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Torasemide 5mg Tablets

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PATIENT INFORMATION LEAFLET

Your prescription for Torasemide 5mg Tablets

Please read this leaflet carefully before you start to take your tablets.

•    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 Torasemide is and what it is used for

2.    Before you use Torasemide

3.    How to use Torasemide

4.    Possible side effects

5.    How to store Torasemide

6.    Further information

1.    what are torasemide 5MG tablets and what are they used for?

Torasemide is a type of medicine called a diuretic, which increases the amount of urine (water) passed.

Torasemide 5mg tablets are used when your body is retaining too much water (oedema) due to heart failure. You will be given a dose of torasemide that will make you pass more water.

2.    BEFORE YOU USE TORASEMIDE

Do not take Torasemide 5mg Tablets

You should not take Torasemide 5mg Tablets if you:

•    Have you ever taken a medicine containing torasemide or any of the other ingredients listed below (in section 6), or have you taken similar medicines before (sulphonylureas e.g. chlorpropamide, glibenclamide, glipizide) and had an unusual or allergic reaction (refer to section 4 for the symptoms of allergic reactions)

•    Are you suffering from severe kidney problems

•    Are you suffering from liver disease

•    Have you been told you have very low blood pressure

•    Have you been told you suffer from heart problems

•    Are you pregnant or is there a chance you may be pregnant

•    Are you breastfeeding

Torasemide 5mg Tablets should not be given to children.

Take special care with Torasemide

You should take special care with Torasemide tablets if:

•    you have been told you have low blood potassium or sodium levels or a low volume of blood in your body

•    you suffer from gout or diabetes mellitus

•    you have any kidney problems or problems passing urine

Taking Torasemide 5mg Tablets with other medicines:

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine including those that you have bought without a prescription, especially any of the following medicines

•    cisplatin

•    lithium

•    antibiotics

•    digoxin

•    steroids (e.g. prednisolone)

•    any medicine for high blood    pressure

•    laxatives

•    theophylline (for asthma)

•    any medicines that belong to a group called ACE-inhibitors

•    non-steroidal anti-inflammatory drug (NSAID, e.g. ibuprofen, naproxen)

•    cholestyramine (for lowering    blood fats)

•    anti-diabetic medicines

•    muscle relaxants

•    any medicine for low blood pressure (e.g. noradrenaline)

•    probenecid

If you are not sure whether another medicine you are taking may be one of the types listed above, check with your doctor or pharmacist.

Taking Torasemide 5mg tablets with food and drink

The tablet should be swallowed whole with a glass of water. You can take Torasemide 5mg tablets with or without food.

Pregnancy and breast-feeding

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

Torasemide 5mg tablets should not be taken during pregnancy. Before taking Torasemide, tell your doctor if you are pregnant or trying to become pregnant.

You should not breast-feed while taking Torasemide 5mg tablets.

Effects on your ability to drive and use machines

You may feel dizzy or drowsy when you have taken your medicine. If you do, you should not drive or operate machinery.

Important information about some of the ingredients of Torasemide 5mg Tablets

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to certain types of sugar, contact your doctor before taking this medicine.

3. HOW TO TAKE TORASEMIDE 5mg TABLETS

Always take Torasemide 5mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with water.

The usual dose is 5mg daily, but your doctor may tell you to take more tablets. Do not take more than two 10mg tablets daily, unless your doctor tells you to.

Elderly

The normal adult doses may be given.

Children

These tablets are not recommended for children.

If you take too many tablets

It is important to stick to the dose on the label of your medicine. If you or someone else takes an overdose of torasemide tablets a lot of urine may be passed and there may be sleepiness, confusion, faintness and dizziness. There also may be an upset stomach. You should contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.

If you forget to take a dose

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose though, do not take twice the number of tablets, just carry on as before.

Marketing Authorisation Holder

The marketing authorisation holder for Torasemide 5mg Tablets: Pharmathen S.A. Dervenakion 6, Pallini, Attiki, 153 51, Greece.

If you stop taking Torasemide 5mg tablets

Always take your medicine exactly as the doctor has prescribed. Do not stop taking your tablets without prior consultation with your doctor.

Manufactuer

The tablets are manufactured by:

PLIVA Hrvatska d.o.o. Prilaz baruna Filipovica 25, 10 000 Zagreb, Croatia and Pliva Krakow S.A.Mogilska Str. 80, 31 546 Krakow, Poland

4.    POSSIBLE SIDE EFFECTS

Like all medicines, torasemide may occasionally cause side-effects in some patients. Date of last revision: May 2008

Some effects, such as headache, dizziness, weakness, loss of appetite or cramps, may happen if your medicine makes you pass too much water, especially when you start taking these tablets. Your doctor may change your dose of torasemide if this happens.

Some people may experience difficulty in passing water.

Other effects do not happen often. These may include:

•    stomach upsets

•    dry mouth

•    numbness or tingling in the legs or arms

•    allergic reactions (itching, rash, increased sensitivity of the skin to light)

•    blurred eyesight

•    confusion

•    drowsiness

•    decreases in red and white blood cells

•    clotting disorders

In rare cases, you might experience:

•    pancreatitis (inflammation of the pancreas causing pain)

•    tinnitus (ringing in the    ears)

•    loss of hearing

The levels of potassium, sodium, sugar, uric acid, creatinine and lipids (fats) in your blood may be affected by this medicine and your doctor may wish to test your blood from time to time to make sure that torasemide is working safely.

Changes in some liver enzymes may also occur.

If any of the side effects gets serious or you experience any side effects not listed in this leaflet please tell your doctor or pharmacist.

5.    HOW TO STORE TORASEMIDE 5mg TABLETS

Keep out of the reach and sight of children.

Do not store above 300C. Store your tablets in the original package.

On the label you will find expiry date:' followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use this medicine after this date.

Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    Further Information What Torasemide contains

The active substance in your tablets is torasemide.

Other ingredients are: lactose monohydrate, maize starch, sodium starch glycollate Type A, silica, colloidal anhydrous and magnesium stearate.

What Torasemide looks like and contents of the pack

These are white to off-white, round, biconvex tablets with a break line on one side and marked with ‘915' on the other.

Torasemide 5mg Tablets are available in blister packs of 14, 28, 30, 50, 100 or 112 tablets.