BRAVACOR FILM-COATED TABLETS 5MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ivabradine hydrochloride eqv. Ivabradine

Available from:

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

ATC code:

C01EB17

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Ivabradine hydrochloride eqv. Ivabradine 5.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

KRKA, d.d., Novo mesto

Authorization status:

ACTIVE

Authorization date:

2023-03-02

Summary of Product characteristics

PI_Text035769_3
09.06.2022 - Updated: 21.10.2022
Page 1 of 14
BRAVACOR FILM-COATED TABLET P I
1.
NAME OF THE MEDICINAL PRODUCT
Bravacor 5 mg film-coated tablets
Bravacor 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg ivabradine (as ivabradine
hydrochloride).
Each film-coated tablet contains 7.5 mg ivabradine (as ivabradine
hydrochloride).
Excipient with known effect
Each 5 mg film-coated tablet contains 45.36 mg lactose.
Each 7.5 mg film-coated tablet contains 68.04 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
5 mg: pale pinkish orange, rectangular shaped, slightly biconvex film
coated tablets with score line on
one side. Dimensions of tablets are 8 mm × 4.5 mm. The tablet can be
divided into equal doses.
7.5 mg: pale pinkish orange, round, slightly biconvex film coated
tablets with bevelled edge.
Dimensions of tablets are 7 mm in diameter.
_ _
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.
PI_Text035769_3
09.06.2022 - Updated: 21.10.2022
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