Diuver

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Diuver (Torasemide Teva)
5 mg, tablets
Torasemidum
Diuver and Torasemide Teva are different trade names for the same medicinal product.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any doubts, please 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform a 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 concentrations occurring within 1 to 2 hours. Approximately 80% of the administered dose is excreted in the urine.

Therapeutic 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, sulfonylurea derivatives (drugs used in diabetes), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has renal dysfunction with anuria;
• if the patient has hepatic coma or pre-comatose conditions;
• if the patient has arterial 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 disturbances in urine excretion, the cause of these disturbances should be eliminated and water-electrolyte balance restored before starting treatment (especially in patients receiving concomitant therapy with cardiac glycosides, glucocorticoids, mineralocorticoids, 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 predisposition to 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 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 or recently used, as well as any medicines the patient plans to use.
When torasemide is used concomitantly with cardiac glycosides (drugs that stimulate heart function, increase myocardial contractility, and simultaneously reduce heart rate), increased myocardial sensitivity to these drugs may occur due to decreased serum potassium and (or) magnesium levels.
In combination with mineralocorticoids (hormones regulating mineral and ionic balance) and glucocorticoids (hormones regulating protein, carbohydrate and fat metabolism), as well as with laxatives, it may increase urinary potassium excretion.
As with other diuretics (also known as diuretic drugs, drugs increasing urine volume), an enhanced blood pressure-lowering effect may occur when used concomitantly with other antihypertensive drugs.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, nephrotoxic effects of cephalosporins, and cardiotoxic and central nervous system toxic effects 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 effectiveness of antidiabetic drugs may be reduced.
Initiating treatment with angiotensin-converting enzyme (ACE) inhibitors after torasemide therapy, or starting 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 of, 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).
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 renal tubular excretion.
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 dysfunction
Patients with impaired liver function should be under special surveillance 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 is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy:
Diuver is contraindicated during pregnancy.
Breastfeeding:
There are no data on the 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, i.e. the medicine is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken according to the doctor's instructions. In case of 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
per day 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 necessary, the dose may be gradually increased
up to 20 mg once daily. In individual, exceptional cases, a dose of 40 mg per day has been used.
Taking a higher than recommended dose of Diuver
The typical clinical picture of torasemide overdose is not well known. In case of overdose,
marked diuresis may occur, with risk of fluid and electrolyte loss, and consequently
drowsiness, confusion, hypotension, circulatory collapse. Gastrointestinal disturbances may also appear.
There is no specific antidote. Symptoms of overdose require dose reduction or discontinuation of the
medicine, along with simultaneous administration of fluids and electrolytes.
If a higher than recommended dose has been taken, seek medical advice immediately from a doctor or
pharmacist.
Missed dose of Diuver
If a dose has been 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 everyone will experience them.

Common (may occur in up to 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, especially when a low-sodium diet is followed. Hypokalaemia (reduced potassium levels in the blood) may occur, particularly in patients on a potassium-deficient diet, those experiencing vomiting or diarrhoea, those using large amounts of laxatives, and in patients with impaired liver function.

In cases of significant diuresis, especially 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 may be 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, such as gammaGT (gamma-glutamyl transferase).

Uncommon (may occur in up to 1 in 100 patients):
In patients with impaired urinary outflow, sudden urinary retention may occur. Increased plasma concentrations of urea and creatinine may appear.

Rare (may occur in up to 1 in 1,000 patients):
Paresthesia of the limbs.

Very rare (occurring in fewer than 1 in 10,000 patients, including isolated cases):
In isolated cases, thrombotic complications and disturbances in cardiac and cerebral circulation due to blood concentration (including cardiac and cerebral ischaemia) have been observed, 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 auditory 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide further information on the safety of this 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. These measures help protect the environment.

6. Contents of the pack and other information

What Diuver contains

• The active substance is torasemide. Each tablet contains 5 mg of torasemide.

The other ingredients are: monohydrate lactose, maize starch,
sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Diuver looks like and contents of the pack

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

Pack size:
30 tablets per pack.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Lithuania, the country of export:
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Pliva Croatia Ltd.
Prilaz baruna Filipovića 25
10 000 Zagreb
Croatia

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Numbers of marketing authorisation in Lithuania, the country of export: LT/1/05/0227/013
LT/1/05/0227/003
Number of parallel import authorisation: 219/23