Diuver

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Diuver (Torasemid AbZ 10 mg Tabletten)
10 mg, tablets
Torasemidum
Diuver and Torasemid AbZ 10 mg Tabletten 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 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 the patient experiences any adverse effects, including any adverse effects 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 concentrations 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 (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-coma 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 before initiating treatment (especially in patients receiving concomitant therapy 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. In these 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 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 (medicines that enhance heart function by increasing myocardial contractility while reducing heart rate), increased sensitivity of the heart muscle to these medicines may occur due to decreased serum potassium and/or magnesium levels.

When used together with mineralocorticoids (hormones regulating mineral and ion balance), glucocorticoids (hormones regulating protein, carbohydrate and fat metabolism), and laxatives, increased potassium excretion in urine may occur.

As with other diuretics (medicines that increase urine volume), an enhanced blood pressure-lowering effect may occur 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 central nervous system toxicity of lithium.

The muscle-relaxing 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 of salicylates may increase in patients receiving high doses.

The effectiveness 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 by reducing the dose of torasemide or temporarily discontinuing it 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 antihypertensive 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 impaired liver function should be under special monitoring during torasemide treatment due to the risk of increased blood concentration of torasemide.

Elderly patients
There is no need to adjust the dosage 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:
Diuver is contraindicated during pregnancy.

Breastfeeding:
There is no data available 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 or mechanical equipment in motion.

Diuver contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Diuver 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.
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, a dose of 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 a 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 prescribed 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. However, 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 medicinal product, this medicine can cause adverse reactions, although not everyone experiences them.

Common (may occur in no more than 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 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 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 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 occur in no more than 1 in 100 patients):
In patients with impaired urine outflow, sudden urinary retention may occur. Increased serum levels of urea and creatinine may occur.

Rare (may occur in no more than 1 in 1,000 patients):
Paresthesia of the limbs.

Very rare (occurring less frequently than in 1 in 10,000 individuals, including single cases):
In isolated cases, thrombotic complications and disturbances in cardiac and cerebral circulation due to blood concentration (including myocardial and cerebral ischaemia) have been observed, leading, for example, to cardiac arrhythmias, angina pectoris, acute myocardial infarction, or fainting.

Pancreatitis.

There have been isolated reports 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) have been reported.

Rarely, reports have included sensations of numbness, tingling, and limb paralysis (paresthesia).

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions helps to provide more information on the safety of this medicine.

5. How to store Diuver

Keep the medicine out of the 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.
Translation of some information on the blister:
Ch.-B. und verwendbar bis: siehe Prägung – Batch number and expiry date: see imprint
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 pack 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 is a white or almost white, round, biconvex tablet, with a dividing line on one side and embossing 916 on the other side.

Pack size: 30 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Germany, country of export:
AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer:
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

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

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

German marketing authorization number (country of export): 57632.01.00
Parallel import authorization number: 219/22