Ivabradine 7.5 mg Film-coated Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ivabradine

Tersedia dari:

Accord Healthcare Ireland Ltd.

Kode ATC:

C01EB; C01EB17

INN (Nama Internasional):

Ivabradine

Dosis:

7.5 milligram(s)

Bentuk farmasi:

Film-coated tablet

Area terapi:

Other cardiac preparations; ivabradine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2017-08-11

Karakteristik produk

Health Products Regulatory Authority
23 July 2019
CRN00949K
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine 7.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 7.5 mg ivabradine (as
hydrochloride).
Excipient with known effect: 80.48 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White or almost white, triangular, biconvex, film-coated tablet,
marked with “A267” on one side, tablet dimensions 7.5 x 7.2
mm.
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 symptomatic, if the initial dose is well
tolerated and if rest