Torasemide Zentiva

Patient Information Leaflet

Torasemide Zentiva 10 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Torasemide Zentiva is and what it is used for
2. What you need to know before taking Torasemide Zentiva
3. How to take Torasemide Zentiva
4. Possible side effects
5. How to store Torasemide Zentiva
6. Contents of the pack and other information

1. What Torasemide Zentiva is and what it is used for

Torasemide Zentiva is used to treat swelling caused by fluid accumulation in body tissues (edema).
Torasemide Zentiva is indicated in adults and adolescents over 12 years of age.

2. What you need to know before taking Torasemide Zentiva

Do not take Torasemide Zentiva if you

• are allergic to torasemide or to any of the other ingredients of this medicine (listed in section 6);
• are allergic to sulfonamides (medicines used to treat diabetes);
• have severe liver disease;
• have reduced blood volume;
• have no urine production;
• have low blood pressure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Torasemide Zentiva if you:

• have low levels of potassium or sodium in your blood;
• have problems with urination;
• are dehydrated;
• have impaired kidney function;
• have an irregular heartbeat;
• have diabetes;
• suffer from liver cirrhosis or have fluid in the abdomen.

Children and adolescents
Torasemide Zentiva must not be used in children under 12 years of age.
Other medicines and Torasemide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Torasemide Zentiva may affect, or be affected by, the following medicines when taken at the same time:

• probenecid (treatment for gout);
• acetylsalicylic acid (analgesic);
• coumarin-type anticoagulants (such as warfarin);
• certain medicines for heart conditions such as digitalis glycosides and ACE inhibitors;
• antidiabetic medicines;
• cholestyramine (a medicine that lowers cholesterol and triglycerides);
• certain medicines for infections such as gentamicin, tobramycin, and cephalosporins;
• certain non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs);
• cisplatin (cytostatic – for cancer treatment);
• lithium (antipsychotic);
• laxatives;
• glucocorticoids and mineralocorticoids;
• theophylline (e.g. for asthma);
• medicines used to relax muscles (muscle relaxants).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There is a risk that the fetus may be harmed. Therefore, consult your doctor before taking Torasemide Zentiva during pregnancy.
It is not known whether torasemide passes into breast milk. Therefore, consult your doctor before taking this medicine while breastfeeding.
Driving and using machines
Torasemide Zentiva may impair your reaction abilities. This is particularly true at the beginning of treatment or when treatment is changed.
Torasemide Zentiva contains lactose
If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Torasemide Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swelling (edema)
The usual dose for adults and adolescents over 12 years of age with edema due to heart or liver failure is 5–10 mg daily, preferably at breakfast. If necessary, your doctor 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 edema due to reduced kidney function is 20 mg daily, preferably at breakfast. Your doctor may increase the dose to 50 mg daily and then, if necessary, gradually increase it up to 200 mg once daily.
How to take the tablets
The tablets should be swallowed with some liquid and must not be chewed. The tablets should preferably be taken in the morning. They can be taken with or without food.
If you take more Torasemide Zentiva than you should
If you have taken too much medicine or, for example, a child has accidentally ingested the medicine, contact your doctor immediately for an assessment and advice on potential risks.
If you forget to take Torasemide Zentiva
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Torasemide Zentiva and contact a doctor immediately or go to the nearest emergency room if you experience any of the following symptoms:

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

Other possible side effects include:
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 blood sugar levels, blood triglycerides, and cholesterol; 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 the blood;
• changes in blood count;
• increased sensitivity to sunlight;
• itching, hives (urticaria);
• hearing loss, tinnitus (ringing in the ears);
• tingling sensations in arms and legs;
• dry mouth.

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

• stroke, blood clot;
• pancreatitis (inflammation of the pancreas);
• visual disturbances;
• fainting;
• confusion.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Torasemide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the carton after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Torasemide Zentiva contains

• The active substance is torasemide.

Each tablet contains 10 mg of torasemide.

• The other components are monohydrate lactose, hypromellose (E464), sodium starch glycolate (type A), anhydrous colloidal silica, and sodium stearil fumarate.

Description of the appearance of Torasemide Zentiva and contents of the pack
White to almost white, round tablet with a diameter of approximately 9 mm, imprinted with the letter "e" in the centre on one side.
Blister packs made of PVC/aluminum.
Pack sizes: 14 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa 7,
Milan, Italy

Manufacturer:
Zentiva k.s.
U kabelovny 130
102 37, Praha 10 – Dolní Měcholupy
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden: Torasemid Zentiva
Estonia, Italy, Latvia, Lithuania: Torasemide Zentiva
Bulgaria: Sistonale
Poland: Ebozan