Document: Torasemid Sandoz tablet ENG PL change

• Torasemid Sandoz tablet PL
• Torasemid Sandoz tablet ENG PL

---

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.

• 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

Torasemid Sandoz 2,5 mg/ - 5mg is used to treat:

Torasemid Sandoz 5mg/ - 10 mg/ - 20 mg is used to treat:

Torasemide is a diuretic, which is a medicine that increases the urine output.

2. BEFORE YOU TAKE TORASEMID SANDOZ

Do not take Torasemid Sandoz if you are/have

• 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 with insufficient urine production

• severe liver disorders with loss of consciousness

• blood pressure lower than 100/60 mmHg (women) or 110/60 mmHg (men)

• breastfeeding

Take special care with Torasemid Sandoz

Inform your doctor if any of the following apply to you:

• 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

• 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 onlyprescribe 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 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

• 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

Torasemid Sandozis not recommendedfor women who are breastfeeding as it may harm the baby.

Only takeTorasemid Sandozduring pregnancy if your doctor indicates that it is absolutely necessary. The lowest possible doseshould 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 doseis:

Torasemid Sandoz 2,5 mg tablets

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

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:

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

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

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

• 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

• 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 cartonafter “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

 The active substance is torasemide.

One tablet contains 2.5 mg of torasemide

One tablet contains 5 mg of torasemide.

One tablet contains 10 mg of torasemide.

One tablet contains 20 mg of torasemide.

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.