Diuver

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Diuver (Torasemid-ratiopharm 5 mg Tabletten)
5 mg, tablets
Torasemidum
Diuver and Torasemid-ratiopharm 5 mg Tabletten are different brand names of the same medicinal product.
Please read this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any 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. 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, torasemid is rapidly and almost completely absorbed, with peak plasma concentrations reached within 1 to 2 hours. Approximately 80% of the administered dose is excreted in the urine.
Indications:

• essential hypertension;
• oedema caused by congestive heart failure, pulmonary oedema, hepatic oedema, renal oedema.

2. Important information before using Diuver

When not to use Diuver

• if the patient is hypersensitive to torasemide, sulfonylureas (drugs used in diabetes) or any of the other ingredients 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 arterial 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 urine excretion, the cause of these disorders should be eliminated and water-electrolyte balance restored before initiating treatment (especially in patients receiving concomitant therapy with cardiac glycosides, glucocorticosteroids, mineralocorticosteroids or laxatives);
• 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 disturbances in acid-base balance,
• concomitant treatment with lithium, aminoglycosides or cephalosporins,
• renal failure caused by nephrotoxic agents,
• 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.
Diuvver with other medicines
Tell your doctor or pharmacist about any other 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 heart rate), increased myocardial sensitivity to these drugs may occur due to reduced plasma potassium and (or) magnesium levels.
When used together with mineralocorticosteroids (hormones regulating mineral and electrolyte balance) and glucocorticosteroids (hormones regulating protein, carbohydrate and fat metabolism) as well as laxatives, increased potassium excretion in urine may occur.
Like other diuretics (i.e. drugs that increase urine volume), concomitant use with other antihypertensive drugs may enhance blood pressure-lowering effects.
Torasemide, especially at high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin, nephrotoxic effects of cephalosporins and cardiotoxic and neurotoxic effects of lithium.
The muscle-relaxant effect of curare-like drugs and the effect of 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 effect of antidiabetic drugs may be reduced.
Initiating angiotensin-converting enzyme (ACE) inhibitors after torasemide treatment, or starting 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) by reducing the dose of or temporarily discontinuing torasemide 2–3 days before administering the ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictive 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 efficacy 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.
Diuvver with food and drink
Diuvver 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 levels of torasemide.
Elderly patients
Dosage adjustment is not required in elderly patients.
Pregnancy, breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy:
Diuvver is contraindicated during pregnancy.
Breastfeeding:
There is no data on passage of the drug into breast milk. Diuvver 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.
Diuvver contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Diuvver 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 directed by the physician. In case of 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 necessary, 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 prescribed
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, and consequently somnolence,
confusion, hypotension, circulatory collapse. Gastrointestinal disturbances may also appear.
There is no specific antidote. Symptoms of overdose require dose reduction or discontinuation
of the medicine, together with administration of fluids and electrolytes.
In case of taking more than the prescribed dose, seek immediate medical advice from your doctor
or pharmacist.
Missing a dose of Diuver
If a dose is missed, it should be taken as soon as possible. If it is almost time for the 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 reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.

Common (may occur in up to 10 out of 100 patients):
As with other diuretics, disturbances in water and electrolyte balance may occur depending on the dose administered 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 or diarrhoea, those taking large amounts of laxatives, and in patients with impaired liver function.
In cases of pronounced diuresis, especially at the beginning of treatment and in elderly patients, symptoms of fluid and electrolyte loss may appear, such as headache, dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, and muscle cramps. A dose adjustment of the medicine may become necessary.
Torasemide may increase plasma concentrations 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 out of 100 patients):
In patients with impaired urinary outflow, sudden urinary retention may occur.
Increased plasma concentrations of urea and creatinine may occur.

Rare (may occur in fewer than 1 out of 1,000 patients):
Limb paraesthesia

Very rare (occurring in fewer than 1 out of 10,000 people, including single cases):
In isolated cases, thrombotic complications and circulatory disorders of the heart and brain due to blood concentration (including cardiac and cerebral ischaemia) have occurred, leading, for example, to cardiac arrhythmias, angina pectoris, acute myocardial infarction, or syncope.
Pancreatitis.
Isolated cases of reduced red blood cell and white blood cell counts, as well as thrombocytopenia, have been reported.
Allergic reactions such as itching, rash, and photosensitivity have occurred in isolated cases.
Isolated cases of visual and hearing disturbances (tinnitus, hearing loss) may occur.
Rarely, sensations of numbness, tingling, and limb paraesthesia have been reported.

Frequency not known (cannot be estimated from the available data):
Dryness of the oral mucosa.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions enables continued monitoring of the medicine's safety and helps to provide more information on its safe use.

5. How to store Diuver

Keep this medicine out of the sight and reach of children.
Do not store above 25 ° 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.
Translation of some texts found on the blister:
Ch.-B. und Verw. bis siehe Prägung - Batch number and expiry date see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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: 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 responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

Parallel Importer:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland

CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

German Marketing Authorisation Number (country of export): 57688.00.00
Parallel Import Licence Number: 307/22