APO-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 beforetaking your medicine.

This leaflet answers some commonquestions about furosemide(frusemide). It does not contain allthe available information. It does nottake the place of talking to yourdoctor or pharmacist.

The information in this leaflet waslast updated on the date listed on thelast page. More recent information onthis medicine may be available.

Ask your doctor or pharmacist:

• if there is anything you do notunderstand in this leaflet,

• if you are worried about takingyour medicine, or

• to obtain the most up-to-dateinformation.

You can also download the most upto date leaflet fromwww.apotex.com.au.

All medicines have risks andbenefits. Your doctor has weighedthe risks of you using this medicineagainst the benefits they expect itwill have for you.

Pharmaceutical companies cannotgive you medical advice or anindividual diagnosis.

Keep this leaflet with your medicine.You may want to read it again.

What this medicine isused for

The name of your medicine is APO-Frusemide. It contains the activeingredient furosemide (frusemide).

Furosemide (frusemide) is used totreat swelling of the ankles, feet, legsor even the brain or lungs. Thisswelling is called oedema and canoccur in some heart, lung, liver orkidney conditions.

Furosemide (frusemide) may be usedin some patients with more seriouskidney problems who may havesome fluid retention.

Furosemide (frusemide) may also beused to lower high blood pressure(which is also called hypertension).

Everyone has blood pressure. Thispressure helps move your bloodaround your body. Your bloodpressure may be different at differenttimes of the day, depending on howbusy or worried you are. You havehypertension (high blood pressure)when your blood pressure stayshigher than is needed, even when youare calm and relaxed.

If high blood pressure is not treated itcan lead to serious health problems,including stroke, heart disease andkidney failure.

Furosemide (frusemide) may betaken alone or in combination withother medicines to treat yourcondition.

Your doctor may have prescribedfurosemide (frusemide) for anotherpurpose.

Ask your doctor if you have anyquestions about why it has beenprescribed for you.

This medicine is only available witha doctor's prescription.

How it works

Furosemide (frusemide) belongs to afamily of drugs called diuretics. Adiuretic helps reduce the amount ofexcess fluid in the body by increasingthe amount of urine produced.

This medicine is not addictive.

Before you take thismedicine

When you must not take it

Do not take this medicine if:

• You have or have had any ofthe following:

- certain kidney problems

- no production or no passing ofurine

- low blood pressure(hypotension)

- low sodium levels in your blood

- low potassium levels in yourblood

- dehydration.

• You are pregnant.

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Furosemide (frusemide) mayaffect your developing baby ifyou take it during pregnancy.

• You are breastfeeding.

Furosemide (frusemide) may passinto human breast milk.

• You are hypersensitive to, orhave had an allergic reaction to,furosemide (frusemide),sulfonamides or any of theingredients listed at the end ofthis leaflet.

Symptoms of an allergic reactionmay include: cough, shortness ofbreath, wheezing or difficultybreathing; swelling of the face,lips, tongue, throat or other partsof the body; rash, itching or hiveson the skin; fainting; or hayfever-like symptoms.

If you think you are having anallergic reaction, do not takeany more of the medicine andcontact your doctorimmediately or go to theAccident and Emergencydepartment at the nearesthospital.

• The expiry date (EXP) printedon the pack has passed.

• The packaging is torn, showssigns of tampering or it does notlook quite right.

Before you start to take it

Before you start taking thismedicine, tell your doctor if:

1. You have allergies to:

• any other medicines

• any other substances, such asfoods, preservatives or dyes.

2. You have or have had anymedical conditions, especially thefollowing:

• liver problems

• kidney problems

• heart problems

• high cholesterol levels

• asthma

• diabetes

• gout, a disease with painful,swollen joints

• passing less urine than is normalfor you

• difficulty passing urine

• prostate problems

• Systemic Lupus Erythematosus(SLE), a disease affecting theskin, joints and kidneys.

