Bisocor 5 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
BISOPROLOL FUMARATE
Available from:
Niche Generics Limited
ATC code:
C07AB; C07AB07
INN (International Name):
BISOPROLOL FUMARATE
Dosage:
5 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Beta blocking agents, selective; bisoprolol
Authorization status:
Marketed
Authorization number:
PA1063/013/001
Authorization date:
2001-06-29

What is in this leaflet:

1. What Bisocor Tablets are and what they are

used for

2. What you need to know before you take

Bisocor Tablets

3. How to take Bisocor Tablets

4. Possible side effects

5. How to store Bisocor Tablets

6. Contents of the pack and other information

1.What Bisocor Tablets are and

what they are used for

Bisocor Tablets belong to a group of

medicines called beta-blockers. These

medicines protect the heart against too much

activity, which makes the heart more relaxed

and reduces the blood pressure.

Bisoprolol fumarate may be used to treat

angina pectoris (pains in the chest caused

by blockages in the arteries that supply the

heart muscle) or hypertension (high blood

pressure).

2.What you need to know

before you take Bisocor

Tablets

Do not take Bisocor Tablets if you:

have ever suffered from severe wheezing

or severe asthma, as they can affect your

breathing.

have a slow or irregular heart rate caused

by problems in the heart muscle. Ask your

doctor if you are not sure.

have very low blood pressure which may

cause you to feel dizzy when you stand up.

have severe blood circulation problems

(which may cause your fingers and toes to

tingle or turn pale or blue).

are allergic to bisoprolol fumarate or to any

of the other ingredients of this medicine

(listed in section 6).

have heart failure, which has just occurred

or which has recently become worse, or

you are receiving treatment for circulatory

shock due to acute heart failure by

intravenous drip feed to help your heart

work.

have a condition in which there is an

accumulation of excessive acid in the body

known as metabolic acidosis. Your doctor

will be able to advise you.

you suffer from a tumour of the adrenal

glands known as phaeochromocytoma

which is untreated.

Tell your doctor if you are not sure about any

of the above.

Warnings and Precautions

Talk to your doctor or pharmacist before

taking Bisocor Tablets if you:

have liver or kidney problems.

have heart failure which may cause

breathlessness and ankle swelling.

are taking medicine for your high blood

sugar levels (diabetes). The tablets can hide

the symptoms of low blood sugar.

suffer (or have suffered) from psoriasis (a

recurrent skin disorder involving scaling

and dry skin rash).

are treated for hypersensitivity (allergic)

reactions.

are being treated for phaeochromocytoma

(a tumour of the adrenal gland).

have a thyroid problem. The tablets can

hide symptoms of an overactive thyroid.

suffer from wheezing or difficulty breathing

(asthma).

are fasting from solid food.

are known to have a condition of the heart

called 1st degree AV block which causes

the heart beat to be slow and irregular.

suffer from Prinzmetal’s angina which is a

type of chest pain that may appear while

you are at rest and is caused by spasm of

the coronary arteries that supply the heart

muscle.

have any problems with the circulation to

the extremities of the body, such as hands

and feet.

consult a doctor, attend hospital or the

dentist for surgery involving an

anaesthetic, let them know what medicines

you are taking.

This medicine contains an active substance

which results in a positive result during

antidoping controls for athletes.

Other medicines and Bisocor Tablets

Tell your doctor or pharmacist if you are

taking, have recently taken or might take any

other medicines. It is particularly important to

mention any of the following drugs as their

action may be affected:

Medicines used for controlling blood

pressure or medicines used for the

treatment of heart problems, such as:

adrenaline, amlodipine, amiodarone,

bepridil, clonidine, diltiazem, disopyramide,

digoxin, dobutamine, flecainide,

isoprenaline, lidocaine, methyldopa,

moxonidine, noradrenaline, propafenone,

quinidine, rilmenidine, verapamil and other

beta blocking agents.

Medicines for the treatment of depression

and mental disorders such as tricyclic

antidepressants, phenothiazines,

monoamine oxidase inhibitors and

barbiturates.

