Bisoprolol Krka 5 mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

BISOPROLOL FUMARATE

Beschikbaar vanaf:

KRKA, d.d., Novo mesto

ATC-code:

C07AB; C07AB07

INN (Algemene Internationale Benaming):

BISOPROLOL FUMARATE

Dosering:

5 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Beta blocking agents, selective; bisoprolol

Autorisatie-status:

Marketed

Autorisatie datum:

2013-12-13

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOL KRKA 2.5 MG FILM-COATED TABLETS
BISOPROLOL KRKA 5 MG FILM-COATED TABLETS
BISOPROLOL KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Bisoprolol Krka
3.
How to take Bisoprolol Krka
4.
Possible side effects
5.
How to store Bisoprolol Krka
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL KRKA IS AND WHAT IT IS USED FOR
The active substance in Bisoprolol Krka 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
bisoprolol reduces the oxygen demand
and blood supply of the heart. Heart failure occurs when the heart
muscle is weak and unable to pump
enough blood to supply the body’s needs.
Bisoprolol Krka is used to
-
treat high blood pressure (hypertension).
-
treat angina pectoris.
-
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 KRKA
DO NOT TAKE BISOPROLOL KRKA
Do not take Bisoprolol Krka if you have one of the following
conditions:
-
allergy to the active subst

Productkenmerken

Health Products Regulatory Authority
20 December 2021
CRN00CN4P
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Krka 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale brownish yellow, oval, slightly biconvex film-coated tablets,
scored on one side (length: 8.3–8.7 mm, width: 5.5 mm,
thickness: 2.8–3.6 mm). The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment of ischemic heart disease (angina pectoris).
Treatment of stable chronic heart failure with reduced systolic left
ventricular function with ACE inhibitors, diuretics, and
optionally cardiac glycosides (for further information see section
5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_HYPERTENSION AND ANGINA PECTORIS_
_Adults_
The dosage should be individually adjusted. The usual dose is 10 mg
once daily with a maximum recommended dose of 20 mg
per day. In some patients 5 mg per day may be adequate.
_Renal or hepatic impairment_
In patients with mild to moderate impairment of renal or hepatic
function no dosage adjustment is normally required.
In patients with final stage impairment of renal function (creatinine
clearance < 20 ml/min) or liver function, the dose should
not exceed 10 mg bisoprolol once daily. A lower dose should be used.
Experiences with the use of bisoprolol in patients
undergoing dialysis are limited; but there is no evidence supporting a
change in dosage.
_Elderly _
No dosage adjustment is normally required, but 5 mg per day may be
adequate in some patients; as for other adults, dosage
may have to be reduced in cases of severe renal or hepatic
dysfunction.
_Paediatric population_
There is no paediatric experience with bisoprolol, therefore its use
cannot be recommended in paediatric patients.
_STABLE CHRONIC HEART FAILURE_
Healt