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), 20 mg, tablets

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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine 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 pack and other information

1. What is Torsemed and what is it used for

Torsemed is used to treat:

• -edema 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:
• torasemideor any of the other ingredients of this medicine (listed in section 6)
• similar medicines called "sulfonylurea derivatives" used to treat high blood sugar, containing active substances with names ending in "-mid"
• in case of renal failurewith insufficient urine production
• in case of severe liver dysfunctionwith loss of consciousness
• in case of low blood pressure
• in case of reduced blood volume
• during breastfeeding
• in case of low potassium or sodium levels in the blood
• in 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 medicines 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 medicines that can 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 medicine used to treat depression

If the patient is taking Torsemed continuously, their doctor will regularly prescribe blood tests, especially if the patient is also taking other medicines, 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 medicines

The patient should tell their doctor or pharmacistabout all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The following medicines may affect the action of Torsemed and vice versa:

• medicines used to treat high blood pressure, especially those containing active substances with names ending in "-pril"
• medicines that increase the heart's ability to pump blood, such as digitoxin, digoxin, or methyldigoxin
• medicines used to treat diabetes
• probenecid(a medicine used to treat gout)
• medicines used to treat inflammation and pain, such as acetylsalicylic acid or indomethacin
• sulfasalazine, mesalazine, or olsalazine(medicines used to treat chronic inflammatory bowel diseases)
• medicines 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 medicine used to treat cancer)
• lithium(a medicine used to treat depression)
• theophylline(a medicine used to treat asthma)
• certain muscle relaxantswith names ending in "-curonium" or "-curium"
• all laxatives
• medicines containingcorticosteroids, such as hydrocortisone, prednisone, or prednisolone
• cholestyramine(a medicine used to reduce blood fat levels)
• adrenalineor noradrenaline(medicines used to increase blood pressure or accelerate heart rate)
• warfarin, a medicine 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 medicine.

Pregnancy

Torsemed can be used during pregnancy only if the doctor considers it absolutely necessary. In this case, the lowest possible doseshould be used.

Breastfeeding

Torsemed should not be usedin breastfeeding women, as it may harm the baby.

Driving and using machines

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

Torsemed contains lactose monohydrate

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

3. How to take Torsemed

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended doseis:

• -1/4 tablet (5 mg) once a day. If necessary, the doctor may gradually increase the dose to 1 tablet (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 four equal parts.
.

Use in children and adolescents

Due to insufficient experience with the use of torasemide 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 torasemide levels in the blood.

Method of administration

The tablets should be taken once a day in the 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 edema (excess fluid in the tissues) subsides.

Taking a higher dose of Torsemed than recommended

The patient should contact their doctor immediately.
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 medicine to facilitate identification of the taken medicine.

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 medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Side effects may occur with the following frequency:

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

• disorders of water and mineral balance in the body, especially with restricted 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

Infrequent(may occur in less than 1 in 100 people)

• increased levels of urea and creatinine in the blood
• dry mouth
• tingling or numbness in the hands and feet
• difficulty urinating (e.g. due to prostate enlargement) Very rare(may occur in less than 1 in 10,000 people)
• vasoconstriction due to blood thickening
• lower than normal blood pressure
• circulatory disorders, especially when standing up
• irregular heart rhythm
• angina pectoris - a condition characterized by frequent severe chest pain
• myocardial infarction
• fainting
• pancreatitis
• allergic reactions with itching and rash
• increased skin sensitivity 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: frequency cannot be estimated 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 this 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 collected on the safety of the medicine.

5. How to store Torsemed

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

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 medicine should not be stored at a temperature above 25°C.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Torsemed contains

• The active substanceof the medicine is torasemide. Each tablet contains 20 mg of torasemide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, corn starch, colloidal anhydrous silica.

What Torsemed looks like and what the pack contains

White or almost white, round tablets with a cross-breaking dividing groove.
Pack 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: 58015.02.00

Parallel import authorization number: 296/15

Date of leaflet approval: 28.05.2025

[Information about the trademark]