3. You are currently pregnant or youplan to become pregnant. Do nottake this medicine whilstpregnant.

4. You are currently breastfeedingor you plan to breast-feed. Do nottake this medicine whilstbreastfeeding.

5. You are planning to have surgeryor an anaesthetic.

6. You are currently receiving or areplanning to receive dentaltreatment.

7. You are taking or are planning totake any other medicines. Thisincludes vitamins andsupplements that are availablefrom your pharmacy, supermarketor health food shop.

Tell your doctor if you are on a saltrestricted diet.

If you have not told your doctorabout any of the above, tell thembefore you take furosemide(frusemide).

Some medicines may interfere withfurosemide (frusemide). Theseinclude:

• certain other fluid tablets ordiuretic medicines such asethacrynic acid

• medicines used to treat highblood pressure and some otherheart conditions, especially ACEinhibitors or angiotensin receptorantagonists

• digoxin and other medicines usedto treat heart failure

• non-steroidal anti-inflammatorydrugs (NSAIDs) and aspirin,medicines used to relieve pain,swelling and other symptoms ofinflammation, including arthritis

• medicines used to relax musclessuch as tubocurarine andsuccinylcholine

• lithium, a medicine used to treatmood swings and some types ofdepression

• medicines used in emergencysituations such as adrenaline andnoradrenaline

• cisplatin, a medicine used to treatcancer

• theophylline, a medicine used totreat asthma

• certain antibiotics, especiallycephalosporins andaminoglycosides

• amphotericin, a medicine used totreat fungal infections

• barbiturates, medicine used totreat epilepsy, to producecalmness, or to help you sleep

• narcotic/strong pain killers suchas codeine and morphine

• medicines used to treat diabetessuch as insulin

• sucralfate, a medicine used totreat stomach ulcers

• anticonvulsant medicines such aschloral hydrate or phenytoin

• corticosteroids such as cortisone,prednisone or dexamethasone

• medicines used during scans tosee the images of your body

• methotrexate and cyclosporine A,medicines that suppress theimmune

• carbenoxolone, used to treatulcers of the mouth oroesophagus

• medicines used to treat thyroidconditions

• risperidone, used to treat anumber of mood disorders

• large amounts of laxatives(medicines for constipation).

These medicines may be affected byfurosemide (frusemide), or mayaffect how well it works. If you aretaking any of these you may need adifferent dose or you may need to

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take different medicines. Your doctorwill advise you.

You should not eat large amounts ofliquorice when you are takingfurosemide (frusemide).

Other medicines not listed abovemay also interact with furosemide(frusemide).

How to take thismedicine

Follow the directions given to you byyour doctor carefully.

Their instructions may be different tothe information in this leaflet.

How much to take

Your doctor will tell you how muchof this medicine you should take.This will depend on your conditionand whether you are taking any othermedicines.

Do not stop taking your medicine orchange your dosage without firstchecking with your doctor.

Oedema

Adults: 20 to 80 mg as a single dose.The dose may be increased inexceptional cases up to 400 mg perday.

Children: 2 mg per kg bodyweightper day. The dose may be increasedby 1-2mg per kg and should notexceed 6mg per kg bodyweight.

Hypertension

Adults: The recommended dosage is40 mg twice daily. The dose may beadjusted according to the patient'sresponse.

How to take it

Swallow furosemide (frusemide)tablets with a glass of water.

When to take it

Furosemide (frusemide) tablets areusually taken once or twice a day.

Take furosemide (frusemide) tabletson an empty stomach. For example,

one hour before food or two hoursafter food. Food can interfere withthe absorption of furosemide(frusemide) tablets.

Take furosemide (frusemide) tabletsat about the same time each dayunless your doctor tells youotherwise.

Taking your medicine at the sametime each day will have the besteffect. It will also help you rememberwhen to take the medicine.

If you are taking a single dose a day,take it in the morning, for examplebefore breakfast. If you are takingmore than one dose a day, take thelast dose no later than 2 pm, unlessyour doctor tells you otherwise.

