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

4.9 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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFRUSMD.gif 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

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NOUFURST.gif