Bisoprolol Fumarate 10 mg Tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

BISOPROLOL FUMARATE

Disponibbli minn:

Chanelle Medical Unlimited Company

Kodiċi ATC:

C07AB; C07AB07

INN (Isem Internazzjonali):

BISOPROLOL FUMARATE

Dożaġġ:

10 milligram(s)

Għamla farmaċewtika:

Tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Beta blocking agents, selective; bisoprolol

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2008-02-01

Fuljett ta 'informazzjoni

ID: PL 130-134M IE
(OLS Clonmel)
VERSION:
07
EFFECTIVE DATE:
25/08/2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOPROLOL FUMARATE 1.25 MG TABLETS
BISOPROLOL FUMARATE 2.5 MG TABLETS
BISOPROLOL FUMARATE 3.75 MG TABLETS
BISOPROLOL FUMARATE 5 MG TABLETS
BISOPROLOL FUMARATE 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 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 Fumarate Tablets are and what they are used for
2.
What you need to know before you take Bisoprolol Fumarate Tablets
3.
How to take Bisoprolol Fumarate Tablets
4.
Possible side effects
5.
How to store Bisoprolol Fumarate Tablets
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL FUMARATE TABLETS ARE AND WHAT THEY ARE USED FOR
The active substance in Bisoprolol Fumarate Tablets is bisoprolol
fumarate. It 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.
Heart failure occurs when the heart muscle is weak and unable to pump
enough blood to
supply the body’s needs. Bisoprolol fumarate is used to treat stable
chronic heart failure.
It is used in combination with other medicines suitable for this
condition (such as ACE
inhibitors, diuretics, and heart glycosides)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL FUMARATE TABLETS
DO NOT TAKE BISOPROLOL FUMARATE TABLETS
Do not take Bisoprolol F

Karatteristiċi tal-prodott

Health Products Regulatory Authority
13 October 2022
CRN00D6JW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Fumarate 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg bisoprolol fumarate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Bisoprolol Fumarate 10mg Tablet is a white to off white round biconvex
tablet with a breakline on one side.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of stable chronic heart failure with reduced systolic
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, Patient 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 fumarate
requires a titration phase
The treatment with bisoprolol fumarate 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 si