Bisoprolol Fumarate 10mg tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

BISOPROLOL FUMARATE

זמין מ:

Accord Healthcare Ireland Ltd.

קוד ATC:

C07AB; C07AB07

INN (שם בינלאומי):

BISOPROLOL FUMARATE

כמות:

10 milligram(s)

טופס פרצבטיות:

Tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Beta blocking agents, selective; bisoprolol

מצב אישור:

Not marketed

תאריך אישור:

2018-01-26

עלון מידע

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bisoprolol fumarate is and what it is used for
2.
What you need to know before you take Bisoprolol fumarate
3.
How to take Bisoprolol fumarate
4.
Possible side effects
5.
How to store Bisoprolol fumarate
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL FUMARATE IS AND WHAT IT IS USED FOR
Bisoprolol fumarate belongs to a group of medicinal products called
beta-blockers. It is used to treat:
-
high blood pressure
-
angina pectoris (pain in the chest caused by blockages in the arteries
leading to the heart).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL FUMARATE
DO NOT TAKE BISOPROLOL FUMARATE:
-
if you are ALLERGIC to bisoprolol fumarate or any of the other
ingredients of this medicine (listed
in section 6)
-
if you suffer from SEVERE ASTHMA or from other SEVERE breathing
difficulties
-
if you have ACUTE HEART FAILURE or are in shock caused by heart
problems
-
if you suffer with HEART CONDUCTION or RHYTHM PROBLEMS (2nd or 3rd
degree AV-block, sick
sinus syndrome or sinoatrial block)
-
if you have a SLOW HEART RATE of less than 60 beats per minute before
starting treatment
-
if you have LOW BLOOD PRESSURE
-
if you suffer from severely BLOCKED BLOOD VESSELS, including BLOOD
CIRCULATION PROBLEMS
(which may cause your fingers and toes to tingle or turn pale or blue)
-
if

מאפייני מוצר

Health Products Regulatory Authority
30 October 2019
CRN00998H
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Fumarate 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet Bisoprolol fumarate 10 mg contains 8.49 mg bisoprolol
equivalent to 10 mg bisoprolol fumarate.
Excipient with known effect
Each tablet contains 130.20 mg of lactose monohydrate per tablet
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Bisoprolol fumarate 10 mg tablets are mottled beige, round and convex
with the following identification markings: BI centrally
above a break-line with 10 below.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be individually adjusted. It is recommended to start
with the lowest possible dose. In some patients, 5 mg
per day may be adequate. The usual dose is 10 mg once daily with a
maximum recommended dose of 20 mg per day.
_Special Populations_
_Renal or liver impairment_
Adjustment of dose in patients with mild to moderate liver- or kidney
impairment is usually not necessary. In patients with
severe renal impairment (creatinine clearance < 20 ml/min) or severe
liver impairment, the dose should not exceed 10 mg once
daily. This dosage may eventually be divided into halves.
_Elderly_
No dosage adjustment is normally required. It is recommended to start
with the lowest possible dose.
_Paediatric population_
Bisoprolol fumarate tablets are not recommended for use in children
due to a lack of data (see section 5.3).
_Discontinuation of treatment_
Treatment should not be stopped abruptly (see section 4.4). The dosage
should be diminished slowly by a weekly halving of
the dose.
Method of administration
Health Products Regulatory Authority
30 October 2019
CRN00998H
Page 2 of 9
Bisoprolol fumarate tablets are for oral administration.
The tablet should be swallowed with a suffic