Bisoprolol tablets coated

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

bisoprolol (bisoprolol fumarate)

Fáanlegur frá:

Arpimed LLC

ATC númer:

C07AB07

INN (Alþjóðlegt nafn):

bisoprolol (bisoprolol fumarate)

Skammtar:

5mg

Lyfjaform:

tablets coated

Einingar í pakka:

(30/3x10/) in blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2018-02-28

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
BISOPROLOL
5 MG COATED TABLETS
1.1 NAME OF THE MEDICAL PRODUCT -
BISOPROLOL
1.2 INTERNATIONAL NON-PROPERTY NAME -
BISOPROLOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated-tablet contains bisoprolol fumarate 5 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablets.
Yellow-orange heart-shaped tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in
addition to ACE inhibitors, and diuretics, and optionally cardiac
glycosides (for additional
information see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker in
case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and
when appropriate cardiac
glycosides. Patients should be stable (without acute failure) when
bisoprolol treatment is
initiated.
It is recommended that the treating physician should be experienced in
the management of
chronic heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may
occur during the titration
period and thereafter.
Posology
_Titration phase_
The treatment of stable chronic heart failure with bisoprolol requires
a titration phase
The treatment with bisoprolol is to be started with a gradual
uptitration according to the
following steps:
• 1.25 mg once daily for 1 week, if well tolerated increase to
• 2.5 mg once daily for a further week, if well tolerated increase
to
• 3.75 mg once daily for a further week, if well tolerated increase
to
• 5 mg once daily for the 4 following weeks, if well tolerated
increase to
• 7.5 mg once daily for the 4 following weeks, if well tolerated
increase to
• 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and
symptoms of worsening heart
failure is recommended during the titration phase.