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PACKAGE LEAFLET: INFORMATION FOR THE USER Furosemide 20mg Tablets Furosemide 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.

-    If you have any further questions, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Furosemide Tablets are and what are they 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 ARE THEY USED

FOR

Furosemide Tablets contain furosemide as the active ingredient. This belongs to a group of medicines called diuretics (also called water tablets).

Furosemide Tablets are used to treat oedema (fluid retention) caused by heart failure, mild to moderate hypertension (high blood pressure) and certain liver and kidney disorders. They are also used to manage a condition called oliguria where the body produces an abnormally small amount of urine, due to kidney disease.

2.    BEFORE YOU TAKE FUROSEMIDE TABLETS

Do not take Furosemide Tablets if you have:

•    an allergy (hypersensitivity) to furosemide or any of the other ingredients in the product (see Section 6 and end of Section 2)

•    an allergy to any other diuretics or sulphonamides (e.g. sulphamethoxazole)

•    absence of urine production

•    an electrolyte deficiency (various ions, such as sodium or chloride, required by your body)

•    precoma associated with liver disease

•    taken a heart medicine overdose (digitalis intoxication)

•    porphyria, a metabolic disorder.

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Take special care with Furosemide Tablets if you

•    have low blood pressure or an abnormally increased volume of blood. Your fluid and electrolyte balance should be regularly monitored.

•    suffer from gout or diabetes

•    have kidney/adrenal or liver problems

•    have a prostate problem or difficulty in passing urine

•    are elderly.

Taking other medicines

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

In particular, tell your doctor if you are taking:

•    medicines used to treat high blood pressure, such as methyldopa.

•    antibiotics such as cephaloridine.

•    non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen.

•    lithium, a treatment for depression.

•    medicines used to treat heart conditions such as digoxin, lidocaine, mexiletine and tocainide.

•    medicines used for diabetes.

•    glucocorticoids involved in carbohydrate, fat and protein metabolism.

•    salicylates, for example aspirin.

•    theophyllines which are used to help breathing.

•    muscle relaxants and antihistamines.

•    ACE inhibitors (low blood pressure may occur if ACE inhibitors are added to furosemide therapy. The dose of furosemide should be reduced or the drug stopped before initiating the ACE inhibitor).

Pregnancy and breast-feeding

Furosemide Tablets should only be taken during pregnancy if considered essential by your doctor, and only for short-term treatment. Furosemide passes into breast milk, so inform your doctor if you are breast-feeding.

Ask your doctor for advice before taking any medicine.

Driving and using machines

As this medicine may reduce mental alertness and cause dizziness, you should not drive or operate machinery until you know how the drug affects you.

Important information about some of the ingredients of Furosemide Tablets Lactose - if you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE FUROSEMIDE TABLETS For Oral Use Only.

Furosemide Tablets should be swallowed with a drink of water.

Always take the tablets exactly as your doctor has told you. The pharmacist’s label should tell you how much to take and how often.

Adults and the Elderly: The usual dose is 20 - 40mg daily. If you suffer from long term kidney trouble, your doctor may prescribe a starting dose of 250mg furosemide per day which may be increased to 250mg every 4 to 6 hours, up to a maximum of 1500mg per day.

Children: The dose is worked out according to the child’s weight. A dose of 1 -3mg for each kilogram of the child’s body weight should be given daily. Do not exceed 40mg per day.

If you take more Furosemide Tablets than you should

If you or anyone else has swallowed a lot of the tablets, contact your doctor or nearest hospital casualty department immediately.

If you forget to take Furosemide Tablets

If you miss a dose, take another as soon as you remember and carry on as before (do not take a double dose to make up for a forgotten dose). You should continue to take these tablets for as long as your doctor tells you to.

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

4. POSSIBLE SIDE EFFECTS

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

Skin rash or itching suggest an allergic reaction, in which case you should stop taking the tablets immediately and inform your doctor.

Furosemide Tablets may cause other unwanted effects including:

• hearing difficulty or ringing in the ears, dizziness, stomach upset, nausea, diarrhoea, blurred vision, headache, abdominal pain, inflammation of the pancreas, over-sensitivity to light, muscle cramps, pins and needles, gout, diabetes, kidney or liver disorders, low blood pressure, inflammation of blood vessels.

The tablets may occasionally alter the composition of your blood, and your doctor may want to do some blood tests from time to time. If you are to undergo a blood test, remember to tell the doctor of your treatment with furosemide.

If any of the side effects gets 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 all medicines out of the reach and sight of children.

Do not store above 25°C.

Store in the original package/container and keep tightly closed.

This medicine should not be used after the expiry date printed on the pack. 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

What Furosemide Tablets contain

The active substance is furosemide, 20mg or 40mg.

The other ingredients are lactose, magnesium stearate (E572), sodium starch glycollate maize starch and starch paste 15% (see Section 2 ‘Important information about some of the ingredients of Furosemide Tablets’).

What Furosemide Tablets look like and contents of the pack

20mg tablets - white circular flat bevelled edged tablet with ‘F scoreline 20’

embossed on one face and plain on the reverse.

40mg tablets - white circular flat bevelled edged tablet with ‘F scoreline 40’ embossed on one face and plain on the reverse.

Pack sizes (not all may be marketed):

20mg - 28, 56, 100, 250, 500, 1000 tablets.

40mg - 28, 56, 100, 250, 500, 504, 1000, 1008 tablets.

Marketing Authorisation Holder

Aurobindo Pharma Limited Ares, Odyssey Business Park West End Road South Ruislip, F1A4 6QD United Kingdom

Manufacturer

Aurex Generics Limited Ares, Odyssey Business Park West End Road South Ruislip, HA4 6QD United Kingdom

This leaflet was last approved in {12/2007}