PACKAGE LEAFLET: INFORMATION FOR THE USER Furosemide 20mg or 40mg Tablets Furosemide

Read all of this leaflet carefully before you start

taking 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 nurse.

-    This medicine has been prescribed for you. Do not pass it onto 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.

The name of your medicine is Furosemide 20mg or

40mg Tablets. In the rest of this leaflet it is called

Furosemide Tablets.

In this leaflet:

1.    What Furosemide Tablets are and what they are used for

2.    Before you take Furosemide Tablets

3.    How to take Furosemide Tablets

4.    Possible side effects

5.    How to store Furosemide Tablets

6.    Further information

1. What Furosemide Tablets are and what they are used for

Furosemide Tablets are one of a group of medicines called diuretics (‘water tablets’).

What this medicine does

Furosemide Tablets are used to get rid of excess fluid from the body, to manage a condition called oliguria where the body produces an abnormally small amount of urine due to kidney disease, and in the treatment of high blood pressure.

2. Before you take Furosemide Tablets

Do not take Furosemide Tablets if you:

•    are allergic (hypersensitive) to furosemide or any of the other ingredients of Furosemide Tablets (see section 6, Further information)

•    you have been told you are allergic to certain antibiotics, called suphonamides

•    have kidney failure

•    you have been told you have severe liver problems with cirrhosis of the liver

•    you are unable to pass urine (water)

•    you have Digitalis intoxication (characterised by loss of appetite, nausea and vomiting)

•    you have Addison's disease (disease of the adrenal glands)

•    you are breast-feeding.

Talk to your doctor, if any of the

following apply to you:

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

•    if you are taking medication for high blood pressure or heart failure

•    if you are taking risperidone

•    if you are pregnant or breast-feeding are thinking of getting pregnant or starting breast-feeding

•    if you have problems with your prostate gland or difficulty in passing water

•    if you have, or have previously had, low blood protein, potassium or sodium

•    if you have low blood pressure or are suffering from dehydration

•    if you have diabetes

•    if you have gout

•    if you have parathyroid problems

•    if you have liver failure

•    if you have kidney failure

•    if you have porphyria

•    if you have, or have previously had, pancreatitis

•    if you have, or have previously had, systemic lupus erythematosus

•    if you have severe asthma and are taking medicines called beta-agonists; these include salbutamol, terbutaline, formoterol and salmeterol

Using other medicines

Make sure your doctor knows if you are

taking any medicine listed here:

•    Medicines used for heart problems

including sotalol, disopyramide, flecainide, quinidine, lidocaine, mexilitine, digoxin, digitoxin and amiodarone.

•    Drugs to lower blood pressure, such as ACE inhibitors (captopril), beta-blockers, calcium channel blockers (hydralazine), alpha-blockers (prazosin) or vasodilators: when taken with furosemide may cause your blood pressure to fall too low or affect your heart, or kidney. Your doctor may need to change your dose of furosemide

•    Aldesleukin, to treat cancer of the kidney

•    Alprostadil for impotence: when taken with furosemide may cause your blood pressure to fall too low

•    Anaesthetics

•    Levodopa, used to treat Parkinson's disease

•    Nitrates, used to treat chest pain associated with angina

Other medicines can affect how it or the

other medicine works:

•    Antibiotics for infections e.g. some cephalosporins, aminoglycosides (examples include amikacin, gentamicin, netilmicin) and vancomycin. Some antibiotics can affect your kidneys and/or hearing and furosemide can make these effects worse.

•    Anticoagulants, furosemide may reduce the effects of anticoagulants

•    Anti-gout medicine, when taken with furosemide may have an effect on the kidneys

•    Carbenoxolone and ranitidine, ulcer healing drugs

•    Lithium, for depression or mania: as the effect of lithium may be increased. Your doctor will check your lithium levels and may change your dose

•    Risperidone, used to treat mental illness

•    Medicines to control diabetes:

these medicines may not work as well when taken with Furosemide

•    Cisplatin to treat cancer: furosemide may increase the side effects of cisplatin. Your doctor may change your dose of furosemide

•    Phenytoin to control epilepsy (fits): furosemide may not work as well

•    Carbamazepine to control epilepsy: it may increase the side effects of furosemide if taken together

•    Ciclosporin, may increase risk of gouty arthritis when taken with Furosemide

•    Corticosteroids such as cortisone and hydrocortisone, used to treat allergic reactions: your salt balance may be altered causing your muscles to feel weak

•    Amphotericin for fungal infections: your salt balance may be altered causing your muscles to feel weak

•    Certain treatments for asthma, including theophylline and beta-agonists such as salbutamol, when taken in large amounts: your salt balance may be altered causing your muscles to feel weak

•    Indometacin, for rheumatism: indometacin can reduce the effect of furosemide

•    Probenecid for gout: furosemide will not work as well or the effect of probenecid may be increased

•    Laxative, when used with furosemide may increase the risk of low blood potassium

•    Metolazone (another diuretic): when taken together with furosemide can increase the amount of urine you pass which, in turn, could lead to dehydration

•    Other diuretics e.g acetazolamide and thiazide diuretics; when taken together with furosemide your salt balance may be altered causing your muscles to feel weak

•    Medicines used to reduce inflammation (NSAIDs) such as ibuprofen and ketoralac

•    Medicines taken for depression including tricyclic antidepressants, such as amitriptyline, and monoamine oxidase inhibitors (MAOIs), such as phenelzine.

•    Terfenadine, taken for allergies

•    Colestyramine and colestipol, used to treat high levels of cholesterol in the blood

•    Pimozide and sertindole, medicines used in the treatment of mental illness

•    Tizanidine, used to treat muscle spasm.

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

Smoking may make your furosemide tablets less effective.

Do not take alcohol while taking this medicine.

Pregnancy and breast-feeding

Speak to your doctor before you take Furosemide Tablets if you are pregnant, thinking of getting pregnant, or breast-feeding.

•    If you become pregnant while taking Furosemide Tablets, speak to your doctor as he will check the growth of your baby.

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Driving and using machines

• Do not drive or operate machinery if you feel drowsy or have blurred vision after taking Furosemide Tablets.

Important information about some of the ingredients in Furosemide Tablets

Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Tell your doctor you are taking Furosemide, if you are having a glucose tolerance test. You will need to discontinue treatment with Furosemide before having the test.

3. How to take Furosemide Tablets

Always take Furosemide Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how much to take.

Unless told otherwise, take your tablets with water.

Adults including elderly

•    The usual starting dose for excess fluid is 40mg in the morning which may be reduced to 20mg daily or 40mg every other day

•    The dose may be increased if necessary to 80mg or more as one or two doses daily or every other day.

•    The usual starting dose to improve urine production is 250mg daily.

•    This may be increased if necessary, in steps of 250mg, to larger doses given every four to six hours.

•    The usual dose for high blood pressure is 40-80mg daily. If you are taking these tablets for high blood pressure, your doctor may also prescribe another drug for high blood pressure, to be taken together with your furosemide treatment.

Children

•    For children, the usual dose is 1 to 3mg per kg bodyweight daily up to a maximum of 40mg daily.

You will find that you have the urge to pass water soon after taking your medicine. 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. This will leave you free to go about your usual routine, undisturbed. If you work at night, it may be better for you to take your tablet(s) in the evening.

If you take more Furosemide Tablets than you should

•    If you take more medicine than your doctor has told you to, contact a doctor or your nearest hospital casualty department immediately and take your Furosemide Tablets with you.

If you forget to take Furosemide Tablets

•    If you forget to take a dose, take another as soon as you remember. Then take your next dose at the normal time.

•    Do not take double the amount to make up for a forgotten dose.

If you stop taking Furosemide Tablets

•    Speak to your doctor before you stop taking Furosemide Tablets.

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

or on your skin; a sore throat or repeated infections.

Other effects which may occur:

•    if you have diabetes, this may not be as well

controlled

•    gout

causing pain normally in the joints of your legs

•    low blood pressure and a low body level of salts

such as sodium or potassium (symptoms of this include dry mouth, thirst, weakness, drowsiness, confusion (caused by liver failure if liver was already damaged), blackouts, fainting, numbness, malaise, headache, muscle cramps and irregular heart beat).

•    sickness, vomiting, diarrhoea, or generally feeling unwell

•    in newborn infants, long-term treatment with furosemide may cause weakening of the bones due to calcium loss

•    hearing problems or ringing in your ears (tinnitus)

•    dehydration

•    blurred or yellow vision, and dizziness (including dizziness or light-headedness on standing).

•    skin reactions such as itching, marks on the skin, flaky or scaly skin

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

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.

5. How to store Furosemide Tablets

•    Keep out of the reach and sight of children.

•    Do not store above 25°C. Store in the original container in which the tablets were given to you in order to protect from light. Do not transfer your tablets to another container.

•    Do not use after the expiry date stated on the carton and the bottle. 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.

6. Further information

4. Possible side effects

Like all medicines, Furosemide Tablets can cause side effects, although not everybody gets them.

If you have any of the following side effects while taking your medicine tell your doctor immediately or go to hospital straight away:

•    severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away

•    jaundice (your skin or whites of your eyes look yellow)

•    inflammation of the pancreas which may cause severe pains in your abdomen or back, nausea, vomiting and fever

•    kidney problems (blood in the urine or lower back pain)

•    increased sensitivity to touch, skin prickling, skin is sensitive to sunlight.

•    effects to your blood composition.

The symptoms of this include anaemia, leading to tiredness and lethargy; ulcers in your throat, mouth

What Furosemide Tablets contain

-    The active substance is furosemide

-    The tablets come in two strengths, 20mg and 40mg.

-    The other ingredients are lactose, maize starch, pre-gelatinised maize starch and magnesium stearate.

What Furosemide Tablets look like and contents of the pack

Furosemide 20mg Tablets are white, circular, flat tablets with a breakline and F20 on one side and CP on the other.

Furosemide 40mg Tablets are white, circular, flat tablets with a breakline and F40 on one side and CP on the other.

Furosemide Tablets are available in strip packs of 28 tablets

Marketing Authorisation Holder

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

Manufacturer

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

Other formats:

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0800 198 5000 (UK Only). Please be ready to give the following information:

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

This leaflet was last revised in August 2012

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