BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack

Main information

  • Trade name:
  • BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175913
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175913

BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

20/10/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

20/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of stable chronic moderate to severe heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, circular, biconvex, film-coated tablets, debossed with 'P and

breakline' on one side and '7' on the other side

Active Ingredients

Bisoprolol fumarate

7.5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 01:39:34 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Bisoprolol AN tablets – Consumer Medicine Information

Doc ID: 43.AN.M.2.0

Page 1

Bisoprolol AN tablets

Bisoprolol fumerate

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

BISOPROLOL AN.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed

risks

taking

BISOPROLOL

against

benefits they expect it will have

for you.

If

you

have

any

concerns

about

taking

this

medicine,

talk

to

your

doctor

or

pharmacist.

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What Bisoprolol AN

is used for

BISOPROLOL

used

treat heart failure. It is usually

used in combination with other

medicines.

Heart

failure

occurs

when

heart muscle is weak and unable

to pump enough blood to supply

the body's needs. Heart failure

may start off with no symptoms,

but as the condition progresses

patients may feel short of breath

and notice swelling of the feet

and ankles due to fluid build up.

BISOPROLOL AN belongs to a

group of medicines called beta-

blockers. These medicines work

by affecting the body's response

some

nerve

impulses,

especially

heart.

result, it decreases the heart's

need for blood and oxygen and

therefore reduces the amount of

work

heart

BISOPROLOL

also

slows

your

heart

rate,

which

turn

increases the efficiency of your

heart.

BISOPROLOL AN can help to

reduce

number

heart

failure episodes needing hospital

admission and also the risk of

sudden death.

Your

doctor

have

prescribed BISOPROLOL AN for

another reason. Ask your doctor

if you have any questions about

why BISOPROLOL AN has been

prescribed for you.

BISOPROLOL

recommended

children,

safety

efficacy

children

have

been established.

BISOPROLOL

available

only with a doctor's prescription.

There

evidence

that

BISOPROLOL AN is addictive.

Before You Take

Bisoprolol AN

When you must not take

BISOPROLOL AN

Do not take BISOPROLOL AN

if you are allergic to medicines

containing

bisoprolol

or

any

of the ingredients listed at the

end of this leaflet.

Some

symptoms

allergic

reaction

include

skin

rash,

itching

hives,

swelling

face,

lips

tongue

which

cause

difficulty

swallowing

breathing,

wheezing

shortness of breath.

Do not take BISOPROLOL AN

if you have any of the

following heart problems:

severe heart failure that is not

controlled medically

worsening heart failure

requiring injection of medicines

into a vein

cardiogenic shock, a serious

heart condition causing low

blood pressure and circulatory

failure

certain heart conditions where

the electrical activity controlling

your heart rate does not work

properly, causing a very slow

heart rate or uneven heart

beating

low blood pressure.

Do not take BISOPROLOL AN

if you have any of the following

medical conditions:

severe asthma or severe

chronic obstructive lung

disease

severe blood circulation

problems in your limbs (such

as Raynaud's syndrome),

which may cause your fingers

and toes to tingle or turn pale

or blue

untreated haeochromocytoma,

a rare tumour of the adrenal

gland

metabolic acidosis, a condition

when there is too much acid in

the blood.

Do not take this medicine after

the expiry date printed on the

pack

or

if

the

packaging

is

torn

or

shows

signs

of

tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal

Before you start to take

BISOPROLOL AN

Tell

your

doctor

if

you

are

allergic

to

any

other

medicines,

foods,

dyes

or

preservatives.

Bisoprolol AN tablets – Consumer Medicine Information

Doc ID: 43.AN.M.2.0

Page 2

Tell

your

doctor

if

you

are

pregnant

or

plan

to

become

pregnant.

BISOPROLOL

affect

your developing baby if you take

it during pregnancy. Your doctor

will

discuss

risks

benefits of taking BISOPROLOL

AN during pregnancy.

Tell

your

doctor

if

you

are

breastfeeding

or

wish

to

breastfeed.

Like

most

beta-blocker

medicines, BISOPROLOL AN is

not recommended while you are

breastfeeding.

Your

doctor

will

discuss the risks and benefits of

taking BISOPROLOL AN when

breastfeeding.

Tell your doctor if you have or

have had any of the following

medical conditions:

asthma, difficulty breathing or

other lung problems

certain heart diseases (such as

disturbances in heart rhythm or

Prinzmetal angina)

diabetes

any allergic conditions

psoriasis, a skin disease with

thickened patches of red skin,

often with silvery scales

thyroid disorder

any blood vessel disorder

causing poor circulation in the

arms and legs

kidney problems

liver problems

phaeochromocytoma, a rare

tumour of the adrenal gland.

Your doctor may want to take

special care if you have any of

these conditions.

Tell

your

doctor

if

you

are

going to have anaesthesia (for

example for surgery).

BISOPROLOL AN may influence

your

body

reacts

this

situation.

If you have not told your doctor

about any of the above, tell them

before

start

taking

BISOPROLOL AN.

Taking other medicines

Tell your doctor if you are taking

other

medicines,

including

that

without

prescription

from

pharmacy,

supermarket

health

food

shop.

Some

medicines

BISOPROLOL AN may interfere

with each other.

take

following

medicines

with

BISOPROLOL

AN without special advice from

your doctor:

certain anti-arrhythmic

medicines such as

disopyramide, lidocaine,

phenytoin or flecainide (used to

treat irregular or abnormal

heartbeat)

certain calcium antagonists

such as diltiazem or verapamil

(used to treat high blood

pressure and angina)

certain medicines used to treat

high blood pressure such as

clonidine, methyldopa or

moxonidine.

However, do not stop taking

these

medicines

without

checking with your doctor.

Check with your doctor before

taking the following medicines

with BISOPROLOL AN.

Your doctor may need to check

your condition more frequently.

anti-arrhythmic medicines such

as amiodarone (used to treat

irregular or abnormal

heartbeat)

calcium antagonists such as

felodipine or amlodipine (used

to treat high blood pressure

and angina)

certain medicines used to treat

arthritis, pain or inflammation,

such as ibuprofen or diclofenac

eye drops for glaucoma

treatment

insulin and oral drugs for

diabetes

anaesthetic agents used in

surgery

digoxin, a medicine used to

treat heart failure

ergot derivatives, medicines

commonly used to treat

migraines

rifampicin, a medicine used to

treat tuberculosis

tricyclic antidepressants

barbiturates, medicines used to

treat epilepsy

phenothiazines, medicines

used to treat some mental

conditions

mefloquine, a medicine used to

treat malaria

adrenaline, a medicine used to

treat allergic reactions

certain medicines used to treat

depression called monoamine

oxidase inhibitors, such as

phenelzine or tranylcypromine.

These

medicines

affected by BISOPROLOL AN or

affect

well

works.

You may need different amounts

of your medicines, or you may

need to take different medicines.

Your

doctor

pharmacist

have

more

information

medicines to be careful with or

avoid while taking BISOPROLOL

How to take

Bisoprolol AN

How much to take

The usual starting dose is 1.25

mg once daily for a week. If well

tolerated,

your

doctor

will

gradually

increase

your

dose

over the next ten weeks. The

usual

dose

maintenance

therapy is 10 mg once daily.

If your conditions gets worse or

you no longer tolerate the drug,

it may be necessary to reduce

dose

again

interrupt

treatment.

some

patients

maintenance dose lower than 10

sufficient.

Your

doctor will tell you what to do.

Your

doctor

will

monitor

your

blood pressure, heart rate and

other vital signs carefully after

start

treatment

with

BISOPROLOL

during

dose increase.

Follow all directions given to you

by your doctor and pharmacist

carefully.

How to take BISOPROLOL

Bisoprolol AN tablets – Consumer Medicine Information

Doc ID: 43.AN.M.2.0

Page 3

AN

Swallow

the

tablets

with

a

glass of water.

Do

not

crush

or

chew

the

tablets.

crush

chew

BISOPROLOL AN, they will not

work as well.

When to take

BISOPROLOL AN

Take BISOPROLOL in the

morning, with or without food.

If you forget to take

BISOPROLOL AN

If it is almost time for

your

next dose, skip the dose you

missed

and

take

your

next

dose when you are meant to.

Otherwise,

take

the

missed

dose

as

soon

as

you

remember, and then go back

to taking your tablets as you

would normally.

Do not take a double dose to

make

up

for

the

dose

you

missed.

