Torasemide

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Torsemed (Torasemid - 1 A Pharma)
20 mg, tablets
Torasemidum
Torsemed and Torasemid - 1 A Pharma are different trade names of the same medicinal product.
Please read carefully the information contained in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. 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 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 renal failure with insufficient urine production
• in case of severe liver dysfunction associated with 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 rhythm
• in case of concomitant use of drugs used to treat infections, such as cefixime, cefuroxime, cefaclor, cephalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin or tobramycin
• in case of drug-induced kidney dysfunction caused by medicines that damage the kidneys.

Warnings and precautions
If any of the situations listed below 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 in the treatment of depression.

If the patient is taking Torsemed continuously, the treating physician will regularly order blood tests, especially if the patient is also taking other medicines, has diabetes or an 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 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 "-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
• corticosteroid-containing medicines, 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 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, during dose escalation, when switching medications, starting an additional medicine, 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. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Treatment of oedema caused by excess body water

• / one tablet (5 mg) once daily. If necessary, the physician may gradually increase the dose up to 1 tablet (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 score line facing upwards. Press with a finger in the centre of the tablet and divide it into four equal parts.
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 physician. Torsemed may be used continuously for several years or until oedema (excess fluid in tissues) resolves.
Taking more than the recommended dose of Torsemed
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 ingested medicine.
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 treatment effectiveness.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side 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
• headaches
• dizziness
• feeling tired
• 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 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 blood pressure
• circulatory disturbances, particularly upon standing
• irregular heart function
• 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
• 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 the available data

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps 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 month indicated.
• Do not store above 25°C.
• Translation of some information on the immediate packaging: Ch.-B. / verwendbar bis : siehe Prägung – Batch number/Expiry date: see embossing.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are: 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 mark.
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:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Germany, the country of export: 58031.03.00
Parallel Import Licence Number: 160/20