LEAFLET: 1. What Tensipine MR is and what it is used for 2. What you need to know before you take Tensipine MR 3. How to take Tensipine MR 4. Possible side-effects 5. How to store Tensipine MR 6. Contents of the pack and other information Tensipine MR contains nifedipine, which belongs to a group of medicines called calcium antagonists. Tensipine MR is used to treat high blood pressure or angina (chest pain). For high blood pressure: Tensipine MR 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: Tensipine MR 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. DO NOT TAKE TENSIPINE MR: • if you are allergic (hypersensitive) to nifedipine, any other similar medicines (known as _dihydropyridines_) or any of the other ingredients of Tensipine MR (listed in Section 6). • if you have had a heart attack within the last month or if you suspect that you are having a heart attack. • if you get a sudden angina attack. Tensipine MR will not help to relieve the symptoms of angina quickly. • if you have unstable angina. • if you are pregnant, think you may be pregnant, are planning to become pregnant or are breast- feeding. • if you are taking rifampicin, an antibiotic. • if you have been told that you have a narrowing of the aortic heart valve (stenosis). • if you have ever had a collapse caused by a heart problem (cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth. • if the severity or frequency of your angina has rapidly worsened over a matter of hours or if your blood pressure continues to rise despite treatment (malignant hypertension). • if you have been told to avoid lactose, that you have a hereditary condition called Přečtěte si celý dokument
OBJECT 1 TENSIPINE MR 10 Summary of Product Characteristics Updated 15-Nov-2016 | Genus Pharmaceuticals 1. Name of the medicinal product Tensipine MR 10 Tensipine MR 20 2. Qualitative and quantitative composition Tensipine MR 10 One film-coated tablet contains 10mg nifedipine. Tensipine MR 20 One film-coated tablet contains 20mg nifedipine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Modified release tablets for oral administration. Tensipine MR 10 Pink-grey lacquered, modified release tablets each containing 10mg nifedipine, one side marked TMR and the reverse side marked 10. Tensipine MR 20 Pink-grey lacquered, modified release tablets each containing 20mg nifedipine, one side marked TMR and the reverse side marked 20. 4. Clinical particulars 4.1 Therapeutic indications For the prophylaxis of chronic stable angina pectoris and the treatment of hypertension. 4.2 Posology and method of administration _Method of Administration_ Oral use. As a rule, tablets are swallowed whole with a little liquid, either with or without food. Tensipine MR should not be taken with grapefruit juice (see Section 4.5). _Dosage regimen_ The recommended starting dose of Tensipine MR is 10mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40mg every 12 hours, to a maximum daily dose of 80mg. Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see Section 4.5). _Duration of treatment_ Treatment may be continued indefinitely. _Additional information on special populations_ _Children and adolescents_ The safety and efficacy of nifedipine in children below 18 years of age has not been established. Currently available data for the use of nifedipine in hypertension are described in section 5.1. _Elderly patients_ The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required com Přečtěte si celý dokument