Diuver

Package Leaflet: Information for the User

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

Diuver (Torasemide Teva), 10 mg, tablets

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

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of 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 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 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

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

Warnings and precautions

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

• if the patient has urinary disorders, before starting treatment, the cause of these disorders should be eliminated and water-electrolyte balance restored (especially in patients undergoing concomitant treatment with cardiac 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 the patient has a tendency to increased uric acid levels in the blood and gout;
• if the patient has 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 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 medicines you are taking, have recently taken, or plan to take.

When torasemide is used concomitantly with cardiac glycosides (medicines that stimulate heart function), it may increase the sensitivity of the heart muscle to these medicines due to decreased potassium and/or magnesium levels in the serum.

In combination with mineralocorticoids (hormones that regulate mineral and ion metabolism) 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, the hypotensive effect may be enhanced when other antihypertensive medicines are administered concomitantly.

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.

Because 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 reduced.

The use of angiotensin-converting enzyme inhibitors after torasemide treatment, or the initiation of combination therapy with these medicines, may cause transient blood pressure decreases. 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 medicines (e.g., adrenaline, noradrenaline).

Nonsteroidal anti-inflammatory medicines (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.

Elderly patients

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, 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 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 medicines that affect blood pressure, 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 consult 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 the doctor. In case of doubts, you should consult a 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, doses of up to 40 mg per day have been used.

Overdose of Diuver

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

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missed 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.

A double dose should not be taken to make up for a 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 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 headache, dizziness, decreased blood pressure, 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).

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

In patients with urinary disorders, sudden cessation of urine production 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 circulatory disorders of the heart and brain, caused by blood thickening (including myocardial infarction and stroke), leading to arrhythmias, angina pectoris, or fainting.

Pancreatitis.

There have been reports of single cases of decreased red and white blood cell and platelet counts.

Single cases of allergic reactions, such as itching, rash, and photosensitivity, have been reported.

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

Rarely, there have been 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 of the 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 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 month stated.

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 needed. 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 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 contents of the pack

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: 30 tablets in a package.

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

Marketing authorization holder in Lithuania, the country of export:

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Krakow, Poland

Pliva Croatia Ltd.

Prilaz baruna Filipovića 25, 10 000 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

Lithuanian, export country marketing authorization number: LT/1/05/0227/009

Parallel import authorization number: 8/22 Date of leaflet approval: 11.01.2022

[Information about the trademark]