Bisoprololhemifumaraat Genthon 10 mg, film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Bisoprolol hemifumarate

متاح من:

Genthon B.V.

ATC رمز:

C07AB; C07AB07

INN (الاسم الدولي):

Bisoprolol hemifumarate

جرعة:

10 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Beta blocking agents, selective; bisoprolol

الوضع إذن:

Not marketed

تاريخ الترخيص:

2002-11-22

نشرة المعلومات

Common Technical Document
Bisoprolol hemifumarate
10 mg tablets
SynthonBV
Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet
page 1/9
issue date: 22-08-2016
version:M131_03.BSL.hfu.tab10.025.01.IE.296.02 approved: MJo
1.31
Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOPROLOL HEMIFUMARATE GENTHON 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.
WHAT IS IN THIS LEAFLET:
1. What Bisoprolol hemifumarate Genthon 10 mg is and what it is used
for
2. What you need to know before you take Bisoprolol hemifumarate
Genthon
10 mg
3. How to take Bisoprolol hemifumarate Genthon 10 mg
4. Possible side effects
5. How to store Bisoprolol hemifumarate Genthon 10 mg
6. Contents of the pack and other information
1. WHAT BISOPROLOL HEMIFUMARATE GENTHON 10 MG IS AND WHAT IT IS USED
FOR
Bisoprolol hemifumarate Genthon 5 mg contains the active substance
bisoprolol
fumarate. Bisoprolol fumarate belongs to the group of blood pressure
lowering
medicines.
Bisoprolol fumarate is used for:

the treatment of high blood pressure

a certain form of chest pain (chronic stable angina pectoris) caused
by the
heart muscle receiving less oxygen than required. This usually occurs
under
stress.
You must talk to your doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL HEMIFUMARATE
GENTHON 10 MG
Common Technical Document
Bisoprolol hemifumarate
10 mg tablets
SynthonBV
Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet
page 2/9
issue date: 22-08-2

خصائص المنتج

Health Products Regulatory Authority
11 November 2019
CRN009G1H
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprololhemifumaraat Genthon 10 mg, film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg bisoprolol hemifumarate, equivalent to
8.49mg of bisoprolol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The tablet is yellow to orange, round, biconvex, scored on both sides
and embossed with BSL10 on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Hypertension.
- Chronic stable angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Renal or hepatic impairment
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 bisoprolol hemifumarate
is not exceeded.
Elderly:
No dosage adjustment is normally required. It is recommended to start
with the lowest possible dose.
Paediatric population:
There is no experience with bisoprolol in children, therefore its use
cannot be recommended in children.
Method of administration
Bisoprolol 10 mg tablets are for oral administration.
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.
The tablets should be taken in the morning. They should be swallowed
with liquid and should not be chewed.
Discontinuation of treatment
Treatment should not be stopped abruptly (see section 4.4 Special
warnings and precautions for use). The dosage should be
diminished slowly by a weekly halving of the dose.
4.3 CONTRAINDICATIONS
· hypersensitivity to the active substance or to any of the
excipients listed in section 6.1
· acute heart failure or during episode