Medicines used as anaesthetics during an

operation.

Anti-inflammatory medicines known as

NSAIDS, e.g.ibuprofen, naproxen.

Medicines for the treatment of: malaria,

e.g. mefloquine and migraine, e.g.

ergotamine.

Medicine used for controlling diabetes.

Medicines for asthma, blocked nose or

certain eye disorders such as glaucoma

(increased pressure in the eye) or dilation

(widening) of the pupil.

All these medicines may influence your blood

pressure and/or heart function.

With medicines used for controlling diabetes,

bisoprolol fumarate may influence blood

sugar levels.

Taking Bisocor Tablets with food, drink

and alcohol

Bisocor Tablets may be taken with or without

food and should be swallowed whole with a

drink of water.

The dizziness and light-headedness that may

be caused by Bisocor Tablets can be made

worse if you drink alcohol. If this happens to

you, you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think

you may be pregnant or are planning to have

a baby, ask your doctor or pharmacist for

advice before taking this medicine.

Bisocor Tablets may be harmful to the

pregnancy and/or the unborn child. There is

an increased possibility of premature birth,

miscarriage, low blood sugar level and

reduced heart rate of the child. The growth of

the baby may also be affected. Therefore,

bisoprolol fumarate should not be taken

during pregnancy unless clearly necessary.

Your doctor will be able to make this decision.

It is not known if bisoprolol fumarate is

excreted in the breast milk and therefore it is

not recommended while breastfeeding.

Ask your doctor or pharmacist for advice

before taking any medicinal product.

Driving and using machines

These tablets may make you feel tired,

drowsy or dizzy. If you suffer from these side

effects, do not operate vehicles and/or

machines. Be aware of the possibility of these

effects particularly at the beginning of the

treatment, with changes in medication and

with use in combination with alcohol.

Bisocor Tablets contain lactose

Bisocor Tablets contain milk sugar (lactose). If

you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking this medicinal

product.

3. How to take Bisocor Tablets

Always take this medicine exactly as your

doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are

not sure.

The tablets should be swallowed whole

with water and taken in the morning

Your doctor will tell you your correct

dosage and will usually start with the

lowest dose (5 mg). The normal regular

dose is 10 mg once daily with a maximum

recommended dose of 20 mg. The tablets

should be taken at about the same time

each day.

Package Leaflet: Information for the User

Bisocor 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 or pharmacist.

This medicine has been prescribed for you. Do not give it to others. It may harm them, even if

their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

Patients with kidney disease

Patients with severe kidney disease should

not exceed

10 mg of bisoprolol fumarate once daily.

Please consult your doctor before starting to

use this medicine.

Patients with liver disease

Patients with severe liver disease should not

exceed a daily dose of 10 mg. Please consult

your doctor before starting to use this

medicine.

Use in children and adolescents

Not recommended as there is no experience

with this medicine in children under 12 years

and adolescents.

If you take more Bisocor Tablets than

you should

If you have accidentally taken more than the

prescribed dose, tell your doctor/pharmacist

immediately. Take any remaining tablets or

this leaflet with you so the medical staff know

exactly what you have taken.

Symptoms of overdose may include dizziness,

light-headedness, fatigue, breathlessness

and/or wheezing. Also there may be reduced

heart rate, reduced blood pressure,

insufficient action of the heart and a low

blood glucose level (which may involve

feelings of hunger, sweating and palpitations).

If you forget to take Bisocor Tablets

If you forget to take a tablet, take it if you

remember within 12 hours of your usual time.

If more than 12 hours have passed, you

should not take the missed tablet but should

take your next tablet at the normal time when

it is due. Do not take a double dose to make

up for a forgotten tablet.

If you stop taking Bisocor Tablets

Treatment with Bisocor Tablets must not be

stopped abruptly, particularly if you have had

angina or a heart attack. If you suddenly stop

the use of bisoprolol fumarate your condition

may get worse or your blood pressure may

start to rise again. Instead, it must be

reduced gradually over one or two weeks as

advised by your doctor. If you have any

further questions on the use of this product,

ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

While taking this medicine, you may

experience some of the following side effects.

