TORASEMIDE 10 mg Coated Tablet

Зміст інструкції

1. Torasemide Zentiva 10 mg tablets
   1. What is Torasemide Zentiva and what it is used for
   2. What you need to know before you take Torasemide Zentiva
   3. How to take Torasemide Zentiva
   4. Possible side effects
   5. How to store Torasemide Zentiva
   6. Package Contents and Other Information

Torasemide Zentiva 10 mg tablets

Generic medicine
Read this 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. Do not ever give it to other people, even if they have the same symptoms as you, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Torasemide Zentiva 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 for adults and adolescents over the age of 12 years.

2. What you need to know before you take Torasemide Zentiva

Do not take Torasemide Zentiva if you

• are allergic to torasemide or any of the other ingredients of this medicine (listed in section 6);
• are allergic to sulfonylureas (medicines used to treat diabetes);
• have a severe liver disease;
• have a 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 and 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 fluid in the abdomen.

Children and adolescents
Torasemide Zentiva should 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 can affect or be affected if taken at the same time as the following
medicines:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice 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 during breastfeeding.

Driving and using machines
Torasemide Zentiva can impair reaction ability. This is particularly true at the beginning of
treatment or when treatment is changed.

Torasemide Zentiva contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

3. How to take Torasemide Zentiva

Take this medicine following exactly the instructions of 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 caused by heart or liver
failure is 5-10 mg per day, preferably in the morning. If necessary, your 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 reduced
kidney function is 20 mg per day, preferably in the morning. Your doctor may increase the dose to 50
mg per day and then, if necessary, increase it gradually up to 200 mg once a day.

How to take the tablets
The tablets must be swallowed with some liquid and must not be chewed. The tablets
should be taken preferably in the morning. They can be taken with or without food.

If you take more Torasemide Zentiva than you should
If you have swallowed too much medicine or if, for example, a child has accidentally swallowed the medicine,
contact your doctor immediately for an assessment and advice on the 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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Stop taking Torasemide Zentiva and contact a doctor immediately or go to the nearest emergency room if you experience any of the following symptoms:

• Very serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (frequency cannot be estimated based on available data) have been reported during the use of Torasemide Zentiva. Skin reactions may consist of skin rashes with or without blisters. Redness of the skin, sores or swelling of the mouth, throat, eyes, nose and around the genitals, as well as fever and flu-like symptoms may also occur. The rash may develop into severe widespread skin damage (detachment of the epidermis 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;
• high levels of sugar in the blood, triglycerides in the blood and cholesterol; 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 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 counts;
• hypersensitivity to sunlight;
• itching, hives (urticaria);
• hearing loss, tinnitus (ringing in the ears);
• tingling and numbness in the arms and legs;
• dry mouth.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the blister and the carton after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is torasemide.

Each tablet contains 10 mg of torasemide.

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

Description of the appearance of Torasemide Zentiva and package contents
Tablet of colour from white to off-white, round with a diameter of approximately 9 mm and with “e” imprinted in
the middle of one side.
Blisters in PVC/Aluminum.
Packs of 14, 30 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa 7,
20121
Milan
Manufacturer:
Zentiva k.s.
U kabelovny 130
102 37, Praha 10 – Dolní Měcholupy
Czech Republic

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