Diuver

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Diuver (Torasemide Teva Italia)
10 mg, tablets
Torasemidum
Diuver and Torasemide Teva Italia are different brand names for 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 the urine.
Indications:

• Edema caused by congestive heart failure, pulmonary edema, hepatic edema, and renal edema.

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 ingredients of this medicine (listed in section 6);
• if the patient has renal dysfunction with anuria;
• if the patient has hepatic coma or pre-comatose conditions;
• if the patient has arterial 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 (especially in

patients receiving concomitant treatment with cardiac glycosides, glucocorticosteroids,
mineralocorticosteroids, or laxative drugs);

• 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. In such 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 agents,
• children under 12 years of age.

Use of Diuver may lead to positive results in doping controls. Using Diuver as a doping agent may pose a health risk.
Children and adolescents
There is no clinical experience with the use of torasemide in this age group.
Diuretic and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
When torasemide is used concomitantly with cardiac glycosides (drugs that stimulate heart function, increase myocardial contractility, and simultaneously reduce heart rate), increased myocardial sensitivity to these drugs may occur due to reduced serum potassium and/or magnesium levels.
In combination with mineralocorticosteroids (hormones regulating mineral and ion metabolism) and glucocorticosteroids (hormones regulating protein, carbohydrate and fat metabolism), as well as laxative agents, increased urinary potassium excretion may occur.
As with other diuretics (drugs that increase urine volume), enhanced blood pressure-lowering effects may occur when used concomitantly with other antihypertensive drugs.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, nephrotoxic effects of cephalosporins, and cardiotoxic and central nervous system toxicity of lithium.
The muscle-relaxing effect of curare-like drugs and the effect of theophylline may be enhanced during concomitant use 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.
Administration of angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or initiation of combined 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 or temporarily discontinuing torasemide 2–3 days before starting the ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictive 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 excretion.
Concomitant administration of torasemide and cholestyramine has not been studied in humans, but animal studies have shown reduced absorption of torasemide.
Diuretic and food/drink
Diuretic 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 levels of torasemide.
Elderly patients
Dosage adjustment is not required in elderly patients.
Pregnancy, breastfeeding and fertility
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:
Diuretic is contraindicated during pregnancy.
Breastfeeding:
There are no data on the passage of the drug into breast milk. Diuretic 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 using torasemide who experience dizziness or similar symptoms should not drive or operate machinery.
Diuretic 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.
Diuretic 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. In case of doubt, consult
your doctor or pharmacist.
Recommended dose
Adults:
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, a dose of 40 mg daily has been used.
Taking more Diuver than recommended
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 drowsiness, 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 recommended dose of Diuver, seek immediate medical advice
from your doctor or pharmacist.
Missing a dose of Diuver
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose,
skip the missed dose and 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 any medicine, this medicine can cause adverse effects, although not everyone will experience them.

Common (may occur in up to 10 out of 100 patients):
As with other diuretics, disturbances in water and electrolyte balance may occur depending on the dose administered and duration of treatment, especially when a low-sodium diet is followed. Hypokalaemia (reduced potassium levels in the blood) may occur, particularly in patients on a potassium-deficient diet, with vomiting, diarrhoea, those using large amounts of laxatives, and in patients with impaired liver function.
In cases of significant diuresis, especially at the beginning of treatment and in elderly patients, symptoms of fluid and electrolyte loss may appear, such as pain, dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment of the medicine may become necessary.
Torasemide may increase plasma concentrations 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 occur in up to 1 out of 100 patients):
In patients with impaired urine outflow, sudden urinary retention may occur.
Increased plasma concentrations of urea and creatinine may occur.

Rare (may occur in fewer than 1 out of 1,000 patients):
Paresthesia of the limbs.

Very rare (occurring in fewer than 1 out of 10,000 people, including single cases):
In isolated cases, thrombotic complications and circulatory disturbances affecting the heart and brain have been observed due to blood concentration (including cardiac and cerebral ischaemia), leading, 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 pruritus, rash, and photosensitivity have been reported.
Isolated cases of visual and auditory 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 or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Diuver contains

• The active substance is torasemide. Each tablet contains 10 mg of torasemide.
• Other components of the medicine 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 10 mg tablets are white or almost white, round, biconvex tablets, with a division line on one side and the imprint "916" on the other, 8 mm in diameter.
The tablet can be divided into two equal doses.
Pack size:
28 tablets in PVC/PVDC/Al blister packs, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Italy, country of export:
Teva Italia S.r.l.
Piazzale Luigi Cadorna 4
20123 Milan
Italy
Manufacturer:
Pliva Croatia Ltd.
Prilaz baruna Filipovića 25
10 000 Zagreb
Croatia
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Italy, country of export: 042564029
Parallel import licence number: 308/24