Torasemide

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Torsemed (Torasemid - 1 A Pharma)
5 mg, tablets
Torasemidum
Torsemed and Torasemid - 1 A Pharma are different trade names for the same medicine.
Please read carefully the entire leaflet 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 to treat:

• high blood pressure in adults
• 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 rhythm
• 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 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 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 irregular heart rhythm.

Children and adolescents
Use of Torsemed is not recommended 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, has recently taken, or plans 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 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 during treatment with Torsemed, especially at the beginning of treatment, when increasing the dose, changing medication, starting an additional medicine, or when consuming alcohol simultaneously. If concentration is impaired, the patient should not drive or operate machinery.

Torsemed contains monohydrate lactose
This medicine contains a 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 according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
Recommended dose:
Treatment of high blood pressure

• 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 fluid in the body

• 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 can be divided into equal doses.

Place the tablet on a hard, flat surface with the dividing line facing upwards.
Press with your finger in the middle 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 severe impairment)
Treatment requires caution due to the possibility of increased torasemide blood concentration.
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 doctor. 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 urine production, 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 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 treatment with Torsemed
Do not stop taking the 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 all medicines, this medicine can cause adverse reactions, although not everyone 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 mineral balance, especially with restricted salt intake
• increased alkalinity in the body
• muscle cramps
• increased levels of uric acid, sugar, and fats in the blood
• decreased levels of potassium and sodium 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 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 sensitivity of the skin 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 adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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 adverse reactions helps to provide more information on the safety of the 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.

Translation of some information on the immediate packaging:
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 required. These measures help protect the environment.

6. Contents of the packaging and other information

What Torsemed contains

• The active substance is torasemide. Each tablet contains 5 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 score line.
Pack sizes: 30, 60 or 90 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party 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
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorisation number in Germany, the country of export: 58031.01.00
Parallel import authorisation number: 157/20