Consumer medicine information

Noumed Furosemide

Furosemide (frusemide)

BRAND INFORMATION

Brand name

Noumed Furosemide

Active ingredient

Furosemide (frusemide)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Noumed Furosemide.

What is in this leaflet

This leaflet answers some common questions about NOUMED FUROSEMIDE.

It does not contain all of 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 taking this medicine 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 NOUMED FUROSEMIDE is used for

NOUMED FUROSEMIDE tablets contain the active ingredient furosemide (frusemide).

Furosemide belongs to a group of medicines called diuretics ("fluid tablets"), which are used to reduce oedema (swelling) by removing fluid from swollen ankles, feet, legs or even the brain or lungs.

It is also used to treat hypertension (high blood pressure) either alone or in combination with other drugs.

It works in your kidneys by increasing the amount of urine produced. This reduces the amount of excess fluid in the body.

This medicine is available only with a doctor's prescription.

Ask your doctor if you have any questions about why NOUMED FUROSEMIDE has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

Before you take it

When you must not take it

Do not take this medicine if you have an allergy to:

  • furosemide, the active ingredient, or any of the inactive ingredients listed at the end of this leaflet under Product Description.
  • any other similar medicines such as diuretics.
  • medicines containing sulfonamides, such as sulphur antibiotics or sulfonylureas which are medicines used to treat diabetes.

Some of the symptoms of an allergic reaction may include shortness of breath; wheezing or difficulty in breathing; swelling of the face, lips tongue or other parts of the body; rash, itching or hives on the skin.

Do not take this medicine if you have or have had any of the following medical conditions:

  • certain liver or kidney problems
  • have difficulty or unable to produce or pass urine
  • low blood pressure (hypotension)
  • low sodium or potassium levels in your blood
  • dehydration
  • jaundice or history of jaundice
  • hepatic coma or precoma.

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.

Do not breastfeed if you are taking this medicine. The active ingredient in NOUMED FUROSEMIDE passes into breast milk and there is a possibility that your baby may be affected.

Do not give this medicine to children.

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 you take it after the expiry date has passed, it may not work as well.

If it has expired or is damaged, return the pack to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to the ingredients in this medicine, to medicines called sulfonamides or sulfonylureas, any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, NOUMED FUROSEMIDE is not recommended for use during pregnancy. If there is a need to consider its use during your pregnancy, your doctor will discuss the risks and benefits of taking it if you are pregnant.

Tell your doctor if you are breast-feeding or planning to breast-feed. Furosemide passes into breast milk and there is a possibility your baby may be affected. Your doctor will discuss the risks and benefits of taking it if you are breast-feeding or planning to breast-feed.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver problems
  • kidney problems
  • heart and lung problems
  • high cholesterol levels.
  • asthma
  • diabetes
  • gout, a disease with painful, swollen joints
  • passing less urine than is normal for you
  • difficulty passing urine
  • no production or no passing of urine
  • prostate problems
  • systemic lupus erythematosus (SLE), a disease affecting the skin, joints and kidneys
  • a severe imbalance in your electrolytes (the salts in your body)

Tell your doctor if you are on a salt restricted diet.

If you have not told your doctor about any of the above, tell him/her before you start taking NOUMED FUROSEMIDE.

Taking other medicines

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

Some medicines should not be taken with furosemide. This includes large amounts of laxatives.

Some medicines and NOUMED FUROSEMIDE may interfere with each other. These include:

  • certain other fluid tablets or diuretic medicines
  • 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, used to relieve pain, swelling and other symptoms of inflammation, including arthritis
  • methotrexate, a medicine used to treat arthritis and some types of cancer
  • probenecid, a medicine used to treat gout
  • medicines used to relax muscle before or during surgery
  • lithium, used to treat mood disorders and some types of depression
  • medicines used in emergency situations such as adrenaline (epinephrine) and noradrenaline (norepinephrine)
  • cisplatin, used to treat cancer
  • theophylline, a medicine used to treat asthma
  • certain antibiotics, especially cephalosporin and aminoglycosides
  • amphotericin B (amphotericin), used to treat fungal infections
  • barbiturates, medicine used to treat epilepsy, to produce calmness, or to help you sleep
  • narcotics/strong pain killers such as codeine and morphine
  • insulin and tablet medicines used to treat diabetes, e.g. metformin
  • sucralfate or carbenoxolone, used to treat stomach ulcers
  • anticonvulsant medicines used to treat epilepsy, e.g. chloral hydrate, or phenytoin
  • corticosteroids such as cortisone, prednisone or dexamethasone
  • medicines treat hypothyroidism, such as levothyroxine
  • risperidone, an antipsychotic medication used to treat schizophrenia
  • medicines used during scans to see the images of your body.

These medicines may be affected by NOUMED FUROSEMIDE, or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines. Your doctor will be able to tell you what to do when taking NOUMED FUROSEMIDE with other medicines.

You should not eat large amounts of liquorice when you are taking this medicine.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking NOUMED FUROSEMIDE.

How to take NOUMED FUROSEMIDE

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

Oedema (swelling)

The usual dose is 20 mg to 80 mg (a half to two tablets) given as a single dose, once or twice daily. If given twice daily, 8 am and 2 pm are the suggested times to take Noumed Furosemide. In some cases, up to 400 mg (ten tablets) a day may be taken. Some people may only take NOUMED FUROSEMIDE on a few days per week (i.e. two to four consecutive days).

Hypertension (high blood pressure)

The usual starting dose is 40 mg (one tablet) twice daily. This will then be increased or decreased depending on the individual response to treatment. Your doctor may reduce or even cease other high blood pressure medication you may be taking.

If you need to break NOUMED FUROSEMIDE, hold the tablet with both hands and snap along the break line.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you. If you take the wrong dose, NOUMED FUROSEMIDE may not work as well and your problem may not improve.

How to take it

Swallow the tablets with water on an empty stomach. Food can interfere with how furosemide is absorbed. A good time to take NOUMED FUROSEMIDE is one hour before eating or 2 hours after eating.

Take the 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 your doctor told you to take NOUMED FUROSEMIDE once a day, it is best done in the morning, for example, before breakfast.

If you are taking it more than once a day, take your first dose immediately before breakfast and take your last dose around 2 pm (on an empty stomach). Since furosemide may increase the amount of urine you pass and may increase the number of times you need to visit the toilet, taking your last dose around 2 pm can mean less disruptions during your night time sleep

How long to take it

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

The dosage recommendation and duration of treatment will be determined for your specific condition by your doctor.

Do not take any more than prescribed by your doctor.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

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. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else has taken too much NOUMED FUROSEMIDE. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep this telephone number handy.

Overdosage of NOUMED FUROSEMIDE can result in dehydration. Symptoms of dehydration include dizziness, excessive thirst and dry mouth, headache and visual disturbances, weakness and muscle cramps.

While you are taking it

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking NOUMED FUROSEMIDE.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon, dentist or anaesthetist that you are taking this medicine. Your blood pressure may drop suddenly.

It may also affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

Inform your doctor if you are on a low salt diet.

Tell your doctor if you have severe vomiting, diarrhoea or if you experience symptoms of dehydration. The signs that you are too low in body salts include: dry mouth, thirst, fainting, muscle weakness, pain or cramps, tiredness, drowsiness, passing less urine than normal, and a fast or irregular heartbeat.

Make sure you drink enough water in hot weather and during exercise while you are taking NOUMED FUROSEMIDE, especially if you sweat a lot. If you do not drink enough water, you may feel faint, light-headed or sick. This is because your blood pressure is dropping suddenly and you are losing too much fluid.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests such as check your blood pressure from time to time to make sure the medicine is working and to prevent unwanted side effects.

Tell your doctor if you feel NOUMED FUROSEMIDE is not helping your condition or you continue to feel unwell.

Things you must not do

Do not take NOUMED FUROSEMIDE to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not stop taking NOUMED FUROSEMIDE, or change the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how NOUMED FUROSEMIDE affects you. This medicine may cause dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Be careful getting up from a sitting or lying position. Dizziness, light-headedness or fainting may occur, especially when you get up quickly. Getting up slowly may help.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness and light-headedness may be worse. It is not recommended that you drink alcohol while taking NOUMED FUROSEMIDE.

Avoid prolonged exposure to direct sunlight. NOUMED FUROSEMIDE may cause your skin to become more sensitive to the sun. If this happens you should wear protective clothing including a hat and sun screen when you are outside.

If you are taking NOUMED FUROSEMIDE 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.

