Diuver

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Diuver (Torasemide Teva Italia), 10 mg, tablets

Torasemide
Diuver and Torasemide Teva Italia are different trade names for the same medicine.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 the 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: edema caused by congestive heart failure, pulmonary edema, hepatic edema, and renal edema.

2. Important information before taking Diuver

When not to take Diuver

Warnings and precautions

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

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 may pose a health risk.

Children and adolescents

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

Diuver and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

When torasemide is used concomitantly with cardiac glycosides (drugs that stimulate heart function, increase the strength of myocardial contraction, and at the same time reduce the frequency of this contraction), there may be an increased sensitivity of the myocardium to these drugs due to decreased potassium and (or) magnesium levels in the serum.

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

Similarly, as with other diuretics (also known as diuretic drugs, drugs that increase urine output), there may be an enhancement of the blood pressure-lowering effect when other antihypertensive drugs are administered concomitantly.

Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the toxic effect of cephalosporins on the kidneys, and the toxic effect of lithium on the heart and central nervous system.

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

Because torasemide inhibits the tubular secretion of salicylates in patients receiving high doses of salicylates, their toxicity may increase.

The action of antidiabetic drugs may be weakened.

The use of angiotensin-converting enzyme inhibitors after torasemide treatment, or the initiation of combined therapy with these drugs, 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 drug from the group of angiotensin-converting enzyme inhibitors.

Torasemide may reduce the reactivity of arteries to vasoconstrictor drugs (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 old age

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy:

Diuver is contraindicated during pregnancy.

Breastfeeding:

There is no data on the penetration of the drug 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 drugs, patients who take torasemide and experience dizziness or similar symptoms should not drive vehicles or operate machines.

Diuver contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 have any doubts, you should consult your doctor or pharmacist.

Recommended dose

Adults:

Edema

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

Using a higher dose of Diuver than recommended

The typical picture of torasemide overdose is not known. In case of overdose, there may be significant diuresis with a 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 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, you should immediately consult your doctor or pharmacist.

Missing a dose of Diuver

A missed dose should be taken as soon as possible. If it is almost time for the next dose, it should be taken at the scheduled time.

You should not take a double dose to make up for a missed dose.

4. Possible side effects

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

Common(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 low-potassium diet, with vomiting, diarrhea, using large amounts of laxatives, and in cases of liver function disorders.

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

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

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

In patients with urinary excretion disorders, there may be a sudden cessation of urine production.

There may be an increase in urea and creatinine levels in the blood.

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):

In single cases, there were reports of thrombotic complications and disorders of cardiac and cerebral circulation, caused by blood thickening (including myocardial infarction and cerebral infarction), leading to arrhythmias, angina pectoris, acute myocardial infarction, or fainting.

Pancreatitis.

There were reports of single cases of decreased red and white blood cell counts, as well as platelet counts.

In single cases, allergic reactions may occur, such as itching, rash, and hypersensitivity to light.

There may be single cases of vision and hearing disorders (tinnitus, hearing loss).

Rarely, there were reports of paresthesia (tingling, numbness) of the limbs.

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 any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 gather more information on the safety of the medicine.

5. How to store Diuver

The medicine should be stored out of sight and reach of children.

Do not store above 25°C.

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

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

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Diuver contains

• The active substance of the medicine is torasemide. Each tablet contains 10 mg of torasemide.

Other ingredients of the medicine are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), colloidal silicon dioxide, magnesium stearate.

What Diuver looks like and what the packaging contains

Diuver 10 mg is a white or almost white, round, biconvex tablet with a score line on one side and the imprint 916 on the other side of the tablet.

Package size:

28 tablets in a package.

To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Italy, the country of export:

Teva Italia S.r.l.

Piazzale Luigi Cadorna, 4

20123 Milan, Italy

Manufacturer:

Pliva Croatia Ltd.

Prilaz baruna Filipovića 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

Italian authorization number, in the country of export: 042564029

042564031

Parallel import authorization number: 107/25

Date of leaflet approval: 25.03.2025

[Information about the trademark]