UREX, UREX-M, UREX FORTE
Consumer Medicine Information
What is in this leaflet
This Leaflet answers some common questions about Urex, (Urex, Urex-M and Urex Forte tablets)
It does not contain all of the available information about Urex.
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 or your child taking Urex against the benefits he/she expect it will have.
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 is Urex
The name of your medicine is Urex. Urex is available in tablets of three different strengths.
The active ingredient is called frusemide .
Frusemide belongs to a group of medicines called diuretics. Diuretics are used to help the kidneys remove excess fluid from the body.
Urex is available as a 40 mg tablet, Urex-M is a 20 mg tablet and Urex Forte is a 500 mg tablet.
What Urex is used for
Urex is used to treat a number of medical conditions.
Oedema (swelling of the body due to excess fluid). This problem can also occur in cases of heart disease, liver disease, kidney disease.
Hypertension (high blood pressure). This can occur by itself or in severe heart, liver or kidney disease.
Your doctor, however, may have prescribed Urex for another purpose.
Ask your doctor if you have any questions about why Urex has been prescribed for you.
If you have any concerns, you should discuss this with your doctor.
This medicine is available only with a doctor's prescription.
Before you take Urex
When you must not take it
Do not take Urex if you are allergic to:
Frusemide or other sulphonamide type medications, or any of the of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction to Urex may include red, itchy skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.
Do not take Urex if you have severe kidney disease or have no urine output or if you know you are allergic to frusemide or sulfonamides.
Do not take Urex if you are breastfeeding or plan to breast feed.
Do not use Urex after the expiry date (EXP.) printed on the pack.
If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.
Do not purchase or use Urex if the packaging is torn or shows signs of tampering.
Do not give it to children unless your doctor has prescribed it. If the medicine is for a newborn child, tell your doctor if the baby was jaundiced.
Before you start to take it
You must tell your doctor if you are:
1.allergic to any other medicines or any foods, dyes or preservatives.
2.you have any other medical conditions/ health problems, including:
suffer from inflammation of the prostrate (if you are a male).
suffer from low blood pressure and/or take any medications to treat low blood pressure.
Lithium should not be taken with Urex.
4.You are pregnant or plan to become pregnant.
Urex like all medicines should not be used during pregnancy, unless your doctor tells you.
5.You are breastfeeding or plan to breastfeed.
6.You are on a salt restricted diet.
7.You are taking antibiotics
8.You are taking other antihypertensive drugs
9.You suffer from gout
10.You are at risk of low blood pressure
11.You have liver or kidney disease
12.You are taking phenytoin
If you have not told your doctor about any of the above, tell them before you take any Urex.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Urex. These include:
drugs which are used to treat allergic conditions (e.g. corticosteroids)
drugs used to treat some types of mental illnesses (e.g. Lithium Carbonate)
medicines used to treat constipation. Check with your Pharmacist.
some medicines including aspirin or anti-arthritic medication such as indomethacin.
some common antibiotics (e.g. aminoglycosides), cephalosporin, cephalothin or cephaloridine)
some medications used to treat high blood pressure (e.g. ACE inhibitors such as Asig)
alcohol, barbiturates or narcotics. These may cause fainting or dizziness when rising due to low blood pressure.
Carbenoxolone, used to treat gastric ulcers
Phenytoin, used to treat epilepsy.
DO NOT TAKE UREX IF YOU ARE TAKING THIS MEDICATION.
Probenicid, used to treat gout.
Antidiabetics such as Metformin, Diabex or Rastiron.
Pressor amines such as adrenaline and noradrenaline
Ingestion of large amounts of liquorice may increase the risk of side effects
The above medicines may either reduce the effectiveness of Urex, reduce its own effectiveness and/ or react with Urex resulting in untoward or sometimes dangerous side effects.
This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Urex.
How to take Urex
a) how much to take
The dose of Urex may be different for each person and their medical condition. Your doctor will decide the right dose for you.
The recommended doses are for:
For children: 2 mg per kg per day up to a maximum of 6 mg per kg per day or 40 mg per day.
For adults: 20 to 80 mg as a single dose. The dose may be increased in exceptional cases up to 400 mg per day.
For adults: 20 to 40 mg twice daily.
Only in unusual cases of reduced glomerular filtration (kidney disease) will a high dose using Urex Forte be required
b) how to take it
Swallow the medicine with water. If the dose is one-half tablet, there is a breakline on the tablet to help you divide it.
c) when to take it
Urex should be taken either early in the day or in the morning and no later than 4 hours before retiring if a twice daily dose is required.
d) how long to take it
Continue taking Urex as long as your doctor recommends it.
e) If you forget to take it
If your dosing schedule is one dose a day, take the missed dose as soon as possible, but not later than 4 hours before bedtime. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
Do not try to make up for missed doses by taking more than one dose at a time.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (Overdose):
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much Urex. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol (including any barbiturates or narcotics) which has been taken. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you take too much Urex you may have symptoms of weakness, dizziness, lethargy, nausea, vomiting, diarrhoea, anorexia, sweating, mental confusion, blurred vision, tingling in the arms or legs, restlessness, headache, tinnitus (ringing in the ears), cramping, constipation, and symptoms associated with electrolyte and fluid depletion and hypotension.
While you are using Urex
Things you must do:
Use Urex exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Urex.
Tell your doctor (immediately) if you become pregnant while you are taking Urex.
Tell your doctor if you feel Urex is not helping your condition.
Visit your doctor regularly.
Your doctor needs to check your progress and see whether you need to keep taking Urex.
Always discuss with your doctor any problems or difficulties during or after taking Urex.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.
Keep enough Urex to last weekends and holidays.
Things you must not do:
Do not take any other medicines while you are taking Urex without first telling your doctor.
Do not drive or operate machinery until you know how Urex affects you.
Urex may cause dizziness in some people and therefore may affect alertness. Make sure you know how you react to Urex before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or have blurred vision.
Do not take Urex for a longer time than your doctor has prescribed.
Avoid prolonged exposure to direct sunlight.
Do not change your dose without first checking with your doctor.
Do not stop taking Urex or lower the dose, without first checking with your doctor.
Stopping the medicine suddenly on your own accord may cause some unwanted effects, or your condition may reappear. Your doctor will advise you when you can stop taking Urex completely.
Do not use this medicine to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Things to be careful of:
Be careful drinking alcohol while taking Urex. If you drink alcohol, it could make some of the unwanted side effects of Urex worse.
Your doctor may suggest that you avoid alcohol completely or reduce the amount of alcohol you drink while you are taking Urex.
Some people may experience side effects such as nausea, headache, dizziness or faintness or lightheadedness when standing up after resting, which may further affect the risk when using dangerous machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Urex.
Urex helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people, especially in elderly patients and children.
All medicines 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 any questions you may have.
Common Side Effects:
Tell your doctor if you notice any of the following and they worry you:
nausea (feeling sick)
loss of appetite
There are other side effects which occur less often, for example some blood disorders. If you get unusual bruising or a sore throat tell your doctor immediately.
There are other side effects like feeling dizzy when getting up quickly, swelling in the arms or legs, yellowing of the skin or eyes, tinnitus (ringing in the ears) and muscle spasms. These are all rare but serious side effects. If you develop a severe or persistent headache shortness of breath, severe palpitations, confusion or vision problems, or get severe diarrhoea tell your doctor immediately.
Some people may get other side effects of Urex.
Your doctor may lower the dose to help control serious side effects and decide on necessary tests to monitor any of the above problems.
Check with your doctor as soon as possible if you have any problems while taking Urex even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
After using Urex
Keep it 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.
Keep Urex in a cool dry place where the temperature stays below 30 °C and protect from light. Do not store it, or any other medicines, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines. Do not take Urex if the tablets do not look quite right.
Keep your tablets in the glass bottle or blister pack they were provided in until it is time to take them.
If your doctor tells you to stop taking the tablets OR they have passed their expiry date, ask your pharmacist what to do with any left over.
a) What it looks like
Urex-M 20 mg tablet is a white to off-white round plain uncoated tablet. It comes in bottles containing 50 tablets.
Urex 40 mg tablet is a white round uncoated tablet, one side plain and the other scored with a break line and a cross in each half. It comes in bottles containing 50, 100 and 250 tablets and in blister packs containing 30, 60 and 100 tablets.
Urex Forte 500mg tablet is a-white tablet with one side plain and the other scored with a break line. It comes in bottles containing 50 tablets.
Each Urex-M tablet contains 20 mg of the active ingredient, (frusemide).
The excipients or other non-active ingredients are lactose, starch - maize, and magnesium stearate.
Each Urex tablet contains 40 mg of the active ingredient, (frusemide).
The excipients or other non-active ingredients are lactose, starch - maize, and magnesium stearate
Each Urex Forte tablet contains 500mg of the active ingredient, (frusemide).
The excipients or other non-active ingredients are lactose, starch - maize, magnesium stearate, maltodextrin and silica-colloidal anhydrous.
The tablets do not contain a colouring agent.
Urex does contain lactose, but not gluten.
Sponsor or Supplier
Fawns and McAllan Pty Ltd
(a subsidiary of Sigma Pharmaceuticals Pty Ltd)
(A.C.N. 004 118 594)
1408 Centre Road
Clayton Victoria 3168
Telephone: 03 - 9839 2800 03 - 9839 2800
The Australian Registration Number for Urex -M 20 mg tablet is AUST R 13475.
The Australian Registration Numbers for Urex -40 mg tablet are AUST R 13474 (bottles) and 34494 (blister packs).
The Australian Registration Number for Urex Forte 500mg tablet is AUST R 56090.
This leaflet was prepared on 15th April 1998..
Published by MIMS/myDr May 1999
Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from