Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Furosemide AN. 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 Furosemide AN 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 Furosemide AN is used for

Furosemide AN 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.

Furosemide AN 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.

There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure.

Furosemide AN helps to lower your blood pressure.

Furosemide AN 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 Furosemide AN for another reason.

Ask your doctor if you have any questions about why Furosemide AN has been prescribed for you.

There is no evidence that furosemide is addictive.

Before You Take Furosemide AN

When you must not take it:

Do not take Furosemide AN if:

• You have an allergy to furosemide 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. Furosemide AN 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 Furosemide AN, talk to your doctor.

Before you start to take it

You must tell your doctor if you have any allergies 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 a restricted diet

Tell your doctor or pharmacist if you are breast-feeding or intend to breast-feed.

Furosemide passes into breast milk. Your doctor will decide whether or not you should take Furosemide AN.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Your doctor will discuss the possible risks of using Furosemide AN during pregnancy.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some of the medicines in common use that may interfere with Furosemide AN 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 Furosemide AN, 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 Furosemide AN.

If you have not told your doctor about any of the above, tell them before you take any Furosemide AN.

How to take Furosemide AN

How much to take

Take Furosemide 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 the tablets with a glass of water.

When to take it

Take your Furosemide AN tablets every day at about the same time each day, unless your doctor tells you otherwise.

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 6 pm, unless your doctor tells you otherwise.

Furosemide AN 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 6 pm there may be less chance of your sleep being disturbed.

How long to take it

If you have high blood pressure or swelling, Furosemide AN helps to control the condition but does not cure it. Therefore, Furosemide AN must be taken every day.

Continue taking Furosemide AN 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.

If you take too much (overdose)

Immediately telephone your doctor or the 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 too much Furosemide AN. 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 taking Furosemide AN

Things you must do

Have your blood pressure checked when your doctor says to make sure Furosemide AN is working.

Tell your doctor and pharmacist that you are taking Furosemide AN if you are about to be started on any new medicine.

Get up slowly when getting out of bed or standing up if you feel light-headed, dizzy or faint.

You may feel light-headed or dizzy when you begin to take Furosemide AN. 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 Furosemide 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 Furosemide AN 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 Furosemide AN or lower the dose because you are feeling better, unless advised to by your doctor.

Do not give Furosemide AN to anyone else even if their symptoms seem similar to yours.

Do not give Furosemide AN to a child, as there have been no studies into its effects in children.

Things to be careful of

Be careful driving or operating machinery until you know how Furosemide AN affects you.

Furosemide AN may cause dizziness or light- headedness in some people, especially after the first few doses. Make sure you know how you react to Furosemide AN 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 a high potassium content.

Long term Furosemide AN 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 pharmacist about these measures 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 Furosemide AN.

Furosemide AN 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 Furosemide AN.

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 Furosemide AN

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 25°C and away from light.

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 Furosemide AN.

If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Product description

What it looks like

Furosemide AN 20mg tablets are white to off-white, round, tablets, debossed with “F2” on one side and plain on the other. Available in HDPE bottles containing 100 tablets (AUST R 283339).

Furosemide AN 40mg tablets are white to off-white, round, tablets, debossed with “F4” on one side and with a breakline on the other. Available in HDPE bottles containing 100 tablets (AUST R 283338).

Ingredients

Active Ingredient:
Furosemide

Each tablet may contain either 20 mg or 40 mg of Furosemide per tablet.

Other Ingredients:

• lactose monohydrate
• magnesium stearate
• maize starch
• pregelatinised maize starch
• sodium starch glycollate.

Name and Address of the Sponsor

Amneal Pharma Australia Pty Ltd
12 River St
South Yarra
Vic 3141

Date of Preparation

03 February 2017

Name of the medicine

Furosemide (frusemide).

Excipients.

