Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ivabradine hydrochloride
Servier Laboratories Ltd
C01EB17
Ivabradine hydrochloride
5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060300; GTIN: 5017476151100
OBJECT 1 PROCORALAN Summary of Product Characteristics Updated 05-Mar-2018 | Servier Laboratories Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets 2. Qualitative and quantitative composition Procoralan 5 mg One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Excipient with known effect: 63.91 mg lactose monohydrate Procoralan 7.5 mg One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Procoralan 5 mg: 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 doses. Procoralan 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 adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contraindication 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 Read the complete document