Diuver

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Diuver(Torasemide ratio 5 mg tablets EFG)

5 mg, tablets

Torasemidum
Diuver and Torasemida ratio 5 mg tablets EFG are different trade names for the same medicine.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 concentration occurs in the serum after 1 to 2 hours. About 80% of the administered dose is excreted in the urine.

• 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

Warnings and precautions

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

if torasemide therapy is long-term. 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.

Due to insufficient experience with torasemide treatment, caution should be exercised in the following situations:

• pathological changes in acid 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 can 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

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.

In the case of concomitant use of torasemide with cardiac glycosides (medicines that stimulate heart function, increase the strength of heart muscle contractions, and at the same time 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 serum.

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

Similarly, as with other diuretics, the effect of lowering blood pressure may be enhanced 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 effect of curare-like muscle relaxants and theophylline may be enhanced during concomitant use with torasemide.

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

The effect 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 a 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 effect 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.

Patients of advanced age

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a 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 has been found.

Driving and using machines

As with other blood pressure medicines, patients taking torasemide who experience dizziness or similar symptoms should not drive vehicles or operate machines.

Diuver contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their 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 according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Recommended dose

Adults:

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 the risk of fluid and electrolyte loss, and subsequently drowsiness, confusion, blood pressure drop, circulatory collapse. Gastrointestinal disorders may occur.

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

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Diuver

A missed dose should be taken as soon as possible. If it is almost time for the next dose, it should be taken at the scheduled time.

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

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

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

Similarly to other diuretics, depending on the dose used and the duration of treatment, water-electrolyte disorders may occur, especially when using a low-sodium diet. Hypokalemia (decreased potassium levels in the blood) may occur, especially in patients on a potassium-poor diet, with vomiting, diarrhea, using 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 electrolyte and fluid loss may occur, such as headaches and dizziness, blood pressure drops, weakness, drowsiness, confusion, loss of appetite, muscle cramps. It may be necessary to adjust the dose of the medicine.

Torasemide may cause increased uric acid, glucose, and lipid levels in the serum.

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 some liver enzymes, e.g., gammaGT (gamma-glutamyltransferase).

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

In patients with urinary disorders, sudden cessation of urination may occur. Increased levels of urea and creatinine in the blood may occur.

Rare(may occur in less than 1 in 1000 patients):

Paresthesia of the limbs.

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

Thrombotic complications and disorders of cardiac and cerebral circulation, caused by blood thickening (including cardiac and cerebral ischemia), leading to arrhythmias, angina pectoris, acute myocardial infarction, or fainting.

Pancreatitis.

Single cases of reduced red and white blood cell counts, as well as platelet counts, have been reported.

Single cases of allergic reactions, such as itching, rash, and hypersensitivity to light, have been reported.

Single cases of vision and hearing disorders (tinnitus, hearing loss) may occur.

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

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 any side effects not listed in this leaflet, you should tell 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 181 C, 02-222 Warsaw.

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

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

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

5. How to store Diuver

The medicine should be stored in a place invisible and inaccessible to children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 silica anhydrous, magnesium stearate.

What Diuver looks like and what the packaging contains

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 the packaging.

To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

TEVA PHARMA, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren

Germany

Teva Operations Poland sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25

Zagreb

Croatia

Parallel importer:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Laboratorium Galenowe Olsztyn Sp. z o.o.

ul. Spółdzielcza 25A

11-001 Dywity

CEFEA Sp. z o.o. Sp. komandytowa

ul. Działkowa 56

02-234 Warszawa

Pharma Innovations Sp. z o. o.

ul. Jagiellońska 76

03-301 Warszawa

Number of the marketing authorization in Spain, the country of export: 665104.9

Number of the parallel import authorization: 219/18

Date of approval of the leaflet: 24.05.2023

[Information about the trademark]