TERRY WHITE CHEMISTS FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186530
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186530

TERRY WHITE CHEMISTS FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

28/06/2012

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. TERRY WHITE CHEMISTS FRUSEMIDE furosemide (frusemide) 40 mg tablet bottle

Product Type

Single Medicine Product

Effective date

10/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oedema

Frusemide is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal

disease including the nephrotic syndrome. Frusemide is particularly useful when an agent with greater diuretic potential than that of those commonly

employed is desired.,Parenteral therapy with frusemide should be reserved for patients unable to take oral medication or for patients in emergency

clinical situations. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, frusemide is indicated by the intravenous or

intramuscular route. Parenteral use should be replaced with oral frusemide as soon as practical.,Hypertension

Oral Frusemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive

patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with frusemide alone.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

1000

(S4) Prescription Only Medicine

Components

1. TERRY WHITE CHEMISTS FRUSEMIDE frusemide 40 mg tablet bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, round tablets, debossed with 'F4' on one side and

breakline on the other side.

Active Ingredients

furosemide (frusemide)

40 mg

Public Summary

Page 1 of

Produced at 29.11.2017 at 02:42:46 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

© 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 2 of

Produced at 29.11.2017 at 02:42:46 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

TERRY WHITE

CHEMISTS Frusemide

Tablets

Contains the active ingredient furosemide (frusemide)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about furosemide

(frusemide). It does not contain all

the available information. It does not

take the place of talking to your

doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is Terry

White chemists Frusemide. It

contains the active ingredient

furosemide (frusemide).

Furosemide (frusemide) is used to

treat swelling of the ankles, feet, legs

or even the brain or lungs. This

swelling is called oedema and can

occur in some heart, lung, liver or

kidney conditions.

Furosemide (frusemide) may be used

in some patients with more serious

kidney problems who may have

some fluid retention.

Furosemide (frusemide) may also be

used to lower high blood pressure

(which is also called hypertension).

Everyone has blood pressure. This

pressure helps move your blood

around your body. Your blood

pressure may be different at different

times of the day, depending on how

busy or worried you are. You have

hypertension (high blood pressure)

when your blood pressure stays

higher than is needed, even when you

are calm and relaxed.

If high blood pressure is not treated it

can lead to serious health problems,

including stroke, heart disease and

kidney failure.

Furosemide (frusemide) may be

taken alone or in combination with

other medicines to treat your

condition.

Your doctor may have prescribed

furosemide (frusemide) for another

purpose.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

This medicine is only available with

a doctor's prescription.

How it works

Furosemide (frusemide) belongs to a

family of drugs called diuretics. A

diuretic helps reduce the amount of

excess fluid in the body by increasing

the amount of urine produced.

This medicine is not addictive.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

-

certain kidney problems

-

no production or no passing of

urine

-

low blood pressure

(hypotension)

-

low sodium levels in your blood

TERRY WHITE CHEMISTS FRUSEMIDE TABLETS

-

low potassium levels in your

blood

-

dehydration.

You are pregnant.

Furosemide (frusemide) may

affect your developing baby if

you take it during pregnancy.

You are breastfeeding.

Furosemide (frusemide) may pass

into human breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

furosemide (frusemide),

sulfonamides or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

liver problems

kidney problems

heart problems

high cholesterol levels

asthma

diabetes

gout, a disease with painful,

swollen joints

passing less urine than is normal

for you

difficulty passing urine

prostate problems

Systemic Lupus Erythematosus

(SLE), a disease affecting the

skin, joints and kidneys.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Tell your doctor if you are on a salt

restricted diet.

If you have not told your doctor

about any of the above, tell them

before you take furosemide

(frusemide).

Some medicines may interfere with

furosemide (frusemide). These

include:

certain other fluid tablets or

diuretic medicines such as

ethacrynic acid

medicines used to treat high

blood pressure and some other

heart conditions, especially ACE

inhibitors or angiotensin receptor

antagonists

digoxin and other medicines used

to treat heart failure

non-steroidal anti-inflammatory

drugs (NSAIDs) and aspirin,

medicines used to relieve pain,

swelling and other symptoms of

inflammation, including arthritis

medicines used to relax muscles

such as tubocurarine and

succinylcholine

lithium, a medicine used to treat

mood swings and some types of

depression

medicines used in emergency

situations such as adrenaline and

noradrenaline

cisplatin, a medicine used to treat

cancer

theophylline, a medicine used to

treat asthma

certain antibiotics, especially

cephalosporins and

aminoglycosides

amphotericin, a medicine used to

treat fungal infections

barbiturates, medicine used to

treat epilepsy, to produce

calmness, or to help you sleep

narcotic/strong pain killers such

as codeine and morphine

medicines used to treat diabetes

such as insulin

sucralfate, a medicine used to

treat stomach ulcers

anticonvulsant medicines such as

chloral hydrate or phenytoin

corticosteroids such as cortisone,

prednisone or dexamethasone

medicines used during scans to

see the images of your body

methotrexate and cyclosporine A,

medicines that suppress the

immune

carbenoxolone, used to treat

ulcers of the mouth or

oesophagus

medicines used to treat thyroid

conditions

risperidone, used to treat a

number of mood disorders

large amounts of laxatives

(medicines for constipation).

TERRY WHITE CHEMISTS FRUSEMIDE TABLETS

These medicines may be affected by

furosemide (frusemide), or may

affect how well it works. If you are

taking any of these you may need a

different dose or you may need to

take different medicines. Your doctor

will advise you.

You should not eat large amounts of

liquorice when you are taking

furosemide (frusemide).

Other medicines not listed above

may also interact with furosemide

(frusemide).

How to take this

medicine

Follow the directions given to you by

your doctor carefully.

Their instructions may be different to

the information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

Oedema

Adults: 20 to 80 mg as a single dose.

The dose may be increased in

exceptional cases up to 400 mg per

day.

Children: 2 mg per kg bodyweight

per day. The dose may be increased

by 1-2mg per kg and should not

exceed 6mg per kg bodyweight.

Hypertension

Adults: The recommended dosage is

40 mg twice daily. The dose may be

adjusted according to the patient's

response.

How to take it

Swallow furosemide (frusemide)

tablets with a glass of water.

When to take it

Furosemide (frusemide) tablets are

usually taken once or twice a day.

Take furosemide (frusemide) tablets

on an empty stomach. For example,

one hour before food or two hours

after food. Food can interfere with

the absorption of furosemide

(frusemide) tablets.

Take furosemide (frusemide) tablets

at about the same time each day

unless your doctor tells you

otherwise.

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take the medicine.

If you are taking a single dose a day,

take it in the morning, for example

before breakfast. If you are taking

more than one dose a day, take the

last dose no later than 2 pm, unless

your doctor tells you otherwise.

Furosemide (frusemide) may

increase the amount of urine you

pass; it will also increase the number

of times you need to go to the toilet.

By taking your last dose around 2

pm, there may be less chance that

your sleep is disturbed.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Ask your doctor if you are not sure

how long to take the medicine for.

If you forget to take it

This may increase the chance of

getting an unwanted side effect.

If it is almost time for your next

dose, skip the dose you missed and

take the next dose when you are

meant to.

If there is still a long time to go

before your next dose, take it as soon

as you remember, and then go back

to taking it as you would normally.

Do not take a double dose to make

up for missed doses.

If you are not sure what to do, ask

your doctor.

If you have trouble remembering

when to take your medicine, ask your

pharmacist for hints to help you

remember.

If you take too much

(overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre (telephone 13 11 26), or go

to Accident and Emergency at

your nearest hospital, if you think

you or anyone else may have taken

too much furosemide (frusemide).

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too much furosemide

(frusemide), you may feel confused,

dehydrated, dizzy or you may pass

excessive urine.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

TERRY WHITE CHEMISTS FRUSEMIDE TABLETS

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Make sure you drink enough water

during any exercise and during hot

weather when you are taking

furosemide (frusemide), especially

if you sweat a lot.

If you do not drink enough water

while taking furosemide (frusemide),

you may feel faint or light-headed or

sick. This is because your blood

pressure is dropping suddenly and

you are dehydrating. If you continue

to feel unwell, tell your doctor.

If you feel light-headed, dizzy or

faint, get up slowly when getting

out of bed or standing up.

You may feel light-headed or dizzy

when you begin to take furosemide

(frusemide). This is because your

blood pressure is falling suddenly.

Standing up slowly, especially when

you get up from beds or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Be careful driving or operating

machinery until you know how

furosemide (frusemide) affects you.

Diuretic medicines may cause

dizziness or light-headedness in some

people. Make sure you know how

you react to your medicine before

you drive a car, operate machinery,

or do anything else that could be

dangerous if you are dizzy or

lightheaded.

If this occurs do not drive.

If you drink alcohol or take strong

painkillers, dizziness or light-

headedness may be worse.

