Diuver

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Diuver (Torasemide Teva), 5 mg, tablets
Torasemidum
Diuver and Torasemide Teva are different trade names of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are similar.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Diuver is and what it is used for
2. What you need to know 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 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 urine.
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 (drugs used in diabetes), or any of the other components of this medicine (listed in section 6);
• if the patient has renal function disorders 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 disorders in urine excretion, the cause of these disorders should be eliminated and water-electrolyte balance restored before initiating therapy (especially in patients receiving concomitant treatment with cardiac glycosides, glucocorticoids, 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. Carbohydrate metabolism should be monitored in such patients.

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 anti-doping controls.
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.

Diuvеr and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

When torasemide is used concomitantly with cardiac glycosides (drugs that stimulate heart function, increase myocardial contraction force, and simultaneously reduce heart rate), increased myocardial sensitivity to these drugs may occur due to reduced plasma potassium and/or magnesium levels.

In combination with mineralocorticoids (hormones regulating mineral and ionic balance) and glucocorticoids (hormones regulating protein, carbohydrate, and fat metabolism), as well as laxatives, torasemide may increase urinary potassium excretion.

As with other diuretics (i.e., drugs increasing urine volume), concomitant administration with other antihypertensive drugs may enhance blood pressure-lowering effects.

Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, nephrotoxic effects of cephalosporins, and cardiotoxic and central nervous system toxic effects of lithium.

The action of curare-like muscle relaxants and the effect of theophylline may be enhanced when used concomitantly with torasemide.

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

The effectiveness of antidiabetic drugs may be reduced.

Initiating treatment with angiotensin-converting enzyme (ACE) inhibitors after torasemide therapy, or starting combination therapy with these drugs, 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 of or temporarily discontinuing torasemide for 2–3 days before administering the ACE inhibitor.

Torasemide may reduce arterial responsiveness 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 efficacy of torasemide by inhibiting its renal tubular secretion.

Concomitant administration of torasemide and cholestyramine has not been studied in humans, but animal studies have shown reduced absorption of torasemide.

Diuvеr with food and drink
Diuvеr should be taken in the morning with a small amount of fluid, regardless of meals.

Patients with liver function disorders
Patients with impaired liver function should be closely monitored during torasemide treatment due to the risk of increased blood concentration 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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy:
Diuvеr is contraindicated during pregnancy.

Breastfeeding:
There are no data on the passage of the drug into breast milk. Diuvеr is contraindicated during breastfeeding.

Fertility:
Non-clinical studies have not shown any effect of torasemide on fertility.

Driving and operating machinery
As with other drugs affecting blood pressure, patients treated with torasemide who experience dizziness or similar symptoms should not drive or operate machinery.

Diuvеr 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.

Diuvеr 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 prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Diuver is available in the following strengths: 5 mg and 10 mg.
Recommended dose
Adults:
Essential 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 daily do not lead to further blood pressure reduction. The maximum therapeutic effect is achieved after approximately 12 weeks of treatment.
Oedema
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, 40 mg daily has been used.
Taking more Diuver than prescribed
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, together with administration of fluids and electrolytes.
If you have taken more than the prescribed dose of Diuver, seek immediate medical advice from your doctor or pharmacist.
Missing a dose of Diuver
Take the missed dose as soon as possible. If it is almost time for the 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 all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common (may affect up to 1 in 100 patients):
As with other diuretics, disturbances in water and electrolyte balance may occur, depending on the dose used and duration of treatment, especially when a low-sodium diet is followed. Hypokalaemia (reduced potassium levels in blood) may occur, particularly in patients on a potassium-poor diet, with vomiting, diarrhoea, using large amounts of laxatives, or 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 headaches, dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment of the medicine may become necessary.
Torasemide may increase serum levels 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 affect up to 1 in 100 patients):
In patients with impaired urine outflow, sudden urinary retention may occur.
Increased levels of urea and creatinine in blood plasma may occur.

Rare (may affect up to 1 in 1000 patients):
Paresthesia of the limbs.

Very rare (affects fewer than 1 in 10,000 people, including isolated cases):
In isolated cases, thrombotic complications and circulatory disorders of cardiac and cerebral origin due to blood concentration (including cardiac and cerebral ischaemia) have been observed, which may lead, for example, to cardiac arrhythmias, angina pectoris, acute myocardial infarction, or fainting.
Pancreatitis.
There have been reports of isolated cases of reduced numbers of red blood cells, white blood cells, and platelets.
Isolated cases of allergic reactions such as itching, rash, and photosensitivity may occur.
Isolated cases of visual and hearing disturbances (tinnitus, hearing loss) may occur.
Rarely, reports have included sensations of numbness, tingling, and limb paraesthesia.

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, inform 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,
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 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Diuver contains

• The active substance in Diuver is torasemide. Each tablet contains 5 mg of torasemide.

The other ingredients are: monohydrate lactose, corn starch,
sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Diuver looks like and contents of the pack

Diuver 5 mg 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.

Pack size:
30 tablets per pack.

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

Marketing authorisation holder in Lithuania, country of export:
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands

Manufacturer:
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, Poland

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

Marketing authorisation number in Lithuania, country of export: LT/1/05/0227/003
Parallel import authorisation number: 140/25