PACKAGE LEAFLET: INFORMATION FOR THE USER
Torasemid Sandoz 2,5 mg tablets
Torasemid Sandoz 5 mg tablets
Torasemid Sandoz 10 mg tablets
Torasemid Sandoz 20 mg tablets
Torasemide
Read all of this leaflet carefully before you start taking this medicine.
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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 Torasemid Sandoz is and what it is used for
2.
Before you take Torasemid Sandoz
3.
How to take Torasemid Sandoz
4.
Possible side effects
5.
How to store Torasemid Sandoz
6.
Further information
1. WHAT TORASEMID SANDOZ IS AND WHAT IT IS USED FOR
Torasemid Sandoz 2,5 mg/ - 5mg is used to treat:
 high blood pressure
Torasemid Sandoz 5mg/ - 10 mg/ - 20 mg is used to treat:
 swelling caused by excess fluid in the tissues , occurring in patients with heart failure.
Torasemide is a diuretic, which is a medicine that increases the urine output.
2. BEFORE YOU TAKE TORASEMID SANDOZ
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Do not take Torasemid Sandoz if you are/have
 allergic (hypersensitive) to:
 torasemide
 chemical analogue medicines such as certain medicines to treat diabetes, containing active substances with names mostly ending in “-mide”
 or any of the other ingredients kidney failure breastfeeding
with insufficient urine production severe liver disorders with loss of consciousness blood pressure lower than 100/60 mmHg (women) or 110/60 mmHg (men)
Take special care with Torasemid Sandoz
Inform your doctor if any of the following apply to you:
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 gout and/or an increase in uric acid levels in the blood an irregular heart beat reduced blood volume

 reduced potassium or sodium levels in the blood
 abnormal changes in the amount of acid and base in the body
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 severe urinary flow disorders caused for example by an enlarged prostate gland
 reduced kidney function due to medicines which cause kidney damage diabetes
 taking any medicines – See “Taking other medicines”
If you continuously use Torasemide your doctor will check your blood levels regularly, particularly if you use other medicines.
Children under 12 years
Due to insufficient knowledge, the doctor will only prescribe Torasemide when absolutely necessary .
Taking Torasemid Sandoz with food and drink
Do not take these tablets together with alcohol.
The use of Torasemid Sandoz may produce positive results in doping controls.
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 Torasemid Sandoz
 medicines to treat high blood pressure , particularly medicines with active substances ending in
“-pril”
 medicines to encourage the hearts pumping strength, such as digitoxin , digoxin or methyldigoxin
 medicines to treat diabetes
 probenecid , a medicine to treat gout
 medicines to treat inflammation and pain , such as acetyl salicylic acid or indometacin
 sulfasalazine , mesalazine or olsalazine , medicines to treat chronic inflammatory bowel diseases
 medicines to treat infections , such as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamycin, amikacin or tobramycin
 cisplatin , a medicine to treat cancer
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 lithium , a medicine to treat depression theophylline , a medicine to treat asthma
 some muscle-relaxant medicines with active substances ending in “-curonium” or “-curium”
 all medicines to treat constipation
 medicines containing cortisone , such as hydrocortisone, prednisone or prednisolone
 colestyramine , a medicine to reduce blood fat levels
 adrenaline or noradrenaline , medicines to increase blood pressure
Pregnancy and breastfeeding
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Breastfeeding
Torasemid Sandoz is not recommended for women who are breastfeeding as it may harm the baby.
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Pregnancy
Only take Torasemid Sandoz during pregnancy if your doctor indicates that it is absolutely necessary . The lowest possible dose should be used in this case.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Dizziness or drowsiness may occur when taking Torasemid Sandoz particularly at the beginning of treatment, when increasing the dosage, changing the preparation or when concomitantly ingesting alcohol.
If your attention is decreased, do not drive or operate machines.
Important information about some of the incredients of Torasemid Sandoz
This medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars , contact your doctor before taking this medicinal product.
3. HOW TO TAKE TORASEMID SANDOZ
Always take Torasemid Sandoz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Torasemid Sandoz 2,5 mg tablets
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1 tablet once daily
If necessary, your doctor may increase the dose to 2 tablets once daily after two months treatment at the earliest.
Torasemid Sandoz 5 mg tablets
Treatment of high blood pressure
 ½ tablet once daily
If necessary, your doctor may increase the dose to 1 tablet once daily after two months treatment at the earliest.
Treatment of swelling caused by excess fluid in the tissues , occurring in patients with heart failure:
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1 tablet once daily
If necessary, your doctor may gradually increase the dose to 4 tablets once daily.
Dividing the tablet:
Place the tablet on a hard, flat surface with the break-line facing upwards. Press with a finger on the middle of the tablet and the tablet breaks into two equal halves.
Torasemid Sandoz 10 mg tablets
 ½ tablet once daily
If necessary, your doctor may gradually increase the dose to 2 tablets once daily.
Dividing the tablet:
Place the tablet on a hard, flat surface with the break-line facing upwards. Press with one finger each on the left and the right side of a single break-line and the tablet breaks into two equal halves.