Description

Chemical name: 4-chloro-2-(furan-2-ylmethylamino)- 5-sulfamoylbenzoic acid. Molecular formula: C₁₂H₁₁ClN₂O₅S. Molecular weight: 330.7. CAS: 54-31-9.
Furosemide is an anthranilic acid derivative. Chemical name: 4-chloro-N-furfuryl-5- sulfamoylanthranilic acid. Furosemide is a white to off -white odourless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids.
Inactive. Furosemide AN 20 mg, Furosemide AN 40 mg tablets: lactose monohydrate, magnesium stearate, maize starch, pregelatinised maize starch, sodium starch glycollate type A.

Pharmacology

Furosemide is a potent diuretic. It inhibits sodium and chloride absorption in the ascending limb of the loop of Henle and in both the proximal and the distal tubule. The high degree of efficacy is due to this unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase or aldosterone.
Furosemide may promote diuresis in cases which have previously proved resistant to other diuretics.
Furosemide has no significant pharmacological effects other than on renal function.

Pharmacokinetics.

Absorption.

Distribution.

Metabolism.

Excretion.

Half-life.

Indications

Oedema.

Adults and children.

Hypertension.

Adults.

Contraindications

Known hypersensitivity to furosemide, sulfonamides or any of the inactive ingredients (see Excipients). Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross sensitivity to furosemide.
Complete renal shutdown. If increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. Severe hypokalaemia, hyponatraemia, hypovolaemia or hypotension must be regarded as contraindications until serum electrolytes, fluid balance and blood pressure have been restored to normal levels.
In hepatic coma or precoma and conditions producing electrolyte depletion, furosemide therapy should not be instituted until the underlying conditions have been corrected or ameliorated.
Do not administer furosemide to newborn infants with jaundice or to infants with conditions which might induce hyperbilirubinaemia or kernicterus (e.g. Rhesus incompatibility, familial nonhaemolytic jaundice) because of furosemide's in vitro potential to displace bilirubin from albumin.
Breastfeeding women.

Precautions

Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse and with the possibility of vascular thrombosis and embolism, particularly in elderly patients.
Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity.
In patients with hepatic cirrhosis and ascites, initiation of therapy with furosemide is best carried out in hospital. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma, therefore, strict observation is necessary during the period of diuresis.
Cases of reversible or irreversible tinnitus or hearing impairment have been reported. Usually reports indicate that ototoxicity is associated with severe renal impairment, hypoproteinaemia, doses exceeding several times the usual recommended dose, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid or other ototoxic drugs.
Caution should be exercised when administering curare or its derivatives to patients undergoing furosemide therapy. It is also advisable to discontinue furosemide for one week prior to any elective surgery.
Rigid sodium restriction is conducive to both hyponatraemia and hypokalaemia, thus strict restriction of sodium intake is not advisable in patients receiving furosemide. Furosemide should be used with care, especially in the initial stages, in patients with prostatic hypertrophy or impairment of micturition. Urinary outflow must be secured. Particularly careful monitoring is required in patients with gout, patients with partial obstruction of urinary outflow, in patients at risk from hypotension (e.g. patients with coronary artery stenosis), in patients with hepatorenal syndrome or in patients with hypoproteinaemia (e.g. associated with nephrotic syndrome). Dose titration, especially in this latter case, is required. In premature infants, furosemide administered during the first weeks of life may increase the risk of persistence of Botallo's duct. In patients with hypoproteinaemia, e.g. associated with nephrotic syndrome, the effects of furosemide may be weakened and its ototoxicity potentiated. Cautious dose titration is required.
As with any effective diuretic, electrolyte depletion may occur during therapy with furosemide, especially in patients receiving higher doses and a restricted salt intake. Periodic determinations of serum electrolytes to detect possible imbalance should be performed at appropriate intervals, as well as creatinine, blood urea and CO₂ content.
All patients receiving furosemide therapy should be observed for signs of fluid or electrolyte imbalance, namely hyponatraemia, hypochloraemic alkalosis and hypokalaemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids.
Warning signs of fluid or electrolyte imbalance, irrespective of cause, are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia and gastrointestinal disturbances, e.g. nausea and vomiting.
Hypovolaemia or dehydration as well as any significant electrolyte and acid/ base disturbances must be corrected. This may require temporary discontinuation of furosemide.
During long-term therapy a high potassium diet is recommended. Potassium supplements may be required especially when high doses are used for prolonged periods. Particular caution with potassium is necessary when the patient is on digitalis glycosides, potassium depleting steroids or in the case of infants and children. Potassium supplementation, diminution in dose or discontinuation of furosemide therapy may be required.
Periodic checks on urine and blood glucose should be made in diabetic patients, and even in those suspected of having latent diabetes, who are receiving furosemide. Increases in blood glucose and alterations in glucose tolerance tests with abnormalities of the fasting and 2 hour postprandial sugar have been observed and rare cases of precipitation of diabetes mellitus have been reported.
Furosemide may lower calcium levels, and rare cases of tetany have been reported. Accordingly, periodic serum calcium levels should be obtained.
In children, urge to defaecate, complaints of abdominal pain and cramping have been reported after intravenous furosemide. An association of these symptoms with a low serum calcium and/or a low calcium:protein ratio is possible.
Reversible elevations of blood urea may be seen. These have been observed in association with dehydration, which should be avoided, particularly in patients with renal insufficiency.
Furosemide increases cholesterol and triglycerides short-term. It is not clear whether this effect persists long-term; however, the current evidence does not indicate this. As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, hepatic damage or other idiosyncratic reactions.
Renal calcifications (from barely visible on X-ray to staghorn) have occurred in some severely premature infants treated with intravenous furosemide for oedema due to patent ductus arteriosus and hyaline membrane disease. The concurrent use of chlorothiazides has been reported to decrease hypercalciuria and to dissolve some calculi.
The possibility exists of exacerbation or activation of systemic lupus erythematosus.
Asymptomatic hyperuricaemia can occur and rarely gout may be precipitated.

