Diuver

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Diuver (Torasemida ratio 5 mg comprimidos EFG), 5 mg, tablets
Torasemidum
Diuver and Torasemida ratio 5 mg comprimidos EFG are different trade names for the same
medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Diuver is and what it is used for
2. What you need to know 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, and renal oedema.

2. Important information before using Diuver

When not to use Diuver

• if the patient has hypersensitivity to torasemide, sulfonylurea derivatives (drugs used in diabetes) or any of the other components of this medicine (listed in section 6);
• if the patient has renal 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, discuss this with your doctor or pharmacist:

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

in patients receiving concomitant treatment with cardiac glycosides,
glucocorticosteroids, mineralocorticoids 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 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 changes in acid-base balance,
• concomitant treatment with lithium, aminoglycosides or cephalosporins,
• renal failure caused by nephrotoxic factors,
• 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.

Diuvеr 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 the force of myocardial contraction, while reducing contraction frequency), 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 in the body) and glucocorticosteroids (hormones regulating protein, carbohydrate and fat metabolism) as well as laxatives, increased potassium excretion in urine may occur.
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 and cisplatin, nephrotoxic effects of cephalosporins, and cardiotoxic and central nervous system toxicity of lithium.
The effects of curare-like muscle relaxants and 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.
Administration of angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or initiation of 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 2–3 days before administering the ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictor drugs (e.g. adrenaline, noradrenaline).
Non-steroidal anti-inflammatory drugs (e.g. indomethacin) may reduce the diuretic and antihypertensive effects of torasemide by inhibiting prostaglandin synthesis.
Probenecid may reduce the efficacy 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.

Diuvеr with food and drink
Diuvеr should be taken in the morning with a small amount of fluid, regardless of meals.

Patients with liver function disorders
Patients with liver function disorders should be under special monitoring during torasemide treatment due to the risk of increased blood concentration 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 plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy:
Diuvеr is contraindicated during pregnancy.
Breastfeeding:
There is no data on passage of the drug into breast milk. Diuvеr 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.

Diuvеr contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Diuvеr contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Diuver

This medicine should always be taken according to the doctor's instructions. If in doubt, 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 more Diuver than recommended
The typical clinical picture of torasemide overdose is not well known. In case of overdose,
marked diuresis may occur, leading to the risk of fluid and electrolyte loss, and consequently
drowsiness, confusion, hypotension, circulatory collapse. Gastrointestinal disturbances may also
occur.
There is no specific antidote. Symptoms of overdose require dose reduction or discontinuation
of the medicine, along with administration of fluids and electrolytes.
If you have taken more than the recommended dose of Diuver, seek immediate medical advice from
your doctor or pharmacist.
Missing a dose of Diuver
If you miss a dose, take it as soon as possible. If it is almost time for your 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 effects

Like any medicine, this medicine may cause adverse effects, 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 used and duration of treatment, especially when following a low-sodium diet. 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 pain and dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment may be necessary.
Torasemide may increase plasma levels 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, e.g. gamma-GT (gamma-glutamyl transferase).

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

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 isolated cases):
In isolated cases, thrombotic complications and circulatory disorders of the heart and brain have been observed due to blood concentration (including cardiac and cerebral ischaemia), 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.
Allergic reactions such as itching, skin rash, and photosensitivity may occur in isolated cases.
Isolated cases of visual and hearing 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse effects 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 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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: lactose, maize starch, sodium carboxymethyl starch (type A),
colloidal silicon dioxide, 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
imprint 915 on the other side of the tablet.
Pack size:
30 tablets per pack.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Spain, 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
Blaubeuren CP: D-89143
Germany

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

PLIVA HRVATSKA D.O.O.
Prilaz Baruna Filipovića 25
10000 Zagreb
Croatia

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spain Marketing Authorisation Number: 665104.9
Parallel Import Licence Number: 748/15