Bisoprolol 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bisoprolol fumarate

Available from:

Relonchem 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: 5055144200408

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 5mg TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Bisoprolol fumarate.
For excipients see 6.1
3
PHARMACEUTICAL FORM
Film coated tablets.
Description: Round, biconvex, ivory coloured, film-coated tablets with
a
breakline on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of hypertension.
Management of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration _
Oral
Posology
_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 (creatinine clearance < 20ml/min) or liver
dysfunction, the
dose should not exceed 10mg Bisoprolol once daily.
_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:_ Not recommended as there is no experience.
The treatment with Bisoprolol is not recommended to be stopped
abruptly since this
might lead to a transitory worsening of heart failure. If
discontinuation is necessary,
the dose should be gradually decreased divided into halves weekly.
4.3
CONTRAINDICATIONS
Bisoprolol is contra-indicated in chronic heart failure patients with:
• acute heart failure or during episodes of heart failure
decompensation requiring i.v.
inotropic therapy
• cardiogenic shock
• second or third degree AV block
• sick sinus syndrome
• sinoatrial block
• symptomatic bradycardia
• symptomatic hypotension
• severe bronchial asthma or severe chronic obstructive pulmonary
disease
• severe forms of peripheral arterial occlusive disease or severe
forms of Raynaud's
syndrome
• untreated phaeochromocytoma (see section 4.4)
• metabolic acidosis
• hypersensitivity to bisoprolol or to any of the excipients listed
in section 6.1
4.4
SPECIAL WARNINGS AND