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
Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Ebozan is and what it is 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 pack and other information

1. What Ebozan is and what it is used for

Ebozan is used in the treatment of swelling caused by fluid accumulation in body tissues (oedema).
Additionally, Ebozan 2.5 mg and 5 mg tablets are used in the treatment of high blood pressure.
This medicine is a diuretic (increases urine excretion), but at doses appropriate for the treatment of hypertension, its diuretic effect is mild. The diuretic effect begins within 1 hour, reaches maximum effect after 2–3 hours, and lasts up to 12 hours. Maximum blood pressure-lowering effect with repeated dosing is observed after 10–12 weeks.
Ebozan is indicated for adults and adolescents aged over 12 years.

2. Important information before using Ebozan

When not to use 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 (medicines used in the treatment of 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 treatment with Ebozan, consult your doctor or pharmacist if:

• the patient has low levels of potassium and sodium 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 accumulation in the abdominal cavity.

Children and adolescents
Ebozan must not be used in children under 12 years of age.

Ebozan with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Ebozan may affect the action of other medicines, or its effect may be altered when used together with the following medicines:

• probenecid (treatment of gout);
• acetylsalicylic acid (pain-relieving medicine);
• anticoagulant medicines of the coumarin type (such as warfarin);
• certain medicines used for heart conditions, such as cardiac glycosides and ACE inhibitors;
• antidiabetic medicines;
• cholestyramine (medicines lowering cholesterol and triglyceride levels);
• certain medicines used for infections, such as gentamicin, tobramycin, and cephalosporins;
• certain non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs);
• cisplatin (cytostatic agent – used in cancer treatment);
• lithium (antipsychotic medicine);
• laxatives;
• glucocorticoids and mineralocorticoids;
• theophylline (e.g. used in asthma treatment);
• muscle relaxants.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

There is a risk of effects on the fetus. Therefore, consult a doctor before using Ebozan during pregnancy.
It is not known whether torasemide passes into human milk. Therefore, consult a doctor before using this medicine during breastfeeding.

Driving and operating machinery
Ebozan may impair reactivity. This is especially relevant at the beginning of treatment or when changing treatment.

Ebozan contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Ebozan

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Essential 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, the physician may increase the dose to
a maximum of 5 mg once daily.
Oedema (swelling)
The usual dose for adults and adolescents over 12 years of age with oedema due to
heart or liver failure is 5–10 mg once daily, preferably during breakfast. If necessary,
the physician may increase the dose to 20 mg daily or, rarely, to 40 mg daily.
The usual dose for adults and adolescents over 12 years of age with oedema due to
kidney dysfunction is 20 mg once daily, preferably during breakfast. The physician may increase the
dose to 50 mg daily and then, if necessary, gradually increase the dose up to 200 mg once
daily.
How to take the tablets
The tablets should be swallowed whole with a small amount of liquid and must not be chewed. The tablets are best taken
in the morning. They may be taken with or without food.
Taking more Ebozan than recommended
If an excessive amount of medicine is ingested or if a child accidentally swallows the medicine,
contact a doctor immediately for risk assessment and advice.
If you miss a dose of Ebozan
Do not take a double dose to make up for a missed dose.
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 experiences them.
If any of the following symptoms occur, stop taking the medicine
Ebozan and contact your doctor or the nearest emergency department immediately:

• Very severe and serious skin reactions have been reported, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (frequency cannot be estimated from available data) during treatment with Ebozan. Skin reactions may include rash, with or without blisters. Redness of the skin, mucosal ulcers or swelling of the mouth, throat, eyes, nose, and genital area may also occur, along with fever and flu-like symptoms. Skin rash may progress to severe, widespread skin damage (detachment of the epidermis and superficial mucous membranes), which can be life-threatening.

Other possible adverse reactions:
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 blood;
• liver problems;
• bladder problems;
• increased levels of glucose, triglycerides, and cholesterol in blood;
• overproduction of uric acid;
• loss of appetite;
• weakness;
• stomach or muscle problems;
• vomiting, diarrhoea, constipation, nausea;
• muscle cramps.

Rare (may affect up to 1 in 1,000 people):

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

• altered levels of creatinine, urea, and sodium in blood;

• changes in blood morphology;

• photosensitivity;

• itching, urticaria;

• hearing loss, tinnitus (ringing in the ears);

• tingling in hands and legs;

• dryness of the mouth.

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

• stroke, blood clots;
• pancreatitis;
• visual disturbances;
• fainting;
• disorientation.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Adverse reactions can also be reported to the marketing authorization holder or its representative. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Ebozan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Ebozan contains

• The active substance 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.
• Other components are: monohydrate lactose, hypromellose (E 464), sodium carboxymethyl starch (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 approximately 5 mm.
Ebozan 5 mg tablets: White to almost white, oblong tablet measuring approximately 9 × 4 mm with a division 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 approximately 9 mm, with an embossed letter "e" in the center on one side.
Ebozan 20 mg tablets: White to almost white, oblong tablet measuring approximately 14 × 7 mm.
Ebozan tablets are packed 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in 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

For further information, please contact the representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: + 48 22 375 92 00
{logo of the Marketing Authorisation Holder}