Bisoprolol Zentiva 1.25mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

Zentiva k.s.

ATC code:

C07AB07

INN (International Name):

BISOPROLOL FUMARATE

Pharmaceutical form:

Tablet

Therapeutic area:

bisoprolol

Authorization status:

Not marketed

Authorization date:

2023-06-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOL ZENTIVA 1.25 MG TABLETS
BISOPROLOL ZENTIVA 2.5 MG TABLETS
BISOPROLOL ZENTIVA 3.75 MG TABLETS
BISOPROLOL ZENTIVA 5 MG TABLETS
BISOPROLOL ZENTIVA 7.5 MG TABLETS
BISOPROLOL ZENTIVA 10 MG TABLETS
bisoprolol fumarate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bisoprolol Zentiva is and what it is used for
2.
What you need to know before you take Bisoprolol Zentiva
3.
How to take Bisoprolol Zentiva
4.
Possible side effects
5.
How to store Bisoprolol Zentiva
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL ZENTIVA IS AND WHAT IT IS USED FOR
The active substance in Bisoprolol Zentiva is bisoprolol. Bisoprolol
belongs to a group
of medicines called beta-blockers. These medicines work by affecting
the body`s response
to some nerve impulses, especially in the heart. As a result,
bisoprolol slows down the heart
rate and makes the heart more efficient at pumping blood around the
body. At the same time, it
reduces the amount of blood required by the heart, as well as its use
of oxygen.
Bisoprolol Zentiva is used to treat stable chronic heart failure.
Heart failure occurs when the
heart muscle is weak and unable to pump enough blood to supply the
body’s needs. It is used
in combination with other medicines suitable for this condition (such
as ACE inhibitors,
diuretics, and heart glycosides).
In addition, Bisoprolol Zentiva 5 mg and 10 mg are used to treat high
blood pressure
(hypertension) and heart pain due to impaired

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DK12
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Zentiva 1.25mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White rounded tablets with embossing 1.25 and diameter 6 mm ± 0.3 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bisoprolol Zentiva is indicated for 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).
In addition, Bisoprolol Zentiva 5 mg and 10 mg are indicated for
treatment of hypertension and ischemic heart disease (angina
pectoris).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment of stable chronic heart failure
Standard treatment of chronic heart failure 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 heart failure) when bisoprolol treatment is initiated.
Recommendation: 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
gradual dose titration.
The treatment with bisoprolol is to be started with a gradual
up-titration according to the following steps:

1.25 mg once daily for 1 week. If this dose is well tolerated,
increase to

2.5 mg once daily for 1 further week. If this dose is well tolerated,
increase to

3.75 mg once daily for 1 further week. If this dose is well tolerated,
increase to

5 mg once daily for the following 4 weeks. If this dose is well
tolerated, in