Diuver

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, 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 adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

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:

• Edema due to congestive heart failure, pulmonary edema, hepatic edema, renal edema.

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 kidney function disorders with anuria;
• if the patient has hepatic coma or pre-coma conditions;
• if the patient has hypotension;
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Diuver, consult a doctor or pharmacist:

• if the patient has disorders in urine excretion, the cause of these disorders should be eliminated before starting treatment and water-electrolyte balance should be restored (especially in

patients receiving concomitant therapy with cardiac glycosides, glucocorticosteroids,
mineralocorticosteroids or laxative drugs);

• 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,
• kidney 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 lack of clinical experience with the use of torasemide in this age group.
Diuretic and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
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 reduced serum potassium and (or) magnesium levels.
In combination with mineralocorticosteroids (hormones regulating mineral and ionic balance) and glucocorticosteroids (hormones regulating protein, carbohydrate and fat metabolism) as well as laxatives, it may increase potassium excretion in urine.
As with other diuretics (drugs that increase urine volume), concomitant use with other antihypertensive drugs may enhance blood pressure-lowering effects.
Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, nephrotoxic effects of cephalosporins, and 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.
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 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.
Diuretic with food and drink
Diuretic 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, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy:
Diuretic is contraindicated during pregnancy.
Breastfeeding:
There are no data on passage of the drug into breast milk. Diuretic 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 using torasemide who experience dizziness or similar symptoms should not drive or operate machinery.
Diuretic 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.
Diuretic contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
Adults:
Oedema
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 daily has been used.

Taking more Diuver than prescribed
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 somnolence, confusion, hypotension, circulatory collapse, and gastrointestinal disturbances.

There is no specific antidote. Symptoms of overdose require dose reduction or discontinuation of the medicine, together with administration of fluids and electrolytes.

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.

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 may cause adverse reactions, although not everyone experiences them.

Common (may occur in up to 1 in 100 patients):
As with other diuretics, disturbances in fluid 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 concentration in 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 particularly in elderly patients, symptoms of fluid and electrolyte loss may appear, such as pain, dizziness, low blood pressure, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment may be necessary.

Torasemide may increase serum 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 gamma-GT (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 concentrations of urea and creatinine in blood serum may appear.

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

Very rare (occurring in fewer than 1 in 10,000 patients, including single cases):
In isolated cases, thrombotic complications and circulatory disorders of cardiac and cerebral origin due to blood concentration (including myocardial and cerebral ischaemia) have been observed, potentially leading 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.

Isolated cases of allergic reactions such as itching, rash, and photosensitivity have been reported.

Cases of visual and hearing disturbances (e.g. tinnitus, hearing loss) have been reported.

Rarely, numbness, tingling, and limb paralysis (paresthesia) have been reported.

Frequency not known (cannot be estimated from available data):
Dryness of the oral mucosa.

Reporting of adverse reactions
If any adverse reactions occur, including those 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 181C, 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 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Diuver contains
The active substance is torasemide. Each tablet contains 10 mg of torasemide.
Other ingredients are: lactose monohydrate, maize starch, sodium carboxymethyl starch (type A),
colloidal anhydrous silica, 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 dividing line on one side and
imprint 916 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Lithuania, the country of export: LT/1/05/0227/009
Parallel Import Authorisation Number: 208/22