Diuver

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

WARNING! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Diuver (Torasemid-ratiopharm 10 mg Tablets), 10 mg, tablets

Torasemidum
Diuver Torasemid-ratiopharm 10 mg Tabletsare different trade names for the same drug.

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 another person, 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 pack 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

You should discuss the use of Diuver with your doctor or pharmacist before starting treatment.

• 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 digitalis 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 results in anti-doping tests. 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.

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 force of myocardial contraction, and at the same time decrease the frequency of this contraction), there may be an 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, the hypotensive effect may be enhanced when used concomitantly with 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 effect of curare-like muscle relaxants and theophylline may be enhanced during concomitant use with torasemide.

Because torasemide inhibits the tubular secretion of salicylates in patients receiving high doses of salicylates, their toxicity may increase.

The effect 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 effects 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, it has been found to reduce the 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

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

Patients of advanced age

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 in motion.

Diuver contains lactose monohydrate.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the 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 according to the doctor's recommendations. If you have any doubts, you should consult a 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.

Using a higher dose of Diuver than recommended

The typical picture of torasemide overdose is not known. In the case of an overdose, significant diuresis may occur with the risk of fluid and electrolyte loss, and subsequently, drowsiness, confusion, blood pressure drop, and circulatory collapse. Gastrointestinal disorders may also occur.

There is no specific antidote. The symptoms of an overdose require a reduction in dose or discontinuation of the medicine, along with the administration of fluids and electrolytes.

If you have taken a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a 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, Diuver can cause side effects, although not everybody gets them.

Frequent(may occur in up to 10 in 100 patients):

Similarly to other diuretics, depending on the size of the dose used and the duration of treatment, water and electrolyte balance disorders may occur, especially when using a low-sodium diet. Hypokalemia (decreased potassium levels in the blood) may occur, especially in patients on a potassium-poor diet, with vomiting, diarrhea, using large amounts of laxatives, and in cases of liver function disorders.

In the case of significant diuresis, especially at the beginning of treatment, and in elderly patients, symptoms of electrolyte and fluid loss may occur, such as headaches and dizziness, blood pressure drops, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. It may be necessary to change 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 certain liver enzymes, e.g., gamma-GT (gamma-glutamyltransferase).

Infrequent(may occur in up to 1 in 100 patients):

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 occur in less than 1 in 1000 patients):

Paresthesia of the limbs

Very rare(occurring in less than 1 in 10,000 patients, including single cases):

Thrombotic complications and disorders of cardiac and cerebral circulation, caused by blood thickening (including cardiac and cerebral ischemia), leading to arrhythmias, angina pectoris, acute myocardial infarction, or fainting.

Pancreatitis.

There have been reports of single cases of decreased red and white blood cell counts, as well as platelet counts.

In single cases, allergic reactions, such as itching, rash, and hypersensitivity to light, may occur.

Single cases of vision and hearing disorders (tinnitus, hearing loss) may occur.

Rarely, there have been reports of paresthesia (tingling, numbness) of the limbs.

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.

Reporting side effects will help to gather more information on the safety of the medicine.

Side effects can also be reported to the marketing authorization holder or parallel importer.

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.

Translation of some information on the blisters:

Ch.-B. und verwendbar bis: siehe Prägung – Batch number and expiry date see imprint

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.

6. Contents of the pack 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, corn starch, sodium carboxymethyl starch (type A), colloidal silica anhydrous, 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 score line on one side and an imprint of 916 on the other side of the tablet.

Package size:

30 tablets in a package.

To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa, Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Authorization number in Germany, the country of export:57688.01.00

Parallel import authorization number:201/17

Date of leaflet approval: 08.06.2022

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