Torsemed

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Torsemed(Torasemid - 1 A Pharma)

5 mg, tablets

Torasemidum
Torsemed and Torasemid - 1 A Pharma are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further doubts, you should consult a doctor or pharmacist.
• 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 tell their doctor or pharmacist. 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:

• 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

• 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"
• kidney failurewith inadequate urine production
• severe liver dysfunction, with loss of consciousness
• low blood pressure
• reduced blood volume
• breastfeeding
• low potassium or sodium levels in the blood
• severe urinary tract disorders, such as due to prostate enlargement
• gout
• irregular heart rhythm
• taking medicines used to treat infections, such as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin or tobramycin
• kidney function disorderscaused by medicines that damage the kidneys.

Warnings and precautions

If any of the following 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
• lithium use, a medicine 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 medicines, has diabetes or an irregular heart rhythm.

Children and adolescents

Torsemed is not recommended for 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, have recently taken, or 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, digoxinor 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, mesalazineor 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.

• PregnancyTorsemed should only be used during pregnancy 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. If concentration is impaired, the patient should not drive vehicles or operate machines.

Torsemed contains lactose monohydrate

The medicine contains sugar - lactose monohydrate. If the patient has previously 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. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose:

Treatment of high blood pressure

• ½ tablet once a dayIf necessary, the doctor may increase the dose to 1 tablet once a day, but not earlier than after 2 months 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 center of the tablet with your finger and divide it into two equal parts.

Use in children and adolescents

Due to insufficient experience with the use of torasemide in children and adolescents, Torsemed is not recommended for 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

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

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 the medicine without their doctor's consent, as this may cause harmful effects and reduce the effectiveness of the treatment.
If the patient has any further doubts about taking this medicine, they 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:

Common(may affect up to 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

Uncommon(may affect up to 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)

Rare(may affect up to 1 in 10,000 people)

• constriction 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: 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 the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information 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 information on the immediate packaging:
Ch.-B. verwendbar bis siehe Prägung– Batch number/Expiry date: see imprint.

• The medicine should not be stored 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 substance of the medicine is torasemide. Each tablet contains 5 mg of torasemide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica.

What Torsemed looks like and contents of the pack

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

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:58031.01.00
Parallel import authorization number:157/20

Date of leaflet approval: 26.05.2025

[Information about the trademark]