Torsemed

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging in a foreign language!
Torsemed ( Torasemid HEXAL 5 mg Tabletten)
5 mg, tablets
Torasemidum
Torsemed and Torasemid HEXAL 5 mg Tabletten are different brand names of the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet:

1. What Torsemed is and what it is used for
2. What you need to know 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 Torsemed is and what it is used for

Torsemed is used to treat:
high blood pressure in adults
oedema (swelling) caused by excessive fluid in the body
Torsemed is a diuretic medicine, which means it increases urine production.

2. Important information before using Torsemed

When not to use Torsemed
in case of hypersensitivity to:

• torasemide or any of the other ingredients of this medicine (listed in section 6)
• similar medicines called "sulfonylurea derivatives", used in the treatment of high blood sugar levels, containing active substances with names ending in "-mid"
• renal failure with insufficient urine production
• severe liver dysfunction accompanied by loss of consciousness
• low arterial blood pressure
• reduced volume of circulating blood
• during breastfeeding
• low potassium or sodium levels in blood
• severe urinary tract disorders, e.g. due to enlarged prostate
• gout
• 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 dysfunction caused by medicines that damage the kidneys.

Warnings and precautions
If any of the situations listed above apply to the patient, discuss them with a doctor before starting treatment with Torsemed:

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

If the patient is continuously taking Torsemed, the treating physician will regularly order blood tests, especially if the patient is also taking other medicines, has diabetes, or has irregular heart rhythm.

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

Torsemed with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

The following medicines may affect the action of Torsemed and vice versa:

• medicines used to treat high blood pressure, particularly those containing active substances with names ending in "-pril"
• medicines that enhance 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)
• some muscle relaxants with names ending in "-curonium" or "-curium"
• all medicines used to treat constipation
• medicines containing cortisone derivatives, such as hydrocortisone, prednisone or prednisolone
• cholestyramine (a medicine used to lower blood lipid levels)
• adrenaline or noradrenaline (medicines used to increase blood pressure or speed up heart rate)
• warfarin, a medicine used to treat blood clots.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Torsemed may be used during pregnancy only if the treating physician considers it absolutely necessary. In such a case, the lowest possible dose should be used.

Breastfeeding
Torsemed must not be used in breastfeeding women, as it may harm the infant.

Driving and operating machinery
Dizziness or drowsiness may occur while taking Torsemed, especially at the beginning of treatment, during dose escalation, when changing medication, starting additional medicines, or consuming alcohol. If concentration is impaired, do not drive or operate machinery.

Torsemed contains monohydrate lactose
This medicine contains the sugar lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Torsemed

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Recommended dose:
Treatment of arterial hypertension
½ tablet once daily
If necessary, the doctor may increase the dose to 1 tablet once daily, but not earlier
than after 2 months of treatment.
Treatment of oedema caused by excess body water
1 tablet once daily
If necessary, the doctor may gradually increase the dose up to 4 tablets (20 mg) once daily.
Tablet splitting
The tablet may be divided into equal doses.

Place the tablet on a hard, flat surface with the score line facing upwards.
Press down with your finger at the centre of the tablet to split it into two halves.
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 cases of marked severity)
Treatment requires caution due to the possibility of increased blood concentration of torasemide.
Method of administration
The tablets should be taken every morning, regardless of meals, without chewing, with
100 ml of water (approximately half a glass).
Duration of treatment
The duration of treatment is determined by the physician. Torsemed may be used continuously for several years
or until oedema (excess fluid in tissues) resolves.
Taking more Torsemed than prescribed
Seek immediate medical advice.
Overdose may cause excessive urine output, drowsiness, confusion, weakness, dizziness, hypotension, circulatory collapse, and gastrointestinal disturbances.
Take any remaining tablets and the medicine packaging with you to assist identification of the ingested drug.
Missed 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 following day. Do not take a double dose to make up for
a missed dose.
Stopping Torsemed treatment
Do not discontinue treatment without consulting your doctor, as this may cause harmful effects
to the patient and reduce treatment effectiveness.
If you have any further questions concerning the use of this medicine, consult
your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects may occur with the following frequency:
Common (may occur in less than 1 in 10 people)
disturbances in body water and electrolyte levels, especially when salt intake is restricted
increased alkalinity in the body
muscle cramps
increased levels of uric acid, blood sugar, and blood lipids
decreased potassium and sodium levels in blood
reduced blood volume
gastrointestinal disturbances such as loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation
increased activity of certain liver enzymes, such as gamma-GT
headaches
dizziness
feeling tired
weakness

Uncommon (may occur in less than 1 in 100 people)
increased levels of urea and creatinine in blood
dryness of the mouth
tingling or numbness in hands and feet
difficulty in passing urine (e.g. due to benign prostatic hyperplasia)

Very rare (may occur in less than 1 in 10,000 people)
narrowing of blood vessels due to blood thickening
lower than normal arterial blood pressure
circulatory disturbances, especially upon standing
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
reduced number of red and white blood cells and platelets
vision disturbances
ringing or noise in the ears
hearing loss

Frequency not known: frequency cannot be estimated from the available data
inadequate blood supply to the brain
disorientation (confusion).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 adverse effects helps to provide more information on the safety of this medicine.

5. How to store Torsemed

Keep this medicine out of 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 stated month.
Do not store above 25 °C.
Translation of some abbreviations on the blister:
Ch.-B./verwendbar bis: siehe Prägung - Batch number/Expiry date: see imprint (on the blister)
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Torsemed contains
Active substance: torasemide. Each tablet contains 5 mg of torasemide.
Other ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate,
corn starch, colloidal anhydrous silicon dioxide.

What Torsemed looks like and contents of the pack
White or almost white, round tablets with a dividing score line.
Packaged in PVC/COC/PVDC/A1 blisters or Al/Al blisters, placed in a cardboard box.
Pack sizes: 30, 60 and 90 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen, Germany

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Germany, the country of export: 58015.01.00
Parallel Import Licence Number: 266/22