Torsemed

Package Leaflet: Information for the Patient

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

Torsemed (Torasemid Hexal 10 mg Tablets)

10 mg, tablets

Torasemidum
Torsemed and Torasemid Hexal 10 mg Tablets are different trade names for the same medicine.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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

• hypersensitivityto:
• 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"
• renal failurewith inadequate urine production
• severe liver dysfunctionwith 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 an enlarged prostate
• 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
• renal dysfunctioncaused by medicines that damage the kidneys.

Warnings and precautions

If any of the following situations apply to you, discuss them with your doctor before starting Torsemed:

• acid-base balance disorders
• blood morphology disorders
• diabetes
• lithium use, a medicine used to treat depression.

If you are taking Torsemed continuously, your doctor will regularly order blood tests, especially if you are taking other medicines, have diabetes, or have an irregular heart rhythm.

Children and adolescents

Torsemed is not recommended for children and adolescents under 18 years of age.

Torsemed and other medicines

Tell your doctor or pharmacistabout all medicines you are taking, have recently taken, or plan to take.
The following medicines may affect 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 you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

While taking Torsemed, you may experience dizziness or drowsiness, especially at the beginning of treatment, when increasing the dose, changing the medicine, starting to take an additional medicine, or consuming alcohol. Do not drive or operate machinery if your concentration is impaired.

Torsemed contains lactose monohydrate

The medicine contains sugar lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Torsemed

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Recommended doseis:
Treatment of edema caused by excess fluid in the body

• ½ tablet (5 mg) once a day. If necessary, your doctor may gradually increase the dose to 2 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 line facing up.
Press one finger on the left and another on the right side of one of the dividing lines and divide the tablet into halves.

Use in children and adolescents

Due to insufficient experience with torasemide in children and adolescents, Torsemed is not recommended for patients under 18 years of age.

Liver dysfunction (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 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 your doctor. Torsemed may be used continuously for several years or until the edema (excess fluid in the tissues) subsides.

Taking a higher dose of Torsemed than recommended

Contact your doctor immediately.
Overdose may cause excessive urine production, drowsiness, confusion, weakness, dizziness, low blood pressure, circulatory collapse, or stomach upset.
Take the remaining tablets and the packaging of the medicine with you to facilitate identification of the taken medicine.

Missing a dose of Torsemed

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

Stopping Torsemed treatment

Do not stop taking Torsemed without your doctor's consent, as this may cause harmful effects and reduce the effectiveness of treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

pacjenta i zmniejszyć skuteczność leczenia.
W razie jakichkolwiek dalszych wątpliwości związanych ze stosowaniem tego leku, należy zwrócić się
do lekarza lub farmaceuty.

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
• 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).

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 in which severe chest pain often occurs
• myocardial infarction
• syncope
• pancreatitis
• allergic reactions with itching and rash
• increased skin sensitivity to light
• severe skin reactions
• decreased red and white blood cell and platelet count
• vision disorders
• ringing or buzzing in the ears
• hearing loss.

Frequency not known(frequency cannot be estimated from available data)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Torsemed

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine 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

• Do not store above 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Torsemed contains

• The active substanceis torasemide. Each tablet contains 10 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 cross-breaking dividing line.
Pack sizes: 30, 60, and 90 tablets.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Germany, the country of export:58015.02.00

Parallel import authorization number: 394/24

Date of leaflet approval: 14.11.2024

[Information about the trademark]