Other things that may help manage your condition

Your doctor or pharmacist can give you more information on other measures to help manage your condition, such as:

  • limit your alcohol intake
  • eat a health diet
  • reduce salt in your diet
  • stop or cut down on smoking
  • regular exercise helps lower blood pressure and strengthen the heart, but it is important not to overdo it. Before starting, you should ask your doctor about the most suitable exercises for you. If you experience discomfort, chest pain or breathlessness when exercising, see your doctor.
  • losing weight: a dietician can help you plan a suitable diet for sustainable weight loss.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NOUMED FUROSEMIDE.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • very dry mouth or unusual thirst
  • weight loss
  • weakness, tiredness
  • numbness or tingling in the hands or feet
  • calf muscle spasms
  • muscle pains or cramps
  • restlessness
  • drowsiness or lack of energy
  • dizziness or light-headedness
  • headache
  • fever
  • nausea, vomiting
  • diarrhoea
  • blurred or visual impairment
  • unusual bleeding or bruising under the skin
  • ringing or buzzing in the ears
  • confusion
  • skin rashes.

These are the more common side effects of NOUMED FUROSEMIDE. Mostly, these are mild and are short-lived.

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

  • irregular or fast heartbeat
  • passing less urine than is normal for you
  • severe stomach pain often with nausea and vomiting
  • severe dizziness or a spinning sensation
  • increased sensitivity to sunlight
  • flaking or peeling of the skin
  • symptoms of anaemia such as, tiredness or weakness, shortness of breath when exercising, dizziness and looking pale
  • increased frequency of infections, i.e. sore throat, fever, severe chills or mouth ulcers
  • bruising or bleeding more easily than normal, nose bleeds
  • loss of control of bladder or bowels (incontinence)
  • gout, a disease with painful, swollen joints
  • deafness or ringing or buzzing in the ears.

These may be serious side effects of NOUMED FUROSEMIDE. You may need urgent medical attention. Serious side effects are uncommon.

If any of the following happen, stop taking NOUMED FUROSEMIDE, and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • sudden signs of allergy such as rash, itching or hives (pinkish, raised areas) on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
  • chest pain
  • fainting or a rapid weak pulse
  • lockjaw
  • red, often itchy spots similar to rash seen with measles which 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 eyes or skin (jaundice).

These are serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

After taking it

Storage

Keep your medicine in the original container until it is time to take them. If you take the tablets out of its original container, they may not keep well.

Keep your medicine in a cool, dry place, protected from light, where the temperature stays below 25°C.

Do not store it, or any other medicine, in the bathroom or near a sink. Do not leave it on a windowsill or in the car especially on hot days.

Heat and dampness can destroy some medicines.

Keep this medicine where 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 this medicine or its expiry date has passed, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

NOUMED FUROSEMIDE 40 mg is a round, white tablet with a score notch on one side.

It is supplied in bottles of 100 tablets.

Ingredients

Active ingredient

NOUMED FUROSEMIDE tablets contain 40 mg of furosemide (frusemide).

Inactive ingredients

  • microcrystalline cellulose
  • maize starch
  • sodium starch glycollate
  • lactose monohydrate
  • magnesium stearate.

NOUMED FUROSEMIDE does not contain sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Avallon Pharmaceuticals Pty Ltd
Level 5, 7 Eden Park Drive
Macquarie Park NSW 2113
Telephone 1800 930 999

Australian Registration number

AUST R 297804

This leaflet was revised in May 2021.

Published by MIMS October 2021

BRAND INFORMATION

Brand name

Noumed Furosemide

Active ingredient

Furosemide (frusemide)

Schedule

S4

 

1 Name of Medicine

Furosemide (frusemide).

2 Qualitative and Quantitative Composition

Noumed Furosemide tablets contain 40 mg of the active ingredient furosemide (frusemide).

Excipients with known effect.

Sugars (as lactose monohydrate). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Noumed Furosemide 40 mg tablets are white, round tablets, slightly convex with a score notch on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Oedema.

Adults.

Treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Noumed Furosemide is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired.

Hypertension.

Adults.

Noumed Furosemide tablets 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 Noumed Furosemide alone.

4.2 Dose and Method of Administration

Oedema.

Therapy should be individualised according to patient's response. This therapy should be titrated to gain maximal therapeutic response with the minimum dose possible to maintain that diuretic response.

Adults.

The usual initial daily dose is 20 to 80 mg given as a single dose. If the diuretic response to a single dose of 20 to 80 mg is not satisfactory, increase this dose by increments of 20 to 40 mg, not sooner than six to eight hours after the previous dose, until the desired diuretic effect is obtained. This individually determined dose should be given once or twice (e.g. at 8 am and 2 pm) daily. The dose of Noumed Furosemide may be carefully titrated up to 400 mg/day (except in advanced renal failure) in those patients with severe clinical oedematous states. The mobilisation of oedema may be most efficiently and safely accomplished by giving Noumed Furosemide on two to four consecutive days each week.
When doses exceeding 80 mg/day are given for prolonged periods, careful clinical laboratory observations are particularly advisable.

