Diuver

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Diuver (Torasemid AbZ)
10 mg, tablets
Torasemidum
Diuver and Torasemid AbZ are different trade names of the same medicinal product.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you may 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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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.

Therapeutic indications:

• Oedema associated with congestive heart failure, pulmonary oedema, hepatic oedema, and 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 function disorders 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 urination, 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, 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 insufficiency 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 a lack of clinical experience with the use of torasemide in this age group.
Diuvеr 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 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 in the body) and glucocorticoids (hormones regulating protein, carbohydrate and fat metabolism) as well as laxatives, it may increase urinary potassium excretion.
As with other diuretics (medicines that increase urine volume), the blood pressure-lowering effect may be enhanced when used concomitantly with other antihypertensive medicines.
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 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 starting 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.
Diuvеr with food and drink
Diuvеr should be taken in the morning with a small amount of fluid, regardless of meals.
Patients with impaired liver function
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
Dosage adjustment is not necessary 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:
Diuvеr is contraindicated during pregnancy.
Breastfeeding:
There is no data on passage of the medicine into breast milk. Diuvеr 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 or mechanical equipment.
Diuvеr contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Diuvеr 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 as directed by your doctor. 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 to 20 mg once daily. In individual, exceptional cases, 40 mg per day has been used.

Taking more Diuver than recommended
The typical clinical picture of torasemide overdose is not 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.
In case of taking more than the recommended dose, seek immediate medical advice from your doctor or pharmacist.

Missed dose of Diuver
If a dose is missed, 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common (may occur in up to 1 in 100 patients):
As with other diuretics, disturbances in water and electrolyte balance may occur depending on the dose administered and duration of treatment, particularly when a low-sodium diet is used. Hypokalaemia (decreased potassium levels in blood) may occur, especially in patients on a potassium-deficient diet, with vomiting, diarrhoea, using large amounts of laxatives, or 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 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-glutamyltransferase).

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

Rare (may occur in up to 1 in 1,000 patients):
Paresthesia of the limbs.

Very rare (occurring in fewer than 1 in 10,000 people, including single cases):
In isolated cases, thrombotic complications and circulatory disorders of cardiac and cerebral origin due to blood concentration (including myocardial and cerebral ischaemia) have been observed, leading, for example, to cardiac arrhythmias, angina pectoris, acute myocardial infarction, or syncope.
Pancreatitis.
There have been reports of isolated cases of decreased red blood cell, white blood cell, and platelet counts.
Allergic reactions such as itching, rash, and photosensitivity have occurred in isolated cases.
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 oral mucous membranes.

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 for 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 4921301, Fax: +48 22 4921309, 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 this 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
Translation of some information on the blister:
Ch.-B. und verwendbar bis: siehe Prägung – Batch number and expiry date: see imprint

6. Contents of the packaging and other information

What Diuver contains

• The active substance is torasemide. Each tablet contains 10 mg of torasemide.
• 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 packaging
Diuver 10 mg is a white or almost white, round, biconvex tablet with a dividing line on one side and an imprint "916" on the other side.

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

Marketing Authorisation Holder in Germany, the 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:
Pharmapoint SA
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warszawa
Poland
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Germany, the country of export: 57632.01.00
Parallel Import Licence Number: 243/18