Furosemide (frusemide) mayincrease the amount of urine youpass; it will also increase the numberof times you need to go to the toilet.By taking your last dose around 2pm, there may be less chance thatyour sleep is disturbed.

How long to take it for

Continue taking your medicine for aslong as your doctor tells you.

Ask your doctor if you are not surehow long to take the medicine for.

If you forget to take it

This may increase the chance ofgetting an unwanted side effect.

If it is almost time for your nextdose, skip the dose you missed andtake the next dose when you aremeant to.

If there is still a long time to gobefore your next dose, take it as soonas you remember, and then go backto taking it as you would normally.

Do not take a double dose to makeup for missed doses.

If you are not sure what to do, askyour doctor.

If you have trouble rememberingwhen to take your medicine, ask yourpharmacist for hints to help youremember.

If you take too much(overdose)

Immediately telephone yourdoctor, or the Poisons InformationCentre (telephone 13 11 26), or goto Accident and Emergency atyour nearest hospital, if you thinkyou or anyone else may have takentoo much furosemide (frusemide).

Do this even if there are no signs ofdiscomfort or poisoning. You mayneed urgent medical attention.

If you take too much furosemide(frusemide), you may feel confused,dehydrated, dizzy or you may passexcessive urine.

While you are takingthis medicine

Things you must do

Tell your doctor that you are takingthis medicine if:

• you are about to be started on anynew medicine

• you are pregnant or are planningto become pregnant

• you are breastfeeding or areplanning to breast-feed

• you are about to have any bloodtests

• you are going to have surgery oran anaesthetic or are going intohospital.

Your doctor may occasionally dotests to make sure the medicine isworking and to prevent side effects.Go to your doctor regularly for acheck-up.

Tell any other doctors, dentists andpharmacists who are treating you thatyou take this medicine.

Things you must not do

Do not:

• Give this medicine to anyoneelse, even if their symptoms seemsimilar to yours.

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• Take your medicine to treat anyother condition unless yourdoctor tells you to.

• Stop taking your medicine, orchange the dosage, without firstchecking with your doctor.

Things to be careful of

Make sure you drink enough waterduring any exercise and during hotweather when you are takingfurosemide (frusemide), especiallyif you sweat a lot.

If you do not drink enough waterwhile taking furosemide (frusemide),you may feel faint or light-headed orsick. This is because your bloodpressure is dropping suddenly andyou are dehydrating. If you continueto feel unwell, tell your doctor.

If you feel light-headed, dizzy orfaint, get up slowly when gettingout of bed or standing up.

You may feel light-headed or dizzywhen you begin to take furosemide(frusemide). This is because yourblood pressure is falling suddenly.Standing up slowly, especially whenyou get up from beds or chairs, willhelp your body get used to thechange in position and bloodpressure. If this problem continues orgets worse, talk to your doctor.

Be careful driving or operatingmachinery until you know howfurosemide (frusemide) affects you.

Diuretic medicines may causedizziness or light-headedness in somepeople. Make sure you know howyou react to your medicine beforeyou drive a car, operate machinery,or do anything else that could bedangerous if you are dizzy orlightheaded.

If this occurs do not drive.

If you drink alcohol or take strongpainkillers, dizziness or light-headedness may be worse.

The effects of alcohol could bemade worse while takingfurosemide (frusemide). It is notrecommended that you drinkalcohol while taking furosemide(frusemide).

If you are taking furosemide(frusemide) for a long period of time,you should check with your doctor todetermine whether or not you shouldeat more potassium-containing foodsor take potassium supplements.However, increasing the amount ofpotassium in your diet may not benecessary and could be harmful.Check with your doctor.

Furosemide (frusemide) may causeyour skin to become more sensitiveto the sun. If this happens you shouldtake care to wear protective clothingincluding a hat and sun block whenyou are outside.

Possible side effects

Tell your doctor as soon as possibleif you do not feel well while you aretaking this medicine or if you haveany questions or concerns.