Hypertension.

Therapy should be individualised according to the patient's response. This therapy should be titrated to gain maximal therapeutic response with the minimum dose possible to maintain that therapeutic response.

Adults.

The usual initial daily dose of Noumed Furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
Changes in blood pressure must be carefully monitored when Noumed Furosemide is used with other antihypertensive drugs, especially during initial therapy.
To prevent an excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when Noumed Furosemide is added to the regimen. As the blood pressure falls under the potentiating effect of Noumed Furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

Method of administration.

It is recommended that Noumed Furosemide tablets be taken orally on an empty stomach (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.3 Contraindications

Known hypersensitivity to furosemide (frusemide) or sulfonamides or any of the inactive ingredients (see Section 6.1 List of Excipients). Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide (frusemide).
Complete renal shutdown, impaired renal function or anuria. If increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide (frusemide).
Severe hypokalaemia (see Section 4.8 Adverse Effects (Undesirable Effects)), hyponatraemia, hypovolaemia, dehydration 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 (frusemide) therapy should not be instituted until the underlying conditions have been corrected or ameliorated.
In breastfeeding or pregnant women.

4.4 Special Warnings and Precautions for Use

Furosemide (frusemide) is a potent diuretic, which, if given in excessive amounts, can lead to a profound diuresis. 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.
Particularly careful monitoring is required in patients with gout, patients with partial obstruction of urinary outflow, in patients with hypotension or who are at particular risk from a pronounced fall in blood pressure (e.g. patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain), in patients with latent or manifest diabetes mellitus, 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.
Cases of reversible or irreversible tinnitus or hearing impairment have been reported. Usually, reports indicate that furosemide (frusemide) ototoxicity is associated with rapid injection or infusion, severe renal impairment, hypoproteinaemia, doses exceeding several times the usual recommended dose or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid or other ototoxic drugs. In patients with hypoproteinaemia, e.g. associated with nephrotic syndrome, the effect of furosemide (frusemide) may be weakened and its ototoxicity potentiated. Cautious dose titration is required.
Caution should be exercised when administering curare or its derivatives to patients undergoing furosemide (frusemide) therapy. It is also advisable to discontinue furosemide (frusemide) for one week prior to any elective surgery.
Caution should be exercised and the risks and benefits of combining risperidone with furosemide (frusemide) or other potent diuretics should be considered prior to the decision to treat (see subsection on Use in the elderly).
Rigid sodium restriction is conducive to both hyponatraemia and hypokalaemia, thus strict restriction of sodium intake is not advisable in patients receiving furosemide (frusemide).
Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity.
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 or on potassium depleting steroids. Potassium supplementation, diminution in dose or discontinuation of furosemide (frusemide) therapy may be required.
As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage or other idiosyncratic reactions.
The possibility exists of exacerbation or activation of systemic lupus erythematosus.
Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide (frusemide), particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.
Hypokalaemia may develop with furosemide (frusemide) as with any other potent diuretic, especially with brisk diuresis, when cirrhosis is present, during long-term therapy or during concomitant use of corticosteroids or adrenocorticotropic hormone (ACTH). Interference with adequate oral electrolyte intake will also contribute to hypokalaemia. Digitalis therapy may exaggerate metabolic effects of hypokalaemia, especially with reference to myocardial effects.

Use in hepatic impairment.

In patients with hepatic cirrhosis and ascites, initiation of therapy with furosemide (frusemide) is best carried out in hospital. In hepatic coma or precoma and states of electrolyte depletion, therapy should not be initiated until the basic condition is improved. 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. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalaemia and metabolic alkalosis.

Use in renal impairment.

In patients with prostatic hypertrophy or if disturbances of micturition exist or are suspected, or where consciousness is impaired, furosemide (frusemide) should be used with care and urinary outflow must be secured. Symptoms of obstructed urine flow (e.g. in hydronephrosis, or ureteric stenosis) may become manifest or intensified in the course of diuretic therapy. In patients with a partial obstruction of urinary outflow (e.g. in patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra), increased production of urine may provoke or aggravate complaints. Thus, these patients require careful monitoring.
Patients who were at high risk for radiocontrast nephropathy treated with furosemide (frusemide) experienced a higher incidence of deterioration in renal function after receiving radiocontrast compared to high risk patients who received only intravenous hydration prior to receiving radiocontrast.
Also see Section 4.3 Contraindications.

Use in the elderly.

