Diuver

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the 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 for the same medicine.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Diuver and what is it 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 package and other information

1. What is Diuver and what is it used for

Diuver is a diuretic. After oral administration, torasemide is rapidly and almost completely absorbed, and the maximum concentration occurs in the serum after 1 to 2 hours. About 80% of the administered dose is excreted in the urine.
Indications for use:

• edema caused by congestive heart failure, pulmonary edema, hepatic edema, renal edema.

2. Important information before taking Diuver

When not to take Diuver:

• if you are hypersensitive to torasemide, sulfonylurea derivatives (drugs used in diabetes) or any of the other ingredients of this medicine (listed in section 6);
• if you have renal function disorders with anuria;
• if you have hepatic coma and pre-coma states;
• if you have arterial hypotension;
• if you are breastfeeding.

Warnings and precautions

Before starting treatment with Diuver, you should discuss it with your doctor or pharmacist:

• if you have urinary disorders, before starting treatment, you should eliminate the cause of these disorders and restore water and electrolyte balance (especially in patients undergoing concomitant treatment with cardiac glycosides, glucocorticoids, mineralocorticoids, or laxatives);
• if torasemide therapy is long-term. During long-term treatment, it is recommended to regularly monitor water and electrolyte balance, glucose, uric acid, creatinine, and lipid levels in the blood, as well as blood morphology (red and white blood cells and platelets);
• if you have a tendency to increased uric acid levels in the blood and gout;
• if you have 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 factors,
• children under 12 years of age.

Taking Diuver may lead to positive doping control results. Using Diuver as a doping agent can pose a health risk.

Children and adolescents

There is a lack of clinical experience with the use of torasemide in this age group.

Diuver and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In the case of concomitant use of torasemide with cardiac glycosides (drugs that stimulate heart function, increase the strength of myocardial contraction, and at the same time reduce the frequency of this contraction) may lead to increased sensitivity of the myocardium to these drugs, due to decreased potassium and (or) magnesium levels in the serum.
In combination with mineralocorticoids (hormones that regulate mineral and ion metabolism in the body) and glucocorticoids (hormones that regulate protein, carbohydrate, and fat metabolism) as well as laxatives, it may cause increased potassium excretion in the urine.
Similarly, as with other diuretics (also known as diuretic drugs, drugs that increase the volume of urine excreted), the blood pressure-lowering effect may be enhanced during concomitant administration of other antihypertensive drugs.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the toxic effect of cephalosporins on the kidneys, and the toxic effect of lithium on the heart and central nervous system.
The action of curare-like muscle relaxants and the action of theophylline may be enhanced during concomitant use with torasemide.
Since torasemide inhibits the tubular secretion of salicylates in patients receiving high doses of salicylates, their toxicity may increase.
The action of antidiabetic drugs may be weakened.
The use of angiotensin-converting enzyme inhibitors after torasemide treatment, or the initiation of combination therapy with these drugs, may cause transient blood pressure drops. This effect can be minimized by reducing the initial dose of the angiotensin-converting enzyme inhibitor and (or) reducing the dose or temporarily discontinuing torasemide for 2-3 days before using the drug from the group of angiotensin-converting enzyme inhibitors.
Torasemide may reduce the reactivity of arteries to vasoconstrictor drugs (e.g., adrenaline, noradrenaline).
Non-steroidal anti-inflammatory drugs (e.g., indomethacin) may reduce the diuretic and hypotensive effect of torasemide by inhibiting prostaglandin synthesis.
Probenecid may reduce the effectiveness of torasemide by inhibiting its secretion in the renal tubules.
The concomitant administration of torasemide and cholestyramine has not been studied in humans, but in animal studies, a decrease in torasemide absorption has been observed.

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

During torasemide treatment, patients with liver function disorders should be under special supervision due to the risk of increased torasemide levels in the blood.

Elderly patients

In elderly patients, there is no need to adjust the dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy:
Diuver is contraindicated during pregnancy.
Breastfeeding:
There is no data on the penetration of the drug into breast milk. Diuver is contraindicated during breastfeeding.
Fertility:
In non-clinical studies, no effect of torasemide on fertility was found.

Driving and using machines

As with other blood pressure-lowering drugs, patients who take torasemide and experience dizziness or similar symptoms should not drive vehicles or operate machinery.

Diuver contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Diuver contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Recommended dose
Adults:

Edema

Usually, 5 mg is taken orally once a day. If necessary, the dose can be gradually increased to 20 mg once a day. In individual, exceptional cases, doses of up to 40 mg per day have been used.

Overdose of Diuver

The typical picture of torasemide overdose is not known. In case of overdose, significant diuresis may occur with the risk of fluid and electrolyte loss, and subsequently drowsiness, confusion, blood pressure drop, circulatory collapse. Gastrointestinal disorders may occur.
There is no specific antidote. The symptoms of overdose require a reduction in dose or discontinuation of the medicine, with simultaneous administration of fluids and electrolytes.
If you have taken more than the recommended dose of the medicine, you should immediately consult a doctor or pharmacist.

Missed dose of Diuver

A missed dose should be taken as soon as possible. If it is almost time for the next dose, you should take it at the scheduled time.
You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):
Similarly to other diuretics, depending on the size of the dose used and the duration of treatment, water and electrolyte disorders may occur, especially when using a low-sodium diet. Hypokalemia (decreased potassium levels in the blood) may occur, especially in patients on a low-potassium diet, with vomiting, diarrhea, using large amounts of laxatives, and in cases of liver function disorders.
In case of significant diuresis, especially at the beginning of treatment, and in elderly patients, symptoms of fluid and electrolyte loss may occur, such as headache, dizziness, blood pressure drop, weakness, drowsiness, confusion, loss of appetite, muscle cramps. It may be necessary to adjust the dose of the medicine.
Torasemide may cause increased levels of uric acid, glucose, and lipids in the serum.
Metabolic alkalosis symptoms may worsen.
Gastrointestinal disorders may occur (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation).
Torasemide may cause increased activity of some liver enzymes, e.g., gamma-GT (gamma-glutamyltransferase).
Uncommon(may affect up to 1 in 100 people):
In patients with urinary disorders, sudden cessation of urine production may occur.
Increased levels of urea and creatinine in the blood may occur.
Rare(may affect up to 1 in 1,000 people):
Paresthesia of the limbs.
Very rare(affects less than 1 in 10,000 people, including single cases):
Thrombotic complications and disorders of cardiac and cerebral circulation, caused by blood thickening (including myocardial infarction and cerebral infarction), leading to arrhythmias, angina pectoris, acute myocardial infarction, or fainting.
Pancreatitis.
Single cases of decreased red and white blood cell count, as well as platelet count, have been reported.
Single cases of allergic reactions, such as itching, rash, and photosensitivity, have been reported.
Single cases of visual and hearing disorders (tinnitus, hearing loss) may occur.
Rarely, paresthesia (tingling, numbness) of the limbs has been reported.
Frequency not known(cannot be estimated from the available data):
Dryness of the mucous membranes of the mouth.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects, you can help provide more information on the safety of this medicine.

5. How to store Diuver

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Translation of some information on the blister pack:
Ch.-B. und verwendbar bis: see imprinting

• Batch number and expiry date: see embossing

6. Contents of the package and other information

What Diuver contains

• The active substance of the medicine is torasemide. Each tablet contains 10 mg of torasemide.
• The other ingredients of the medicine are: lactose monohydrate, cornstarch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Diuver looks like and what the package contains

Diuver 10 mg is a white or almost white, round, biconvex tablet with a score line on one side and an imprint of 916 on the other side of the tablet.
Package size: 30 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
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
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 57632.01.00
Parallel import authorization number: 243/18
Date of leaflet approval: 04.05.2022
[Information about the trademark]