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PATIENT INFORMATION LEAFLET Co-Amilofruse

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR MEDICINE

IF THERE IS ANYTHING YOU DO NOT UNDERSTAND ABOUT YOUR TREATMENT, ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF CO-AMILOFRUSE

What is in Co-amilofruse?

Co-amilofruse tablets are available in two strengths, Coamilofruse 2.25/20 and Co-amilofruse 5/40.

One of the active ingredients in this medicine is Furosemide. This is the new name for Frusemide. This ingredient itself has not changed.

The active ingredients in Co-amilofruse 2.5/20 tablets are: Amiloride Hydrochloride Ph. Eur. equivalent to 2.5 mg of the anhydrous salt and Furosemide BP 20 mg.

Co-amilofruse 2.5/20 tablets also contain the following inactive ingredients: Microcrystalline cellulose, povidone, crospovidone, sunset yellow (E110) and magnesium stearate.

The active ingredients in Co-amilofruse 5/40 tablets are: Amiloride Hydrochloride Ph. Eur. equivalent to 5 mg of the anhydrous salt and Furosemide BP 40 mg.

Co-amilofruse 5/40 tablets also contain the following inactive ingredients: Microcrystalline cellulose, povidone, crospovidone, sunset yellow (E110) and magnesium stearate.

Both strengths of Co-Amilofruse tablets are available in blister packs of 28 and 56 tablets and in high density polypropylene containers of 28, 56, 100 and 500 tablets.

How does Co-Amilofruse work?

Co-Amilofruse is a diuretic (water tablet), helpful in many diseases by causing you to pass more urine than you normally do. If you are not sure why you have been prescribed Co-Amilofruse, then please ask your doctor.

The Manufacturer is:

DDSA Pharmaceuticals Ltd., 310 Old Brompton Road, London SW5 9JQ.

The Product Licence Holder is:

Chelonia Healthcare Limited, 11 Boumpoulinas, 3^rd Floor, 1060 Nicosia, Cyprus What are Co-Amilofruse tablets for?

Co-Amilofruse may be prescribed when excess water in the body is brought about by the following conditions:

•    Congestive cardiac failure

•    Swelling due to fluid retention (oedema)

•    Kidney disease (nephrosis)

•    Liver disease (cirrhosis, together with increased fluid in the abdomen)

•    Treatment with drugs known as cortico-steroids

•    Treatment with certain female hormones known as oestrogens.

or dyes.

Do not take Co-amilofruse if you have:

•    Cirrhosis of the liver, which is affecting your level of consciousness

•    Kidney failure or are unable to pass water (urine) at all

•    Heart disease

•    Addison's disease

•    Low blood volume or are dehydrated

•    Low level of potassium in your blood

•    Low level of sodium in your blood

•    High level of potassium in your blood

•    Or are breast-feeding.

Co-amilofruse is not suitable for children. Do not take Coamilofruse if you are under 18 years of age.

The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor, or pharmacist, if you have any other medical problems, especially:

•    Liver or kidney problems

•    Difficulty in passing urine

•    Diabetes

•    Prostate problems

•    Low blood pressure (dizziness on standing)

•    Suffer from cramps (electrolyte deficiency - salt imbalance)

•    Gout

•    Porphyria

•    Feel dizzy or dehydrated (e.g., lost water through vomiting, diarrhoea, excessive urination or are having trouble drinking or eating)

•    Or you are going to have a glucose test.

Co-amilofruse tablets also contain sunset yellow dye (E110), which can cause allergic reactions including asthma. Allergy is more common in people who are allergic to aspirin.

Use in pregnancy

The safety of Co-Amilofruse during pregnancy and lactation has not been established.

Can you take Co-Amilofruse with other medicines?

You can take these tablets with other medicines, but there are some medicines that can interfere with Co-Amilofruse.

It is very important to tell your doctor or pharmacist about all the medicines, which you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.

This includes the following medicines:

•    Medicines to treat high blood pressure or which can lower blood pressure, or a heart condition. This is particularly important for medicines known as ACE inhibitors or adrenergic neurone blockers or those known as angiotensin II receptor antagonists. Your doctor may ask you to reduce the dose or stop taking Co-amilofruse before starting therapy with these medicines or before increasing their dose

•    Other diuretics (water tablets)

•    Corticosteroids

•    Aminoglutethimide

•    Methotrexate

•    Probenecid (to treat gout)

•    Medicines taken for depression including tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs)

•    Non-steroidal anti-inflammatory agents such as Indometacin, ketorolac and aspirin

