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Co-Amilofruse Tablets 5/40mg

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PATIENT INFORMATION LEAFLET    P/lorlJ

Co-amilofruse Tablets BP 2.5/20mg and 5/40mg


Read all ofthls leaflet carefully before you start taking Co-amllofruse

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information availableonyourmedicine. Ifyou would like further information, have any questions or are not sure about anything, ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this 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 Storing Co-amilofruse


The name ofyour medicine is Co-amilofruse.

What is in your medicine?

Each 2.5/20mg tablet contains 20mg frusemide and amiloride hydrochloride equivalent to 2.5mg anhydrous amiloride hydrochloride. Each 5/40mg tablet contains 40mg frusemide and amiloride hydrochloride equivalent to 5mg anhydrous amiloride hydrochloride. The other ingredients include: lactose, polyvinyl-pyrrolidone, orange E110, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.

These tablets are supplied in packs of" 28, 30, 56, 60, 84, 100, 150, 168 and 200 tablets.

The active principles, frusemide and amiloride hydrochloride, belong to a group of medicines known as diuretics which promote the excretion ofwater and salts in the urine.

MA Holder: Ennogen Pharma Limited Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Pharma code

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

Co-amilofruse is normally prescribed to treat conditions which result in the accumulation of fluid in the body tissues when potassium conservation is required. These include heartfailure, water retention from some types of kidney disease, treatment with steroids or oestrogens, and ascites (the accumulation of fluid in the abdomen sometimes seen in cirrhosis of the liver).

2. Before you take Co-amilofruse

DO NOT take this medicine before telling your doctor if:

•    you are, or might be pregnant, or are breast-feeding

•    you have previously experienced sensitivity to amiloride hydrochloride, frusemide, or any of the other ingredients

•    you suffer from kidney problems

•    you have severe liver problems

•    you    suffer    from Addison's disease

•    you    have been    told you have high

potassium levels or other salt imbalance

•    you    suffer    from    diabetes

•    you    suffer    from    gout

•    you    suffer    from    prostate problems

or have difficulty passing water.


It is very important that you tell your doctor ifyou are taking any other medication, particularly potassium supplements; otherwatertablets; Beta-blockers (e.g. sotalol); ACE inhibitors; Angiotensin-ll receptor antagonists, amiodarone, disopyramide, flecainide, quinidine, lidocaine, mexiletine or cardiac glycosides (for heart problems); trilostane; ciclosporin ortacrolimus (to prevent transplant rejection); hypoglycaemic drugs (to treat diabetes); cephaloridine; non-steroidal antiinflammatory drugs (NSAIDs) used to treat arthritis and other painful conditions; aminoglycoside, polymyxin or vancomycin antibiotics (eg gentamicin, neomycin); digoxin; lithium; muscle relaxants, carbamazepine (to treat epilepsy); terfenadine (antihistamine); pimozide, thioridazine,


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Pharma code

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amisulpharide, sertindole, (used to treat mental conditions); drugs to treat high blood pressure or any other medication you may obtain without a prescription.


Ifyou have been told byyourdoctor thatyou have an intolerance to some sugars, contact your doctor before taking this medicinal product.


Driving and using machines

Reduced mental alertness and confusion may occur. If this does happen, you should avoid driving, operating machinery or any other activity requiring full alertness.

Co-amilofruse tablets should be discontinued 3 days before a glucose tolerance test.

Co-amilofruse tablets contain EHOwhich may cause allergic type reactions including asthma. Allergy is more common in people who are allergic to aspirin.


3.How to take Co-amilofruse

Adults:

The normal dose of Co-amilofruse Tablets is one to two 2.5/20mg tablets OR one 5/40mg tablet a day, to be taken in the morning. Althoughyourdoctormay prescribe up to four 2.5/20mg tablets OR two 5/40mg tablets daily.

Your doctor may prescribe a different dose depending on your condition. You should always follow your doctor's instructions on taking your medicine. Your pharmacist may also help ifyou are not sure.

Elderly;

The dose may need adjusting according to your body's response to diuretics. Your doctorwill keep a close eye on you. Children:

This medicine should not be given to children.


Ifyou take an unintentional extra dose, this should not be of too much concern, but you will pass a lot more urine than usual. Ifyou are concerned or you or someone else has taken a large overdose, consult your doctor or hospital.


Ifyou have forgotten to take your medicine but remember before mid-afternoon, take the missed dose and continue as normal. If you take the missed dose later than midafternoon you may find that you have a


disturbed night's sleep as you need to pass more urine during the night. Ifyou are concerned, consult your doctor or pharmacist.

4. Possible side effects

As with all medicines, some people may experience some side effects. You may sufferfrom tiredness, nausea, vomiting, stomach pain, diarrhoea or constipation, dry mouth, pins and needles, dizziness (particularlywhen you stand up), skin rashes, itching, weakness, muscle cramps, headache and behavioural orvisual changes (such as sensitivity to the light). More rarely, you may suffer from ringing in the ears or deafness, allergic reactions, gout, pancreatitis, jaundice, feel tired more easily, aching or swollen joints, bruise easily or become anaemic.

If any of these effects become severe or 1 upsetting, or you experience any other unexpected effects which you think could be due to taking Co-amilofruse, consult your doctor straight away.

Co-amilofruse tablets may occasionally alter the composition ofyour blood. Your doctor may therefore want to do some tests from time to time. Co-amilofruse tablets may cause reversible changes in liver and kidney function which would be noticeable in a blood test. Remember to tell any doctor who does a blood test on you that you are taking Co-amilofruse tablets.

5.    Storing Co-amilofruse

Do not take Co-amilofruse Tablets after the expiry date shown on the label.

Do not store above 25C. Store in the original package.

If you notice any visible signs of deterioration in your medicine such as broken or chipped tablets, take it to your pharmacist for advice.

Date of revision: June 2004.

Keep all medicines out of the reach and sight of children. Your medicines can harm them.

REMEMBER this medicine is for you. Never give it to others. It may harm them even if their

symptoms are the same as yours.

This leaflet applies to Co-amilofruse Tablets BP 2.5/20mg and 5/40mg only.

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