In the risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide (frusemide) plus risperidone (7.3%; mean age 89 years, range 75 to 97) compared to treatment with risperidone alone (3.1%; mean age 84 years, range 70 to 96) or furosemide (frusemide) alone (4.1%; mean age 80 years, range 67 to 90). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low doses) was not associated with similar mortality findings. No pathophysiological mechanism has been identified to explain this finding and no consistent pattern for cause of death was observed. Nevertheless, caution is advised. Irrespective of treatment, dehydration was an overall risk factor for mortality and should, therefore, be carefully avoided in elderly patients with dementia.
Also see Section 4.8 Adverse Effects (Undesirable Effects), Metabolism and nutritional disorders, Renal and urinary disorders, Vascular disorders.

Paediatric use.

Noumed Furosemide tablets are not recommended for use in children and adolescents.

Effects on laboratory tests.

As with any effective diuretic, electrolyte depletion may occur during therapy with furosemide (frusemide), especially in patients receiving higher doses and a restricted salt intake. All patients receiving furosemide (frusemide) therapy should be observed for signs of fluid or electrolyte imbalance, namely hyponatraemia, hypochloraemic alkalosis and hypokalaemia. Thus, strict restriction of sodium intake is not advisable in patients receiving furosemide (frusemide). Periodic determinations of serum electrolytes to detect a possible imbalance should be performed at appropriate intervals, as well as creatinine, blood urea and CO2 content determinations. This is particularly important when the patient is at high risk of developing electrolyte imbalances (e.g. receiving parenteral fluids) or in case of significant additional fluid loss such as vomiting, diarrhoea and intense sweating. Warning signs of an imbalance, irrespective of cause, include 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 (frusemide).
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 (frusemide). 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 (frusemide) may lower calcium levels, and rare cases of tetany have been reported. Accordingly, periodic serum calcium levels should be obtained.
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.
Transient rises in creatinine levels have also been observed, reflecting a fall in glomerular filtration rate on a haemodynamic basis.
Furosemide (frusemide) increases cholesterol and triglycerides short-term. It is not clear whether this effect persists long-term; however, the current evidence does not indicate this.
Asymptomatic hyperuricaemia can occur and rarely gout may be precipitated.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Interactions with food.

Whether and to what extent the absorption of furosemide (frusemide) is affected by taking it with food seems to depend on the pharmaceutical formulation of furosemide (frusemide). It is recommended that oral formulations of furosemide (frusemide) be taken on an empty stomach.

Combinations that are not recommended.

Antibiotics.

Furosemide (frusemide) may increase the ototoxic and nephrotoxic potential of certain antibiotics (e.g. aminoglycosides and certain cephalosporins (e.g. cephaloridine)) and other ototoxic drugs, especially in the presence of impaired renal function, therefore the simultaneous administration of these drugs are not advisable.

Anticonvulsants.

Anticonvulsants may decrease the response to furosemide (frusemide). In isolated cases, intravenous administration of furosemide (frusemide) within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure and tachycardia. Use of furosemide (frusemide) concomitantly with chloral hydrate is, therefore, not recommended.

Combinations that require precautions.

Etacrynic acid or cisplatin.

Furosemide (frusemide) should not be used concomitantly with ethacrynic acid or cisplatin because of the possibility of ototoxicity. In addition, nephrotoxicity of cisplatin may be enhanced if furosemide (frusemide) is not given in low doses (e.g. 40 mg in patients with normal renal function) and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.

Lithium salts.

Furosemide (frusemide) decreases the excretion of lithium salts and may cause increased serum lithium levels, resulting in increased risk of lithium toxicity, including increased risk of cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended that lithium levels are carefully monitored in patients receiving this combination.

Sucralfate.

Furosemide (frusemide) and sucralfate must not be taken within two hours of each other because sucralfate decreases the absorption of furosemide (frusemide) from the intestine and hence, reduces its effect. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide (frusemide) has been achieved.

Antihypertensives.

The action of other antihypertensive drugs may be potentiated by furosemide (frusemide), especially in combination with angiotensin converting enzyme (ACE) inhibitors. The administration of ACE inhibitors to patients pretreated with furosemide (frusemide) may lead to a deterioration in renal function including renal failure, or may result in severe hypotension, especially when an ACE inhibitor or angiotensin II receptor antagonist is given for the first time or for the first time in an increased dose. Therefore consideration must be given to interrupting the administration of furosemide (frusemide) temporarily or at least reducing the dose of furosemide (frusemide) for three days before starting treatment with or increasing the dose of an ACE inhibitor or angiotensin II receptor antagonist.

Risperidone.

