Bisoprolol Mylan 1.25 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

BISOPROLOL FUMARATE

Disponible des:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codi ATC:

C07AB; C07AB07

Designació comuna internacional (DCI):

BISOPROLOL FUMARATE

Dosis:

1.25 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Beta blocking agents, selective; bisoprolol

Estat d'Autorització:

Not marketed

Data d'autorització:

2011-08-19

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOL MYLAN 1.25 MG, 2.5 MG, 3.75 MG, 5 MG, 7.5 MG OR 10 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 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 Mylan
is and what it is used for.
2.
What you need to know before you take Bisoprolol Mylan.
3.
How to take Bisoprolol Mylan.
4.
Possible side effects.
5.
How to store Bisoprolol Mylan.
6.
Contents of the pack and other information.
1.
WHAT BISOPROLOL MYLAN IS AND WHAT IT IS USED FOR
This medicine contains the active substance bisoprolol fumarate, which
belongs to a family of
medicines called beta-blockers. Bisoprolol is used in combination with
other medicines to treat stable
heart failure
Heart failure occurs when the heart muscle is too weak to pump blood
around the circulation
adequately. This results in breathlessness and swelling.
Bisoprolol slows down the heart rate and makes the heart more
efficient at pumping blood around the
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL MYLAN
DO NOT TAKE BISOPROLOL MYLAN IF YOU:

are allergic to bisoprolol or any of the other ingredients of this
medicine (listed in section 6)

have severe asthma

have a slow or irregular heart rate. Ask your doctor if you are not
sure

have very low blood pressure

have severe blood circulation problems (which may cause your fingers
and toes to tingle or
turn pale or blue)

have heart failure that suddenly becomes worse and / or that may
require hospital treatment

have excess acid

Fitxa tècnica

Health Products Regulatory Authority
16 September 2022
CRN00D5H2
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Mylan 1.25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg of bisoprolol fumarate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oval, biconvex film coated tablets; approximately 9 mm x 7 mm;
'BL' & '1' engraved on one face of the tablet; 'M'
engraved on the other face of the tablet.
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
POSOLOGY
ADULTS
_Treatment of 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.
Transient worsening of heart failure, hypotens