Bisoprolol 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bisoprolol fumarate

Available from:

Actavis UK Ltd

ATC code:

C07AB07

INN (International Name):

Bisoprolol fumarate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5012617011404

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 5 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bisoprolol fumarate 5 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, white, film-coated convex tablets with ”R5” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
The management of hypertension.
2.
The management of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_
The usual adult dose is 10mg once daily with a maximum recommended
dose of
20mg per day. In some patients, 5mg per day may be adequate.
Renal or hepatic impairment:
In patients with final stage impairment of renal function (creatinine
clearance less
than 20ml/min) or in patients with severe hepatic dysfunction, the
dosage should not
exceed 10mg bisoprolol once daily.
Experience of use of bisoprolol in renal dialysis patients is limited,
however.
It is thought that bisoprolol fumarate cannot be dialysed.
_Special populations_
_ _
Elderly
No dosage adjustment is normally required but 5mg per day may be
adequate in some
elderly patients; as for other adults, the dosage may have to be
reduced in cases of
severe renal or hepatic dysfunction.
Paediatric population
There is no paediatric experience with bisoprolol, therefore its use
cannot be
recommended for children.
METHOD OF ADMINISTRATION
Bisoprolol tablet should be taken in morning and can be taken with
food. They should
be swallowed in liquid and should not be chewed.
4.3
CONTRAINDICATIONS
Bisoprolol is contraindicated in patients with:
•
acute heart failure or during episodes of heart failure decompensation
requiring i.v. inotropic therapy
•
cardiogenic shock.
•
sinoatrial
block.
•
second or third degree AV block (without
pacemaker).
•
bradycardia (heart rate less than 60 beats/min prior to start of
therapy).
•
severe bronchial asthma or severe chronic obstructive pulmonary
disease.
•
sick sinus
syndrome.
•
hypoten