Bisoprolol 10mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-11-2019
Summary of Product characteristics
(SPC)
08-04-2016
Public Assessment Report
(PAR)
24-08-2006
Active ingredient:
Bisoprolol fumarate
Available from:
Sterwin Medicines
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
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any of the side effects talk to your doctor or 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 is and what it is used for
2.
What you need to know before you take Bisoprolol
3.
How to take Bisoprolol
4.
Possible side effects.
5.
How to store Bisoprolol
6.
Contents of the pack and other information
The name of this medicine is Bisoprolol 5mg Tablets or Bisoprolol 10mg
Tablets referred to as Bisoprolol throughout this leaflet.
Bisoprolol belongs to a group of medicines commonly called
‘beta-blockers’ which work by blocking the transmission of certain
nerve
impulses. Bisoprolol is used to help treat:
angina pectoris (chest pain)
hypertension (high blood pressure).
DO NOT TAKE BISOPROLOL IF YOU:
are allergic (hypersensitive) to bisoprolol or any of the other
ingredients in this medicine (listed in Section 6)
are in acute heart failure or if you require injection of inotropic
drugs (drugs which increase the force of contraction of the heart)
have had cardiogenic shock (a condition in which your heart is unable
to pump enough blood to your body)
suffer from heart block
suffer from low heart rate or your heart rate is abnormal because of a
condition known as sick sinus syndrome
have very poor circulation or Raynaud’s Syndrome
have unusually low blood pressure
have a tumour of the adrenal gland (phaeochromocytoma)
suffer from severe asthma or have severe breathing difficulties
suffer from metabolic acidosis (a d
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol 10mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Bisoprolol 10 mg tablet 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 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 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
Bisoprolol 10 mg tablets are for oral administration.
The tablet should be swallowed with a sufficient amount of fluid (e.g.
one glass of
water). The tablet can be taken with or without food.
4.3
CONTRAINDICATIONS
Bisoprolol is contraindicated in patients with:
-
hypersensitiv
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