Diuver

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Diuver (Torasemide Teva 10 mg)
10 mg, tablets
Torasemidum
Diuver and Torasemide Teva 10 mg are different trade 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 questions, 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 identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Diuver is and what it is 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 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:

• 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 (medicines used in diabetes), or any of the other components of this medicine (listed in section 6);
• if the patient has renal dysfunction 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, discuss this with your 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 starting treatment (especially in patients receiving concomitant treatment with cardiac glycosides, glucocorticosteroids, mineralocorticosteroids, 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 manifest 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 anti-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.
Diuver with 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 (medicines that stimulate heart function, increase myocardial contractility, and simultaneously reduce heart rate), increased myocardial sensitivity to these medicines may occur due to reduced serum potassium and/or magnesium levels.
In combination with mineralocorticoids (hormones regulating mineral and ion balance) and glucocorticosteroids (hormones regulating protein, carbohydrate, and fat metabolism), as well as laxatives, it may increase potassium excretion in urine.
Like other diuretics (medicines that increase urine volume), Diuver may enhance the blood pressure-lowering effect when used concomitantly with other antihypertensive medicines.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the nephrotoxic effect of cephalosporins, and the cardiotoxic and neurotoxic effects of lithium.
The effect 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 medicines may be reduced.
Starting treatment with angiotensin-converting enzyme (ACE) inhibitors after torasemide therapy, or initiating combination therapy with these medicines, 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 an ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictive 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 renal tubular excretion.
Concomitant administration of torasemide and cholestyramine has not been studied in humans, but animal studies have shown reduced absorption of torasemide.
Diuver with food and drink
Diuver should be taken in the morning with a small amount of fluid, regardless of meals.
Patients with liver function disorders
Patients with liver function disorders should be under special monitoring during treatment with torasemide 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 have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy:
Diuver is contraindicated during pregnancy.
Breastfeeding:
There is no data on the passage of Diuver into breast milk. Diuver is contraindicated during breastfeeding.
Fertility:
Non-clinical studies have not shown any effect of torasemide on fertility.
Driving and operating machinery
As with other medicines affecting blood pressure, patients using torasemide who experience dizziness or similar symptoms should not drive or operate machinery.
Diuver 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.
Diuver contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Recommended dose
Adults:
Edema
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.
Use of a higher than recommended dose of Diuver
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, and as a consequence,
drowsiness, confusion, hypotension, 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.
In case of ingestion of a higher than recommended dose of the medicine, seek immediate
medical advice from a doctor or pharmacist.
Missed dose of Diuver
If a dose is missed, take it 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 reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.

Common (may occur in up to 1 in 100 patients):
As with other diuretics, depending on the dose used and duration of treatment, disturbances in water and electrolyte balance may occur, especially when on a low-sodium diet. Hypokalaemia (reduced potassium levels in the blood) may occur, particularly in patients on a potassium-deficient diet, those experiencing vomiting or 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 occur, 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, such as gammaGT (gamma-glutamyl transferase).

Uncommon (may occur in up to 1 in 100 patients):
In patients with impaired urine outflow, sudden urinary retention may occur. Increased serum levels of urea and creatinine may appear.

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

Very rare (occurring in less than 1 in 10,000 people, including single cases):
In isolated cases, thrombotic complications and circulatory disorders of the heart and brain due to blood concentration (including myocardial and cerebral ischaemia) have occurred, 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.

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

Isolated cases of visual and hearing disturbances (e.g. tinnitus, hearing loss) may occur.

Rarely, numbness, tingling, or pricking sensations (paresthesia) of the limbs have been reported.

Frequency not known (cannot be estimated from available data): Dryness of the oral mucosa.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 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 reactions 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 is torasemide. Each tablet contains 10 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 10 mg are white or almost white, round, biconvex tablets with a score line on one side and an imprint "916" on the other side.

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, the country of export:
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Pliva Croatia Ltd.
Prilaz baruna Filipovića 25
10 000 Zagreb
Croatia

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing authorisation numbers in Lithuania, the country of export: LT/1/05/0227/014
LT/1/05/0227/009
LT/1/05/0227/011
Parallel import licence number: 220/23