Bisocor 10 mg Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Bisoprolol hemifumarate

Saatavilla:

Unichem Laboratories Ltd

ATC-koodi:

C07AB; C07AB07

INN (Kansainvälinen yleisnimi):

Bisoprolol hemifumarate

Annos:

10 milligram(s)

Lääkemuoto:

Tablet

Terapeuttinen alue:

Beta blocking agents, selective; bisoprolol

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2001-06-29

Pakkausseloste

WHAT IS IN THIS LEAFLET:
1. What Bisocor Tablets are and what they are
used for
2. What you need to know before you take
Bisocor Tablets
3. How to take Bisocor Tablets
4. Possible side effects
5. How to store Bisocor Tablets
6. Contents of the pack and other information
1.WHAT BISOCOR TABLETS ARE AND
WHAT THEY ARE USED FOR
Bisocor 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 BISOCOR
TABLETS
DO NOT TAKE BISOCOR 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 has recently become worse, or
you are receiving treatment for circulatory
shock due to acute heart failure by
intravenous drip feed to help your heart
work.
■
have a condition in which there is an
accumulation of excessive acid in the body
known as metabolic acidosis. Your doctor
will be able to advise you.
■
you suffer from a tumour of the adrenal
glands known as phaeochromocytoma
which is untreated.
Tell your doctor if you are not sure about any
of the above.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Bisocor Tablets if you:
■
have liver or kidney problems.
■
have heart failure which may cause
breathlessness and ankle

Valmisteyhteenveto

Health Products Regulatory Authority
04 November 2019
CRN009FPC
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisocor 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of bisoprolol fumarate.
Excipient with known effect: Lactose Monohydrate 131 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
The tablets are mottled beige, round and convex with the following
identification markings: BI centrally above a break-line with
10 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 10mg 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 itsuse
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.
Bisocor 10 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.
Health Products Regulatory Authority
04 November 2019
CRN009FPC
Page 2