Patient Information Leaflet: Read this leaflet carefully before taking this medicine

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Diuver (Torasemida Teva 5 mg comprimidos EFG), 5 mg, tablets
Torasemidum
Diuver and Torasemida Teva 5 mg comprimidos EFG are different brand names for the same
medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

What Diuver is and what it is used for
What you need to know before taking Diuver
How to take Diuver
Possible side effects
How to store Diuver
Contents of the pack and other information

1. What Diuver is and what it is used for

Diuver is a diuretic medicine. After oral administration, torasemide is rapidly and almost completely absorbed, with peak plasma concentration occurring within 1 to 2 hours. Approximately 80% of the administered dose is excreted in the urine.
Therapeutic indications:

essential hypertension;
oedema caused by congestive heart failure, pulmonary oedema, hepatic oedema, renal oedema.

2. Important information before using Diuver

When not to use Diuver

if the patient is hypersensitive to torasemide, sulfonylurea derivatives (medicines used in diabetes), or any of the other ingredients of this medicine (listed in section 6);
if the patient has renal dysfunction with anuria;
if the patient has hepatic coma or pre-coma conditions;
if the patient has hypotension;
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Diuver, consult a doctor or pharmacist:

if the patient has disturbances in urine excretion, the underlying cause should be eliminated and water-electrolyte balance restored (especially
in patients receiving concomitant treatment with cardiac glycosides,
glucocorticosteroids, mineralocorticoids, or laxatives);
if torasemide therapy is long-term. During prolonged treatment, regular monitoring of water-electrolyte balance, blood glucose, uric acid, creatinine, and lipid levels, as well as blood morphology (red and white blood cells and platelets) is recommended;
if the patient has a tendency towards increased blood uric acid levels or a history of gout;
if the patient has latent or overt diabetes. In such patients, carbohydrate metabolism should be monitored.

Due to insufficient experience with torasemide treatment, caution should be exercised
in the following situations:

pathological disturbances in acid-base balance,
concomitant treatment with lithium, aminoglycosides, or cephalosporins,
renal failure caused by nephrotoxic agents,
children under 12 years of age.

Use of Diuver may lead to positive results in doping controls.
Using Diuver as a doping agent may pose a health risk.
Children and adolescents
There is no clinical experience with the use of torasemide in this age group.
Diuvver with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.
When torasemide is used concomitantly with cardiac glycosides (medicines that stimulate heart function, increasing myocardial contractility while reducing heart rate), increased myocardial sensitivity to these medicines may occur due to decreased serum potassium and (or) magnesium levels.
In combination with mineralocorticoids (hormones regulating mineral and ionic balance) and glucocorticosteroids (hormones regulating protein, carbohydrate, and fat metabolism), as well as with laxatives, increased urinary potassium excretion may occur.
As with other diuretics (medicines that increase urine volume), concomitant use with other antihypertensive medicines may enhance blood pressure-lowering effects.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the nephrotoxic effects of cephalosporins, and the cardiotoxic and central nervous system toxic effects of lithium.
The effects of curare-like muscle relaxants and theophylline may be enhanced during concomitant use with torasemide.
Since torasemide inhibits tubular excretion of salicylates, toxicity may increase in patients receiving high doses of salicylates.
The effectiveness of antidiabetic medicines may be reduced.
Administration of angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or initiation of combination therapy with these medicines, may cause transient drops in blood pressure. This effect can be minimized by reducing the initial dose of the ACE inhibitor and (or) reducing the dose or temporarily discontinuing torasemide for 2–3 days before administering the ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictive medicines (e.g., adrenaline, noradrenaline).
Non-steroidal anti-inflammatory drugs (e.g., indomethacin) may reduce the diuretic and antihypertensive effects of torasemide by inhibiting prostaglandin synthesis.
Probenecid may reduce the efficacy of torasemide by inhibiting its renal tubular excretion.
Concomitant administration of torasemide and cholestyramine has not been studied in humans, but animal studies have shown reduced absorption of torasemide.

