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 any side effects not listed in this leaflet, they should inform 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 edema caused by fluid accumulation in the body's tissues (swelling).
Additionally, Ebozan 2.5 mg and 5 mg tablets are used to treat high blood pressure.
This medicine is a diuretic (increasing urine production), but in doses suitable for the treatment of hypertension, it has a mild 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

• if the patient is allergic to torasemide or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to sulfonylurea derivatives (drugs used to treat diabetes);
• if the patient has severe liver disease;
• if the patient has reduced blood volume;
• if the patient does not produce urine;
• if the patient has low blood pressure.

Warnings and precautions

Before starting to take Ebozan, discuss it with your 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

Tell your doctor or pharmacist about all medicines you 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 medications, such as digitalis glycosides and ACE inhibitors;
• antidiabetic drugs;
• cholestyramine (cholesterol and triglyceride-lowering drugs);
• certain antibiotics, such as gentamicin, tobramycin, and cephalosporins;
• certain non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs);
• cisplatin (cytostatic - used to treat cancer);
• lithium (antipsychotic drug);
• laxatives;
• glucocorticosteroids and mineralocorticosteroids;
• theophylline (e.g., 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, consult your doctor.
It is not known whether torasemide passes into human milk. Therefore, before taking the medicine during breastfeeding, consult your 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

Always take this medicine exactly as your doctor has told you. If you are unsure, consult 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 during breakfast. 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 during breakfast. If necessary, your doctor may increase the dose to 20 mg once daily or rarely 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 during breakfast. Your doctor may increase the dose to 50 mg once daily, and then, if necessary, gradually increase the dose to 200 mg once daily.

Tablet administration

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

In case of accidental ingestion of too much medicine or if a child has accidentally ingested 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 missed dose.
If you have any further doubts about taking this medicine, consult 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:

• Very severe and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (frequency cannot be estimated from 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 superficial mucous membranes) 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):

• decreased potassium levels in the blood;
• liver problems;
• bladder 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 available data):

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the EXP label.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 anhydrous silica, and sodium stearylfumarate.

What Ebozan looks like and contents of the packaging

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, oval tablet with dimensions of about 9 × 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 on one side in the center.
Ebozan, 20 mg, tablets: White to almost white, oval tablet with dimensions of about 14 × 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, contact the representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
{logo of the marketing authorization holder}

Date of the last revision of the leaflet: