Страна: Мальта
мова: англійська
Джерело: Medicines Authority
ISOSORBIDE DINITRATE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
C01DA08
ISOSORBIDE DINITRATE 10 mg
TABLET
ISOSORBIDE DINITRATE 10 mg
POM
CARDIAC THERAPY
Authorised
2007-02-15
page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ISOREM 10 MG TABLETS Isosorbide dinitrate 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 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 Isorem is and what it is used for 2. What you need to know before you take Isorem 3. How to take Isorem 4. Possible side effects 5. How to store Isorem 6. Contents of the pack and other information 1. WHAT ISOREM IS AND WHAT IT IS USED FOR Isorem contains the active substance isosorbide dinitrate. Isorem is a medicine used to treat circulatory system disorders in the coronary arteries and belongs to the group of organic nitrates. Organic nitrates extend the blood vessels and thus allow for an increased blood flow to the point where the blood flow is limited. Therapeutic indications: Isorem is used for the prevention and long-term treatment of heart pain due to poor circulation in the coronary arteries (angina pectoris). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOREM DO NOT TAKE ISOREM • if you are allergic to isosorbide dinitrate or any of the other ingredients of this medicine (listed in section 6). • in the event of acute circulatory failure (shock collapse). • in case of shock due to heart failure (cardiogenic shock), unless a sufficiently high filling pressure in the heart (left ventricular pressure, end diastolic pressure) is not ensured, by means of appropriate measures. • if you suffer from cardiomyopathy with narrowing of the inside of the heart (hypertrophic obstructive cardiomyopathy), restrictive pericarditis (constrictive pericarditis Прочитайте повний документ
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Isorem 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains diluted isosorbide dinitrate equivalent to 10 mg isosorbide dinitrate. Excipient(s) with known effect: Each tablet contains 101,5 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round, N.C., scored tablets with Remedica’s logo on one side. The score line is only there to help you break the tablet if you have difficulty swallowing it whole. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and treatment of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Unless otherwise specified, take 2 times daily 1-2 Isorem tablets (equivalent to 2 times 10 mg-20 mg isosorbide dinitrate). For higher nitrate demands, the daily dose can be increased to 3 times 1-2 tablets (corresponds to 3 times 10 mg-20 mg isosorbide dinitrate). When you receive 2 4 tablets a day, you have to maintain a break from the treatment lasting 12 hours every 24 hours without nitrate. _Elderly_ The available data do not indicate that the dose should be adjusted for the elderly. _Children and adolescence _ The safety and efficacy of isosorbide dinitrate in children has not yet been established. Method of Administration Oral administration. Page 2 of 8 The tablets should be swallowed without being chewed and with sufficient amount of fluids (e.g. 1 glass of water). Treatment should be initiated at a lower dose and slowly increased to the desired dose. The duration of use is decided by the attending physician 4.3 CONTRAINDICATIONS Isorem should not be taken in the following cases: • hypersensitivity to the active substance, other nitrates or to any of the excipients listed in section 6.1. • acute circulatory insufficiency (shock, collapse). • cardiac shock unless a sufficiently high final diastolic pressure is ensured by appropriate measures. • hypertrophic obstructive cardiomyopathy. • com Прочитайте повний документ