Bisop 10 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

BISOPROLOL FUMARATE

Disponibil de la:

Rowex Ltd

Codul ATC:

C07AB; C07AB07

INN (nume internaţional):

BISOPROLOL FUMARATE

Dozare:

10 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Beta blocking agents, selective; bisoprolol

Statutul autorizaţiei:

Marketed

Data de autorizare:

2008-12-08

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOP 5 MG FILM-COATED TABLETS
BISOP 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 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:

high blood pressure

angina pectoris(heart pain)

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 or blue)

i

Caracteristicilor produsului

Health Products Regulatory Authority
31 March 2022
CRN00CHCT
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisop 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of bisoprolol fumarate.
Excipient with known effect
Each film-coated tablet contains 2.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Apricot coloured, round, scored film-coated tablet with a one-sided
embossment "BIS 10".
The tablet can be divided into four equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Angina pectoris
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
HYPERTENSION/ANGINA PECTORIS
_Adults_
The dosage should be individually adjusted, in particular according to
the pulse rate and therapeutic success.
It is recommended to start with 5 mg per day. The usual dose is 10 mg
once daily with a maximum recommended dose of 20
mg once daily.
_Elderly_
It is recommended to start with the lowest possible dose.
_Renal or hepatic impairment_
In patients with liver or kidney function disorders of mild to
moderate severity, no dosage adjustment is normally required. In
patients with severe renal impairment (creatinine clearance < 20
ml/min) and in patients with severe liver function disorders it
is recommended that a daily dose of 10 mg is not exceeded.
Experience with the use of bisoprolol in renal dialysis patients is
limited. However, there is no evidence that the dosage regime
needs to be altered.
_Discontinuation of treatment_
Health Products Regulatory Authority
31 March 2022
CRN00CHCT
Page 2 of 10
Treatment must not be stopped abruptly (see section 4.4). The dosage
should be diminished slowly by a weekly halving of the
dose.
STABLE CHRON