frusemide 20 mg and 40 mg tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Frusax™. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Frusax™ against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Frusax™ is used for
Frusax™ is a water tablet (or diuretic). It may be taken alone, or together with other medicines.
One of its uses is to help reduce the amount of water in the body for people who have:
- swelling of the ankles, feet and legs, which doctors call oedema
- swelling of the stomach area due to liver disease.
Frusax™ also helps lower high blood pressure, which doctors call hypertension. Everyone has blood pressure. This pressure helps circulate the blood around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
If high blood pressure is not treated it can lead to serious health problems such as stroke, heart disease and kidney failure. Frusax™ helps to lower your blood pressure.
Frusax™ works by making your kidneys pass more water and salt. This helps reduce high blood pressure and some forms of swelling.
Your doctor may prescribe Frusax™ for another reason.
Ask your doctor if you have any questions about why Frusax™ has been prescribed for you.
There is no evidence that Frusax™ is addictive.
Before you start to take Frusax™
When you must not take it
Do not take Frusax™ if:
- You have an allergy to frusemide or any of the ingredients listed at the end of this leaflet or any other sulphonamide type medication. Usual symptoms of allergy are skin rash, itching, redness or other discolouration of the skin.
- You are pregnant, or intend to become pregnant. Frusax™ may affect your developing baby if you take it during pregnancy.
- You have severe kidney disease
- The expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed it may not work, or it may make you sick.
- The packaging is torn or shows signs of tampering
If you are not sure whether you should start taking Frusax™, talk to your doctor.
Before you start to take it
You must tell your doctor if you have any 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
- any other medical conditions or if you are on salt restricted diet.
Tell your doctor or pharmacist if you are breast-feeding or intend to breast-feed. Frusax™ passes into breast milk. Your doctor will decide whether or not you should take Frusax™.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks of using Frusax™ during pregnancy.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you have bought from your pharmacy, supermarket or health food shop.
Some of the medicines in common use that may interfere with Frusax™ include:
- digoxin for heart conditions
- steroids such as cortisone, prednisone, dexamethasone
- laxatives for constipation
- some antibiotics for treating infections
- theophylline for respiratory diseases
- medicines for epilepsy
- medicines for diabetes
- lithium for mood disorders
- medicines for arthritis such as aspirin, NSAIDs
- medicines for high blood pressure, especially ACE inhibitors
- liquorice when consumed in large amounts.
These medicines may be affected by Frusax™, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Frusax™.
If you have not told your doctor about any of the above, tell them before you take any Frusax™.
How to take Frusax™
How much to take
Take Frusax™ only when prescribed by your doctor. Your doctor will tell you how many tablets you need to take each day.
The number will depend on your condition and whether you are taking other medicines.
Do not take more tablets than your doctor has prescribed. Your doctor will follow your progress and adjust the dose accordingly.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How to take it
Swallow Frusax™ with a glass of water.
When to take it
Take your Frusax™ everyday at about the same time each day, unless your doctor tells you otherwise. Take Frusax™ on an empty stomach. Taking your tablets at the same time each day will have the best effect. It will also help you to remember when to take the tablets.
If you are taking a single dose a day, take it in the morning, for example at breakfast time.
If you are taking more than one dose a day, take the last dose no later than 2 pm, unless your doctor tells you otherwise.
Frusax™ will increase the amount of water (urine) you pass and also the number of times you go to the toilet. By taking the last dose no later than 2 pm there may be less chance of your sleep being disturbed.
How long to take it
If you have high blood pressure or swelling, Frusax™ helps to control the condition but does not cure it. Therefore, Frusax™ must be taken every day.
Continue taking Frusax™ for as long as your doctor prescribes.
If you forget to take it
Take it as soon as you remember, and then go back to taking your tablets as you would normally. However, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (13 11 26), or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much Frusax™. Do this even if there are no signs of discomfort or poisoning.
Keep telephone numbers of these places handy.
If you take too many tablets, you will probably feel light-headed or dizzy. You may also become very thirsty, confused, have a change in the amount of urine passed or have a fast heart beat.
While you are using Frusax™
Things you must do
Have your blood pressure checked when your doctor says to make sure Frusax™ is working.
Tell your doctor and pharmacist that you are taking Frusax™ if you are about to be started on any new medicine.
You may feel light-headed or dizzy when you begin to take Frusax™. This is because your blood pressure is falling suddenly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure.
Tell your doctor if you have excessive vomiting and/or diarrhoea while taking Frusax™, or you have any of the following symptoms:
- dry mouth, thirst
- weakness, tiredness, drowsiness
- muscle pains or cramps
- fast heart beat
- passing less urine than normal
You may be dehydrated because you are losing too much water.
Tell your doctor or dentist that you are taking Frusax™ if you plan to have surgery (even at the dentist) that needs a general anaesthetic. Your blood pressure may drop suddenly.
Things you must not do
Do not stop taking Frusax™ or lower the dose because you are feeling better, unless advised to by your doctor.
Do not give Frusax™ to anyone else even if their symptoms seem similar to yours.
Things to be careful of
Be careful driving or operating machinery until you know how Frusax™ affects you.
Frusax™ may cause dizziness or light-headedness in some people, especially after the first few doses. Make sure you know how you react to Frusax™ before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If you drink alcohol, dizziness or light-headedness may be worse.
Talk to your doctor about foods or drinks that have high potassium content. Long term Frusax™ therapy causes a fall in potassium levels in your body. However, if you eat foods or have drinks that are high in potassium this will help maintain normal levels of potassium in your body. Too much potassium can, however, be harmful, therefore, it is important to discuss your diet with your doctor.
Things that would be helpful for your blood pressure
Some self help measures suggested below may help your blood pressure. Talk to your doctor or pharmacist about these measures and for more information.
- Alcohol – your doctor may advise you to limit your alcohol intake.
- Diet – eat a healthy diet that includes plenty of fresh vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar.
- Exercise – regular exercise helps to reduce blood pressure. Try regular walking, swimming, cycling or games such as tennis and golf. Before starting any exercise, ask your doctor about the best kind of program for you.
- Salt – your doctor may advise you to watch the amount of salt in your diet. To reduce your salt intake you should avoid using salt in cooking or at the table.
- Smoking – your doctor may advise you to stop smoking or at least cut down.
- Weight – your doctor may suggest losing some weight to help lower your blood pressure. Some people may need a dietician’s help to lose weight.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Frusax™. Frusax™ helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- stomach pain
- constipation, diarrhoea
- dry mouth
These are mild side effects of Frusax™.
Tell your doctor immediately if you notice any of the following:
- muscle cramps
- skin rash, itching
- ringing in your ears (tinnitus)
- loss of hearing
- chest pain or tightness
- blurred vision
- changes in the way your heart beats
- yellowing of the skin and eyes, also called jaundice
- unusual bruising or bleeding
- increasing frequency of infections such as fever, severe chills, sore throat or mouth ulcers
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
After taking Frusax™
Keep your tablets in the bottle until it is time to take them. Keep the bottle tightly closed.
If you take the tablets out of the bottle they may not keep well.
Keep it in a cool dry place where the temperature stays below 30°C and away from light and moisture.
Do not store it or any other medicines in the bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking the tablets, ask your pharmacist what to do with any tablets left over.
This is not all the information that is available on Frusax™. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.
What it looks like
- Frusax™ 20 mg tablets: An off-white, round, flat bevelled edged tablet engraved 20 over a breakline on one side and plain on the other. A bottle contains 100 tablets.
- Frusax™ 40 mg tablets: An off-white, round, flat bevelled edged tablet engraved 40 over a breakline on one side and plain on the other. A bottle contains 100 tablets.
- Frusax™ 40mg contains frusemide 40mg per tablet.
- Frusax™ 20mg contains frusemide 20mg per tablet.
- magnesium stearate
- butyl hydroxybenzoate
- microcrystalline cellulose
- propyl hydroxybenzoate
- silica colloidal anhydrous
- sodium starch glycollate
Sponsor/Marketing Authorisation Holder
Eris Pharmaceuticals (Australia) Pty Ltd
6 Eastern Road
South Melbourne VIC 3205
Australian Registration Number:
FRUSAX™ 20mg – AUST R 176033
FRUSAX™ 40mg – AUST R 176034
Prepared in June 2011 and updated in November 2012
Published by MIMS August 2014