Ebozan

Package Leaflet: Information for the Patient

Ebozan, 2.5 mg, tablets

Ebozan, 5 mg, tablets

Ebozan, 10 mg, tablets

Ebozan, 20 mg, tablets

Torasemide

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package 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 used to treat 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, discuss it with your doctor or pharmacist if:

• you have low potassium and sodium levels in your blood;
• you have problems with urination;
• you are dehydrated;
• you have impaired kidney function;
• you have irregular heartbeat;
• you have diabetes;
• you have 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 such as warfarin;
• certain heart medications, such as digitalis glycosides and ACE inhibitors;
• antidiabetic drugs;
• cholestyramine (used to lower cholesterol and triglyceride levels);
• certain antibiotics, such as gentamicin, tobramycin, and cephalosporins;
• certain nonsteroidal anti-inflammatory and anti-rheumatic drugs (NSAIDs);
• cisplatin (used to treat cancer);
• lithium (used to treat mental disorders);
• laxatives;
• glucocorticoids and mineralocorticoids;
• theophylline (used to treat asthma);
• muscle relaxants.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
There is a risk of affecting the fetus. Therefore, before taking Ebozan during pregnancy, consult your doctor.
It is not known whether torasemide passes into breast milk. Therefore, before taking the medicine during breastfeeding, consult your doctor.

Driving and using machines

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

Ebozan contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Ebozan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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 once daily, preferably in the morning. If necessary, your doctor may increase the dose to a maximum of 5 mg once daily.

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 once daily, preferably in the morning. If necessary, your doctor may increase the dose to 20 mg once daily or rarely up to 40 mg once daily.
The usual dose for adults and adolescents over 12 years of age with edema caused by kidney function disorders is 20 mg once daily, preferably in the morning. Your doctor may increase the dose to 50 mg once daily and then, if necessary, gradually increase the dose to 200 mg once daily.

How to take the tablets

Swallow the tablets with a small amount of liquid and do not chew them. It is best to take the tablets in the morning. They can be taken with or without food.

Overdose of Ebozan

If you have taken too much of the medicine or if a child has accidentally taken the medicine, contact your doctor immediately to assess the risk and get advice.

Missed dose of Ebozan

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Ebozan and contact your doctor or the nearest emergency department immediately:

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

• Very rare 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. It may also cause redness of the skin, ulcers, or swelling of the mouth, throat, eyes, nose, and genital areas, as well as fever and flu-like symptoms. The skin rash may develop into severe widespread skin damage (exfoliative dermatitis and superficial mucosal blistering) with life-threatening consequences.

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

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

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

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

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

• myocardial infarction (heart attack), 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 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 you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ebozan

Keep the medicine out of the 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.
There are no special storage instructions for this medicine.
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 package 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 anhydrous silica, and sodium stearyl fumarate.

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:

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
For more detailed information, please contact the representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
{logo of the marketing authorization holder}

Date of last revision of the package leaflet: