FRUSAX

Main information

  • Trade name:
  • FRUSAX
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FRUSAX
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176034
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176034

FRUSAX furosemide (frusemide) 40mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Eris Pharmaceuticals (Australia) Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

28/04/2011

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. FRUSAX

Product Type

Single Medicine Product

Effective date

21/07/2011

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oedema: Adults and children. 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 intravenous or intramuscular route.

Parenteral use should be replaced with oral Frusax as soon as practical. Hypertension: Adults. Oral Frusax 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 Frusax alone.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

100 TABLETS

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

An off-white, round, flat, bevelled edged tablet engraved with 40 over

breakline on one side and plain on the other side

Active Ingredients

furosemide (frusemide)

40 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 01:22:16 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

frusemide 20 mg and 40 mg tablets

Frusax

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Frusax™. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of you

taking Frusax™ against the benefits it is

expected to have for you.

If you have any concerns about taking this

medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Frusax

is used for

Frusax™ is a water tablet (or diuretic).

It may be taken alone, or together with

other medicines.

One of its uses is to help reduce the

amount of water in the body for people

who have:

swelling of the ankles, feet and legs,

which doctors call oedema

swelling of the stomach area due to

liver disease.

Frusax™ also helps lower high blood

pressure, which doctors call hypertension.

Everyone has blood pressure. This

pressure helps circulate the 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

such as stroke, heart disease and

kidney failure. Frusax™ helps to lower

your blood pressure.

Frusax™ works by making your kidneys

pass more water and salt. This helps

reduce high blood pressure and some

forms of swelling.

Your doctor may prescribe Frusax™ for

another reason.

Ask your doctor if you have any questions

about why Frusax™ has been prescribed

for you.

There is no evidence that Frusax™ is

addictive.

Before you start to take

Frusax

When you must not take it

Do not take Frusax™ if:

You have an allergy to frusemide or any

of the ingredients listed at the end of

this leaflet or any other sulfonamide

type medication. Usual symptoms of

allergy are skin rash, itching, redness or

other discolouration of the skin.

You are pregnant, or intend to become

pregnant. Frusax™ may affect your

developing baby if you take it during

pregnancy.

You have severe kidney disease

The expiry date (EXP) printed on

the pack has passed. If you take this

medicine after the expiry date has

passed it may not work, or it may make

you sick.

The packaging is torn or shows signs of

tampering

If you are not sure whether you should

start taking Frusax™, talk to your doctor.

Before you start to take it

You must tell your doctor if you have

any alle

rgies to any other medicines or

any other substances, such as foods,

preservatives or dyes.

Tell your doctor or pharmacist if you have

any of these medical conditions:

diabetes mellitus

liver disease

heart and lung disease

kidney disease

prostrate problems

gout

any other medical conditions or if you

are on salt restricted diet.

Tell your doctor or pharmacist if you are

breast-feeding or intend to breast-feed.

Frusax™ passes into breast milk. Your

doctor will decide whether or not you

should take Frusax™.

Tell your doctor or pharmacist if you are

pregnant or intend to become pregnant.

Your doctor will discuss the possible risks

of using Frusax™ during pregnancy.

Taking other medicines

Tell your doctor if you are taking any

other medicines, including any that

you have bought from your pharmacy,

supermarket or health food shop.

Some of the medicines in common

use that may interfere with Frusax™

include:

digoxin for heart conditions

steroids such as cortisone, prednisone,

dexamethasone

laxatives for constipation

some antibiotics for treating infections

theophylline for respiratory diseases

medicines for epilepsy

medicines for diabetes

lithium for mood disorders

medicines for arthritis such as aspirin,

NSAIDs

medicines for high blood pressure,

especially ACE inhibitors

liquorice when consumed in large

amounts.

These medicines may be affected by

Frusax™, or may affect how well it

works. You may need to take different

amounts of your medicine, or you

may need to take different medicines.

Your doctor or pharmacist has a more

complete list of medicines to avoid while

taking Frusax™.