If you are not sure what to do,

ask

your

doctor

or

pharmacist.

How long to take

BISOPROLOL AN for

properly

control

your

condition,

BISOPROLOL

must be taken every day, usually

as a long term treatment.

Keep taking BISOPROLOL AN

for

as

long

as

your

doctor

recommends.

It is very important that you do

stop

taking

BISOPROLOL

AN suddenly.

If you take too much

(overdose)

Immediately

telephone

your

doctor

Poisons

Information

Centre

(telephone

13 11 26) for advice, or go to

Accident and Emergency at the

nearest hospital, if you think you

or anyone else may have taken

much

ABISOPROLOL

Do this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include

slowed

heart

rate,

difficulty breathing, marked drop

in blood pressure, severe heart

failure, or a decrease in blood

sugar.

While you are taking

Bisoprolol AN

Things you must do

Before

starting

any

new

medicine, tell your doctor or

pharmacist that you are taking

BISOPROLOL AN.

Tell all the doctors, dentists

and

pharmacists

who

are

treating

you

that

you

are

taking BISOPROLOL AN.

If you become pregnant while

taking BISOPROLOL AN, tell

your doctor.

If you plan to have surgery,

including dental surgery, tell

your doctor or dentist that you

are taking BISOPROLOL AN.

If

you

are

being

treated

for

diabetes,

make

sure

you

check your blood sugar level

regularly

and

report

any

changes to your doctor.

BISOPROLOL AN may change

well

your

diabetes

controlled. It may also cover up

some of the symptoms of low

blood

sugar,

called

hypoglycaemia,

such

fast

heart

beat.

BISOPROLOL

make

hypoglycaemia

last

longer.

Your

dose

diabetic

medicines, including insulin, may

need to change.

If you are to have any medical

tests, tell your doctor that you

are taking BISOPROLOL AN.

BISOPROLOL

affect

the results of some tests.

Visit your doctor regularly so

they

can

check

on

your

progress.

Your

doctor

check

your

eyes,

thyroid,

lipid

blood

glucose levels.

Tell

your

doctor

if,

for

any

reason,

you

have

not

taken

your

medicine

exactly

as

prescribed.

Your doctor may think it is not

working effectively and change

your treatment unnecessarily.

Things you must not do

Do

not

stop

taking

BISOPROLOL AN, or lower the

dose,

without

checking

with

your doctor.

Stopping

BISOPROLOL

suddenly

cause

your

condition

worsen

other

heart complications may occur.

If you have to stop treatment,

your doctor will usually advise

reduce

dose

gradually.

Do not use BISOPROLOL AN

to treat any other conditions

unless your doctor tells you

to.

Do not give BISOPROLOL AN

to anyone else, even if they

have

the

same

condition

as

you.

Things to be careful of

Be careful driving or operating

machinery until you know how

BISOPROLOL AN affects you.

BISOPROLOL

cause

tiredness,

dizziness

lightheadedness in some people,

especially after the first dose. If

any of these occur, do not drive,

operate

machinery

anything

else

that

could

dangerous.

Be careful getting up from a

Bisoprolol AN tablets – Consumer Medicine Information

Doc ID: 43.AN.M.2.0

Page 4

sitting or lying position.

Dizziness,

lightheadedness

fainting

occur,

especially

when you get up quickly. Getting

up slowly may help.

Suggestions to help

manage your condition

Physical activity – regular

exercise when symptoms are

absent or mild helps improve

heart function. Before starting

any exercise, ask your doctor

for advice.

Weight reduction - your doctor

may suggest losing some

weight to help lessen the

amount of work your heart has

to do.

Diet - eat a healthy low fat diet

which includes plenty of fresh

fruit and vegetables, bread,

cereals and fish. Also, try to

eat less fat and sugar.

Salt restriction - too much salt

can make your heart failure

worse. Try to avoid using salt

in cooking and at the table.

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

taking BISOPROLOL AN.

BISOPROLOL

helps

most

people with heart failure, but it

may have unwanted side effects

in some people.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

Do not be alarmed by this list

of possible side effects.

You may not experience any of

them.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

tiredness, feeling weak

dizziness

headache

sleep disturbances, nightmares

nausea, vomiting

diarrhoea, constipation

feeling of coldness or

numbness in hands or feet

allergic runny nose

hair loss

sexual problems

Tell your doctor as soon as

possible if you notice any of

the following:

muscular weakness or cramps

dizziness or lightheadedness

(sometimes with fainting),

especially on standing up,

which may be due to low blood

pressure

a very slow heart beat

hallucinations

depression

irritation or redness of the eye

skin reactions such as rash,

flush, itching, worsening of

psoriasis

difficulty hearing.

The above list includes serious

side

effects

that

require

medical attention.

Tell your doctor immediately

or

go

to

Accident

and

Emergency

at

the

nearest

hospital if you notice any of

the following:

swelling of the face, lips,

tongue throat which may cause

difficulty breathing or

swallowing

signs of worsening heart failure

such as shortness of breath,

sometimes with tiredness or

weakness, swelling of the feet

or legs due to fluid build up

chest tightness, wheezing,

rattly Breathing

yellowing of the skin or eyes,

dark coloured urine, itching,

generally feeling unwell

irregular heart beating.

above

list

includes

very

serious

side

effects.

need urgent medical attention or

hospitalisation.

Tell your doctor if you notice

anything that is making you

feel unwell.

Other

side

effects

listed

above may also occur in some

patients.

After taking

Bisoprolol AN

Storage

Keep BISOPROLOL AN where

children cannot reach it.

A locked cupboard at least one-

and-a-half

metres

above

ground is a good place to store

medicines.

Keep your tablets in the blister

pack until it is time to take

them.

If you take the tablets out of the

blister pack they may not keep

well.

Keep your tablets in a cool dry

place.

BISOPROLOL

should

stored below 25 degrees C.

Do not store BISOPROLOL AN

or any other medicine in the

bathroom or near a sink.

Do not leave BISOPROLOL AN

in the car or on window sills.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking

BISOPROLOL

AN,

or

your tablets have passed their

expiry

date,

ask

your

pharmacist

what

to

do

with

any that are left over.

Product description

What it looks like

BISOPROLOL AN 1.25 mg, 2.5

mg, 3.75 mg, 5 mg, 7.5 mg & 10

bisoprolol

fumarate)

presented in pack size of 28, 30

& 100 tablets in blister.

BISOPROLOL

AN

1.25

(AUST R 175919)

White,

circular,

biconvex,

film-

coated tablets debossed with ‘P’

on one side and ‘1’ on the other

Bisoprolol AN tablets – Consumer Medicine Information

Doc ID: 43.AN.M.2.0

Page 5

side.

BISOPROLOL AN 2.5 mg

(AUST R 175930)

White,

circular,

biconvex,

film-

coated tablets debossed with ‘P

and break line’ on one side and

‘2’ on the other side.

BISOPROLOL AN 3.75 mg

(AUST R 175914)

White,

circular,

biconvex,

film-

coated tablets debossed with ‘P’

and break line’ on one side and

‘3’ on the other side.

BISOPROLOL AN 5 mg (AUST

R 175922)

White,

circular,

biconvex,

film-

coated tablets debossed with ‘P’

and break line’ on one side and

‘5’ on the other side.

BISOPROLOL AN 7.5 mg

(AUST R 175913)

White,

circular,

biconvex,

film-

coated tablets debossed with ‘P’

and break line’ on one side and

‘7’ on the other side.

AURO-BISOPROLOL 10 mg

(AUST R 175917)

White,

circular,

biconvex,

film-

coated tablets debossed with ‘P’

and break line’ on one side and

‘10’ on the other side.

Ingredients

Active Ingredient:

Bisoprolol fumarate

Each tablet may contain either

1.25 mg, 2.5 mg, 3.75 mg, 5 mg,

7.5 mg & 10 mg of bisoprolol

fumarate.

Other Ingredients:

microcrystalline cellulose

calcium hydrogen phosphate

colloidal anhydrous silica

crospovidone

magnesium stearate

opadry white 03B28796 (PI-

ARTG No. 11377).

Please read this leaflet carefully

before

start

taking

BISOPROLOL

wish to keep it to read again.

Name

and

Address

of

the

Sponsor

Amneal

Pharma

Australia

12 River St, South Yarra

VIC – 3141

Australia

Date of Preparation

June 2014

Doc ID: 43.AN.M.2.0