Caution should be exercised and the risks and benefits of treating a patient on risperidone with furosemide (frusemide) or other potent diuretics should be considered prior to the decision to use. See Section 4.4 Special Warnings and Precautions for Use regarding increased mortality in elderly patients with dementia concomitantly receiving risperidone.

Levothyroxine sodium.

High doses of furosemide (frusemide) may inhibit binding of thyroid hormones to carrier proteins when administered with levothyroxine, and thereby lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. It is recommended that thyroid hormones be monitored.

Other combinations to be considered.

Drugs inducing QT interval prolongation.

The effects of digitalis preparations and drugs inducing QT interval prolongation syndrome may be potentiated by changes in electrolyte concentrations (e.g. hypokalaemia, hypomagnesaemia) due to furosemide (frusemide). When a cardiac glycoside is administered concurrently, it should be remembered that potassium or magnesium deficiency increases the sensitivity of the myocardium to digitalis and may increase the toxicity of drugs which induce QT interval prolongation syndrome. When a glucocorticoid is administered during diuretic treatment, the potassium-lowering effect of the steroid should be borne in mind (see Section 4.4 Special Warnings and Precautions for Use).
Carbenoxolone, corticosteroids, prolonged use of laxatives or ingestion of liquorice in large amounts may also predispose a patient to hypokalaemia.

Salicylates.

Patients receiving high doses of salicylates, as in rheumatic disease, in conjunction with furosemide (frusemide) may experience salicylate toxicity at lower doses because of competitive renal excretory sites.

Neuromuscular blockers.

Interactions between furosemide (frusemide) and neuromuscular blocking agents have been reported. These appear to be dependent on the dose of furosemide (frusemide) and the neuromuscular blocking agent involved. Low doses of furosemide (frusemide) (0.1 to 10 microgram/kg) enhance the neuromuscular blockade of tubocurarine and succinylcholine. High doses (1 to 5 mg/kg) of furosemide (frusemide) have a tendency to antagonise the skeletal muscle relaxing effect of tubocurarine but may potentiate the action of succinylcholine. The clinical relevance of these findings is uncertain.

Amphotericin B (amphotericin).

The combination of furosemide (frusemide) and amphotericin B (amphotericin) may result in an excessive loss of potassium.

Noradrenaline (norepinephrine).

Furosemide (frusemide) may decrease arterial responsiveness to noradrenaline (norepinephrine). This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
If antihypertensive agents, diuretics or other drugs with blood pressure lowering potential are given concomitantly with furosemide (frusemide), a more pronounced fall in blood-pressure must be anticipated.

Non-steroidal anti-inflammatory drugs.

Non-steroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid may reduce the natriuretic and antihypertensive effects of furosemide (frusemide) in some patients by inhibiting prostaglandin synthesis. In patients with dehydration or pre-existing hypovolaemia, non-steroidal anti-inflammatory drugs may cause acute renal failure. Salicylate toxicity may be increased by furosemide (frusemide).

Drugs eliminated by renal tubular secretion.

Phenytoin, methotrexate, probenecid and drugs which, like furosemide (frusemide), undergo significant renal tubular secretion may attenuate the effects of furosemide (frusemide). Conversely, furosemide (frusemide) may decrease renal elimination of these drugs. In the case of high-dose treatment (in particular of both furosemide (frusemide) and the other drugs), this may lead to an increased risk of adverse effects due to furosemide (frusemide) or the concomitant medication.

Muscle relaxants.

The effects of curare-type muscle relaxants or of theophylline may be increased.

Antidiabetic agents and adrenaline (epinephrine).

It should be borne in mind that the effect of antidiabetics and pressor amines (e.g. adrenaline (epinephrine) and noradrenaline (norepinephrine)) may be attenuated by furosemide (frusemide) (see Section 4.4 Special Warnings and Precautions for Use).

Cephalosporins.

Impairment of renal function may develop in patients receiving concurrent treatment with furosemide (frusemide) and high doses of certain cephalosporins. The harmful effects of nephrotoxic drugs on the kidney may be increased.

Ciclosporin.

Concomitant use of cyclosporin A and furosemide (frusemide) is associated with increased risk of gouty arthritis secondary to furosemide (frusemide)-induced hyperuricaemia and cyclosporin impairment of renal urate excretion.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Furosemide (frusemide) must not be given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of foetal growth.
Thiazides, related diuretics and loop diuretics enter the foetal circulation and may cause electrolyte disturbances. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics like furosemide (frusemide) and bumetanide are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose.
In pregnancy, furosemide (frusemide) must only be used in patients with a marked reduction in glomerular filtration.
 Furosemide (frusemide) passes into the breast milk and inhibits lactation. Women must not breastfeed if being treated with furosemide (frusemide).

