Torahexal tablet ENG

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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 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 Torahexal is and what it is used for
2. Before you take Torahexal
3. How to take Torahexal
4. Possible side effects
5. How to store Torahexal
6. Further information
1. WHAT TORAHEXAL IS AND WHAT IT IS USED FOR
Torahexal 2,5 mg/ - 5mg is used to treat:
 high blood pressure
Torahexal 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 TORAHEXAL
Do not take Torahexal 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 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 Torahexal
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




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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 only prescribe Torasemide when absolutely necessary.
Taking Torahexal with food and drink
Do not take these tablets together with alcohol.
The use of Torahexal 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 Torahexal
 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
 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
 Breastfeeding
Torahexal is not recommended for women who are breastfeeding as it may harm the baby.

Pregnancy
Only take Torahexal 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 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.
Important information about some of the incredients of Torahexal
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 TORAHEXAL
Always take Torahexal exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Torahexal 2,5 mg tablets
 1 tablet once daily
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
 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:
 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.
Torahexal 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.
Torahexal 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. 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 compensate the 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Torahexal 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 TORAHEXAL
Keep out of the reach and sight of children.
Do not use Torahexal 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 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.
 The other ingredients are:
microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, colloidal
anhydrous silica
What Torahexal looks like and contents on 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
<[for Sweden only]>
Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany
Tel: +49 8024 908 0
Fax: +49 8024 908 1277
Sandoz A/S
C.F. Tietgens Boulevard 40
5220 Odense SØ
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 30 November 2011.
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