PACKAGE LEAFLET: INFORMATION FOR THE USER Co-Amilofruse 2.5mg/20mg Tablets Co-Amilofruse 5mg/40mg Tablets Co-Amilofruse 10mg/80mg Tablets

Amiloride Hydrochloride and Furosemide

Read all of this leaflet carefully before

you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please 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.

In this leaflet:

1.    What Co-Amilofruse Tablets are and what they are used for

2.    Before you take Co-Amilofruse Tablets

3.    How to take Co-Amilofruse Tablets

4.    Possible side effects

5.    How to store Co-Amilofruse Tablets

6.    Further information

1. What Co-Amilofruse Tablets are and what they are used for

The name of your medicine is Co-Amilofruse Tablets. This is a medicine containing two active ingredients, amiloride hydrochloride and furosemide. Amiloride hydrochloride belongs to a group of medicines called potassium sparing diuretics which also remove excess water and prevent a reduction in potassium levels. Furosemide belongs to a group of medicines called loop diuretics which remove excess water from the body but can cause a reduction of potassium levels.

Co-Amilofruse Tablets comes in three strengths and is used in the treatment of:

•    heart failure

•    fluid retention in kidney disease

•    fluid retention due to liver disease

•    fluid retention due to treatment with steroids or hormones (oestrogens).

2. Before you take Co-Amilofruse Tablets

You should not take Co-Amilofruse

Tablets if you:

•    are allergic (hypersensitive) to furosemide, amiloride hydrochloride or to any of the other ingredients in Co-Amilofruse Tablets (see section 6, Further information)

•    have high blood potassium levels

•    have Addison’s disease (a disease of the adrenal glands)

•    have acute kidney failure or are unable to pass water

•    have severe, progressive kidney disease

•    have liver failure or cirrhosis that is affecting your level of consciousness

•    have been told you have an imbalance of salts in your blood

•    are taking potassium supplements or other potassium sparing diuretics

•    are dehydrated

•    have low blood pressure

•    have digitalis intoxication

•    are a woman who is breast-feeding

•    are under 18 years.

Talk to your doctor before taking

Co-Amilofruse Tablets if you:

•    if you are going to have, or have recently had an X ray with contrast media (dye).

•    if you are taking risperidone

•    if you are taking medicine for asthma (beta2-agonists)

•    are elderly

•    have or are likely to develop abnormal blood chemistry with high or low salts or acidosis

•    are dehydrated

•    have kidney problems

•    have diabetes

•    suffer from gout (a condition where too much uric acid in the body causes joint pains)

•    have an enlarged prostate or have problems passing water

•    are vomiting and/or have diarrhoea

•    have low blood pressure

•    have liver failure

•    have porphyria (a disease of blood proteins that effects the skin, gut and nervous system)

•    have or have ever suffered from pancreatitis (an inflammation of the pancreas)

•    have congestive heart failure

•    have an excess of the hormone aldosterone in the kidney, which could lead to decreased levels of potassium in the blood.

•    are not producing enough parathyroid hormone (PTH) from your parathyroid glands, which could lead to decreased levels of calcium in the blood

•    suffer from systemic lupus erythematosus (a disease were the immune system attacks the tissues of the body)

•    are due to take a glucose tolerance test (this medicine should be discontinued for at least three days before).

This medicine may cause falsely high reading in blood test for kidney function (creatinine). Cholesterol levels may also rise during the first 6 months of treatment, but usually return to normal thereafter.

Electrolyte levels such as sodium, potassium and blood urea nitrogen levels, require monitoring. Regular monitoring of the blood, liver, and for rare side effects are required.

In infants, there is a risk of Patent Ductus Aretiosus (PDA). Renal function must be monitored as there is also a risk of raised calcium levels within the kidneys, and kidney stones.

The renal function of patients with diabetes mellitus should be assessed prior to the start of treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Co-Amilofruse Tablets:

•    medicines used to treat high blood pressure (e g. beta-blockers, calcium-channel blockers, hydralazine, alpha-blockers, such as prazosin, ACE inhibitors, such as captopril, and angiotensin II antagonists, such as losartan)

•    amphotericin used to treat fungal infections

•    anaesthetics

•    aldesleukin, used to treat cancer of the kidney

•    carbamazepine and phenytoin used to treat epilepsy

•    nitrates, used to treat angina

•    Nephrotoxic drugs, or drugs which have a toxic effect on the kidneys

•    quinidine, flecainide, amiodarone, disopyramine, sotaolol, mexilitine and lidocaine, used to treat abnormal heart rhythms

•    anion-exchange resins used to reduce cholesterol (e g. colestyramine and colestipol)

•    Levodopa, used to treat Parkinson's disease

•    medicines used in chemotherapy (e g. cisplatin, methotrexate)

•    phenothiazines and risperidone, medicines used to treat mental illness

•    medicines used to treat depression (e g. tricyclic antidepressants and monoamine oxidase inhibitors [MAOIs])

•    medicines used to suppress the immune system following organ transplant (e g. ciclosporin and tacrolimus)

•    medicines used to treat inflammation such as indometacin, keterolac, acetylsalicylic acid

•    carbenoxolone, sucralfate and ranitidine, used to treat stomach ulcers

•    medicines called muscle relaxants, such as tizanidine or baclofen, used to treat muscle pain, spasms and twitching

•    triostane, used to treat hormone disturbances

•    diuretics, used to treat water retention (e g. metolazone)

•    laxatives

•    medicines used to treat bacterial infections

•    medicines used to treat diabetes, such as chlorpropamide

•    lithium, a medicine used to treat manic depression/bipolar disorder

•    aprostadil, a medicine used to treat impotence

•    probenecid, a medicine used to prevent gout

•    theophylline, used in the treatment of respiratory conditions such as COPD or asthma

•    asthma or COPD ‘relieved inhalers such as salbutamol, terbutaline

•    terfenadine, used to treat allergic conditions

•    steroids or potassium supplements

•    Warfarin, used to thin the blood.

