Diuver

Package Leaflet: Information for the Patient

Diuver, 20 mg, Tablets

Torasemide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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, the active substance of the medicine, is quickly and almost completely absorbed, and the maximum concentration occurs in the blood 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, liver-related edema, kidney-related edema. Diuver is used in adults.

2. Important information before taking Diuver

When not to take Diuver:

Warnings and precautions

Before starting treatment with Diuver, discuss it with your doctor or pharmacist.

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 and adolescents under 18 years of age.

Taking Diuver may lead to positive doping control results. 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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.

In the case of concomitant use of torasemide with cardiac glycosides (medicines that stimulate heart function, increase the strength of muscle contraction, and at the same time reduce the frequency of this contraction), there may be an increased sensitivity of the heart muscle to these medicines due to decreased potassium and (or) magnesium levels in the blood.

In combination with mineralocorticoids (hormones regulating mineral and ion metabolism) and glucocorticoids (hormones regulating protein, carbohydrate, and fat metabolism), as well as laxatives, it may cause increased potassium excretion in the urine.

Similarly, as with other diuretics (also known as diuretic medicines, medicines that increase urine output), there may be an enhancement of the blood pressure-lowering effect during concomitant administration of other antihypertensive medicines.

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 action of curare-like muscle relaxants and the action of theophylline may be enhanced during concomitant use with torasemide.

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

The action of antidiabetic medicines may be weakened.

The use of angiotensin-converting enzyme inhibitors after torasemide treatment, or the initiation of combined therapy with these medicines, 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 medicine from the group of angiotensin-converting enzyme inhibitors.

Torasemide may reduce the reactivity of arteries to vasoconstrictor medicines (e.g., adrenaline, noradrenaline).

Non-steroidal anti-inflammatory medicines (e.g., indomethacin) may reduce the diuretic and hypotensive (blood pressure-lowering) 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, 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 liquid, 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.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 medicine 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 medicines, patients who take torasemide and experience dizziness or similar symptoms should not drive vehicles or operate machinery.

Diuver contains lactose monohydrate

The medicine contains sugar lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Diuver

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your 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, 40 mg per day has been used.

The tablet can be divided into equal doses.

Diuver is usually used for long-term treatment or until the edema subsides.

Use in the elderly

In elderly patients, there is no need to adjust the dosage.

Use in children and adolescents

Due to insufficient experience with the use of torasemide in children and adolescents, Diuver is not recommended for patients under 18 years of age.

Method of administration

Oral administration.

Diuver should be taken in the morning with a small amount of liquid, regardless of meals.

Overdose of Diuver

In case of overdose, consult your doctor or pharmacist immediately.

The typical picture of torasemide overdose is not known. In case of overdose, significant diuresis may occur with a risk of fluid and electrolyte loss, and subsequently drowsiness, confusion, blood pressure drop, 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, with simultaneous administration of fluids and electrolytes.

Missed dose of Diuver

A missed dose should be taken as soon as possible. If it is almost time for the next dose, take it at the scheduled time. Do not take a double dose to make up for the missed dose.

Discontinuation of Diuver

Do not stop taking Diuver without consulting your doctor, as this may cause harmful effects and reduce the effectiveness of treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diuver can cause side effects, although not everybody gets them.

Side effects may occur with the following frequency:

Common(may affect up to 1 in 10 people):

• dose- and duration-dependent water-electrolyte disorders, especially with a low-sodium diet
• decreased potassium levels in the blood (hypokalemia), especially in patients on a low-potassium diet, with vomiting, diarrhea, taking 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 fluid and electrolyte loss may occur, such as headache and dizziness, blood pressure drop, weakness, drowsiness, confusion, loss of appetite, muscle cramps. It may be necessary to adjust the dose of the medicine.
• increased metabolic alkalosis
• gastrointestinal disorders, e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation
• increased uric acid, glucose, and lipid levels in the blood
• increased activity of certain liver enzymes (e.g., gamma-glutamyltransferase)

Uncommon(may affect up to 1 in 100 people):

• in patients with urinary excretion disorders, sudden cessation of urine production may occur. An increase in urea and creatinine levels in the blood may occur.

Rare(may affect up to 1 in 1,000 people):

• paresthesia of the limbs (numbness or tingling)

Very rare(may affect up to 1 in 10,000 people, including single cases):

• decreased red and white blood cell and platelet count
• visual and hearing disorders (tinnitus, hearing loss)
• thrombotic complications and disorders of cardiac and cerebral circulation, caused by blood thickening (including cardiac arrhythmias, angina pectoris, acute myocardial infarction, or fainting)
• pancreatitis
• allergic reactions (such as itching, rash, hypersensitivity to light), severe skin reactions

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, please inform 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 181C, 02-222 Warsaw.

tel.: +48 22 49 21 301,

faks: + 48 22 49 21 309,

Website: https://smz.ezdrowie.gov.pl

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diuver

Keep the medicine out of the sight and reach of children.

There are no special precautions for storing the medicine.

Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. 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 20 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 is a white or almost white, round, biconvex tablet with a score line on one side and the imprint T20 on the other side of the tablet.

Package size:

30 or 60 tablets in a cardboard box. The tablets are packaged in PVC/PVDC/Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

Pliva Croatia Ltd.

Prilaz Baruna Filipovića 25

10000 Zagreb

Croatia

To obtain more detailed information about the medicine, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53,

00-113 Warsaw

Tel.: (22) 345 93 00

Date of last revision of the package leaflet: