Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride)
SERVIER (S) PTE LTD
C01EB17
5mg
TABLET, FILM COATED
Ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride) 5mg
ORAL
Prescription Only
Les Laboratoires Servier Industrie
ACTIVE
2008-02-14
1 C ORALAN –C OMMON P ACKAGE I NSERT (5 MG & 7.5 MG ) CORALAN ® 1. NAME OF THE MEDICINAL PRODUCT Coralan 5 mg film-coated tablets Coralan 7.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Coralan 5 mg One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Coralan 7.5 mg One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Coralan 5 mg: salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face. Coralan 7.5 mg: 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 Treatment of coronary artery disease Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated: - in patients 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 and whose heart rate is > 60 bpm. 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 contraindicat Read the complete document
1 C ORALAN –C OMMON P ACKAGE I NSERT (5 MG & 7.5 MG ) CORALAN ® 1. NAME OF THE MEDICINAL PRODUCT Coralan 5 mg film-coated tablets Coralan 7.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Coralan 5 mg One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Coralan 7.5 mg One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Coralan 5 mg: salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face. Coralan 7.5 mg: 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 Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm and heart rate ≥ 70bpm. 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. 2 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 startin Read the complete document