Torasemide

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Torsemed (Torasemid HEXAL), 20 mg, tablets
Torasemidum
Torsemed and Torasemid HEXAL are different trade 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. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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:

• oedema (swelling) caused by excess fluid in the body. Torsemed is a diuretic (water tablet), which 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 associated 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 gland
• in case of gout
• in case of irregular heart rhythm
• in case of taking antibiotics such as cefixime, cefuroxime, cefaclor, cephalexin, cefadroxil, proxetil of cefpodoxime, 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 to treat depression

If the patient is continuously taking Torsemed, the treating doctor will regularly order blood tests, especially if the patient is also taking other medicines, has diabetes or an irregular heartbeat.
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 intends to take.
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 "-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, proxetil of cefpodoxime, 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 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 doctor considers it absolutely necessary.
In such cases, 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 monohydrate 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

• ¼ tablet (5 mg) once daily. If necessary, the doctor may gradually increase the dose up to 1 tablet (20 mg) once daily.

Tablet division
The tablet can be divided into equal doses.

Place the tablet on a hard, flat surface with the dividing groove facing upwards.
Press with a finger in the centre of the tablet to divide it into four equal parts.
.
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 marked 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 resolution of oedema (excess fluid in tissues).
Accidental overdose of Torsemed
Seek immediate medical advice.
Overdose may cause excessive urination, drowsiness, confusion, weakness, dizziness, hypotension, circulatory collapse, and gastrointestinal disturbances.
Take with you any remaining tablets and the medicine packaging to facilitate 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.
Discontinuation of Torsemed
Do not stop taking this medicine 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions may occur with the following frequency:
Common (may occur in less than 1 in 10 people)

• disturbances in body water and electrolyte levels, especially with restricted salt intake
• increased alkalinity in the body
• muscle cramps
• increased levels of uric acid, glucose and fats in the blood
• 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 tiredness
• 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 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 sensitivity of the skin to light
• severe skin reactions
• decreased 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 the available data

• insufficient blood supply to the brain
• disorientation (confusion)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows further information on the safety of the medicine to 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 month indicated.

Translation of some abbreviations appearing on the blister:
Ch.-B./verwendbar bis: siehe Prägung - Expiry date: see imprint (on the blister)

• 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 you no longer 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 20 mg of torasemide.
• Other ingredients: 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-scored groove.
Pack sizes: 30, 60 and 90 tablets.

For more detailed information, please contact the responsible party or 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:
Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

German Marketing Authorisation Number (country of export): 58015.02.00
Parallel Import Authorisation Number: 296/15