Bisopine 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

Niche Generics Limited

ATC code:

C07AB; C07AB07

INN (International Name):

BISOPROLOL FUMARATE

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective; bisoprolol

Authorization status:

Marketed

Authorization date:

2000-12-08

Patient Information leaflet

1
PA 1063/009/01-02
May 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOPINE 5 MG &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 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 Bisopine Tablets are and what they are used for
2.
What you need to know before you take Bisopine Tablets
3.
How to take Bisopine Tablets
4.
Possible side effects
5.
How to store Bisopine Tablets
6.
Contents of the pack and other information
1.
WHAT BISOPINE TABLETS ARE AND WHAT THEY ARE USED FOR
Bisopine Tablets belong to a group of medicines called beta-blockers.
These medicines protect the heart
against too much activity, which makes the heart more relaxed and
reduces the blood pressure_. _
Bisoprolol fumarate may be used to treat ANGINA PECTORIS (pains in the
chest caused by blockages in the
arteries that supply the heart muscle) or HYPERTENSION (high blood
pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPINE TABLETS
DO NOT TAKE BISOPINE TABLETS IF YOU:
-
have ever suffered from severe wheezing or severe asthma, as they can
affect your breathing.
-
have a slow or irregular heart rate caused by problems in the heart
muscle. Ask your doctor if you
are not sure.
-
have very low blood pressure which may cause you to feel dizzy when
you stand up.
-
have severe blood circulation problems (which may cause your fingers
and toes to tingle or turn
pale or blue).
-
are allergic to bisoprolol fumarate or to any of the other ingredients
of this medicine (listed in
section 6).
-
have heart failure, which has just occurred or which

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisopine 5 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of bisoprolol fumarate.
Excipient with known effect: Lactose Monohydrate 136 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
The tablets are pale yellow mottled in colour, round and convex with
the following identification markings: BI
centrally above a break-line with 5 below. The tablets can be divided
into equal halves.
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.
Patients with kidney impairment
In patients with severe renal impairment, (creatinine clearance <
20ml/min) the dose should not exceed 10 mg once
daily. This dosage may eventually be divided into halves.
Patients with severe liver impairment
No dosage adjustment is required, however careful monitoring is
advised. In patients with severe liver function
disorders a daily dose of 10 mg bisoprolol should not be exceeded
Elderly:
No dosage adjustment is normally required. It is recommended to start
with the lowest possible dose
Paediatric population:
There is no paediatric experience with this medicine, therefore its
use cannot be recommended.
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
Bisopine 5 mg Tablets are for oral administration.
The tablet should be taken in the morning and be swallowed with a
sufficient amount of fluid (e.g. one glass of
water).The tablet can be taken with food.
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