Torsemed

Package Leaflet: Information for the Patient

Torsemed, 5 mg, Tablets

Torasemidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any further questions, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Torsemed and what is it 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 is Torsemed and what is it used for

Torsemed is used to treat:
high blood pressure in adults
swelling caused by excess fluid in the body
Torsemed is a diuretic, which means it increases urine production.

2. Important information before taking Torsemed

When not to take Torsemed

In case of allergyto:

• - torasemideor any other ingredient of this medicine (listed in section 6)
• -similar medicines called "sulfonylurea derivatives", used to treat high blood sugar, containing active substances with names ending in "-mid" in case of kidney failurewith insufficient urine production in case of severe liver dysfunctionwith loss of consciousness in case of low blood pressurein case of reduced blood volumeduring breastfeedingin case of low potassium or sodium levels in the bloodin case of severe urinary tract disorders, e.g. due to prostate enlargement in case of goutin case of irregular heart rhythmwhen taking antibiotics, such as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin or tobramycin in case of kidney dysfunctioncaused by medicines that damage the kidneys.

Warnings and precautions

If any of the above situations apply to you, discuss them with your doctor before taking Torsemed:
acid-base balance disorders
blood morphology disorders
diabetes
lithium use, a medicine used to treat depression.
If you are taking Torsemed continuously, your doctor will regularly order blood tests, especially if you are taking other medicines, have diabetes or irregular heart rhythm.

Children and adolescents

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

Torsemed and other medicines

Tell your doctor or pharmacistabout all medicines you are taking, have recently taken, or plan to take.
The following medicines may affect Torsemed and vice versa:
medicines used to treat high blood pressure, especially those containing active substances with names ending in "-pril"
medicines that increase 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, mesalazineor olsalazine(medicines used to treat chronic inflammatory bowel diseases)
medicines used to treat infections, such as cefixime, cefuroxime, cefaclor, cefalexin, 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 relaxantswith names ending in "-curonium" or "-curium"
all laxatives
medicines containingcorticosteroids, such as hydrocortisone, prednisone or prednisolone
cholestyramine(a medicine used to reduce blood fat levels)
adrenalineor noradrenaline(medicines used to increase blood pressure or heart rate)
warfarin, a medicine used to treat blood clots.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Torsemed can be used during pregnancy only if your doctor considers it absolutely necessary.
In this case, use the lowest possible dose.

Breastfeeding

Torsemed must not be usedin breastfeeding women, as it may harm the baby.

Driving and using machines

While taking Torsemed, dizziness or drowsiness may occur, especially at the beginning of treatment, when increasing the dose, changing the medicine, starting to take an additional medicine, or consuming alcohol. Do not drive or operate machinery if your concentration is impaired.

Torsemed contains lactose

The medicine contains the sugar lactose. If you have been diagnosed with intolerance to some sugars,
consult your doctor before taking this medicine.

3. How to take Torsemed

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended doseis:
Treatment of high blood pressure
½ tablet once a day
If necessary, your doctor may increase the dose to 1 tablet once a day, but not earlier than 2 months after starting treatment.
Treatment of swelling caused by excess fluid in the body

1 tablet once a day

If necessary, your doctor may gradually increase the dose to 4 tablets (20 mg) once a day.

Dividing the tablet

The tablet can be divided into equal doses.
Place the tablet on a hard, flat surface with the dividing line facing up.
Press your finger on the center of the tablet and divide it into halves.

Use in children and adolescents

Due to insufficient experience with torasemide in children and adolescents, Torsemed is not recommended for patients under 18 years of age.

Liver dysfunction (except in severe cases)

Treatment requires caution due to the possibility of increased torasemide levels in the blood.

Method of administration

Tablets should be taken every morning, regardless of meals, without chewing, with 100 ml of water (about half a glass).

Duration of treatment

The duration of treatment is determined by your doctor. Torsemed can be used continuously for several years or until swelling (excess fluid in the tissues) subsides.

Taking more than the recommended dose of Torsemed

Consult your doctor immediately.
Overdose may cause excessive urine production, drowsiness, confusion, weakness, dizziness, low blood pressure, circulatory collapse, stomach upset.
Take the remaining tablets and the packaging with you to help identify the medicine taken.

Missing a 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 next day. Do not take a double dose to make up for the missed dose.

Stopping Torsemed treatment

Do not stop taking Torsemed without consulting your doctor, as this may cause harmful effects and reduce the effectiveness of treatment.
In case of any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Torsemed can cause side effects, although not everybody gets them.

Side effects may occur with the following frequency:

Common(may affect up to 1 in 10 people)
disorders of water and mineral balance in the body, especially with restricted salt intake
increased alkalinity in the body
muscle cramps
increased levels of uric acid, sugar and fat in the blood
decreased levels of potassium and sodium in the blood
decreased blood volume
gastrointestinal disorders, such as loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation
increased activity of certain liver enzymes, such as gamma-GT
headaches
dizziness
feeling of tiredness
weakness
Uncommon(may affect up to 1 in 100 people)
increased levels of urea and creatinine in the blood
dry mouth
tingling or numbness in hands and feet
difficulty urinating (e.g. due to prostate enlargement)
Rare(may affect up to 1 in 10,000 people)
blood vessel constriction due to blood thickening
lower than normal blood pressure
circulatory disorders, especially when standing up
irregular heart rhythm
angina pectoris - a condition characterized by severe chest pain
heart attack
fainting
pancreatitis
allergic reactions with itching and rash
increased skin sensitivity to light
severe skin reactions
decreased red and white blood cell and platelet count
vision disorders
ringing or buzzing in the ears
hearing loss
Frequency not known: frequency cannot be estimated from the available data
insufficient blood flow to the brain
disorientation (confusion).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 blister and carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 25 ° C.
Medicines should 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 of Torsemed 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 dividing line.
Pack sizes: 30, 60 and 90 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek S.A.
ul. Podlipie 16
95-010 Stryków
LEK Pharmaceuticals d.d
Trimlini 2D
9220 Lendava
Slovenia