PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Diuver (Torasemid-ratiopharm 10 mg Tabletten)
10 mg, tablets
Torasemidum
Diuver and Torasemid-ratiopharm 10 mg Tabletten are different brand names of the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, 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:

What Diuver is and what it is used for
Important information before taking Diuver
How to take Diuver
Possible side effects
How to store Diuver
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 reached 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, renal edema.

2. Important information before using Diuver

When not to use Diuver

if the patient is hypersensitive to torasemide, sulfonylurea derivatives (drugs 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 urination, the underlying cause should be eliminated and water-electrolyte balance restored before initiating treatment (especially in
patients receiving concomitant therapy with cardiac glycosides,
glucocorticoids,
mineralocorticoids, or laxative drugs);
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. Carbohydrate metabolism should be monitored in these patients. Due to insufficient experience with torasemide treatment, caution should be exercised in the following situations:
pathological disturbances 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 to be used by the patient.
When torasemide is used concomitantly with cardiac glycosides (drugs 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 ion metabolism) and glucocorticoids (hormones regulating protein, carbohydrate and fat metabolism), as well as with laxative agents, it may increase urinary potassium excretion.
As with other diuretic drugs (alternatively, diuretics, drugs increasing urine volume), concomitant administration with other antihypertensive drugs 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-relaxing effect of curare-like drugs 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 effect of antidiabetic drugs may be reduced.
Administration of angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or initiation of combination 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) reducing the dose or temporarily discontinuing torasemide for 2–3 days before administering the ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictive drugs (e.g., adrenaline, noradrenaline).
Nonsteroidal 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 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
There is no need to adjust the dosage in elderly patients.
Pregnancy, 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 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 drugs 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
This 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. 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, 40 mg daily 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, circulatory collapse. Gastrointestinal disturbances
may also occur.
There is no specific antidote. Symptoms of overdose require dose reduction or
discontinuation of the drug, along with administration of fluids and electrolytes.
If you have taken more than the recommended dose of Diuver, seek immediate advice from your doctor or
pharmacist.
Missing a 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 all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common (may occur in no more than 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 followed.
Hypokalaemia (reduced potassium levels in the blood) may occur, especially in patients on a potassium-deficient diet, those experiencing vomiting or diarrhoea, those taking large amounts of laxatives, and in patients with impaired liver function.
In cases of significant diuresis, particularly at the beginning of treatment and 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-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 plasma concentrations of urea and creatinine may occur.

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

Very rare (occurring less frequently than in 1 in 10,000 people, including isolated cases):
In isolated cases, thrombotic complications and circulatory disorders affecting the heart and brain have been observed, 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, skin rash, and photosensitivity may occur.
Isolated cases of visual and hearing disturbances (e.g. 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 reactions
If any adverse reactions occur, including any 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 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.
Translation of some texts on the blister:
Ch.-B. und verwendbar bis: siehe Prägung - Batch number and expiry date: see embossing.
Medicines should 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 in Diuver is torasemide. Each tablet contains 10 mg of torasemide.

Other ingredients in 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 dividing line on one side and the imprint 916 on the other side of the tablet.

Pack size: 30 tablets per pack.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:

ratiopharm 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
Poland

Repackaged by:

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

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Germany, the country of export: 57688.01.00
Parallel Import Licence Number: 308/22