•    Carbamazepine and phenytoin to treat epilepsy

•    Carbenoxolone to treat ulcer

•    Amphotericin (treatment of fungal infections)

•    Liquorice

•    Medicines for diabetes (e.g. chlorpropamide)

•    Chloral and triclofos to treat insomnia

•    Acetazolamide to treat glaucoma

•    Theophylline and B2 sympathomimetics for breathing difficulties and asthma

•    Lithium and reboxetine used to treat excessive mood swings

•    Medicines for your heart such as ramipril and verapamil

•    Certain antibiotics (particularly cephaloridine, aminoglycosides, polymyxins and vancoycin)

•    Moxisylyte used in Raynaud's syndrome

•    The Curare-type muscle relaxants baclofen and tizanidine

•    Ciclosporin and tacrolimus used to prevent transplant rejection

•    Cisplatin for certain types of cancer

•    Aldesleukin (drugs affecting the immune response)

•    Laxatives

•    Alprostadil used to treat heart defects in babies, and impotence

•    Potassium salts

•    Oral contraceptives

•    Radiocontrast drugs (help doctors view X-rays).

If you are taking sucralfate, you should not take your dose at the same time as Co-amilofruse. Take your dose at least 2 hours before or after Co-amilofruse otherwise your medicine may not be absorbed properly.

If you have limited kidney function associated with lowered removal of a substance called creatinine from your blood, or Coamilofruse is given in combination with certain other drugs, frequent checks of the potassium level in your blood will be necessary.

If you feel sleepy or unwell after taking Co-amilofruse do not drive or operate dangerous machinery.

When and how to take Co-Amilofruse tablets

Co-Amilofruse tablets are best taken first thing in the morning, swallowed with a little milk or water, and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often.

Do not stop taking your medicine, or change the dose unless your doctor tells you to.

You will be prescribed the lowest dose necessary to control your symptoms.

What to do if too many tablets are taken at the same time

If you accidentally take more tablets than recommended, contact your doctor or hospital casualty at once.

What if you miss a dose?

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.

(If you feel that this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.)

What side effects can Co-Amilofruse have?

In some patients Co-Amilofruse may have some unwanted effects.

These include nausea (feeling of being sick), vomiting, diarrhoea, stomach upset, constipation, dry mouth, undue tiredness (malaise), pins and needles, weakness, muscle cramp, headache, visual changes, sensitivity to light and confusion.

Due to an increase in the amount of urine passed when taking Coamilofruse, this may cause dehydration (increased thirst), or pain in urinating in some patients with bladder and prostatic problems.

Reduced mental alertness may impair driving or using machinery, usually occurring only when treatment begins.

Hypersensitivity reactions are rare and usually cause skin rashes and itching although kidney problems can also occur.

Severe allergic reactions are rare, but may include symptoms of shock such as difficulty in breathing, cold clammy skin, pale skin colour and racing heart beat. If these reactions occur stop taking your Co-amilofruse and immediately tell your doctor.

Also tell your doctor, in the case of any of the following: Buzzing or ringing in the ears, hearing difficulty, swelling of the joints, aching joints or dizziness.

The following conditions can also occur on rare occasions: A fall in blood pressure when rising from sitting or lying down, liver problems including yellowing of the skin and whites of the eyes (jaundice), minor psychiatric (mental) disturbances, changes in behaviour, changes in stomach acidity and low blood pressure.

Inflamed pancreas, which may result in nausea and vomiting with pain in the abdomen and back, may also occur.

In diabetic patients deterioration in glucose control may develop.

An increase in blood uric acid may occur, on rare occasions resulting in gout.

Changes in the levels of sodium, calcium, chloride, magnesium, potassium, sugars, creatinine, urea, cholesterol, triglycerides and fats found in the blood may occur. Anaemia may also develop which is marked by unusual tiredness and loss of colour in the lining of eyes and skin.

Serious bone marrow disorders may also occur but these are very rare. If affected your doctor may decide to stop your treatment.

If your doctor sends you for blood tests, then tell the doctor who is going to do the test that you are taking Co-Amilofruse.

Tell your doctor immediately if you notice any change in your health while taking Co-Amilofruse.

Storing your medicine

You must keep the medicine in a safe place where children cannot get at it. Your medicine could harm them.

Keep your medicine in a dry place below 25«C. Protect from light. Keep the tablets in the container in which they were given to you.

If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist.

On the carton and blister packs you will find the words "Expiry Date" followed by numbers indicating the day, month and year.

This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.

A reminder

REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

Product Licence nos: PL 33414/0028 and PL 33414/0029

This leaflet was revised in December 2008