Torsemed

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Torsemed (Torasemid HEXAL), 5 mg, tablets

Torasemidum
Torsemed and Torasemid HEXAL are different trade names for the same drug.

Before taking the drug, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

The patient should keep this leaflet so that they can read it again if necessary.
In case of any further doubts, the patient should consult a doctor or pharmacist.
This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Torsemed and what is it used for
• 2. Important information before taking Torsemed
• 3. How to take Torsemed
• 4. Possible side effects
• 5. How to store Torsemed
• 6. Contents of the packaging and other information

1. What is Torsemed and what is it used for

Torsemed is used to treat:
high blood pressure in adults;
swelling caused by excess fluid in the body.
Torsemed is a diuretic, which means it increases urine production.

2. Important information before taking Torsemed

When not to take Torsemed
in case of allergyto:

• -torasemidor any of the other ingredients of this drug (listed in section 6)
• -similar drugs called "sulfonylurea derivatives", used to treat high blood sugar, containing active substances with names ending in "-mid" in case of kidney failure, with insufficient urine production in case of severe liver dysfunction, with loss of consciousness in case of low blood pressurein case of reduced blood volumeduring breastfeedingin case of low potassium or sodium levels in the bloodin case of severe urinary tract disorders, e.g. due to prostate enlargement in case of gout

in case of irregular heart rhythm
in case of taking drugs used to treat infections, such as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin, or tobramycin
in case of kidney function disorderscaused by drugs that damage the kidneys.

Warnings and precautions

If any of the above situations apply to the patient, they should discuss this with their doctor before starting to take Torsemed:
acid-base balance disorders
blood morphology disorders
diabetes
use of lithium, a drug used to treat depression.
If the patient is taking Torsemed continuously, their doctor will regularly order blood tests, especially if the patient is also taking other drugs, has diabetes, or has an irregular heart rhythm.

Children and adolescents

Torsemed should not be used in children and adolescents under 18 years of age.

Torsemed and other drugs

The patient should tell their doctor or pharmacistabout all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
The following drugs may affect the action of Torsemed and vice versa:
drugs used to treat high blood pressure, especially those containing active substances whose names end in "-pril";
drugs that increase the heart's ability to pump blood, such as digitoxin digoxinor methyldigoxin;
drugs used to treat diabetes;
probenecid(a drug used to treat gout);
drugs used to treat inflammation and pain, such as acetylsalicylic acid or indomethacin;
sulfasalazine mesalazineor olsalazine(drugs used to treat chronic inflammatory bowel diseases);

• drugs used to treat infections, such as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin, or tobramycin;
• platinum compounds, such as cisplatin (a drug used to treat cancer);
• lithium(a drug used to treat depression);
• theophylline(a drug used to treat asthma);
• some muscle relaxantswhose names end in "-curonium" or "-curium";
• all laxatives;
• drugs containingcorticosteroid derivatives, such as hydrocortisone, prednisone, or prednisolone;
• cholestyramine(a drug used to reduce blood fat levels);
• adrenalineor noradrenaline(drugs used to increase blood pressure or accelerate heart rate); warfarin, a drug used to treat blood clots.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this drug.

• PregnancyTorsemed can be used during pregnancy only if the doctor considers it absolutely necessary. In such cases, the smallest possible doseshould be used.
• BreastfeedingTorsemed should notbe used in breastfeeding women, as it may harm the baby.

Driving and operating machinery

While taking Torsemed, the patient may experience dizziness or drowsiness, especially at the beginning of treatment, when increasing the dose, changing the drug, starting to take an additional drug, or consuming alcohol. In case of impaired concentration, the patient should not drive vehicles or operate machinery.

Torsemed contains lactose monohydrate

The drug contains the sugar lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this drug.

3. How to take Torsemed

This drug should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Torsemed is available in the following doses: 5 mg, 10 mg, and 20 mg.
The recommended doseis:

• ½ tablet once a dayIf necessary, the doctor may increase the dose to 1 tablet once a day, but not earlier than 2 months after the start of treatment.