Torasemid Sandoz 20 mg tablets
 ¼ tablet once daily
If necessary, your doctor may gradually increase the dose to 1 tablet once daily.
Dividing the tablet:
Place the tablet on a hard, flat surface with the break-line facing upwards. Press with a finger on the middle of the tablet and the tablet breaks into four equal parts.
Tablets containing higher and lower active substance amounts are also available.
Reduced liver function which is not severe
Your doctor will treat you carefully as the torasemide level might increase.
Kind of administration
Take the tablets each morning independent of meals, unchewed, with 100 ml of water, equivalent to a half glass.
Duration of use
To be decided by your attending doctor. Torasemid Sandoz can be continuously used for some years or until excess tissue fluid has disappeared.
If you take more Torasemid Sandoz than you should
Contact your doctor immediately.
An overdose is likely to cause pass a lot of water (urine), sleepiness, confusion, weakness, dizziness, hypotension, circulatory collapse, upset stomach.
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 Torasemid Sandoz
Take the forgotten dose as soon as possible at the same day or take the next dose normally the next day. Do not take a double dose to compensate the forgotten dose.
If you stop taking Torasemid Sandoz
Do not stop Torasemide use without your doctors’ permission, as this can seriously harm you and reduce the therapy effect.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Torasemid Sandoz can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies:
Common , occurs in 1 to 10 per 100 users:
 disturbances in the amount of body water and minerals, particularly when there is clearly limited salt intake
 excessive alkaline in the body
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 muscle cramps, especially when beginning treatment
 increased blood concentrations of uric acid, sugar and fats reduced potassium and sodium levels in blood
 reduced blood volume
 stomach and/or bowel disorders, such as loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation

 increase of certain liver enzyme levels, such as gamma-GT
 headache
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 dizziness
 tiredness weakness
Uncommon , occurs in 1 to 10 per 1000 users:
 increase of blood concentrations in the substances urea and creatinine
 dry mouth
 creeping sensation or tingling in arms and legs
 difficulty in passing water (urine) (e.g. due to prostatic hyperplasia)
Very rare , occurs in fewer than 1 per 10,000 users:
 narrowed or constricted blood vessels caused by blood thickening
 lower blood pressure than normal
 circulation problems, especially when standing up
 irregular heart beat
 angina pectoris, a condition often marked by severe chest pain
 heart attack
 fainting
 confusion
 inflammation of the pancreas
 allergic reactions with itching and rash
 increased light sensitivity
 severe skin reactions
 reduction in red and white blood cells and platelets
 problems with sight
 ringing or buzzing in the ears
 hearing loss
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 TORASEMID SANDOZ
Keep out of the reach and sight of children.
Do not use Torasemid Sandoz after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Medicines should not be disposed 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 Torasemid Sandoz contains
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The active substance is torasemide .
One tablet contains 2.5 mg of torasemide
One tablet contains 5 mg of torasemide.
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One tablet contains 10 mg of torasemide.
One tablet contains 20 mg of torasemide.
The other ingredients are:

microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica
What Torasemid Sandoz looks like and contents on the pack
Torasemid Sandoz 2.5 mg tablets
Torasemid Sandoz tablets are round, white to off-white.
Torasemid Sandoz 5 mg tablets
Torasemid Sandoz tablets are round, white to off-white with break notch.
Torasemid Sandoz 10 mg/- 20 mg tablets
Torasemid Sandoz tablets are round, white to off-white with cross break notch.
2,5 mg, 5 mg and 20 mg tablets:
Pack sizes: 10, 14, 20, 28, 30, 50, 56, 100, 400 (20 x 20) tablets
10 mg tablets:
Pack sizes: 10, 14, 20, 28, 30, 50, 56, 98, 100, 400 (20 x 20) tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
<[for Sweden only]>
Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany
Tel: +49 8024 908 0
Fax: +49 8024 908 1277
Sandoz A/S
Edvard Thomsens Vej 14
2300 Köpenhamn S
Denmark
This medicinal product is authorized in the Member States of the EEA under the following names:
[To be completed nationally]
This leaflet was last approved in 25 June 2012.