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Torasemide 10mg Tablets

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Document: leaflet MAH BRAND_PLPI 20636-1788 change

Torem® 10 mg Tablets    19.05.15[8]

Torasemide 10 mg Tablets

(torasemide)

PATIENT INFORMATION LEAFLET

Your medicine is available using any of the above names but will be referred to as Torem throughout this leaflet

Torem is available in other strengths.

Please 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 troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Torem is and what it is used for

2.    Before you take Torem

3.    How to take Torem

4.    Possible side effects

5.    How to store Torem

6.    Further information

1.    WHAT TOREM IS AND WHAT IT IS USED FOR

Torem contains a medicine called torasemide. This belongs to a group of medicines called ‘diuretics' or ‘water tablets'.

-    Torem 5 mg tablets are used to treat high blood pressure (hypertension).

-    Torem 5 mg and 10 mg tablets are used to treat swelling caused by too much water in the body (oedema).

The tablets work by making you pass more water (urine).

2.    BEFORE YOU TAKE TOREM

Do not take Torem if you are allergic (hypersensitive) to:

-    Torasemide or any of the other ingredients of Torem (see Section 6: Further information).

-    Similar medicines called ‘sulphonylureas'. These are used to treat diabetes (high blood sugar). These medicines include chlorpropamide, glibenclamide, glipizide and tolbutamide.

Do not take Torem if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Torem.

Do not take Torem if:

-    You have kidney problems (renal failure).

-    You have kidney problems that have been caused by medicines.

-    You have liver problems.

-    You have low blood pressure (hypotension).

-    You have heart beat problems (cardiac arrhythmia).

-    You are taking an antibiotic called an ‘aminoglycoside' or ‘cephalosporin' (for an infection). These medicines include streptomycin, gentamycin, cephalexin and ceftriaxone. See the section on ‘Taking other medicines'.

-    You are pregnant or breast-feeding a baby. See the section on ‘Pregnancy and breast-feeding'.

Do not take Torem if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Torem.

Take special care with Torem

Check with your doctor or pharmacist before taking Torem if:

-    You have low levels of potassium or sodium in your blood (shown in blood tests).

-    You have a low volume of blood (hypovolaemia).

-    You have difficulty passing water (urinating).

-    You have gout or high levels of uric acid in your blood.

-    You have diabetes (diabetes mellitus).

If any of these apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Torem.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

This is because Torem can affect the way some other medicines work.

Also some other medicines can affect the way Torem works.

Do not take Torem if you are already taking an antibiotic called an ‘aminoglycoside' or ‘cephalosporin' (for an infection). These medicines include streptomycin, gentamycin, cephalexin and ceftriaxone. If this applies to you, ask your doctor or pharmacist for advice.

It is particularly important to tell your doctor or pharmacist if you are taking any of the following medicines:

-    Other medicines to treat high blood pressure.

-    Medicines called ‘ACE inhibitors' (used to treat heart disease).

-    Medicines like digoxin or digitoxin (used to treat heart disease).

-    Adrenaline (also called epinephrine) or noradrenaline (also called norepinephrine). These are used to treat low blood pressure.

-    Cholestyramine, or other ‘ion-exchange resins' (used to treat high levels of cholesterol in your blood).

-    High doses of medicines called ‘salicylates', such as aspirin.

-    Medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs). These include indomethacin and ibuprofen.

-    Laxatives.

-    Steroid medicines, such as hydrocortisone, prednisolone and dexamethasone.

-    Medicines to relax your muscles (muscle relaxants).

-    Cisplatin (used to treat cancer).

-    Lithium (used to treat mental health problems).

-    Probenecid (used to treat gout).

-    Theophylline (used to treat asthma).

Pregnancy and breast-feeding

Do not take Torem if you are pregnant, might become pregnant or are breast-feeding. This is because it is not known if Torem will affect your baby.

Driving and using machines

You may feel dizzy while taking Torem. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Torem

This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

3.    HOW TO TAKE TOREM

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

High blood pressure

-    The usual dose for adults and elderly people is between 2.5 mg and 5 mg once a day

Water retention (oedema)

-    The usual dose for adults and elderly people is 5 mg once a day.

-    Your doctor may increase the dose to 20 mg a day if needed.

If you take more Torem than you should

-    If you take more Torem than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

-    If you take too many tablets, you may pass a lot of urine, become sleepy, or feel confused, faint or dizzy. You may also have stomach upset.

If you forget to take Torem

-    If you forget to take a dose, take it as soon as you remember it.

-    However, if it is nearly time for the next dose, skip the missed dose.

-    Do not take a double dose to make up for a forgotten dose.

If someone else takes your Torem tablets by mistake, they should talk to a doctor or go to a hospital straight away.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Torem can cause side effects, although not everyone will get them.

See your doctor as soon as possible if you get the following side effects:

-    Low levels of sodium or potassium in your blood. This may cause headache, feeling dizzy, fainting, feeling weak, feeling sleepy, feeling confused, a loss of appetite or cramps. Your doctor may change your dose of Torem if this happens.

-    Problems with your circulation or blood clots (these have only been seen occasionally).

-    Reduced numbers of red or white blood cells or platelets in your blood. This may make you feel tired, get infections more easily, or bruise more easily.

Other possible side effects:

Blood

-    An increase in the levels of certain substances in your blood, including sugar, uric acid and fats (lipids).

Your doctor may do blood tests from time to time to make sure that Torem is working safely.

Stomach and gut

-    Stomach upset.

-    Inflammation of the pancreas causing pain in the stomach (pancreatitis).

-    Changes in how your liver is working (shown by blood tests).

Skin

-    Skin rashes and itchy skin.

-    Skin being more sensitive to the sun (photo-sensitivity).

Eyes and ears

-    Blurred eyesight.

-    Ringing in the ears (tinnitus) and loss of hearing.

Other

-    Feeling numb or tingling in the legs or arms.

-    Dry mouth.

-    Some people may have difficulty passing water (urinating).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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 TOREM

-    Store in the original package.

-    Keep out of the sight and reach of children.

-    Do not use this medicine after the expiry date shown on the blister strip and carton.

-    If your doctor decides to stop the treatment, return any leftover tablets to the pharmacist. Only keep them if your doctor tells you to.

-    If your tablets become discoloured or shown any other signs of deterioration, please contact your doctor or pharmacist before taking your medicine.

6.    FURTHER INFORMATION What Torem contains

Each tablet contains 10mg torasemide as active ingredient.

The tablets also contain lactose monohydrate, maize starch, colloidal silicon dioxide and magnesium stearate.

What Torem looks like and contents of the pack

Torem are available as round, white to off-white tablets, scored on one side and plain on the other.

Torem are supplied in blister strip packs of 30, 50 and 100 tablets. Manufacturer and Product Licence Holder

Manufactured by BERLIN-CHEMIE AG, Glienicker Weg 125, 12489 Berlin, Germany. Procured from within the EU by Product Licence holder:

Star Pharmaceuticals Ltd, 5 Sandridge close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

POM


PL 20636/1788


Leaflet revision and issue date (Ref) 19.05.15[8]

Torem is a registered trademark of F. Hoffmann-La Roche AG.