Diuver

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Diuver(Torasemid-ratiopharm 5 mg Tablets)

5 mg, tablets

Torasemidum
Diuver and Torasemid-ratiopharm 5 mg Tablets 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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 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:

• primary hypertension;
• edema caused by congestive heart failure, pulmonary edema, hepatic edema, and renal edema.

2. Important information before taking Diuver

When not to take Diuver

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

Warnings and precautions

Before starting treatment with Diuver, the patient should discuss it with their doctor or pharmacist.

• if the patient has urinary excretion disorders, before starting treatment, the cause of these disorders should be eliminated and water-electrolyte balance should be restored (especially in patients undergoing concurrent treatment with digitalis glycosides, glucocorticoids, mineralocorticoids, or laxatives);

if the patient is undergoing long-term torasemide therapy. During long-term treatment, regular monitoring of water-electrolyte balance, glucose, uric acid, creatinine, and lipid levels in the blood, as well as blood morphology (red and white blood cells and platelets), is recommended;

• if the patient has a tendency to increased uric acid levels in the blood and 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 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In the case of concomitant use of torasemide with cardiac glycosides (drugs that stimulate heart activity, increase the strength of myocardial contraction, and at the same time reduce the frequency of this contraction), there may be an increased sensitivity of the heart muscle 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) and laxatives, it may cause increased potassium excretion in the urine.
Similarly, as with other diuretics, the effect of lowering blood pressure may be enhanced during concurrent administration of other antihypertensive drugs.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, and the toxic effect of cephalosporins on the kidneys, as well as 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 concurrent use with torasemide.
Since torasemide inhibits the tubular excretion of salicylates in patients receiving large 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 combined 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 concurrent 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, breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 machines.

Diuver contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose
Adults:

Primary hypertension

A dose of 2.5 mg orally once a day is recommended. If necessary, the dose can be increased to 5 mg once a day. Studies suggest that doses greater than 5 mg per day do not lead to further blood pressure reduction. The maximum therapeutic effect is achieved after approximately 12 weeks of treatment.

Edema

Usually, a dose of 5 mg orally once a day is used. 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.

Taking a higher dose of Diuver than recommended

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, and 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, along with the administration of fluids and electrolytes.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their 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, the patient should take it at the scheduled time.
The patient 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.
Common(may occur in up to 10 in 100 patients):
Similarly to other diuretics, depending on the dose used and the duration of treatment, water-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 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 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 (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation) may occur.
Torasemide may cause increased activity of certain liver enzymes, e.g., gamma-GT (gamma-glutamyltransferase).
Uncommon(may occur in up to 1 in 100 patients):
In patients with urinary excretion 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.
Single cases of reduced red and white blood cell counts, as well as platelet counts, have been reported.
Single cases of allergic reactions, such as itching, rash, and photosensitivity, have been reported.
Single cases of vision and hearing disorders (tinnitus, hearing loss) may occur.
Rarely, paresthesia 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department for 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, it is possible to gather more information on the safety of the 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.
Translation of some inscriptions on the blister pack:
Ch.-B. und Verw. bis siehe Prägung - Batch number and expiry date see imprint
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 5 mg of torasemide.

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 5 mg is a white or almost white, round, biconvex tablet with a score line on one side and an imprint of 915 on the other side of the tablet.
Pack size: 30 tablets in a pack.
For more detailed information, the patient should contact the marketing authorization holder or the 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:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Germany, the country of export: 57688.00.00

Parallel import authorization number: 307/22 Date of leaflet approval: 16.08.2022

[Information about the trademark]