If you have not told your doctor about

any of the above, tell them before you

take any Frusax™.

How to take Frusax

How much to take

Take Frusax™ only when prescribed by

your doctor. Your doctor will tell you how

many tablets you need to take each day.

The number will depend on your

condition and whether you are taking

other medicines. Do not take more

tablets than your doctor has prescribed.

Your doctor will follow your progress and

adjust the dose accordingly.

If you do not understand the instructions

on the label, ask your doctor or

pharmacist for help.

How to take it

Swallow Frusax™ with a glass of water.

When to take it

Take your Frusax™ everyday at about

the same time each day, unless your

doctor tells you otherwise. Take Frusax™

on an empty stomach.

Taking your tablets at the same time each

day will have the best effect. It will also help

you to remember when to take the tablets.

If you are taking a single dose a day,

take it in the morning, for example at

breakfast time.

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.

Frusax™ will increase the amount

of water (urine) you pass and also the

number of times you go to the toilet. By

taking the last dose no later than 2 pm

there may be less chance of your sleep

being disturbed.

How long to take it

If you have high blood pressure or

swelling, Frusax™ helps to control the

condition but does not cure it. Therefore,

Frusax™ must be taken every day.

Continue taking Frusax™ for as long as

your doctor prescribes.

If you forget to take it

Take it as soon as you remember, and

then go back to taking your tablets as

you would normally. However, if it is

almost time for your next dose, skip the

dose you missed and take your next dose

when you are meant to.

Do not take a double dose to make up

for the dose that you missed.

If you have trouble remembering to take

your tablets, ask your pharmacist for

some hints.

Artwork for Frusax CMI.

Dieline: 250 x 170 mm

file: Frusax_CMI_v1

27-07-11, EM

If you take too much (overdose)

Immediately telephone your doctor or

Poisons Information Centre (13 11 26), or

go to casualty at your nearest hospital,

if you think that you or anyone else may

have taken too much Frusax™. Do this

even if there are no signs of discomfort or

poisoning.

Keep telephone numbers of these places

handy.

If you take too many tablets, you will

probably feel light-headed or dizzy. You

may also become very thirsty, confused,

have a change in the amount of urine

passed or have a fast heart beat.

While you are using Frusax

Things you must do

Have your blood pressure checked when

your doctor says to make sure Frusax™

is working.

Tell your doctor and pharmacist that you

are taking Frusax™ if you are about to

be started on any new medicine.

You may feel light-headed or dizzy when

you begin to take Frusax™. This is

because your blood pressure is falling

suddenly. Standing up slowly, especially

when you get up from bed or chairs, will

help your body get used to the change in

position and blood pressure.

Tell your doctor if you have excessive

vomiting and/or diarrhoea while taking

Frusax™, or you have any of the

following symptoms:

dry mouth, thirst

weakness, tiredness, drowsiness

muscle pains or cramps

fast heart beat

passing less urine than normal

You may be dehydrated because you are

losing too much water.

Tell your doctor or dentist that you are

taking Frusax™ if you plan to have

surgery (even at the dentist) that needs a

general anaesthetic. Your blood pressure

may drop suddenly.

Things you must not do

Do not stop taking Frusax™ or lower

the dose because you are feeling better,

unless advised to by your doctor.

Do not give Frusax™ to anyone else even

if their symptoms seem similar to yours.

Things to be careful of

Be careful driving or operating machinery

until you know how Frusax™ affects you.

Frusax™ may cause dizziness or light-

headedness in some people, especially after

the first few doses. Make sure you know how

you react t

o Frusax™ before you drive a

car, operate machinery, or do anything else

that could be dangerous if you are dizzy or

light-headed. If you drink alcohol, dizziness

or light-headedness may be worse.

Talk to your doctor about foods or drinks

that have high potassium content.

Long term Frusax™ therapy causes a fall

in potassium levels in your body. However,

if you eat foods or have drinks that are

high in potassium this will help maintain

normal levels of potassium in your body.