If you do, mention it to your doctor:

Common (may affect up to 1 in 10

people):

Tiredness, dizziness, headache (especially

at the beginning of therapy; these are

generally mild and often disappear within

1-2 weeks).

Feeling of coldness or numbness in the

extremities (fingers or toes, ears and nose);

more frequent occurrence of a cramp-like

pain in the legs when walking.

Feeling sick (nausea), being sick (vomiting).

Diarrhoea.

Abdominal pain.

Constipation.

Light headedness, due to low blood

pressure, particularly on sudden standing.

Uncommon (may affect up to 1 in 100

people):

Sleep disturbances.

Depression.

Slow or irregular heart beat.

Worsening of heart failure.

Patients with asthma or a history of

breathing problems may experience

difficulty in breathing.

Muscular weakness, cramps and joint ache.

Rare (may affect up to 1 in 1,000 people):

Nightmares.

Hallucinations.

Fainting.

Hearing impairment.

Inflammation of the lining of the nose,

causing a runny nose with irritation.

Allergic reactions (itching, flushed

appearance, rash).

Dry eyes from reduced tear flow (which can

be very troublesome if you use contact

lenses).

Inflammation of the liver (hepatitis), causing

abdominal pain, loss of appetite and

sometimes jaundice with yellowing of the

whites of the eyes and skin, and dark urine.

Changes to blood tests for liver function

and increased fats in the blood.

Reduced sexual performance (impotency).

Very rare (may affect up to 1 in 10,000

people):

This medicine may aggravate the skin

condition psoriasis or cause a similar dry,

scaly rash and hair loss.

Itchiness or redness of the eye

(conjunctivitis).

Patients with pre-existing heart failure may

also experience: slow heart rate (very

common); worsening of heart failure causing

breathlessness and tiredness (common).

Reporting of side effects

If you get any side effects, talk to your doctor

or pharmacist. This includes any possible side

effects not listed in this leaflet.

You can also report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace,

IRL – Dublin 2; Tel +353 1 6764971; Fax +353

1 6762517. Website: www.hpra.ie; email:

medsafety@hpra.ie. By reporting side effects

you can help provide more information on the

safety of this medicine.

5. How to store Bisocor Tablets

Keep this medicine out of the sight and reach

of children.

Do not use Bisocor Tablets after the expiry

date which is stated on the blister and carton.

The expiry date refers to the last day of that

month.

Store below 30°C.

Do not use Bisocor Tablets if you notice your

tablets become discoloured or show any

other signs of deterioration, and return to

your pharmacist for advice.

Do not throw away any medicine via

wastewater or household waste. Ask your

pharmacist how to throw away medicines you

no longer use. These measures will help to

protect the environment.

6. Contents of the pack and

other information

What Bisocor Tablets contain

The active substance is bisoprolol

fumarate.

Each 5 mg tablet contains 5 mg of

bisoprolol fumarate.

Each 10 mg tablet contains 10 mg of

bisoprolol fumarate.

The other ingredients are lactose

monohydrate, microcrystalline cellulose,

magnesium stearate and crospovidone.

Each 5 mg tablet also contains a yellow

colour (which contains lactose and iron

oxide yellow).

Each 10 mg tablet also contains a beige

colour (which contains lactose and iron

oxide red and yellow).

What Bisocor Tablets look like and

contents of the pack

The 5 mg tablets are mottled yellow, round

and convex, embossed with BI centrally

above a breakline with 5 below. The tablets

can be divided into two equal halves.

The 10 mg tablets are mottled beige, round

and convex, embossed with BI centrally

above a breakline with 10 below. The tablets

can be divided into two equal halves.

The tablets are packed in aluminium

PVC/PVdC blisters which are contained within

a printed box board carton.

Each carton will contain either 10, 20, 28, 30,

50, 56, 60, 90 or 100 tablets. Not all pack

sizes may be marketed.