Do not be alarmed by the followinglist of side effects.You may notexperience any of them. Allmedicines can have side effects.Sometimes they are serious, but mostof the time they are not.

Tell your doctor if you notice anyof the following:

• very dry mouth or unusual thirst

• weight loss

• weakness or tiredness

• numbness or tingling in the handsand/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 bruisingunder the skin

• ringing or buzzing in the ears

• confusion.

Tell your doctor as soon as possibleif you notice any of the following:

These may be serious side effects offurosemide (frusemide) and you mayneed urgent medical attention.

• irregular or fast heart beat

• passing less urine than is normalfor you

• severe stomach pain, often withnausea or vomiting

• severe dizziness or a spinningsensation

• increased sensitivity to sunlight

• flaking or peeling of the skin

• symptoms of anaemia such astiredness, being short of breathwhen exercising, dizziness andlooking pale

• frequent infections such as fever,severe chills, sore throat or mouthulcers

• bleeding or bruising more easilythan normal, nose bleeds

• loss of control of your bladder orbowels (incontinence)

• gout, a disease with painful,swollen joints

• deafness or ringing in the ears.

If you experience any of thefollowing stop taking yourmedicine and contact your doctoror immediately go to the Accidentand Emergency at your nearesthospital:

These are very serious side effectsand you may need urgent medicalattention or hospitalisation:

• chest pain

• fainting or having a rapid, weakpulse

• lockjaw

• red, often itchy spots similar tothe rash seen with measles whichstarts on the limbs and sometimeson the face and body. The spotsmay blister and may progress toform raised red, pale-centredmarks. Those affected may have

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fever, sore throat, headache withor without diarrhoea.

• yellowing of the skin and/or eyes(jaundice).

Other side effects not listed abovemay occur in some people.

Allergic reactions

If you think you are having anallergic reaction to furosemide(frusemide), do not take any moreof this medicine and tell yourdoctor immediately or go to theAccident and Emergencydepartment at your nearesthospital.

Symptoms of an allergic reactionmay include some or all of thefollowing:

• 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 totake them.

If you store your furosemide(frusemide) tablets out of thecontainer they may not keep well.

Keep your furosemide (frusemide)tablets in a cool dry place where thetemperature stays below 25°C.

Do not store furosemide (frusemide)tablets or any other medicine in thebathroom, near a sink, or on awindowsill.

Do not leave it in the car.

Heat, sunlight and dampness candestroy some medicines.

Keep it where children cannot reachit.

A locked cupboard at least one-and-a-half metres above the ground is agood place to store medicines.

Disposal

If your doctor tells you to stop takingfurosemide (frusemide) or themedicine has passed its expiry date,ask your pharmacist what to do withany that is left over. Return anyunused medicine to your pharmacist.

Product description

What APO-Frusemide lookslike

20 mg tablets:

White to off-white round tablets,debossed with 'F2' on one side andplain on the other side.

Packaged in bottles of 50 and 100tablets.

Packaged in bottles of 50 and 100tablets.

Packaged in bottles of 50 and 100tablets.

40 mg tablets:

White to off-white round tablets,debossed with 'F4' on one side andbreakline on the other side.

Packaged in bottles of 30, 50, 60 and100 tablets.

* Not all strengths and/or pack sizesmay be available.

Ingredients

Each tablet contains 20 mg or 40 mgof furosemide (frusemide) as theactive ingredient.

It also contains the following inactiveingredients:

• lactose monohydrate

• maize starch

• pregelatinised maize starch,

• sodium starch glycollate (type A)

• magnesium stearate.

This medicine is gluten-free and freeof azo dyes.

Australian RegistrationNumbers

APO-Frusemide 20 mg tablets:AUST R 186517.

APO-Frusemide 40 mg tablets:AUST R 186516.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registeredtrade marks of Apotex Inc.

This leaflet was last updated in:

February 2018

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