Bisoprolol 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bisoprolol fumarate

Available from:

Milpharm 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: 8901175013418

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol Fumarate 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of the active ingredient bisoprolol
fumarate.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White, round tablets engraved with ‘Bisoprolol 10’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_ The usual dose is 10mg once daily with a maximum recommended
dose of
20mg per day. In some patients 5mg per day may be adequate. In
patients with final
stage impairment of renal function (creatinine clearance <20ml/min) or
liver function,
the dose should not exceed 10mg bisoprolol once daily.
Experience of the use of bisoprolol in renal dialysis patients is
limited, however, there
is no evidence that the dosage regimen needs to be altered.
_Elderly: _
No dosage adjustment is normally required but 5mg per day may be
adequate in some patients; as for other adults, dosage may have to be
reduced in cases
of severe renal or hepatic dysfunction.
_ _
_Children: _
There is no paediatric experience with bisoprolol, therefore its use
cannot be recommended for children.
_Method of administration:_
For oral administration.
4.3
CONTRAINDICATIONS
Patients with:
•
uncontrolled cardiac failure.
•
cardiogenic shock.
•
sinoatrial block.
•
second or third degree AV block.
•
marked bradycardia (heart rate less than 50 beats/min).
•
extreme hypotension.
•
Sick sinus syndrome
•
Prinzmetal’s (variant) angina.
•
severe peripheral vascular disease (Raynaud’s disease or syndrome,
intermittent claudication).
•
use of anaesthetics which depress the myocardial activity (e.g.
cyclopropane
and trichlorethylene).
•
untreated phaeochromocytoma.
•
a history of bronchospasm, bronchial asthma or chronic obstructive
airways
disease.
•
metabolic acidosis (eg in some diabetics).
•
after prolonged fasting.
•
hypersensit