Diuver

PACKAGE LEAFLET: INFORMATION FOR THE USER

WARNING! Keep the leaflet, information on the immediate packaging in a foreign language.
Diuver (Torasemid-ratiopharm 5 mg Tabletten), 5 mg, tablets
Torasemidum
Diuver and Torasemid-ratiopharm 5 mg Tabletten are different brand names for the same
medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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 any 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.
Indications:

• essential hypertension;
• oedema caused by congestive heart failure, pulmonary oedema, hepatic oedema, renal oedema.

2. Important information before using Diuver

When not to use Diuver

• if the patient is hypersensitive to torasemide, sulfonylureas (drugs 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 arterial hypotension;
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Diuver, consult your doctor or pharmacist.

• if the patient has disorders in urine excretion, 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, glucocorticosteroids, mineralocorticosteroids 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 such 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 agents;
• children under 12 years of age.

Use of Diuver may lead to positive results in 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 any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

When torasemide is used concomitantly with cardiac glycosides (drugs that stimulate heart function, increase the force of myocardial contraction, while decreasing contraction rate), increased myocardial sensitivity to these drugs may occur due to reduced plasma potassium and (or) magnesium levels.

When used together with mineralocorticosteroids (hormones regulating mineral and ionic balance in the body), glucocorticosteroids (hormones regulating protein, carbohydrate and fat metabolism), and laxatives, torasemide may increase potassium excretion in urine.

As with other diuretics (also known as diuretic drugs, drugs increasing urine volume excreted), concomitant use with other antihypertensive drugs may enhance the blood pressure-lowering effect.

Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the nephrotoxic effect of cephalosporins on the kidneys, and the 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 drugs may be reduced.

Administration of angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or initiation of combined 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 2–3 days before administering the ACE inhibitor.

Torasemide may reduce arterial responsiveness to vasoconstrictive drugs (e.g., adrenaline, noradrenaline).

Non-steroidal anti-inflammatory drugs (NSAIDs) (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 liver function disorders
Patients with impaired liver function should be under special monitoring during torasemide treatment due to the risk of increased blood levels of torasemide.

Elderly patients
Dosage adjustment is not required 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 her doctor or pharmacist before using this medicine.

Pregnancy:
Diuver is contraindicated during pregnancy.

Breastfeeding:
There is no data available on the passage of Diuver 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, which means the medicine is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Recommended dose
Adults:
Primary hypertension
The recommended dose is 2.5 mg orally once daily. If necessary, the dose may be increased
to 5 mg once daily. Clinical studies suggest that doses higher than 5 mg daily do not lead to
further blood pressure reduction. The maximum therapeutic effect is achieved after approximately
12 weeks of treatment.
Edema
The usual dose is 5 mg orally once daily. If needed, the dose may be gradually increased
up to 20 mg once daily. In individual, exceptional cases, a dose of 40 mg daily has been used.
Taking more Diuver than recommended
The typical clinical picture of torasemide overdose is not well known. In case of overdose,
marked diuresis may occur, with the risk of fluid and electrolyte loss, leading to drowsiness,
confusion, hypotension, and circulatory collapse. Gastrointestinal disturbances may also appear.
There is no specific antidote. Management of overdose symptoms includes reducing or discontinuing
the dose, along with administration of fluids and electrolytes.
If you have taken more than the recommended dose of Diuver, seek immediate medical advice
from your doctor or pharmacist.
If you forget to take Diuver
Take the missed dose 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 any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Common (may occur in no more than 10 out of 100 patients):
As with other diuretics, depending on the dose used and duration of treatment, disturbances in water-electrolyte balance may occur, especially when following a low-sodium diet. Hypokalaemia (reduced potassium concentration in blood) may occur, particularly in patients on a potassium-deficient diet, with vomiting, diarrhoea, those using large amounts of laxatives, and in patients with impaired liver function.
In case of significant diuresis, especially at the beginning of treatment, and also in elderly patients, symptoms of fluid and electrolyte loss may appear, such as headache, dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment of the medicine may become necessary.
Torasemide may increase serum 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-glutamyl transferase).

Uncommon (may occur in no more than 1 out of 100 patients):
In patients with impaired urine outflow, sudden urine retention may occur.
Increased plasma concentrations of urea and creatinine may occur.

Rare (may occur in less than 1 out of 1,000 patients):
Limb paraesthesia

Very rare (occurring in less than 1 out of 10,000 people, including single cases):
In isolated cases, thrombotic complications and circulatory disorders of the heart and brain have occurred due to blood concentration (including myocardial 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, rash, and photosensitivity may occur.
Isolated cases of visual and hearing 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 the oral mucosa.

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 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 to provide more information on the safety of the medicine.

5. How to store Diuver

Keep this medicine 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 stated month.
Medicines must 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 blisters:
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 5 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 pack

Diuver 5 mg is a white or almost white, round, biconvex tablet, with a score line on one side and the imprint "915" on the other side.

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

Repackaged in:
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

German Marketing Authorisation Number, country of export: 57688.00.00
Parallel Import Licence Number: 200/17