Ebozan

Leaflet attached to the packaging: patient information

Ebozan, 2.5 mg, tablets

Ebozan, 5 mg, tablets

Ebozan, 10 mg, tablets

Ebozan, 20 mg, tablets

Torasemide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ebozan and what is it used for
• 2. Important information before taking Ebozan
• 3. How to take Ebozan
• 4. Possible side effects
• 5. How to store Ebozan
• 6. Contents of the packaging and other information

1. What is Ebozan and what is it used for

Ebozan is used to treat swelling caused by fluid accumulation in the body tissues (edema).
Additionally, Ebozan 2.5 mg and 5 mg tablets are used to treat high blood pressure.
This medicine is a diuretic (increases urine production), but in doses suitable for the treatment of hypertension, it has a weak diuretic effect. The diuretic effect occurs within 1 hour with a maximum effect after 2-3 hours and lasts up to 12 hours. The maximum blood pressure-lowering effect after multiple administrations is observed after 10-12 weeks.
Ebozan is indicated for adults and adolescents over 12 years of age.

2. Important information before taking Ebozan

When not to take Ebozan

Warnings and precautions

Before starting to take Ebozan, the patient should discuss it with their doctor or pharmacist if:

• the patient has low potassium and sodium levels in the blood;
• the patient has problems with urination;
• the patient is dehydrated;
• the patient has impaired kidney function;
• the patient has irregular heartbeat;
• the patient has diabetes;
• the patient has liver cirrhosis or fluid in the abdominal cavity.

Children and adolescents

Ebozan should not be taken by children under 12 years of age.

Ebozan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Ebozan may affect the action of or change the action of the following medicines when taken together:

• probenecid (used to treat gout);
• acetylsalicylic acid (pain reliever);
• blood thinners of the coumarin type (such as warfarin);
• certain heart medicines, such as digitalis glycosides and ACE inhibitors;
• antidiabetic medicines;
• cholestyramine (medicines that lower cholesterol and triglyceride levels);
• certain antibiotics, such as gentamicin, tobramycin, and cephalosporins;
• certain non-steroidal anti-inflammatory and anti-rheumatic medicines (NSAIDs);
• cisplatin (cytostatic used to treat cancer);
• lithium (antipsychotic medicine);
• laxatives;
• glucocorticosteroids and mineralocorticosteroids;
• theophylline (used to treat asthma);
• muscle relaxants.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There is a risk of affecting the fetus. Therefore, before taking Ebozan during pregnancy, the patient should consult their doctor.
It is not known whether torasemide passes into breast milk. Therefore, before taking the medicine during breastfeeding, the patient should consult their doctor.

Driving and using machines

Ebozan may impair reactivity. This is especially true at the beginning of treatment or when changing treatment.

Ebozan contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Ebozan

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.

Primary hypertension

The recommended dose for adults and adolescents over 12 years of age with high blood pressure is 2.5 mg per day, preferably during breakfast. If necessary, the doctor may increase the dose to a maximum of 5 mg once a day.

Edema (swelling)

The usual dose for adults and adolescents over 12 years of age with edema caused by heart or liver failure is 5-10 mg per day, preferably during breakfast. If necessary, the doctor may increase the dose to 20 mg per day or rarely to 40 mg per day.
The usual dose for adults and adolescents over 12 years of age with edema caused by kidney function disorders is 20 mg per day, preferably during breakfast. The doctor may increase the dose to 50 mg per day, and then, if necessary, gradually increase the dose to 200 mg once a day.

Tablet administration

Tablets should be swallowed with a small amount of liquid and not chewed. Tablets are best taken in the morning. They can be taken with or without food.

Taking a higher dose of Ebozan than recommended

In case of swallowing too much medicine or accidental swallowing by a child, the patient should immediately contact their doctor to assess the risk and obtain advice.

Missing a dose of Ebozan

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms occur, the patient should stop taking Ebozan and immediately contact their doctor or the nearest emergency department:

Ebozan and immediately contact their doctor or the nearest emergency department:

• Very severe and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (frequency cannot be estimated from the available data), have been reported during treatment with Ebozan. Skin reactions may include rash with blisters or without blisters. Redness of the skin, ulcers, or swelling of the mouth, throat, eyes, nose, and genital areas, as well as fever and flu-like symptoms, may also occur. The skin rash may develop into severe widespread skin damage (exfoliation of the skin and mucous membranes) with life-threatening consequences.

Other side effects that may occur:
Common(may affect up to 1 in 10 people):

• headaches;
• dizziness;
• fatigue (tiredness).

Uncommon(may affect up to 1 in 100 people):

• decreased potassium levels in the blood;
• liver problems;
• urinary bladder problems;
• increased glucose, triglyceride, and cholesterol levels in the blood;
• overproduction of uric acid;
• loss of appetite;
• weakness;
• stomach or muscle problems;
• vomiting, diarrhea, constipation, nausea;
• muscle cramps.

Rare(may affect up to 1 in 1000 people):

• heart attack (myocardial infarction), irregular heartbeat, angina pectoris (chest pain);

changed creatinine, urea, and sodium levels in the blood;

• changes in blood morphology;
• increased sensitivity to sunlight;
• itching, hives;
• hearing loss, tinnitus (ringing in the ears);
• tingling in the hands and feet;
• dry mouth.

Frequency not known(frequency cannot be estimated from the available data):

• stroke (cerebral infarction), blood clots;
• pancreatitis;
• vision disorders;
• fainting;
• disorientation.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ebozan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the words EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ebozan contains

• The active substance of the medicine is torasemide. Ebozan 2.5 mg tablets: Each tablet contains 2.5 mg of torasemide. Ebozan 5 mg tablets: Each tablet contains 5 mg of torasemide. Ebozan 10 mg tablets: Each tablet contains 10 mg of torasemide. Ebozan 20 mg tablets: Each tablet contains 20 mg of torasemide.
• The other ingredients of the medicine are: lactose monohydrate, hypromellose (E 464), sodium carboxymethylcellulose (type A), colloidal silica anhydrous, and sodium stearylfumarate.

What Ebozan looks like and contents of the pack

Ebozan 2.5 mg tablets: White to almost white, round tablet with a diameter of about 5 mm.
Ebozan 5 mg tablets: White to almost white, oblong tablet with dimensions of about 9 x 4 mm with a dividing line on one side. The tablet can be divided into equal doses.
Ebozan 10 mg tablets: White to almost white, round tablet with a diameter of about 9 mm with the letter "e" embossed in the center on one side.
Ebozan 20 mg tablets: White to almost white, oblong tablet with dimensions of about 14 x 7 mm.
Ebozan tablets are packaged in PVC/Aluminum blisters.
Ebozan 10 mg tablets: 14, 30 tablets
Ebozan 2.5 mg, 5 mg, 20 mg tablets: 14, 28, 30, 56, 60, 84, 90, 98, 112, 120, 150, 168, 180 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer:
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic

This medicine is authorized in the Member States of the European Economic Area

under the following names:
Bulgaria: Систонал 5 mg таблетки, Систонал 10 mg таблетки, Систонал 20 mg таблетки
Estonia, Italy: Torasemide Zentiva
Lithuania: Torasemide Zentiva 5 mg tabletės, Torasemide Zentiva 10 mg tabletės
Latvia: Torasemide Zentiva 5 mg tabletes, Torasemide Zentiva 10 mg tabletes
Poland: Ebozan
Sweden: Torasemid Zentiva
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: +48 22 375 92 00
{logo of the marketing authorization holder}

Date of the last revision of the leaflet: