Torsemed

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Torsemed (Torasemid Hexal 10 mg Tabletten)
10 mg, tablets
Torasemidum
Torsemed and Torasemid Hexal 10 mg Tabletten are different brand names for the same medicine.
Please read this leaflet carefully before using 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. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Torsemed is and what it is 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 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, i.e. a medicine that 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 "sulfonamide derivatives", used in the treatment of high blood sugar levels, containing active substances with names ending in "-mid"
• in case of renal 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 potassium or sodium levels in the blood
• in case of severe urinary tract disorders, e.g. due to enlarged prostate gland
• in case of gout
• in case of irregular heart function
• in case of taking medications 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 situations listed above apply to the patient, discuss them with a doctor before starting treatment with Torsemed:

• acid-base balance disorders
• blood morphology disorders
• diabetes
• use of lithium, a medicine used in the treatment of 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 irregular heart function.
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 the patient is currently taking or has recently taken, as well as any medicines the patient intends 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 "-pryl"
• 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)
• certain 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 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 during treatment with Torsemed, especially at the beginning of treatment, when increasing the dose, changing medication, starting additional medicines, or consuming alcohol simultaneously. 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 a
physician or pharmacist.
Recommended dose:
Treatment of edema caused by excess fluid in the body

• ½ tablet (5 mg) once daily. If necessary, the physician may gradually increase the dose up to 2 tablets (20 mg) once daily.

Tablet splitting
The tablet can 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 side and another finger on the right side of one of the grooves and
split the tablet into halves.
Use in children and adolescents
Due to insufficient experience with the use of torasemide in children and adolescents,
the use of Torsemed is not recommended in patients under 18 years of age.
Liver function disorders (except in cases of significant severity)
Treatment requires caution due to the possibility of increased torasemide blood concentration.
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 physician. Torsemed may be used continuously for several years or until resolution of edema (excess fluid in tissues).
Accidental overdose of Torsemed
Seek immediate medical advice from a physician.
Overdose may cause excessive urine production, drowsiness, confusion, weakness, dizziness, hypotension, circulatory collapse, and gastrointestinal disturbances.
Bring any remaining tablets and the medicine packaging to assist in identifying 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 the medicine without the physician's consent, as this may cause harmful effects for the patient and reduce treatment effectiveness.
In case of any further doubts regarding the use of this medicine, consult a physician 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 affect less than 1 in 10 people)

• disturbances in body fluid and mineral balance, 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 tired
• weakness.

Uncommon (may affect 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 affect 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 function
• angina pectoris – a condition often characterised by severe chest pain
• myocardial infarction
• fainting
• pancreatitis
• allergic reactions with itching and rash
• increased skin sensitivity to light
• severe skin reactions
• decreased number of red blood cells, 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)

• insufficient 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 of Monitoring of 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
Adverse effects may also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse effects helps to provide 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 stated month.
• Translation of some abbreviations appearing on the blister: Ch.-B./verwendbar bis: siehe Prägung - Batch number/Expiry date: see embossing
• Do not store above 25°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Torsemed contains

• The active substance is torasemide. Each tablet contains 10 mg of torasemide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, and colloidal anhydrous silica.

What Torsemed looks like and contents of the pack
White or almost white, round tablets with a cross-score dividing them.
Pack sizes: 30, 60, and 90 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

Synoptis Industrial Sp. z o.o.
Forteczna 35-37
87-100 Toruń
Poland

Shiraz Productions Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing authorisation number in Germany, the country of export: 58015.02.00
Parallel import authorisation number: 394/24