Bisoprolol Mylan 10 mg film-coated tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

BISOPROLOL FUMARATE

Prieinama:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC kodas:

C07AB; C07AB07

INN (Tarptautinis Pavadinimas):

BISOPROLOL FUMARATE

Dozė:

10 milligram(s)

Vaisto forma:

Film-coated tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Beta blocking agents, selective; bisoprolol

Autorizacija statusas:

Marketed

Leidimo data:

2011-08-19

Pakuotės lapelis

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

Prekės savybės

Health Products Regulatory Authority
16 September 2022
CRN00D5H2
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Mylan 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of bisoprolol fumarate
Excipient(s) with known effect
Each tablet contains
0.114 mg sunset yellow (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale orange to light orange, oval, biconvex film coated tablets with
side notches; approximately 9 mm x 7 mm; 'BL' & '6'
engraved on either side of the scoreline on one face of the tablet;
'M' engraved on the other face of the tablet.
The tablet 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
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