Bisoprolol 10mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Bisoprolol fumarate

Tillgänglig från:

Phoenix Healthcare Distribution Ltd

ATC-kod:

C07AB07

INN (International namn):

Bisoprolol fumarate

Dos:

10mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 02040000

Bipacksedel

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

Produktens egenskaper

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