Diuvver with food and drink
Diuvver should be taken in the morning with a small amount of fluid, regardless of meals.
Patients with liver function disorders
Patients with liver function disorders should be under special monitoring during torasemide treatment due to the risk of increased blood levels of torasemide.
Elderly patients
Dosage adjustment is not required in elderly patients.
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.
Pregnancy:
Diuvver is contraindicated during pregnancy.
Breastfeeding:
There are no data on the passage of the medicine into breast milk. Diuvver is contraindicated during breastfeeding.
Fertility:
Non-clinical studies have not shown any effect of torasemide on fertility.
Driving and operating machinery
As with other medicines affecting blood pressure, patients using torasemide who experience dizziness or similar symptoms should not drive or operate machinery.
Diuvver contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Diuvver contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken exactly as directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Recommended dose:
Adults:
Primary hypertension
The recommended dose is 2.5 mg orally once daily. If necessary, the dose may be increased
to 5 mg once daily. Clinical studies suggest that doses higher than 5 mg per day do not lead
to further blood pressure reduction. The maximum therapeutic effect is achieved after approximately
12 weeks of treatment.
Edema
The usual dose is 5 mg orally once daily. If necessary, the dose may be gradually increased
up to 20 mg once daily. In individual, exceptional cases, a dose of 40 mg per day has been used.
Taking more Diuver than recommended
The typical clinical picture of torasemide overdose is not well known. In case of overdose,
marked diuresis may occur, with risk of fluid and electrolyte loss, leading to somnolence,
confusion, hypotension, and circulatory collapse. Gastrointestinal disturbances may also occur.
There is no specific antidote. Symptoms of overdose require dose reduction or discontinuation
of the medicine, along with administration of fluids and electrolytes.
If you have taken more than the recommended dose of Diuver, you should immediately contact
your doctor or pharmacist.
Missing a dose of Diuver
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose,
take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
Common (may occur in up to 10 out of 100 patients):
As with other diuretics, depending on the dose used and duration of treatment, disturbances in water and electrolyte balance may occur, especially when following a low-sodium diet. Hypokalaemia (reduced potassium concentration in the blood) may occur, particularly in patients on a potassium-deficient diet, with vomiting, diarrhoea, those using large amounts of laxatives, and in patients with impaired liver function.
In case of significant diuresis, especially at the beginning of treatment, and also in elderly patients, symptoms of fluid and electrolyte loss may appear, such as pain and dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, muscle cramps. A dose adjustment of the medicine may become necessary.
Torasemide may increase serum concentrations of uric acid, glucose and lipids.
Symptoms of metabolic alkalosis may worsen.
Gastrointestinal disturbances may occur (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation).
Torasemide may increase the activity of certain liver enzymes, e.g. gamma-GT (gamma-glutamyl transferase).

Uncommon (may occur in up to 1 out of 100 patients):
In patients with impaired urine outflow, sudden urine retention may occur.
Increased concentrations of urea and creatinine in blood plasma may appear.

Rare (may occur in less than 1 out of 1,000 patients):
Limb paraesthesia.

Very rare (occurring in less than 1 out of 10,000 people, including single cases):
In isolated cases, thrombotic complications and disturbances in cardiac and cerebral circulation due to blood concentration (including cardiac and cerebral ischaemia) have been reported, leading, for example, to cardiac arrhythmias, angina pectoris, acute myocardial infarction or fainting.
Pancreatitis.
Single cases of reduced numbers of red blood cells, white blood cells and platelets have been reported.
In isolated cases, allergic reactions such as itching, rash and photosensitivity may occur.
Single cases of visual and hearing disturbances (tinnitus, hearing loss) may occur.
Rarely, paraesthesia such as tingling, numbness and abnormal sensations in the limbs have been reported.

Frequency not known (cannot be estimated from available data):
Dryness of the oral mucosa.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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 181 C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diuver

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines must 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 pack and other information

What Diuver contains
The active substance is torasemide. Each tablet contains 5 mg of torasemide.
Other components of the medicine are: monohydrate lactose, maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Diuver looks like and contents of the pack
Diuver is a white or almost white, round, biconvex tablet with a dividing line on one side and the imprint "915" on the other side of the tablet.
Pack size: 30 tablets per pack.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Spain, country of export:
Teva Pharma, S.L.U.
C/Anabel Segura, 11
Edificio Albatros B
1st floor
28108 Alcobendas, Madrid
Spain

Manufacturer:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Pliva Hrvatska d.o.o.
Prilaz Baruna Filipovica 25
10000 Zagreb
Croatia

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in Spain, country of export: 665106.3
Parallel import authorisation number: 428/15