מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicorandil
DE Pharmaceuticals
C01DX16
Nicorandil
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060300
PACKAGE LEAFLET: INFORMATION FOR THE USER NICORANDIL 10 MG TABLETS NICORANDIL 20 MG TABLETS nicorandil READ ALL OF 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 Nicorandil is and what it is used for 2. What you need to know before you take Nicorandil 3. How to take Nicorandil 4. Possible side effects 5. How to store Nicorandil 6. Contents of the pack and other information 1. WHAT NICORANDIL IS AND WHAT IT IS USED FOR Nicorandil contains a medicine called nicorandil. This belongs to a group of medicines called “potassium channel activators”. It works by increasing the blood flow through the blood vessels of the heart. It improves the blood and oxygen supply of your heart muscle and reduces its workload. Nicorandil is used to prevent or attenuate painful, straining symptoms (angina pectoris) of your heart disease. It is used in adult patients who do not tolerate or cannot take heart medicines called beta- blockers and/or calcium antagonists. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICORANDIL DO NOT TAKE NICORANDIL: - If you are allergic to nicorandil or any of the other ingredients of this medicine (listed in section 6). - If you have low blood pressure (hypotension). - If you have heart problems such as cardiogenic shock, or left ventricular failure with low filling pressure or cardiac decompensation or shock. - If you are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil (phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as r קרא את המסמך השלם
OBJECT 1 NICORANDIL 10MG TABLETS Summary of Product Characteristics Updated 29-Jul-2018 | Dexcel Pharma Ltd • 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 Nicorandil 10mg Tablets 2. Qualitative and quantitative composition Nicorandil 10mg Each tablet contains 10mg nicorandil. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet, white to off white, round, scored on one side and engraved with "10" on the other side. The tablet can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications Nicorandil 10mg Tablets are indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). 4.2 Posology and method of administration POSOLOGY The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily (bid), in t קרא את המסמך השלם