Diuver

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Diuver (Torasemide Teva 5 mg tablets EFG), 5 mg, tablets

Torasemide
Diuver and Torasemide Teva 5 mg tablets EFG are different trade names for the same medicine.

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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Diuver and what is it used for
• 2. Important information before taking Diuver
• 3. How to take Diuver
• 4. Possible side effects
• 5. How to store Diuver
• 6. Contents of the pack and other information

1. What is Diuver and what is it used for

Diuver is a diuretic. After oral administration, torasemide is rapidly and almost completely absorbed, and maximum concentration occurs in the serum after 1 to 2 hours. About 80% of the administered dose is excreted in the urine.

• Indications for use:
• primary hypertension;
• edema caused by congestive heart failure, pulmonary edema, hepatic edema, and renal edema.

2. Important information before taking Diuver

When not to take Diuver

• if you are hypersensitive to torasemide, sulfonylurea derivatives (diabetes medications), or any other component of this medicine (listed in section 6);
• if you have renal dysfunction with anuria;
• if you have hepatic coma and pre-coma states;
• if you have arterial hypotension;
• if you are breastfeeding.

Warnings and precautions

Before starting Diuver, discuss it with your doctor or pharmacist:

• if you have urinary disorders, before starting treatment, the cause of these disorders should be eliminated and water-electrolyte balance restored (especially in patients receiving concomitant treatment with digitalis glycosides, glucocorticoids, mineralocorticoids, or laxatives);

if torasemide therapy is long-term. During long-term treatment, regular monitoring of water-electrolyte balance, glucose, uric acid, creatinine, and lipid levels in the blood, as well as blood morphology (red and white blood cells and platelets), is recommended;

• if you have a tendency to increased uric acid levels in the blood and gout;
• if you have latent or overt diabetes. In these patients, carbohydrate metabolism should be monitored.

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

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

Taking Diuver may lead to positive doping control results. Using Diuver as a doping agent can pose a health risk.

Children and adolescents

There is a lack of clinical experience with torasemide in this age group.

Diuver and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

In the case of concomitant use of torasemide with cardiac glycosides (medicines that stimulate heart function, increase the force of cardiac muscle contraction, and simultaneously decrease the frequency of this contraction), there may be an increased sensitivity of the heart muscle to these medicines due to decreased potassium and/or magnesium levels in the serum.

In combination with mineralocorticoids (hormones regulating mineral and ionic balance in the body) and glucocorticoids (hormones regulating protein, carbohydrate, and fat metabolism), as well as laxatives, it may cause increased potassium excretion in the urine.

Similarly, as with other diuretics, the blood pressure-lowering effect may be enhanced when administered concomitantly with other antihypertensive medicines.

Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, and the nephrotoxic effects of cephalosporins, as well as the cardiotoxic and neurotoxic effects of lithium.

The effect of curare-like muscle relaxants and theophylline may be enhanced during concomitant use with torasemide.

Since torasemide inhibits the renal excretion of salicylates in patients receiving high doses of salicylates, their toxicity may increase.

The effect of antidiabetic medicines may be weakened.

The use of angiotensin-converting enzyme inhibitors after torasemide treatment, or the initiation of combination therapy with these medicines, may cause transient blood pressure drops. This effect can be minimized by reducing the initial dose of the angiotensin-converting enzyme inhibitor and/or reducing the dose or temporarily discontinuing torasemide for 2-3 days before using the medicine from the group of angiotensin-converting enzyme inhibitors.

Torasemide may reduce the reactivity of arteries to vasoconstrictor agents (e.g., adrenaline, noradrenaline).

Non-steroidal anti-inflammatory drugs (e.g., indomethacin) may reduce the diuretic and hypotensive effects of torasemide by inhibiting prostaglandin synthesis.

Probenecid may reduce the effectiveness of torasemide by inhibiting its secretion in the renal tubules.

The concomitant administration of torasemide and cholestyramine has not been studied in humans, but in animal studies, it has been found to reduce the absorption of torasemide.

Diuver with food and drink

Diuver should be taken in the morning with a small amount of liquid, regardless of meals.

Patients with liver function disorders

During torasemide treatment, patients with liver function disorders should be under special supervision due to the risk of increased torasemide levels in the blood.

