Diuver

Package Leaflet: Information for the User

DIUVER, 10 mg, tablets

Torasemide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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 plasma 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 you are hypersensitive to torasemide, sulfonylurea derivatives (used in diabetes) or any of the other ingredients of this medicine (listed in section 6);
• if you have renal impairment with anuria;
• if you have hepatic coma and pre-coma states;
• if you have hypotension;
• if you are breastfeeding.

Warnings and precautions

Before starting treatment with 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 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.

lipid levels in the blood, as well as blood morphology (red and white blood cells and platelets).

• 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 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

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

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

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

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

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.

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

The action 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, a decrease in torasemide absorption has been observed.

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 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 who take torasemide and experience dizziness or similar symptoms should not drive vehicles or operate machines.

Diuver contains lactose monohydrate.

If you have been diagnosed with intolerance to some sugars, you should consult 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 exactly as directed by your doctor. If you are unsure, 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, 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, there may be significant diuresis with a risk of fluid and electrolyte loss, and subsequently drowsiness, confusion, blood pressure drop, circulatory collapse. Gastrointestinal disorders may occur.

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

If you have taken more than the recommended dose of the medicine, seek medical attention immediately.

Missed 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, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 people):

Similarly, as with other diuretics, depending on the dose and 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 dysfunction.

In case of significant diuresis, especially at the beginning of treatment, and in elderly patients, symptoms of fluid and electrolyte loss may occur, such as headache and dizziness, blood pressure drop, weakness, drowsiness, confusion, loss of appetite, 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 blood.

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 some liver enzymes, e.g., gamma-GT (gamma-glutamyltransferase).

Uncommon(may affect up to 1 in 100 people):

In patients with urinary 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 affect up to 1 in 1,000 people):

Paresthesia of the limbs

Very rare(may affect up to 1 in 10,000 people, including single cases):

Thromboembolic complications and cardiovascular and cerebrovascular disorders caused by blood thickening (including myocardial infarction and cerebral infarction) leading to arrhythmias, angina pectoris, acute myocardial infarction, or fainting.

Pancreatitis.

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

In single cases, allergic reactions, such as itching, rash, and photosensitivity, may occur.

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

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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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. Side effects can also be reported to the marketing authorization holder.

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

5. How to store Diuver

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

Store in a temperature below 25°C.

Do not use this medicine after the expiry date stated on the carton after "Expiry date". 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 10 mg of torasemide.

The other ingredients of the medicine are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), colloidal silica anhydrous, 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 an imprint of 916 on the other side of the tablet.

Pack size: 30 tablets in a pack.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer/Importer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Manufacturer

Pliva Croatia Ltd. (Pliva Hrvatska d.o.o.), Prilaz Baruna Filipovića 25, 10000 Zagreb, Croatia

Date of last revision of the leaflet: