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CO-AMILOFRUSE 40 mg/5 mg TABLETS FUROSEMIDE AND AMILORIDE HYDROCHLORIDE

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking

this medicine.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

INTHIS LEAFLET:

1.    What Co-amilofruse is and what it is used for

2.    Before you take Co-amilofruse

3.    How to take Co-amilofruse

4.    Possible side effects

5.    How to store Co-amilofruse

6.    Further information

OWHAT CO-AMILOFRUSE IS AND WHAT IT IS USED FOR

Co-amilofruse belongs to a group of drugs known as diuretics. Diuretics increase the amount of urine you produce by making your kidneys allow more water and salts to be removed from your body.

Co-amilofruseTablets are used:

* to treat oedema, which is a build-up of fluid in the body caused by things such as kidney damage * to reduce swelling of the stomach (ascites) associated with cirrhosis (scarring of the liver)

* to treat congestive heart failure, where fluid builds up in the lungs because of a heart problem * to remove fluid which builds up because of the side effects of other drugs, for example corticosteroids or oestrogens.

BEFORE YOU TAKE CO-AMILOFRUSE

Do NOT take Co-amilofruse if you:

* are allergic (hypersensitive) to furosemide or amiloride hydrochloride or any of the other ingredients of this medicine

* have been diagnosed as having high levels of potassium in your blood

* suffer from Addison's disease (where your adrenal gland does not make enough corticosteroid)

* have severe kidney problems or pass very small amounts of urine

* have an imbalance of salts in your body * have cirrhosis of the liver * are taking potassium supplements.

Take special care with Co-amilofruse

Talk to your doctor before you start to take this medicine if you:

* are elderly

*    if you have a tendency to high levels of blood sugar (see section 4, Possible side effects)

*    have a blockage in your urinary tract, e.g. prostate enlargement in men (see section 4, Possible side effects).

Your doctor may want to monitor you by performing blood tests while you are taking Co-amilofruse.

If you need to have a glucose tolerance test (to test for diabetes) whilst taking this medicine, please tell your doctor that you are taking Co-amilofruseTablets. You will need to stop taking the tablets for a while before the test.

Taking other medicines

Do NOT take Co-amilofruse if you are taking:

*    potassium supplements or any medicine containing potassium.

Talk to your doctor if you are taking any of the following:

*    heart drugs or drugs to lower your blood pressure (including other diuretics), especially ACE inhibitors e.g. captopril

*    laxatives

*    cephalosporin antibiotics (to treat an infection)

*    aminoglycoside antibiotics e.g. gentamycin

*    lithium (for mental illness)

*    non-steroidal anti-inflammatory agents (NSAIDs) e.g. indometacin (for pain and swelling)

*    phenytoin (for epilepsy)

*    steroids

*    muscle relaxants

*    anti-diabetics.

If you are going to have an operation, please tell the anaesthetist that you are taking Co-amilofruse as this may affect some of the drugs they may use.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Co-amilofruse

*    Patients who are intolerant to lactose should note that Co-amilofruseTablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

*    Co-amilofruseTablets contain the azo dye E110 as a colouring agent. It can cause allergic reactions including asthma. If you are allergic to aspirin, you are more likely to suffer a reaction.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

Co-amilofruse may make you feel less alert than usual. If affected, do not drive or operate machinery.

HOWTO TAKE CO-AMILOFRUSE

Always take Co-amilofruse exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole, preferably with

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a drink of water.The usual dose is:

*    Adults

One to two tablets in the morning.

*    Elderly

Your doctor may alter the dose you take depending on your response to Co-amilofruse

*    Children

Co-amilofruse is not recommended for use in children.

If you take more Co-amilofruse than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause dehydration.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed

If you forget to take Co-amilofruse

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.

Do not take a double dose to make up for a forgotten dose. If it is almost time to take the next dose, wait until then and then carry on as before.

If you stop taking Co-amilofruse

Do not stop taking your medicine without talking to your doctor first even if you feel better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Co-amilofruse can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

*    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash, itching or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Some effects may occur due to other pre-existing conditions (see section 2Take special care with Co-amilofruse)

*    if you have a tendency to high levels of blood sugar, diabetes may develop.

*    if you have ever had problems passing urine, or you have an enlarged prostate, you may experience a build-up of urine.

If you experience these effects or are worried about them, talk to your doctor.

If you suffer from any of the following for more than a few days, tell your doctor:

*    headache, cramps, low blood pressure (which may make you sweat, feel light-headed or faint), stomach upset, diarrhoea, constipation, feeling or being sick, ora general feeling of being unwell.

You may need to have blood tests to find out if you have any of the following side effects:

*    increased potassium levels

*    increased cholesterol or triglyceride levels, which usually return to normal within 6 months during long term therapy

*    increased uric acid levels, possibly causing gout

*    decreased calcium levels, in very rare cases cramps may occur to the hands, feet or face.

Very rarely the following side effects have been reported:

*    mental disturbances

*    results of liver function tests may be affected

*    damage to the inner ear, which can affect your hearing or balance

*    decreased production of blood cells in the bone marrow.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOWTO STORE CO-AMILOFRUSE

Keep out of the reach and sight of children.

You should keep your tablets in a dry place, below 25°C and away from light. Keep them in the pack they came in. Do not put them into another container.

Do not use Co-amilofruse after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

FURTHER INFORMATION

What Co-amilofruse tablets contain:

*    The active ingredients in Co-amilofruse 40 mg/5 mg tablets are: furosemide 40 mg and amiloride hydrochloride 5 mg.

*    The other ingredients are lactose, starch, pregelatinised starch, croscarmellose sodium, magnesium stearate, talc and dispersed sunset yellow FCF lake 15005 (E110).

What Co-amilofruseTablets look like and contents of the pack:

*    The Co-amilofruseTablets are round, orange, flat, bevel-edged tablets. They are coded "FRU-CO" with a breakline on one side (see diagram) and are plain on the reverse.

* The Co-amilofruseTablets come in packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 500, and 1000. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

TEVA UK Limited, Eastbourne, BN22 9AG.

Company responsible for manufacture:

Teva Pharmaceutical Works Private Limited Company, H2100 Godollo,Tancsics Mihaly ut82, Budapest, Hungary.

This leaflet was last revised: November 2010

PL 00289/1633

83753-A