Diuver

Patient Information Leaflet: Information for the User

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Diuver (Torasemide Teva), 5 mg, tablets
Torasemidum
Diuver and Torasemide Teva are different trade names for the same medicine.
Please read the entire leaflet carefully before taking 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your 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:

• essential hypertension;
• oedema due to 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 ingredients of this medicine (listed in section 6);
• if the patient has renal function disorders with anuria;
• if the patient has hepatic coma or pre-comatose conditions;
• if the patient has hypotension;
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Diuver, discuss with your doctor or pharmacist:

• if the patient has disorders in urine excretion; before initiating treatment, 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 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 blood cells, 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.
Diuver and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
When torasemide is used concomitantly with cardiac glycosides (medicines that enhance heart function by increasing the force of myocardial contraction while decreasing contraction rate), increased myocardial sensitivity to these medicines may occur due to reduced serum potassium and (or) magnesium levels.
In combination with mineralocorticosteroids (hormones regulating mineral and electrolyte balance) and glucocorticosteroids (hormones regulating protein, carbohydrate, and fat metabolism), as well as laxatives, increased potassium excretion in urine may occur.
As with other diuretics (medicines that increase urine volume), concomitant administration with other antihypertensive medicines may enhance blood pressure-lowering effects.
Torasemide, especially at high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the nephrotoxic effects of cephalosporins, and the 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 effect of antidiabetic medicines may be reduced.
Administration of angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or initiation of combined 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 administering the 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 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.
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 torasemide treatment due to the risk of increased blood concentration of torasemide.
Elderly patients
Dosage adjustment is not necessary in elderly patients.
Pregnancy, breastfeeding, and fertility
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 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 the 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 exactly as directed 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.
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 somnolence,
confusion, hypotension, circulatory collapse. Gastrointestinal disturbances may also appear.
There is no specific antidote. Symptoms of overdose require dose reduction or discontinuation
of the medicine, along with administration of fluids and electrolytes.
If you have taken more than the recommended dose of Diuver, contact your doctor or pharmacist
immediately.
Missed 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 they do not occur in everyone.
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 a low-sodium diet is followed. Hypokalaemia (reduced potassium levels in 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 headaches, 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-glutamyltransferase).

Uncommon (may occur in up to 1 in 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 in 1,000 patients):
Limb paraesthesiae.

Very rare (occurring in fewer than 1 in 10,000 patients, including single cases):
In isolated cases, thrombotic complications and circulatory disorders of 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.
In isolated cases, allergic reactions such as itching, rash, and photosensitivity may occur.
Isolated cases of visual and auditory disturbances (tinnitus, hearing loss) may occur.
Rarely, numbness, tingling, and limb paraesthesiae have been reported.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +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 this 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 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 dividing line on one side and imprint "915" on the other side of the tablet.

Pack size:
30 tablets per pack.

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

Marketing Authorisation Holder in Lithuania, the exporting country:
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Lithuania, the exporting country: LT/1/05/0227/003
Parallel Import Authorisation Number: 283/24