País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Ivabradine
Accord Healthcare Ireland Ltd.
C01EB; C01EB17
Ivabradine
5 milligram(s)
Film-coated tablet
Other cardiac preparations; ivabradine
Not marketed
2017-08-11
Health Products Regulatory Authority 23 July 2019 CRN00949K Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ivabradine 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film‑coated tablet contains 5 mg ivabradine (as hydrochloride). Excipient with known effect: 53.65 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White or almost white, oval, biconvex, film-coated tablet, marked with “A274” on one side and score on the other side, tablet dimensions 8.2 x 4.1 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta‑blockers in patients inadequately controlled with an optimal beta‑blocker dose. 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 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 the patient is still Llegiu el document complet