Torsemed

Package Leaflet: Information for the Patient

Torsemed, 20 mg, Tablets

Torasemidum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

Keep this package leaflet, you may need to read it again.
In case of any further questions, consult a doctor or pharmacist.
This medication has been prescribed for a specific person. Do not pass it on to others.
The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this package leaflet, inform a doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 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. Package Contents and Other Information

1. What is Torsemed and What is it Used For

Torsemed is used to treat:
edema caused by excess water 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 other component of this medication (listed in section 6)
• -similar medications 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 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 goutin case of irregular heart rhythmwhen taking antibioticssuch as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin, or tobramycin in case of kidney function disorderscaused by medications that damage the kidneys.

Warnings and Precautions

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

Children and Adolescents

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

Torsemed and Other Medications

Inform a doctor or pharmacistabout all medications the patient is currently taking or plans to take.
The following medications may affect Torsemed's action and vice versa:
medications used to treat high blood pressure, especially those containing active substances with names ending in "-pril"
medications that increase the heart's ability to pump blood, such as digitoxin, digoxin, or methyldigoxin
medications used to treat diabetes
probenecid(a medication used to treat gout)
medications used to treat inflammation and pain, such as acetylsalicylic acid or indomethacin
sulfasalazine, mesalazine, or olsalazine(medications used to treat chronic inflammatory bowel diseases)
medications 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 medication used to treat cancer)
lithium(a medication used to treat depression)
theophylline(a medication used to treat asthma)
certain muscle relaxantswith names ending in "-curonium" or "-curium"
all medications used to treat constipation
medications containingcorticosteroid derivatives, such as hydrocortisone, prednisone, or prednisolone
cholestyramine(a medication used to reduce blood fat levels)
adrenalineor noradrenaline(medications used to increase blood pressure or accelerate heart rate)
warfarin, a medication used to treat blood clots.

Pregnancy and Breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medication.

Pregnancy

Torsemed can be used during pregnancy only if the attending physician considers it absolutely necessary. In such cases, the smallest possible doseshould be used.

Breastfeeding

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

Driving and Operating Machines

During Torsemed treatment, dizziness or drowsiness may occur, especially at the beginning of treatment, when increasing the dose, changing the medication, starting to take additional medication, or consuming alcohol. In case of impaired concentration, do not drive vehicles or operate machines.

Torsemed Contains Lactose

The medication contains the sugar lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medication.

3. How to Take Torsemed

Always take this medication as directed by a doctor. In case of doubts, consult a doctor or pharmacist.
The recommended doseis:
Treatment of edema caused by excess water in the body
¼ 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 line 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 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 a doctor. Torsemed can be used continuously for several years or until the edema (excess fluid in the tissues) subsides.

Taking a Higher Than Recommended Dose of Torsemed

Immediately consult a doctor.
Overdose may cause excessive urine production, drowsiness, confusion, weakness, dizziness, low blood pressure, circulatory collapse, or gastrointestinal disorders.
Bring the remaining tablets and the medication packaging to help identify the medication taken.

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 the medication without a doctor's consent, as it may cause harmful effects and reduce treatment effectiveness.
In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 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, or constipation
increased activity of certain liver enzymes, such as gamma-GT
headaches
dizziness
fatigue
weakness
Uncommon(may occur in less than 1 in 100 people)
increased levels of urea and creatinine in the blood
dry mouth
tingling or numbness in 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 characterized by severe chest pain
myocardial infarction
fainting
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 any side effects occur, including those not listed in this package leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Torsemed

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after "EXP". The expiration date refers to the last day of the month.
Do not store above 25°C.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Torsemed Contains

The active substanceof the medication is torasemide. Each tablet contains 20 mg of torasemide.
Other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, cornstarch, colloidal anhydrous silica.

What Torsemed Looks Like and Package Contents

White or almost white, round tablets with a dividing line.
Package sizes: 30, 60, and 90 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek S.A.
ul. Podlipie 16
95-010 Stryków
LEK Pharmaceuticals d.d
Trimlini 2D
9220 Lendava
Slovenia

For More Detailed Information on the Medication and its Names in European Economic Area Member States, Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Package Leaflet:12/2024
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