Bisop 7.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

Rowex Ltd

ATC code:

C07AB; C07AB07

INN (International Name):

BISOPROLOL FUMARATE

Dosage:

7.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective; bisoprolol

Authorization status:

Marketed

Authorization date:

2008-12-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOP 1.25 MG FILM-COATED TABLETS
BISOP 2.5 MG FILM-COATED TABLETS
BISOP 3.75 MG FILM-COATED TABLETS
BISOP 7.5 MG FILM-COATED 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 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 of the 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 Bisop is and what it is used for
2.
What you need to know before you take Bisop
3.
How to take Bisop
4.
Possible side effects
5.
How to store Bisop
6.
Contents of the pack and other information
1.
WHAT BISOP IS AND WHAT IT IS USED FOR
Bisop
belongs to the group of medicinal products that are indicated as beta
blockers. They protect the
heart from too much activity.
Bisop is used to treat:

Heart failure causing breathlessness on exertion or fluid retention.
In this instance, Bisop may be
given as an additional treatment to other medications for heart
failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOP
DO NOT TAKE BISOP_ _

if you are allergic to bisoprolol fumarate or any of the other
ingredients of this medicine (listed in
section 6)

if you have a cardiogenic shock, a serious heart condition causing a
rapid, weak pulse; low blood
pressure; cold, clammy skin; weakness and fainting

if you have ever suffered from severe wheezing or severe asthma, as
they can affect your
breathing

if you have a slow heart rate (less than 60 beats per minute). Ask
your doctor if you are not sure.

if you have very low blood pressure

if you have severe blood circulation problems (which may cause your
fingers and toes to tingle or
turn pale

Summary of Product characteristics

Health Products Regulatory Authority
31 March 2022
CRN00CHCT
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisop 7.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 7.5 mg of bisoprolol fumarate.
Excipient with known effect
Each film-coated tablet contains 1.7 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow coloured, round, scored film-coated tablet with a one-sided
embossment "BIS 7.5".
The tablets can be divided into three equal doses.
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
Posology
STABLE CHRONIC HEART FAILURE
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker in case of intolerance to ACE
inhibitors), a beta-blocking agent, 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.
_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.