Torasemide

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Torsemed (Torasemid HEXAL 10 mg Tabletten)
10 mg, tablets
Torasemidum
Torsemed and Torasemid HEXAL 10 mg Tabletten are different trade names for 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.
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 in the treatment of:
oedema (swelling) caused by excessive fluid accumulation in the body.
Torsemed is a diuretic medicine, i.e. a medicine that increases urine output.

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 "sulfonamide derivatives", used in the treatment of high blood sugar levels, containing active substances with names ending in "-mid"
  in case of kidney failure with insufficient urine production
  in case of severe liver dysfunction accompanied by loss of consciousness
  in case of low arterial blood pressure
  in case of reduced circulating blood volume
  during breastfeeding
  in case of low blood potassium or sodium levels
  in case of severe urinary tract disorders, e.g. due to enlarged prostate
  in case of gout
  in case of irregular heart function

in case of taking medicines used to treat infections, such as cefixime,
cefuroxime, cefaclor, cephalexin, 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 above situations 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 taking other medicines simultaneously, has diabetes or suffers from irregular heart function.

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

Torsemed and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

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 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, cephalexin, 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 reduce blood lipid levels)
adrenaline or 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, 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 women who are breastfeeding, as it may harm the infant.

Driving and operating machinery
Dizziness or drowsiness may occur during treatment with Torsemed, especially at the beginning of treatment, when increasing the dose, changing medication, starting additional medication, 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 as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Recommended dose:
Treatment of oedema caused by excess fluid in the body
½ tablet (5 mg) once daily
If necessary, the doctor may gradually increase the dose up to 2 tablets (20 mg) once daily.
Dividing the tablet
The tablet may be divided into equal doses.

Place the tablet on a hard, flat surface with the dividing groove facing upwards.
Press with one finger on the left and another on the right side of one of the grooves and
divide the tablet into 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 significant severity)
Treatment requires caution due to the possibility of increased blood concentration of torasemide.
Method of administration
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 doctor. Torsemed may be used continuously for several years or until oedema (fluid accumulation in tissues) resolves.
Taking more Torsemed than recommended
Seek immediate medical advice.
Overdose may cause excessive urination, drowsiness, confusion, weakness, dizziness, hypotension, circulatory collapse, and gastrointestinal disturbances.
Take any remaining tablets and the medicine packaging with you to facilitate identification of the medicine taken.
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 for the patient and reduce the effectiveness of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Uncommon (may occur in less than 1 in 100 people)
increased levels of urea and creatinine in the blood
dryness of the mouth
tingling or numbness of 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, particularly upon standing
irregular heart rhythm
angina pectoris – a condition often characterized by severe chest pain
myocardial infarction
fainting
pancreatitis
allergic reactions with itching and rash
increased skin sensitivity to light
severe skin reactions
reduction in the number of red and white blood cells and platelets
visual disturbances
ringing or buzzing in the ears
hearing loss

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21301, fax: +48 22 49 21309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of this medicine can be collected.

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 appearing on the blister:
Ch.-B./verwendbar bis: siehe Prägung - Batch number/Expiry date: see imprint (on the blister).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Torsemed contains
The active substance in this medicinal product is torasemide. Each tablet contains 10 mg of torasemide.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate,
corn starch, colloidal anhydrous silica.

What Torsemed looks like and contents of the pack
White or almost white, round tablets with a cross-scored break line.
Packs: PVC/COC/PVDC/Al or Al/Al blisters in a cardboard box.
Pack sizes: 30, 60 and 90 tablets.
For more detailed information, please contact the responsible marketing authorisation holder or the parallel importer.

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

Manufacturer:
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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
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, country of export: 58015.02.00
Parallel Import Authorisation Number: 253/22