Bisoprolol 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bisoprolol fumarate

Available from:

Niche Generics Ltd

ATC code:

C07AB07

INN (International Name):

Bisoprolol fumarate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5060020121029

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOL 5 MG AND 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 TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS
3.
HOW TO TAKE BISOPROLOL TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BISOPROLOL TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT BISOPROLOL TABLETS ARE AND WHAT THEY ARE USED FOR
Bisoprolol fumarate belongs to a group of medicines 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 TABLETS
DO NOT TAKE BISOPROLOL TABLETS
-
if you are
ALLERGIC
to Bisoprolol tablets 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 you suffer from
INCREASED ACIDITY OF THE BLOOD
(metabol

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol 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 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
Bisoprolol 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.
4.3
CONTRAINDICATIONS
•
acute heart failure or during episodes of heart failure decompensation
requiring i.v. ino