Patients in advanced age

In elderly patients, there is no need to adjust the dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy:

Diuver is contraindicated during pregnancy.

Breastfeeding:

There is no data on the penetration of the medicine into breast milk. Diuver is contraindicated during breastfeeding.

Fertility:

In non-clinical studies, no effect of torasemide on fertility was found.

Driving and using machines

As with other blood pressure-lowering medicines, patients taking torasemide who experience dizziness or similar symptoms should not drive vehicles or operate machines.

Diuver contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Diuver contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Recommended dose:

Adults:

Primary hypertension

A dose of 2.5 mg orally once a day is recommended. If necessary, the dose can be increased to 5 mg once a day. Studies suggest that doses greater 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

Usually, a dose of 5 mg orally once a day is used. If necessary, the dose can be gradually increased to 20 mg once a day. In individual, exceptional cases, doses of up to 40 mg per day have been used.

Taking a higher dose of Diuver than recommended

The typical picture of torasemide overdose is not known. In the case of an overdose, significant diuresis may occur with the risk of fluid and electrolyte loss, and subsequently, drowsiness, confusion, blood pressure drop, and circulatory collapse. Gastrointestinal disorders may occur.

There is no specific antidote. The symptoms of an overdose require a reduction in dose or discontinuation of the medicine, with simultaneous administration of fluids and electrolytes.

If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Diuver

Take the missed dose as soon as possible. If it is almost time for the next dose, take it at the scheduled time.

Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Diuver can cause side effects, although not everybody gets them.

Frequent(may occur in up to 10 in 100 patients):

Similarly to other diuretics, depending on the dose used and the duration of treatment, water-electrolyte disorders may occur, especially when using a low-sodium diet. Hypokalemia (decreased potassium levels in the blood) may occur, especially in patients on a potassium-poor diet, with vomiting, diarrhea, using large amounts of laxatives, and in cases of liver dysfunction.

In the case of significant diuresis, especially at the beginning of treatment, and in elderly patients, symptoms of electrolyte and fluid loss may occur, such as headaches and dizziness, blood pressure drops, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. It may be necessary to adjust the dose of the medicine.

Torasemide may cause increased levels of uric acid, glucose, and lipids in the serum.

Metabolic alkalosis symptoms may worsen.

Gastrointestinal disorders (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation) may occur.

Torasemide may cause increased activity of certain liver enzymes, e.g., gamma-GT (gamma-glutamyltransferase).

Infrequent(may occur in up to 1 in 100 patients):

In patients with urinary outflow disorders, sudden urinary retention may occur.

Increased levels of urea and creatinine in the blood may occur.

Rare(may occur in less than 1 in 1000 patients):

Paresthesia of the limbs.

Very rare(occurring in less than 1 in 10,000 patients, including single cases):

Thrombotic complications and disorders of cardiac and cerebral circulation, caused by blood thickening (including cardiac and cerebral ischemia), leading to arrhythmias, angina pectoris, acute myocardial infarction, or syncope.

Pancreatitis.

Single cases of decreased red and white blood cell counts, as well as platelet counts, have been reported.

Single cases of allergic reactions, such as itching, rash, and hypersensitivity to light, have been reported.

Single cases of vision and hearing disorders (tinnitus, hearing loss) may occur.

Rarely, paresthesia (tingling, numbness) of the limbs has been reported.

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

Dryness of the mucous membranes of the mouth.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diuver

Keep the medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month.

Medicines should 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 of the medicine is torasemide. Each tablet contains 5 mg of torasemide.

The other ingredients of the medicine are: lactose monohydrate, cornstarch, sodium carboxymethylcellulose (type A), colloidal silica anhydrous, magnesium stearate.

What Diuver looks like and contents of the pack

Diuver is a white or almost white, round, biconvex tablet with a score line on one side and the imprint "915" on the other side of the tablet.

Package size: 30 tablets in a package.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Teva Pharma, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B

1 planta

28108 Alcobendas, Madrid

Spain

Manufacturer:

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Krakow

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

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Spanish authorization number: 665106.3

Parallel import authorization number: 428/15

Date of leaflet approval: 23.06.2025

[Information about the trademark]