The effects of alcohol could be

made worse while taking

furosemide (frusemide). It is not

recommended that you drink

alcohol while taking furosemide

(frusemide).

If you are taking furosemide

(frusemide) for a long period of time,

you should check with your doctor to

determine whether or not you should

eat more potassium-containing foods

or take potassium supplements.

However, increasing the amount of

potassium in your diet may not be

necessary and could be harmful.

Check with your doctor.

Furosemide (frusemide) may cause

your skin to become more sensitive

to the sun. If this happens you should

take care to wear protective clothing

including a hat and sun block when

you are outside.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking this medicine or if you have

any questions or concerns.

Do not be alarmed by the following

list of side effects.You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious, but most

of the time they are not.

Tell your doctor if you notice any

of the following:

very dry mouth or unusual thirst

weight loss

weakness or tiredness

numbness or tingling in the hands

and/or feet

calf muscle spasms

muscle pains or cramps

joint pain or stiffness

restlessness

drowsiness or a lack of energy

dizziness or light-headedness

headache

fever

vomiting or nausea

diarrhoea

blurred or impaired vision

unusual bleeding or bruising

under the skin

ringing or buzzing in the ears

confusion.

Tell your doctor as soon as possible

if you notice any of the following:

These may be serious side effects of

furosemide (frusemide) and you may

need urgent medical attention.

irregular or fast heart beat

passing less urine than is normal

for you

severe stomach pain, often with

nausea or vomiting

severe dizziness or a spinning

sensation

increased sensitivity to sunlight

flaking or peeling of the skin

symptoms of anaemia such as

tiredness, being short of breath

when exercising, dizziness and

looking pale

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

bleeding or bruising more easily

than normal, nose bleeds

loss of control of your bladder or

bowels (incontinence)

gout, a disease with painful,

swollen joints

deafness or ringing in the ears.

If you experience any of the

following stop taking your

medicine and contact your doctor

or immediately go to the Accident

and Emergency at your nearest

hospital:

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

chest pain

fainting or having a rapid, weak

pulse

lockjaw

red, often itchy spots similar to

the rash seen with measles which

TERRY WHITE CHEMISTS FRUSEMIDE TABLETS

starts on the limbs and sometimes

on the face and body. The spots

may blister and may progress to

form raised red, pale-centred

marks. Those affected may have

fever, sore throat, headache with

or without diarrhoea.

yellowing of the skin and/or eyes

(jaundice).

Other side effects not listed above

may occur in some people.

Allergic reactions

If you think you are having an

allergic reaction to furosemide

(frusemide), do not take any more

of this medicine and tell your

doctor immediately or go to the

Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your furosemide (frusemide)

tablets in the bottle until it is time to

take them.

If you store your furosemide

(frusemide) tablets out of the

container they may not keep well.

Keep your furosemide (frusemide)

tablets in a cool dry place where the

temperature stays below 25°C.

Do not store furosemide (frusemide)

tablets or any other medicine in the

bathroom, near a sink, or on a

windowsill.

Do not leave it in the car.

Heat, sunlight and dampness can

destroy some medicines.

Keep it where children cannot reach

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

furosemide (frusemide) or the

medicine has passed its expiry date,

ask your pharmacist what to do with

any that is left over. Return any

unused medicine to your pharmacist.

Product description

What Terry White chemists

Frusemide looks like

20 mg tablets:

White to off-white round tablets,

debossed with 'F2' on one side and

plain on the other side.

Packaged in bottles of 50 and 100

tablets.

Packaged in bottles of 50 and 100

tablets.

Packaged in bottles of 50 and 100

tablets.

40 mg tablets:

White to off-white round tablets,

debossed with 'F4' on one side and

breakline on the other side.

Packaged in bottles of 30, 50, 60 and

100 tablets.

* Not all strengths and/or pack sizes

may be available.

Ingredients

Each tablet contains 20 mg or 40 mg

of furosemide (frusemide) as the

active ingredient.

It also contains the following inactive

ingredients:

lactose monohydrate

maize starch

pregelatinised maize starch,

sodium starch glycollate (type A)

magnesium stearate.

This medicine is gluten-free and free

of azo dyes.

Australian Registration

Numbers

Terry White Chemists Frusemide 20

mg tablets: AUST R 186513.

Terry White Chemists Frusemide 40

mg tablets: AUST R 186530.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

February 2018

TERRY WHITE CHEMISTS FRUSEMIDE TABLETS