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

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Taking Co-Amilofruse Tablets with food and drink

If you feel dizzy while taking this medicine then alcohol may make the effects worse. It is also advised to avoid smoking while you take this medicine as nicotine can reduce the effectiveness of Co-Amilofruse Tablets.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or breast feeding unless your doctor specifically recommends it.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

This medicine can make you feel dizzy, reduce alertness or impair your vision. Do not drive or operate machinery if affected.

Important information about some of the ingredients in Co-Amilofruse Tablets

This medicine contains lactose, if you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine. This medicine also contains a food dye called Sunset Yellow FCF Lake (E110) which may cause allergic reactions.

3. How to take Co-Amilofruse Tablets

Always take Co-Amilofruse Tablets as your doctor has told you. Your doctor will decide the right dose for you. This will be on the pharmacist's label. This medicine should be swallowed whole.

Adults

•    The starting dose is usually 5mg/40mg taken in the morning; this can be adjusted by your doctor according to your response to treatment.

While you are taking this medicine your doctor may want to monitor your salt levels with regular blood tests, especially if you are elderly or unwell, to check for any possible imbalances.

Children

•    This medicine is not recommended for use in children under the age of 18.

If you take more Co-Amilofruse Tablets than you should

If you (or anybody else, including a child), takes more Co-Amilofruse Tablets than you should then you should contact your nearest hospital casualty department or doctor immediately. Always take the container and this leaflet with you.

If you forget to take Co-Amilofruse Tablets

If you forget 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 take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Co-Amilofruse Tablets can cause side effects, although not everybody gets them. As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

•    inflammation of the pancreas (pancreatitis) which causes severe pain in the abdomen and back (may be associated with nausea, vomiting or fever). If you notice these symptoms talk to your doctor as soon as possible

•    yellowing of the skin or whites of the eyes caused by liver or blood problems Gaundice). If you notice these symptoms talk to your doctor as soon as possible

•    rash, itching, difficulty breathing.

Side effects that have been reported with Co-Amilofruse Tablets are:

•    rises in blood urea levels

•    cough

•    shortness of breath

•    nausea

•    vomiting

•    sensitivity to light

•    stomach upsets

•    stomach pains

•    diarrhoea

•    constipation

•    dizziness

•    fainting

•    ringing in the ears

•    deafness

•    blurred vision, visual changes

•    yellow vision, a condition where everything you see appears to have a yellowish tinge

•    skin rashes

•    muscle twitching

•    skin blistering

•    bruising

•    vitamin B1 deficiency

•    gout, a condition that causes pain, inflammation and swelling of your joints

•    high blood sugar (hyperglycaemia). Symptoms include feeling thirsty, needing to pass water frequently, feeling tired and getting infections such as thrush more often than usual

•    Skin: rash, itching, hair loss

•    psychiatric disturbance

•    inflammation of the kidneys

•    blood salt imbalances. Symptoms include dry mouth, thirst, headache, low blood pressure,

drowsiness,

stomach

upsets,

feeling

confused,

muscle

cramps,

muscle

twitching

and an

abnormal

heartbeat

•    angina

•    palpitations

•    general feeling of being unwell

•    aggravation of diabetes

•    low blood pressure on standing

•    inflammation of blood vessels

•    problems with bone formation

•    reduced sex drive, erectile dysfunction

•    disturbance in liver function (seen in blood tests)

•    problems with bone marrow and blood cell production.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any poss ble side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Co-Amilofruse Tablets

Keep out the reach and sight of children.

•    Co-Amilofruse Tablets should not be stored above 25°C. Store in the original container and do not transfer to another container.

•    Co-Amilofruse Tablets should not be taken after the expiry date on the pack; the expiry date refers to the last day of the 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 protect the environment.

6. Further information

What Co-Amilofruse Tablets contains

The active ingredients are: amiloride hydrochloride and furosemide. The other ingredients are: lactose powder, microcrystalline cellulose, dispersed sunset yellow FCF Lake (E110), povidone K30, sodium starch glycollate, magnesium stearate, purified water.

Each Co-Amilofruse 2.5mg/20mg tablet contains 2.84mg of amiloride hydrochloride equivalent to 2.5 mg of amiloride and 20mg of furosemide.

Each Co-Amilofruse 5mg/40mg tablet contains 5.68mg of amiloride hydrochloride equivalent to 5mg of amiloride and 40mg of furosemide.

Each Co-Amilofruse 10mg/80mg tablet contains 11 36mg of amiloride hydrochloride equivalent to 10mg of amiloride and 80mg of furosemide.

What Co-Amilofruse Tablets looks like and the contents of the pack

Co-Amilofruse tablets are supplied in opaque white blister packs (containing 28, 30, 56 or 60 tablets) or in polyethylene plastic containers of 500 tablets.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

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0800 198 5000 (UK Only).

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This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 04/2015 220905⁵    ^WOCKHARDT