Diuver

Package Leaflet: Information for the User

DIUVER, 5 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 is rapidly and almost completely absorbed, and maximum plasma concentrations are reached within 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 you are hypersensitive to torasemide, sulfonylurea derivatives (used in diabetes) or any of the other ingredients of this medicine (listed in section 6);
• if you have renal impairment with anuria;
• if you have hepatic coma and pre-coma states;
• if you have arterial hypotension;
• if you are breastfeeding.

Warnings and precautions

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

• if you have urinary retention disorders, before starting treatment, the cause of these disorders should be eliminated and water-electrolyte balance restored (especially in patients undergoing concomitant treatment with digitalis glycosides, glucocorticoids, mineralocorticoids, or laxatives).

if long-term therapy with torasemide is planned. 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 you have a tendency to increased uric acid levels in the blood and gout.
• if you have 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 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 medicines you are taking, have recently taken, or plan to take.

When torasemide is used concomitantly with digitalis glycosides (medicines that stimulate heart function, increase the strength of heart muscle contractions, and often reduce the frequency of these contractions), 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 that regulate mineral and ion metabolism in the body) and glucocorticoids (hormones that regulate protein, carbohydrate, and fat metabolism), as well as laxatives, it may cause increased potassium excretion in the urine.

Similarly, as with other diuretics, the blood pressure-lowering effect may be enhanced when other antihypertensive medicines are administered concomitantly.

Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, the nephrotoxic effect of cephalosporins, and the cardiotoxic and neurotoxic effects of lithium.

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

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

The effect of antidiabetic medicines may be weakened.

The use of ACE inhibitors after torasemide treatment, or the initiation of combination therapy with these medicines, may cause transient blood pressure drops. 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 using the ACE inhibitor.

Torasemide may reduce the reactivity of blood vessels to vasoconstrictor agents (e.g., adrenaline, noradrenaline).

Non-steroidal anti-inflammatory medicines (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 secretion in the renal tubules.

The concomitant administration of torasemide and cholestyramine has not been studied in humans, but in animal studies, it has been found to reduce the absorption of torasemide.

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.

Elderly patients

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

Pregnancy and breastfeeding

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 excretion 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 or operate machinery.

Diuver contains lactose monohydrate.

If you have been diagnosed with an intolerance to some sugars, you should consult your 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 as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Recommended dose

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 have shown 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 a risk of fluid and electrolyte loss, and subsequently, drowsiness, confusion, blood pressure drop, circulatory collapse, and 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.

If you have taken a higher dose of Diuver than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Diuver

Take the missed dose 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.

4. Possible side effects

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

Frequent(may occur in up to 10 in 100 patients):

Similarly to other diuretics, depending on the dose and duration of treatment, water-electrolyte disturbances may occur, especially when using a low-sodium diet. Hypokalemia (decreased potassium levels in the blood) may occur, especially in patients on a low-potassium diet, with vomiting, diarrhea, or using large amounts of laxatives, as well as in cases of liver dysfunction.

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, dizziness, blood pressure drop, 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 blood.

Metabolic alkalosis symptoms may worsen.

Gastrointestinal disorders may occur (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation).

Torasemide may cause increased activity of certain liver enzymes, such as gamma-GT (gamma-glutamyltransferase).

Infrequent(may occur in up to 1 in 100 patients):

In patients with urinary retention disorders, sudden cessation of urination may occur.

Increased levels of urea and creatinine in the blood may occur.

Rare(may occur in up to 1 in 1,000 patients):

Paresthesia of the limbs

Very rare(occurring in less than 1 in 10,000 patients, including single cases):

Thromboembolic complications and cardiovascular and cerebrovascular disorders due to blood thickening (including myocardial infarction and stroke) may occur.

Pancreatitis has been reported.

Single cases of decreased 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 visual and hearing disturbances (tinnitus, hearing loss) may occur.

Rarely, paresthesia (tingling, numbness) of the limbs has been reported.

Frequency not known(cannot be estimated from 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 Pharmacovigilance of the 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. 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.

Store in a temperature below 25°C.

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 5 mg of torasemide.

The other ingredients of the medicine are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), colloidal silicon dioxide, 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 of the tablet.

Pack size:

30 tablets in a pack.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53, 00-113 Warsaw

tel.: (22) 345 93 00

Manufacturer/Importer

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31-546 Kraków

Manufacturer

Pliva Croatia Ltd. (Pliva Hrvatska d.o.o.)

Prilaz Baruna Filipovića 25, 10000 Zagreb

Croatia

Date of last revision of the leaflet: