Diuver

Package leaflet: Information for the user

Warning! Keep the leaflet. The information on the immediate packaging is 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 brand names of the same
medicinal product.
Please read the entire leaflet carefully before taking 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 concentrations occurring within 1 to 2 hours. Approximately 80% of the administered dose is excreted in urine.
Therapeutic indications:

• essential hypertension;
• oedema due to congestive heart failure, pulmonary oedema, hepatic oedema, and renal oedema.

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 components of this medicine (listed in section 6);
• if the patient has renal dysfunction 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 disturbances in urination, the cause of these disturbances should be eliminated before initiating treatment and water-electrolyte balance should be restored (especially in
  patients receiving concomitant treatment 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,
• renal failure caused by nephrotoxic agents,
• children under 12 years of age.

The use of Diuver may lead to positive results in anti-doping controls.
The use of 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.

Diuver with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken or plan to take.

When torasemide is used concomitantly with cardiac glycosides (drugs that stimulate heart function, increase the force of myocardial contraction and simultaneously reduce contraction rate), increased myocardial sensitivity to these drugs may occur due to reduced plasma potassium and (or) magnesium levels.

In combination with mineralocorticosteroids (hormones regulating mineral and ionic balance in the body) and glucocorticosteroids (hormones regulating protein, carbohydrate and fat metabolism), as well as with laxative agents, torasemide may increase urinary potassium excretion.

As with other diuretics (drugs that increase urine volume), concomitant administration of other antihypertensive drugs may enhance the blood pressure-lowering effect.

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 effect of curare-like muscle relaxants and the effect of theophylline may be enhanced when used concomitantly with torasemide.

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

The effectiveness of antidiabetic drugs may be reduced.

Administration of angiotensin-converting enzyme (ACE) inhibitors after treatment with torasemide, or initiation of combined 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) by reducing the dose of, or temporarily discontinuing, torasemide for 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 hypotensive effects of torasemide by inhibiting prostaglandin synthesis.

Probenecid may reduce the effectiveness of torasemide by inhibiting its renal tubular secretion.

Concomitant administration of torasemide and cholestyramine has not been studied in humans, but animal studies have shown reduced absorption of torasemide.

Diuver with food and drink
Diuver 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 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy:
Diuver is contraindicated during pregnancy.

Breastfeeding:
There is no data on the passage of the drug into breast milk. Diuver 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.

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

Diuver contains sodium
This 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 prescribed by your doctor. 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 daily 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 needed, 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 recommended
The typical clinical picture of torasemide overdose is not well known. In case of overdose, marked diuresis may occur, with risk of fluid and electrolyte loss, leading to drowsiness, confusion, hypotension, and circulatory collapse. Gastrointestinal disturbances may also appear.

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.

Missed dose of Diuver
If you miss a dose, take it as soon as possible. However, if it is almost time for your next scheduled dose, take the next dose at the regular time.

Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can 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, with vomiting, diarrhoea, using large amounts of laxatives, or with impaired liver function.
In case 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, drops in blood pressure, weakness, drowsiness, confusion, loss of appetite, muscle cramps. A dose adjustment of the medicine may become 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. gammaGT (gamma-glutamyl transferase).

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

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

Very rare (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 cardiac and cerebral ischaemia) have occurred, 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.
In isolated cases, allergic reactions such as itching, rash, and photosensitivity may occur.
Isolated cases of visual and hearing disturbances (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 oral mucous membranes.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows further information on the safety of the medicine to be collected.

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. 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 5 mg of torasemide.

The other ingredients are: monohydrate lactose, corn starch,
sodium carboxymethyl starch (type A), colloidal anhydrous silica, 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 per pack.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland

Spanish marketing authorisation number (country of export): 665104.9
Parallel import authorisation number: 219/18