Marketing Authorisation Holder

Niche Generics Limited, 1 The Cam Centre,

Wilbury Way, Hitchin, Herts, SG4 0TW, United

Kingdom.

Manufacturer

Niche Generics Limited, Unit 5, 151 Baldoyle

Industrial Estate, Dublin 13, Ireland.

This medicinal product is authorised in

the Member States of the EEA under the

following names:

The Netherlands: Bisoprololfumaraat 5 &10

mg tabletten

Ireland: Bisocor 5 &10 mg Tablets

Germany: Bisoprolol Atid 5mg & 10 mg

Tabletten

Austria: Bisocor 5 mg & 10 mg Tabletten

France: Bisoprolol Almus 10 mg comprimé

sécable

This leaflet was last revised in 05/2016.

Niche Generics Limited,

Unit 5, 151 Baldoyle Industrial Estate, Baldoyle,

Dublin 13, Ireland

Tel: +353 (0)18167300

e-mail: artwork@nichegenerics.ie

Software: QuarkXpress 4.1

Title:

Bisocor 5mg/10mg Niche IE

MA Number/s:

PA 1063/13/1 and 1063/13/2

Date of Origination:

22/05/2002

Dimensions:

420mm x 148mm

Colours:

Black

Item Code:

320958D

Pharmacode:

Version Number:

Revision Date:

15/05/2016

Reason for Revision:

Update to align with current QRD

template including standard ADR

reporting statements, with increase in

font size from 7.5pt to 9pt and increase

in leaflet size as a result from

260x180mm to 420x148mm

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Bisocor 5 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg of bisoprolol fumarate.

Excipient with known effect: Lactose Monohydrate 136 mg.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

The tablets are pale yellow mottled in colour, round and convex with the following identification markings: BI

centrally above a break-line with 5 below.

The tablets can be divided into equal halves.

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.

Patients with kidney impairment

In patients with severe renal impairment, (creatinine clearance < 20ml/min) the dose should not exceed 10 mg once

daily.

This dosage may eventually be divided into halves.

Patients with severe liver impairment

No dosage adjustment is required, however careful monitoring is advised. In patients with severe liver function

disorders a daily dose of 10mg bisoprolol should not be exceeded.

Elderly:

No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.

Paediatric population:

There is no paediatric experience with this medicine, therefore its use cannot be recommended.

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.

Bisocor 5 mg Tablets are for oral administration.

The tablet should be taken in the morning and be swallowed with a sufficient amount of fluid (e.g. one glass of

water) .The tablet can be taken with food.

4.3 Contraindications

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

1

acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy.

cardiogenic shock.

second or third degree AV block (without a pacemaker).

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,

metabolic acidosis.

untreated phaeochromocytoma (see 4.4).

hypersensitivity to the active substance or to any of theexcipients listed in section 6.1.

4.4 Special warnings and precautions for use

Warnings

Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly

unless clearly indicated, because this may lead to transitional worsening of heart condition (see section 4.2). ). The

initiation of treatment with bisoprolol necessitates regular monitoring. For the posology and method of administration

please refer to section 4.2.

Precautions

Bisoprolol must be used with caution in patients with hypertension or angina pectoris and

accompanying heart failure.

Bisoprolol must be used with caution in

diabetes

mellitus

showing large fluctuations

in blood glucose values.

Symptoms

hypoglycaemia

(e.g.

tachycardia, palpitations or sweating) can be masked.

strict fasting.

ongoing desensitisation therapy.

with other

beta-blockers,

bisoprolol

may increase both the sensitivity

towards allergens and the severity of anaphylactic reactions.

Epinephrine treatment

may not

always yield the

expected therapeutic effect.

First degree AV block.

Prinzmetal's angina.

peripheral arterial occlusive disease. Aggravation of symptoms may occur especially when starting therapy.

Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.g.

bisoprolol) after a careful balancing of benefits against risks.

The symptoms of thyrotoxicosis may be masked under treatment with bisoprolol.

In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade.

In patients

undergoing general

anaesthesia beta-blockade reduces

the incidence of

arrhythmias

and myocardial

ischemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance

beta-blockade be continued peri-operatively.