Too much potassium can, however, be

harmful, therefore, it is important to

discuss your diet with your doctor.

Things that would be helpful for

your blood pressure

Some self help measures suggested

below may help your blood pressure. Talk

to your doctor or pharmacist about these

measures and for more information.

Alcohol – your doctor may advise you

to limit your alcohol intake.

Diet – eat a healthy diet that includes

plenty of fresh vegetables, fruit, bread,

cereals and fish. Also eat less fat and sugar.

Exercise – regular exercise helps to

reduce blood pressure. Try regular

walking, swimming, cycling or games

such as tennis and golf. Before starting

any exercise, ask your doctor about the

best kind of program for you.

Salt – your doctor may advise you to

watch the amount of salt in your diet.

To reduce your salt intake you should

avoid using salt in cooking or at the

table.

Smoking – your doctor may advise you

to stop smoking or at least cut down.

Weight – your doctor may suggest

losing some weight to help lower your

blood pressure. Some people may

need a dietician’s help to lose weight.

Side Effects

Tell your doctor or pharmacist as soon as

possible if you do not feel well while you

are taking Frusax™.

Frusax™ helps most people, but it

may have unwanted side effects in a

few people. All medicines can have side

effects. Sometimes they are serious, most

of the time they are not. You may need

medical treatment if you get some of the

side effects.

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:

nausea

vomiting

stomach pain

constipation, diarrhoea

dizziness

headache

dry mouth

These are mild side effects of Frusax™.

Tell

your doctor immediately if you notice

any of the following:

muscle cramps

weakness

skin rash, itching

ringing in your ears (tinnitus)

loss of hearing

chest pain or tightness

fever

blurred vision

changes in the way your heart beats

yellowing of the skin and eyes, also

called jaundice

unusual bruising or bleeding

increasing frequency of infections such

as fever, severe chills, sore throat or

mouth ulcers

These are serious side effects. You may

need urgent medical attention. Serious

side effects are rare.

Other side effects not listed above may

also occur in some patients. Tell your

doctor if you notice anything else that is

making you feel unwell.

After taking Frusax

Storage

Keep your tablets in the bottle until it is

time to take them.

Keep the bottle tightly

closed.

If you take the tablets out of the bottle

they may not keep well.

Keep it in a cool dry place where the

temperature stays below 30°C and away

from light and moisture.

Do not store it or any other medicines in

the bathroom or near a sink.

Do not leave it in the car or on window

sills. Heat and dampness can destroy

some medicines.

Keep it where young children cannot

reach it.

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 the

tablets, ask your pharmacist what to do

with any tablets left over.

Further information

This is not all the information that is

available on Frusax™. If you have any

more questions or are not sure about

anything, ask your doctor or pharmacist.

Product description

What it looks like

Frusax™ 40 mg tablets: An off-white,

round, flat bevelled edged tablet

engraved 40 over a breakline on one side

and plain on the other. A bottle contains

100 tablets.

Ingredients

Active ingredient:

Frusax™ 40mg contains frusemide

40mg per tablet.

Inactive ingredients:

lactose

magnesium stearate

butyl hydroxybenzoate

microcrystalline cellulose

povidone

propyl hydroxybenzoate

silica colloidal anhydrous

sodium starch glycollate

Eris Pharmaceuticals (Australia) Pty Ltd

6 Eastern Road

South Melbourne VIC 3205

www.eris-pharma.com.au

Australian Registration Number:

FRUSAX™ 40mg AUST R 176034

Prepared in June 2011

and updated in November 2012

Frusax™ 20 mg tablets: An off-white,

round, flat bevelled edged tablet

engraved 20 over a breakline on one side

and plain on the other. A bottle contains

100 tablets.

FRUSAX™ 20mg AUST R 176033

Frusax™ 20mg contains frusemide

20mg per tablet.

Sponsor / Marketing

Authorisation Holder