INFORMATION FOR PATIENTS

Please read this leaflet carefully before you start to take this medicine. It gives a brief outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist.

One of the active ingredients in this medicine is furosemide. This is the new name for frusemide. The ingredient itself has not changed.

THE NAME OF YOUR MEDICINE IS CO-AMILOFRUSE TABLETS BP

The active ingredients in co-amilofruse tablets are furosemide and amiloride hydrochloride. The tablets are available in three strengths.

2.5/20mg tablets are pale orange in colour marked ARD20 and contain 2.5mg of amiloride (as the hydrochloride) and 20mg of furosemide.

5/40mg tablets are pale orange in colour marked ARD40 and contain 5mg of amiloride (as the hydrochloride) and 40mg of furosemide.

10/80mg tablets are pale orange in colour marked ARD80 and contain 10mg of amiloride (as the hydrochloride) and 80mg of furosemide.

Other ingredients include: lactose, microcrystalline cellulose, povidone, K30, sodium starch glycollate, magnesium stearate and sunset yellow E110.

The active ingredient furosemide belongs to a group of medicines called loop diuretics, which get rid of excess water but can cause a loss of potassium from the body. The other active ingredient, amiloride, belongs to a group of medicines known as potassium sparing diuretics which also get rid of excess water and prevent an excessive loss of potassium from the body.

Co-amilofruse Tablets BP are available in strip packs of 28 or 56 tablets.

WHAT IS CO-AMILOFRUSE FOR?

Co-amilofruse tablets are for use (in adults only) in the treatment of heart failure, kidney problems, or fluid retention due to steroids, oestrogens or cirrhosis of the liver.

BEFORE TAKING THIS MEDICINE

You should not take co-amilofruse tablets if:

• You are pregnant or breast-feeding (unless your doctor decides it is essential)
• You are allergic to furosemide or amiloride or to any of the other ingredients in these tablets. Check by reading the list of ingredients above.
• You have kidney failure or are unable to pass water (urine) at all.
• You have been told you have high blood potassium levels or any disturbance of other blood electrolytes (salts) which may make you feel dehydrated.
• You are taking potassium supplements or any other potassium sparing diuretic (e.g. triamterene or spironolactone).
• You have Addison's disease (underactive adrenal glands).
• You have cirrhosis of the liver, which is affecting your level of consciousness.
• You are under 18 years of age.
• You should let your doctor know as soon as possible if you become pregnant or wish to start breast-feeding whilst taking these tablets.

Please tell your doctor before you take your tablets if any of the following apply to you:

• You have problems with your prostate gland or difficulty in passing water
• You have diabetes mellitus or you are prone to-gout.
• You have liver failure.
• You have low blood pressure.
• You have a history of lupus erythematosus.
• You have porphyria.

There may be some problems when co-amilofruse tablets are taken with other medicines. It may be necessary to alter the dose of co - amilofruse or the other medicine.

Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are taking co –amilofruse tablets unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself without a prescription.

 

Examples of medicines that can affect co -amilofruse tablets are:

• Medicines taken for high blood pressure, particularly ACE inhibitors and angiotensin II antagonists but also alpha-blockers, beta-blockers and calcium channel blockers.
• Lithium, used to treat mental problems.
• Medicines used for arthritis or inflammation (NSAIDs) such as indometacin, ibuprofen and ketoralac.
• Certain antibiotics, including some cephalosporins, aminoglycosides (examples include amikacin, gentamicin, netilmicin) and vancomycin given by injection.
• Medicines taken for depression including tricyclic antidepressants such as amitriptyline and monoamine oxidase inhibitors (MAOIs), such as phenelzine.
• Alprostadil, used to treat male impotence and for heart defects in infants.
• Amphotericin (given by injection) used to treat fungal infections.
• Carbamazepine and phenytoin which are taken for epilepsy.
• Carbenoxolone and ranitidine used in ulcer healing.
• Cholestyramine and colestipol, used to treat high levels of cholesterol in the blood.
• Ciclosporin and tacrolimus, used to prevent transplant rejection.
• Cisplatin, used in cancer therapy.
• Metolazone which is a diuretic (water tablet).
• Probenecid, a medicine used for the prevention of gout.
• Quinidine, used to control heart rhythm.
• Steroids, used to suppress inflammation and allergy.
• Trilostane, used to treat adrenal gland problems.
• Tizanidine, used to treat muscle spasm.

ADVICE WHEN TAKING CO-AMILOFRUSE

• You will find that you have the urge to pass water soon after taking your co-amilofruse tablets. Because of this it is better to take your tablet(s) first thing in the morning, so that you pass any extra water early in the day, leaving you free to go about your usual routine, undisturbed. If you work at night, it may be better for you to take your tablets in the evening.
• If you feel dizzy while taking the tablets drinking alcohol can make this problem worse.
• If you feel dizzy or have problems with vision while taking the tablets, don't drive or operate dangerous machinery.
• You may need to have regular blood tests to check your levels of potassium and other electrolytes while you are taking co - amilofruse tablets.
• Co-amilofruse tablets may need to be discontinued at least three days before a glucose tolerance test. Your doctor will advise you.
• If you are elderly or you are seriously ill you may be more sensitive to the effects of co-amilofruse.

TAKING THIS MEDICINE

The usual dose for these tablets is one or two tablets daily. Your doctor will decide the dose which is best for you. Always follow your doctor's instructions completely, and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless instructed differently, take your tablet(s) with a glass of water.

You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Never double the next dose to make up for the one missed. Do not stop taking these tablets without telling your doctor first.

If you accidentally take too many co-amilofruse tablets you may get rid of too much water and become dehydrated. You may notice this by feeling dizzy or having muscle cramps. If this happens contact your doctor or your nearest hospital casualty department.

ARE THERE ANY SIDE-EFFECTS?

Like many medicines, co -amilofruse tablets may cause side-effects in some patients, particularly when treatment is first started. As well as the expected effect of passing a lot of water, you might develop side effects such as feeling sick or vomiting, generally feeling 'unwell', stomach upset, diarrhoea or constipation. If you get a skin rash or itchy skin or your skin is more sensitive to sunlight than it is normally this may be an allergic reaction, in which case you should stop taking the tablets and tell your doctor.

Co-amilofruse tablets could cause disturbance of the levels of potassium and other salts in the blood (symptoms of this include dry mouth, thirst, headache, drowsiness, muscle cramps, feeling faint or dizzy, particularly on standing up). Co-amilofruse may cause raised blood sugar levels, can make diabetes worse and can cause gout. Patients with prostate problems could develop difficulty in passing water. Blurred vision or yellow tinge to vision and reduced sexual desire have also been reported.

Very rarely there has been damage to hearing, minor psychiatric (mental) disturbances, problems with the kidney, pancreas, blood cell production (causing tiredness and throat or mouth ulcers), temporary changes in liver function or jaundice (skin or whites of eyes turn yellow).

Long-term use may cause vitamin B1 deficiency, particularly in people treated for heart failure and the elderly.

If you experience any other side effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

SAFE KEEPING FOR YOUR MEDICINE

• Do not take the tablets if the expiry date on the label has passed or if they show signs of deterioration.
• These tablets should not be stored above 25ºC. Store in the package or container in which they were given to you. Do not transfer them to another container.
• KEEP CO-AMILOFRUSE TABLETS IN A SECURE PLACE OUT OF THE REACH AND SIGHT OF CHILDREN.
• REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours.
• Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to the pharmacist.