Treatment of swelling caused by excess fluid in the body

• 1 tablet once a dayIf necessary, the doctor may gradually increase the dose to 4 tablets (20 mg) once a day.

Dividing the tablet

The tablet can be divided into equal doses.

Place the tablet on a hard, flat surface, with the dividing groove facing up.
Press the finger on the center of the tablet and divide it into halves.

Use in children and adolescents

Due to insufficient experience with the use of torasemid in children and adolescents, Torsemed should not be used in patients under 18 years of age.

Liver function disorders (except in severe cases)

Treatment requires caution due to the possibility of increased torasemid levels in the blood.

Method of administration

Tablets should be taken every morning, regardless of meals, without chewing, with 100 ml of water (about half a glass).

Duration of treatment

The duration of treatment is determined by the doctor. Torsemed can be used continuously for several years or until the swelling (excess fluid in the tissues) subsides.

Taking a higher dose of Torsemed than recommended

The patient should immediately contact their doctor.
Overdose may cause excessive urine production, drowsiness, confusion, weakness, dizziness, low blood pressure, circulatory collapse, or stomach upset.
The patient should take the remaining tablets and the packaging of the drug with them to facilitate identification of the taken drug.

Missing a dose of Torsemed

The patient should take the missed dose as soon as possible on the same day or take the next dose at the usual time the next day. The patient should not take a double dose to make up for the missed dose.

Stopping Torsemed treatment

The patient should not stop taking Torsemed without their doctor's consent, as this may cause harmful effects and reduce the effectiveness of the treatment.
In case of any further doubts about the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Torsemed can cause side effects, although not everybody gets them.

Side effects may occur with the following frequency:

Common(may occur in less than 1 in 10 people)

• disorders of water and mineral balance in the body, especially with limited salt intake;
• increased alkalinity in the body;
• muscle cramps;
• increased levels of uric acid, sugar, and fats in the blood;
• decreased levels of potassium and sodium in the blood;
• decreased blood volume;
• gastrointestinal disorders, such as loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation;
• increased activity of certain liver enzymes, such as gamma-GT;
• headaches;
• dizziness;
• feeling of fatigue;
• weakness. Uncommon(may occur in less than 1 in 100 people)
• increased levels of urea and creatinine in the blood;
• dryness in the mouth;
• feeling of tingling or numbness in the hands and feet;
• difficulty urinating (e.g., due to prostate enlargement).

Rare(may occur in less than 1 in 10,000 people)

• narrowing of blood vessels due to blood thickening;
• lower than normal blood pressure;
• circulatory disorders, especially when standing up;
• irregular heart rhythm;
• angina pectoris - a condition in which severe chest pain often occurs;
• heart attack;
• fainting;
• pancreatitis;
• allergic reactions with itching and rash;
• increased sensitivity of the skin to light;
• severe skin reactions;
• decreased number of red and white blood cells and platelets;
• vision disorders;
• ringing or buzzing in the ears;
• hearing loss.

Frequency not known:the frequency cannot be determined from the available data

• insufficient blood flow to the brain
• disorientation (confusion).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the drug.

5. How to store Torsemed

• The drug should be stored in a place that is out of sight and reach of children.
• The drug should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

Translation of some abbreviations on the blister pack:

Ch.-B./verwendbar bis: see embossing -
Batch number/Expiry date: see embossing (on the blister pack)

• The drug should not be stored at a temperature above 25°C.
• Drugs should not be thrown away into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Torsemed contains

• The active substance of Torsemed is torasemid. Each tablet contains 5 mg of torasemid.
• Other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, corn starch, anhydrous colloidal silica.

What Torsemed looks like and what the packaging contains

White or almost white, round tablets with a dividing groove.
Packaging sizes: 30, 60, and 90 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer:

Marketing authorization holder in Germany, the country of export:

Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

Manufacturer:

Lek S.A.
ul. Podlipie 16
95-010 Stryków
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 58015.01.00

Parallel import authorization number: 294/15

Date of leaflet approval: 28.05.2025

[Information about the trademark]