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), 10 mg, tablets
Torasemidum
Diuver and Torasemide Teva are different trade names for the same medicine.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Leaflet 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 maximum plasma concentration reached 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, sulfonylureas (medicines 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 such disorders should be eliminated and water-electrolyte balance restored before starting treatment (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 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 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 to be used.

When torasemide is used concomitantly with cardiac glycosides (medicines that stimulate heart function, increase myocardial contractility and simultaneously reduce heart rate), it may increase myocardial sensitivity to these drugs due to decreased serum 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, it may increase potassium excretion in urine.

As with other diuretics (medicines that increase urine volume), concomitant use with other antihypertensive medicines 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 toxicity of lithium.

The muscle-relaxant effect of curare-like agents 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 medicines may be reduced.

Administration of angiotensin-converting enzyme (ACE) inhibitors after treatment with torasemide, 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) by reducing or temporarily discontinuing torasemide for 2–3 days before administering the ACE inhibitor.

Torasemide may reduce arterial responsiveness 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 renal tubular secretion.

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 levels 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 a doctor or pharmacist before using this medicine.

Pregnancy:
Diuver is contraindicated during pregnancy.

Breastfeeding:
There are no data on the passage of the drug 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 treated with 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 prescribed by your doctor. If you have any doubts,
you should 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, leading to drowsiness,
confusion, hypotension, and circulatory collapse. Gastrointestinal disturbances may also appear.
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 medical advice immediately
from your doctor or pharmacist.
Missed dose of Diuver
If you miss a dose, take it as soon as possible. If it is almost time for your 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 they do not occur in everyone.
Common (may occur in up to 10 out of 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 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 taking large amounts of laxatives, and in patients with impaired liver function.
In cases of significant diuresis, especially at the beginning of treatment, and also in elderly patients, symptoms of fluid and electrolyte loss may appear, such as pain and dizziness, drops in blood pressure, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment of the medicine may become necessary.
Torasemide may increase plasma 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 occur in up to 1 out of 100 patients):
In patients with impaired urine outflow, sudden urine retention may occur.
Increased plasma concentrations of urea and creatinine may occur.

Rare (may occur in fewer than 1 out of 1,000 patients):
Limb paraesthesia.

Very rare (occurring in fewer than 1 out of 10,000 people, including isolated cases):
In isolated cases, thrombotic complications and circulatory disorders affecting the heart and brain have been reported, caused by 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.
In isolated cases, 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 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 adverse effects, additional information regarding the safety of the medicine can be collected.

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. These measures help protect the environment.

6. Contents of the pack 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 is white or almost white, round, biconvex tablets with a score line on one side and an imprint "916" on the other side of the tablet.

Pack size: 30 tablets per pack.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Lithuania, 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:

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

Repackaged by:

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/1/05/0227/009
Parallel Import Authorisation Number: 8/22