The anaesthetist

must

be aware of

beta-blockade because of

potential

interactions

with other

drugs,

resulting in bradyarrhythmias,

attenuation of

reflex tachycardia,

decreased reflex ability to compensate for blood loss. If it is thought necessary to withdraw beta-blocker therapy before

surgery, this should be done gradually and completed about 48 hours before anaesthesia.

In bronchial

asthma or

other

chronic obstructive pulmonary diseases,

which may cause symptoms,

concomitant

bronchodilating therapy is recommended. Occasionally an increase of the airway resistance may occur in patients with

asthma, therefore the dose of beta2-stimulants may have to be increased.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

2

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp

lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Combinations not recommended

Calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type:

Negative effect on contractility and atrio-ventricular conduction. Intravenous administration of verapamil in patients on

beta-blocker treatment may lead to profound hypotension and atrio-ventricular block.

Centrally-acting antihypertensive drugs (e.g. clonidine methyldopa, moxonodine, rilmenidine):

Concomitant use of centrally-acting antihypertensive drugs may further decrease the central

sympathetic tonus and may thus lead to reduction of heart rate and cardiac output and to

vasodilatation.

Abrupt

withdrawal,

particularly if

prior

to beta-blocker

discontinuation,

may increase the risk of

'rebound hypertension'.

Combinations to be used with caution

Class-I antiarrhythmic drugs (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide propafenone):

Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect increased.

Calcium antagonists of the dihydropyridine type (e.g. felodipine and amlodipine):

Concomitant

use may increase the risk of hypotension,

and an increase in the risk of a further deterioration of the

ventricular pump function in patients with heart failure cannot be excluded.

Class-III antiarrhythmic drugs (e.g. amiodarone):

Effect on atrio-ventricular conduction time may be potentiated.

Parasympathomimetic drugs:

Concomitant use may increase atrio-ventricular conduction time and the risk of bradycardia.

Topical beta-blockers (e.g. eye drops for glaucoma treatment) may add to the systemic effects of bisoprolol.

Insulin and oral antidiabetic drugs:

Increase of blood sugar lowering effect. Blockade of betaadrenoceptors may mask symptoms of hypoglycaemia.

Anaesthetic agents:

Attenuation of

the reflex tachycardia and increase of

the risk of

hypotension (for

further

information on general

anaesthesia see section 4.4).

Digitalis glycosides:

Increase of atrio-ventricular conduction time, reduction in heart rate.

Non-steroidal anti-inflammatory drugs (NSAIDs):

NSAIDs may reduce the hypotensive effect of bisoprolol.

Beta-sympathomimetics (e.g. isoprenaline, dobutamine):

Combination with bisoprolol may reduce the effect of both agents.

Sympathomimetics that activate both beta- and alpha-adrenoceptors (e.g. norepinephrine, epinephrine):

Combination with bisoprolol

may unmask the alpha-adrenoceptor-mediated vasoconstrictor

effects of

these agents

leading to blood pressure increase and exacerbated intermittent

claudication.

Such interactions are considered to be

more likely with nonselective beta-blockers.

Concomitant use with antihypertensive agents as well as with other drugs with blood pressure lowering potential (e.g.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

3

tricyclic antidepressants, barbiturates, phenothiazines) may increase the risk of hypotension.

Combinations to be considered

Mefloquine: increased risk of bradycardia.

Monoamine oxidase inhibitors (except MAO-B inhibitors): Enhanced hypotensive effect of the betablockers but also

risk of hypertensive crisis.

Rifampicin:

Slight

reduction of the half-life of bisoprolol

possible due to the induction of hepatic drugmetabolising

enzymes. Normally no dosage adjustment is necessary.

Ergotamine derivatives: Exacerbation of peripheral circulatory disturbances.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In

general,

-adrenoceptor blocking agents reduce placental perfusion, which has been associated with growth retardation,

intrauterine death, abortion or early labour. Adverse reactions (e.g. hypoglycaemia, bradycardia) may occur in the fetus

and newborn infant. If treatment with

-adrenoceptor blocking agents is necessary,

-adrenoceptor blocking agents are

preferable.

Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered

necessary, monitoring of the uteroplacental blood flow and the foetal growth is recommended In case of harmful effects

on pregnancy or the fetus alternative treatment is recommended. The newborn infant must be closely monitored.

Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.

Lactation:

There are no data on the excretion of bisoprolol in human breast milk or the safety of bisoprolol exposure in infants.

Therefore, breastfeeding is not recommended during administration of bisoprolol

4.7 Effects on ability to drive and use machines

In a study with coronary heart disease patients, bisoprolol did not impair driving performance. However, depending on

the individual patients response to treatment an effect on the ability to drive a vehicle or to use machines cannot

excluded. This needs to be considered particularly at start of treatment, upon change of medication, or in conjunction

with alcohol.

4.8 Undesirable effects

Very common (> 1/10), Common (> 1/100, < 1/10)

), Uncommon (> 1/1,000, <1/100)), Rare (>1/10,000,< 1/1,000 , Very rare (< 1/10,000).

System Order

Class

Very common

(> 1/10)

Common

(>1/100,

< 1/10)

Uncommon

(> 1/1,000 to <

1/100)

Rare

(> 1/10,000 to <

1/1,000)

Very Rare

(< 1/10,000)

Psychiatric

disorders

Depression,

sleep disorders

Nightmares,

hallucinations

Nervous system

disorders

Dizziness*,

headache*

Syncope

Eye disorders

Reduced tear

flow (to be

considered if the

patient uses

Conjunctivitis

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

4

contact lenses)

Ear and

labyrinth

disorders

Hearing

disorders

Cardiac

disorders

Bradycardia

(in patients

with chronic

heart failure)

conduction

disturbances;

worsening of

pre-existing

heart failure (in

patients with

hypertension or

angina

pectoris);

bradycardia (in

patients with

hypertension or

angina pectoris

Vascular

disorders

Feeling of

coldness or

numbness in the

extremities,

hypotension

especially in

patients

with heart

failure

Respiratory,

thoracic and

mediastinal

disorders

Bronchospasm

in patients with

bronchial

asthma or a

history of

obstructive

airways disease

Allergic rhinitis

Gastrointestinal

disorders

Gastrointestinal

complaints such

as nausea,

vomiting,

diarrhoea,

constipation

Hepatobilary

disorders

Hepatitis

Skin and

subcutaneous

tissue disorders

Hypersensitivity

reactions such

as itching, flush,

rash

Alopecia.

Beta-blockers

may provoke

or worsen

psoriasis or

induce

psoriasis-like

rash.

Musculoskeletal

and connective

Muscle

weakness,

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

5

*These symptoms especially occur at

the beginning of the therapy.

They are generally mild and usually disappear

within 1 - 2 weeks.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

4.9 Overdose

The most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute

cardiac insufficiency and hypoglycaemia. There is limited experience with overdose of bisoprolol, only a few cases of

overdose with bisoprolol have been reported. Bradycardia and/or hypotension were noted. All patients recovered. There

is a wide inter-individual variation in sensitivity to one single high dose of bisoprolol and patients with heart failure are

probably very sensitive.

In general,

if overdose occurs,

discontinuation of bisoprolol

treatment

and supportive and symptomatic treatment

recommended.

Based on the expected pharmacologic actions and recommendations for other beta-blockers,

the following general

measures may be considered when clinically warranted.

Bradycardia: Administer intravenous atropine. If the response is inadequate, isoprenaline or another agent with positive

chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be

necessary.

Hypotension: Intravenous fluids and vasopressors should be administered. Intravenous glucagon may be useful.

AV block (second or third degree):

Patients should be carefully monitored and treated with isoprenaline infusion or

temporary pacing.

Acute worsening of heart failure: Administer i.v. diuretics, inotropic agents, vasodilating agents.

Bronchospasm:

Administer

bronchodilator

therapy

such

isoprenaline,

beta2-sympathomimetic

drugs

and/or

aminophylline.

Hypoglycaemia: Administer i.v. glucose.

Limited data suggest that bisoprolol is hardly dialysable.

tissue disorders

muscle cramps

Reproductive

system and

breast disorders

Potency

disorders

General

disorders

Asthenia

(patients with

chronic heart

failure),

fatigue*

Asthenia (in

patients with

hypertension or

angina

pectoris)

Investigations

Increased

triglycerides,

increased liver

enzymes

(ALAT, ASAT)

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

6

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Beta blocking agents, selective ATC Code: C07AB07

Mechanism of action

Bisoprolol fumarate is a highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant

membrane stabilising activity.

Pharmacodynamic effects

It only shows low affinity to the beta2-receptor of the smooth muscles of bronchi and vessels as well as to the beta2-

receptors concerned with metabolic regulation. Therefore, bisoprolol fumarate is generally not to be expected to

influence the airway resistance and beta2-mediated metabolic effects. Its beta1-selectivity extends beyond the

therapeutic dose range.

As with other beta1-blocking agents, the mode of action in hypertension is not clear but it is known that bisoprolol

markedly depresses plasma rennin levels.

Clinical efficacy

In acute administration in patients with coronary heart disease without chronic heart failure bisoprolol fumarate reduces

the heart rate and stroke volume and thus the cardiac output and oxygen consumption. In chronic administration the

initially elevated peripheral resistance decreases. Hence bisoprolol is effective in eliminating or reducing the symptoms

5.2 Pharmacokinetic properties

Absorption

Bisoprolol is absorbed almost completely from the gastrointestinal tract. Together with the very small first pass effect

in the liver, this results in a high bioavailability of approximately 90%. The plasma protein binding of bisoprolol is

about 30 %.

The distribution volume is 3.5 l/kg. The total clearance is approximately 15 l/h.

Biotransformation and Elimination

The plasma elimination half-life (10-12 hours) provides 24 hours efficacy following a once daily dosage.

Linearity

Bisoprolol is excreted from the body by two routes, 50 % is metabolised by the liver to inactive metabolites which are

then excreted by the kidneys. The remaining 50 % is excreted by the kidneys in an unmetabolised form. Since

elimination takes place in the kidneys and the liver to the same extent a dosage adjustment is not required for patients

with impaired liver function or renal insufficiency.

The kinetics of bisoprolol are linear and independent of age.

Special Populations

In patients with chronic heart failure (NYHA stage III) the plasma levels of bisoprolol are higher and the half life is

prolonged compared to healthy volunteers. Maximum plasma concentration at steady state is 64

21 ng/ml at a daily

dose of 10 mg and the half life is 17

5 hours

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology,

repeated

dose toxicity,

genotoxicity or carcinogenicity.

Like other

-blocking agents,

bisoprolol

caused maternal

(decreased

food intake and decreased body weight) and embryo/fetal

toxicity (increased incidence of resorptions,

reduced birth

weight of the offspring, retarded physical development) at high doses but was not teratogenic.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

7

Cellulose, microcrystalline E460

Magnesium stearate E572

Crospovidone E1201

Yellow PB 22812 (lactose monohydrate and iron oxide yellow (E172))

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 30°C.

6.5 Nature and contents of container

Bisocor 5 mg tablets are presented in:

Blisters comprising of PVC/PVdC/aluminium foil, contained within a printed carton box.

Each carton will contain

either; 10, 20, 28, 30, 50, 56, 60, or 100 tablets. Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Niche Generics Limited

1 The Cam Centre

Wilbury Way

Hitchin

Hertfordshire SG4 0TW

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA1063/013/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29 June 2001

Date of last renewal: 05 September 2010

10 DATE OF REVISION OF THE TEXT

June 2016

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

2

3

/

0

6

/

2

0

1

6

C

R

N

2

1

7

6

1

1

7

p

a

g

e

n

u

m

b

e

r

:

8

Similar products

Search alerts related to this product

View documents history

Share this information