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Package leaflet: Information for the user

Torahexal 2,5 mg tablets

Torahexal 5 mg tablets

Torahexal 10 mg tablets

Torahexal 20 mg tablets

Torasemide

Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. WhatTorahexal is and what it is used for

Torahexal 2,5 mg/- 5mg is used to treat:

Torahexal 5mg/ - 10 mg/ - 20 mg is used to treat:

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

2. What you need to know before you take Torahexal

Do not take Torahexalif you are/have

• torasemide or any of the other ingredients of this medicine (listed in section 6)

• chemical analogue medicines such as certain medicines to treat diabetes, containing active substances with names mostly ending in “-mide”

• 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)

• decreased blood volume

• breast-feeding

Warnings and precautions

Talk to your doctor before taking Torahexal 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 “Other medicines and Torahexal”

If you continuously use torasemide your doctor will check your blood regularly regarding cells and levels of certain substances, particularly if you use other medicines.

Children under 12 years

Due to insufficient knowledge, the doctor will onlyprescribe Torasemide when absolutely necessary.

Other medicines and Torahexal

Tell your doctor or pharmacistif you are using, have recently used or might use any other medicines.

The following medicines can affect or be affected by Torahexal:

• 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

Torahexal with food, drink and alcohol

Donot take these tablets together with alcohol.

Pregnancy and breast-feeding

Only take Torahexal during pregnancy if your doctor indicates that it is absolutely necessary. The lowest possible dose should be used in this case.

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Dizziness or drowsiness may occur when taking Torahexal 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.

Torahexal contains lactose

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 medicine.

3. How to take Torahexal

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doseis:

Torahexal 2,5 mg tablets

If necessary, your doctor may increase the dose to 2 tablets once daily after two months treatment at the earliest.

Torahexal 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:

The tablet can be divided into equal doses.

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.

Torahexal 10 mg tablets

If necessary, your doctor may gradually increase the dose to 2 tablets once daily.

Dividing the tablet:

The tablet can be divided into equal doses.

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.

Torahexal 20 mg tablets

If necessary, your doctor may gradually increase the dose to 1 tablet once daily.

Dividing the tablet:

The tablet can be devided into equal doses.

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.

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. Torahexal can be continuously used for some years or until excess tissue fluid has disappeared.

If you take more Torahexal 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 Torahexal

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 make up for a forgotten dose.

If you stop taking Torahexal

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

Side effects can occur with the following frequencies:

Common, affects 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, affects 1 to 10 per 1,000 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, affects less 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

Reportingof side effects

If you get any side effects talk toyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [the national reporting system; to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. Howto store Torahexal

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and otherinformation

What Torahexal 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 Torahexal looks like and contents of the pack

Torahexal 2.5 mg tablets

Torahexal tablets are round, white to off-white

Torahexal 5 mg tablets

Torahexal tablets are round, white to off-white with break notch.

Torahexal 10 mg/- 20 mg tablets

Torahexal tablets are round, white to off-white with cross break notch.

Pack sizes:

10, 14, 20, 28, 30, 50, 56, 100, 400 (20 x 20) tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in 12 August 2013