Country: Israel
Language: English
Source: Ministry of Health
IVABRADINE AS HYDROCHLORIDE
MEDISON PHARMA LTD
C01EB17
FILM COATED TABLETS
IVABRADINE AS HYDROCHLORIDE 7.5 MG
PER OS
Required
LES LABORATOIRES SERVIER, FRANCE
IVABRADINE
IVABRADINE
Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
2014-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied by physician’s prescription only CORALAN 5MG CORALAN 7.5MG FILM-COATED TABLETS ACTIVE INGREDIENTS: Active ingredient: IVABRADINE (AS HYDROCHLORIDE). Each Coralan 5 mg film-coated tablet contains: 5 mg ivabradine (equivalent to 5.390mg ivabradine as hydrochloride). Each Coralan 7.5 mg film-coated tablet contains: 7.5 mg ivabradine (equivalent to 8.085mg ivabradine as hydrochloride). Inactive ingredients and allergens: See section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. Coralan is not intended for use in children and adolescents younger than 18 years. 1. WHAT IS THIS MEDICINE FOR? This medicine is used to treat: - Stable angina pectoris, when treatment with Beta-Blockers is not suitable. The medicine should be only used in patients whose heart rate is 70 bpm or more. - Chronic heart failure in patients whose heart rate is equal to or over 75 beats per minute. It is used in combination with standard therapy, including beta-blocker therapy or when beta- blockers are contraindicated or not suitable. THERAPEUTIC GROUP: Cardiac therapy, other cardiac preparations . About stable angina pectoris (usually referred to as “angina”): Stable angina is a heart disease which happens when the heart does not receive enough oxygen. It usually appears between 40 and 50 years of age. The most common symptom of angina is chest pain or discomfort. Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating. This increase in heart rate can cause the chest pain in people who suffer fr Read the complete document
1 THE FORMAT WAS APPROVED BY THE ISRAELI MINISTRY OF HEALTH IN MARCH 2015 1. NAME OF THE MEDICINAL PRODUCT Coralan 5 mg film-coated tablets Coralan 7.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet of Coralan 5 contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). One film-coated tablet of Coralan 7.5 contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). Excipient with known effect: Coralan 5mg: 63.91 mg lactose monohydrate Coralan 7.5mg: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Coralan 5mg: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face. The tablet can be divided into equal halves. Coralan 7.5mg: Salmon-coloured, triangular, film-coated tablet, engraved with “7.5” on one face and on the other face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 2 For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available. Symptomatic treatment of chronic stable angina pectoris It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring. The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. After three to four weeks of treatment, if Read the complete document