Use in pregnancy.

Use in lactation.

Driving a vehicle or performing other potentially hazardous tasks.

Interactions

Interactions with food.

Adverse Effects

As with other diuretics, electrolytes and water balance may be disturbed during therapy with furosemide, especially in patients receiving high doses for a prolonged period.
Excessive diuresis may give rise especially in elderly patients and children to circulatory disturbances, e.g. headache, dizziness, dry mouth or visual impairment, as symptoms of hypovolaemia. In extreme cases, hypovolaemia and dehydration may lead to hypotension, circulatory collapse and in elderly patients in particular thrombophilia. However, with individualised dosage, acute haemodynamic reactions are generally not to be expected, although diuresis sets in rapidly.
All saluretics may cause hypokalaemia, mainly in cases of low potassium diet, vomiting or chronic diarrhoea.
Factors such as underlying diseases (liver cirrhosis, cardiac failure), concomitant medication (see Interactions with Other Medicines) or nutritional inadequacies (excessive restrictions of salt intake) may lead to sodium or other electrolyte or fluid deficiencies which may produce a fall in orthostatic blood pressure, calf muscle spasms, anorexia, weakness, dizziness, drowsiness, apathy, vomiting and confusion.

Gastrointestinal.

Central nervous system.

Dermatological.

Haematological.

Genitourinary.

Cardiovascular.

Other.

Dosage and Administration

Oral administration.

Oedema.

Adults.

Children.

Hypertension.

Adults.

Overdosage

The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. dehydration, blood volume reduction, hypotention, electrolyte imbalance, cardiac arrhythmias (including A-V block and ventricular fibrillation), hypokalaemia, hypochloraemia alkalosis, and extensions of its diuretic action. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion. The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD₅₀ exceeded 1,000 mg/kg bodyweight, while the intravenous LD₅₀ ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known.
Contact the Poisons Information Centre on 131 126 for advice on the management of an overdose.

Treatment.

Presentation

Furosemide AN tablets.

Furosemide AN tablets.

Storage

Store below 25°C. Protect from light. Store in original container.

Poison Schedule

S4.