4.7 Effects on Ability to Drive and Use Machines

Some adverse effects (e.g. an undesirable pronounced fall in blood pressure) may impair the patient's ability to concentrate and react and therefore constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

4.8 Adverse Effects (Undesirable Effects)

Whenever adverse reactions are moderate or severe, furosemide (frusemide) dose should be reduced or therapy withdrawn.

Metabolism and nutritional disorders.

As with other diuretics, electrolytes and water balance may be disturbed during therapy with furosemide (frusemide), especially in patients receiving high doses for a prolonged period. The serum potassium concentration may decrease, especially at the commencement of treatment (owing to the earlier onset of action of furosemide (frusemide)).
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 Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) or nutritional inadequacies (excessive restriction of salt intake), may lead to sodium (hyponatraemia), chloride (hypochloraemia), or other electrolyte or fluid deficiencies which may produce a fall in orthostatic blood pressure, leg cramps, calf muscle spasms, sweating, bladder spasms, anorexia, weakness, dizziness, drowsiness, apathy, lethargy, vomiting and confusion.
Furosemide (frusemide) may lower the serum calcium level (hypocalcaemia), which may trigger a state of increased neuromuscular irritability. Furosemide (frusemide) may cause a rise in serum cholesterol and triglyceride.
Hypomagnesaemia and, in rare cases, tetany or cardiac arrhythmias have been observed as a consequence of increased renal magnesium loss.
Treatment with furosemide (frusemide) may lead to transitory increases in urine volume, blood creatinine and urea levels. Serum levels of uric acid (hyperuricaemia) may increase and attacks of gout may occur.
Pre-existing metabolic alkalosis (e.g. due to decompensated liver cirrhosis) may be aggravated during furosemide (frusemide) treatment. Metabolic alkalosis has been reported with furosemide (frusemide) use.
Treatment with furosemide (frusemide) has occasionally caused reduced glucose tolerance and deterioration in cases of manifest diabetes, or made latent diabetes manifest.
Pseudo-Bartter syndrome in the context of misuse and/or long-term use of furosemide (frusemide) has been reported.
Very common: electrolyte disturbances (including symptomatic), dehydration and hypovolaemia especially in elderly patients, increased blood creatinine, increased blood triglycerides.
Common: hyponatraemia, hypochloraemia, hypokalaemia, blood cholesterol increased, blood uric acid increased and attacks of gout, urine volume increased.
Uncommon: impaired glucose tolerance. Latent diabetes mellitus may manifest.
In addition, the following rare adverse reactions have been reported: sweet taste, paradoxical swelling, and emboli: however, relationship to the drug has not been definitely established.

Gastrointestinal disorders and hepato-biliary disorders.

Reactions with normal doses are uncommon with furosemide (frusemide). They include anorexia, oral and gastric irritation, nausea, vomiting, cramping, diarrhoea and constipation.
In isolated cases, acute pancreatitis and increases in transaminases have been observed. Additionally, cholestasis and jaundice have been reported. Furosemide (frusemide) may increase the bile flow and distend the biliary tree which is already obstructed.

Central nervous system disorders.

Reactions such as dizziness, vertigo, paraesthesia, headache, blurred vision and xanthopsia occasionally accompany furosemide (frusemide)-induced diuresis.

Ear and labyrinth disorders.

Reversible tinnitus and hearing impairment and rarely, permanent tinnitus and impairment of hearing have been observed, especially in patients with markedly reduced renal function or hypoproteinaemia (e.g. in nephrotic syndrome). This occurs particularly in patients who are also receiving drugs known to be ototoxic.
Cases of deafness, sometimes irreversible, have been reported after oral administration of furosemide (frusemide).

Skin and subcutaneous tissue disorders.

Allergic reactions may occur uncommonly in the form of dermatitis including rash, dermatitis bullous (lesions or eruptions), itching, urticaria, pruritus, photosensitivity reactions, pemphigoid, erythema multiforme, purpura and exfoliative dermatitis, and rare cases of necrotising angiitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Also, photosensitivity reactions have been reported. AGEP (acute generalized exanthematous pustulosis), lichenoid reactions and DRESS (Drug Reactions with Eosinophilia and Systemic Symptoms) have been reported with furosemide (frusemide) use.

Blood and the lymphatic system disorders.

Common: haemoconcentration.
Uncommon: thrombocytopenia.
The following rare adverse reactions have been reported: eosinophilia, thrombophlebitis, haemolytic or aplastic anaemia, leukopaenia and agranulocytosis.

Renal and urinary disorders.

Excessive diuresis and dehydration could cause transient elevation of serum urea, creatinine and blood urea nitrogen (BUN) and reduction of glomerular filtration rate (GFR). Rare cases of tubulointerstitial nephritis have been reported. In elderly men with prostatic hypertrophy, acute urinary retention with overflow incontinence may occur. Symptoms of existing conditions of obstructed micturition, such as ureterostenosis or hydronephrosis, may be triggered or aggravated by pronounced diuresis. Interstitial nephritis has also been reported with furosemide (frusemide) use. In patients with a partial obstruction of urinary outflow, acute retention of urine may occur. Increases in sodium and/or chloride urine levels, and renal failure has been reported with furosemide (frusemide) use.

Vascular disorders.

Very common, orthostatic hypotension may occur and may be aggravated by alcohol, narcotics and barbiturates. Due to the possibility of side effects such as hypotension, the patient's ability to drive or operate machinery may be impaired, especially at the commencement of therapy. Ischaemic complications have also been reported in elderly patients.
A tendency for thromboses has been reported.
Rare: vasculitis.
Cases of thrombosis have been reported.

Immune system disorders.

Severe anaphylactic or anaphylactoid reactions (e.g. with shock) are rare, but is acutely life-threatening if it does occur.
Cases of exacerbation or activation of systemic lupus erythematosus have been reported.

Nervous system disorders.

Common: hepatic encephalopathy in patients with hepatocellular insufficiency.
Rare: paraesthesia.
Headache, dizziness, fainting or loss of consciousness have been reported.

Musculoskeletal and connective tissue disorders.

Cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia (see Section 4.3 Contraindications).

General disorders.

Rarely, fever may occur. Restlessness has also been reported.

Other reactions.

Hyperglycaemia, glycosuria, transient rise in serum cholesterol and triglyceride, muscle weakness.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

The clinical picture in acute or chronic overdose depends on the extent and consequences of electrolyte and fluid loss e.g. dehydration, blood volume reduction, hypotension, electrolyte imbalance, cardiac arrhythmias (including AV block and ventricular fibrillation), hypokalaemia and hypochloraemic 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 (frusemide) has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1,000 mg/kg bodyweight. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide (frusemide) in biological fluids associated with toxicity or death is not known.

Treatment.

No specific antidote to furosemide (frusemide) is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as activated charcoal.
Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Haemodialysis does not accelerate furosemide (frusemide) elimination.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Furosemide (frusemide) 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 (frusemide) may promote diuresis in cases which have previously proved resistant to other diuretics.
Furosemide (frusemide) has no significant pharmacological effects other than on renal function.

Clinical trials.

Data not available.

5.2 Pharmacokinetic Properties

Absorption.

Furosemide (frusemide) is rapidly absorbed from the gastrointestinal tract. Absorption rates have been reported to be from 60 to 69% in healthy subjects and from 43 to 46% in patients with end stage renal failure.
The onset of diuresis following oral administration is within 1 hour. The peak effect occurs within the first or second hour. The duration of diuretic effect is 6 to 8 hours.
In fasted normal men, the mean bioavailability of furosemide (frusemide) tablets is 64% of that from an intravenous injection of the drug. Peak plasma concentrations increase with increasing dose but times to peak do not differ among doses.

Distribution.

Furosemide (frusemide) is extensively bound to plasma proteins, mainly to albumin. Plasma concentrations ranging from 1 to 400 microgram/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations.

Metabolism.

Recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide (frusemide) in humans.

Excretion.

Urinary excretion is accomplished both by glomerular filtration and proximal tubular secretion, which accounts for roughly 66% of the ingested dose, the remainder being excreted in the faeces. A small fraction is metabolised by cleavage of the side chain.
Furosemide (frusemide) has a biphasic half-life in the plasma with t1/2 ranging up to 100 minutes; t1/2 is prolonged by renal and hepatic insufficiency.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Noumed Furosemide tablets contain the following inactive ingredients: maize starch, lactose monohydrate, sodium starch glycollate, microcrystalline cellulose and magnesium stearate.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

The tablets are packed in high density polyethylene (HDPE) bottles with child resistant caps, each containing 100 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Furosemide (frusemide) is an anthranilic acid derivative.
Furosemide (frusemide) 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.
Chemical Name: 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.

Chemical structure.


Empirical formula: C12H11ClN2O5S.
Molecular Weight: 330.7.

CAS number.

54-31-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes