Diuver

Package leaflet: Information for the patient

Diuver, 20 mg, tablets
Torasemide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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, the active substance of the medicine, is rapidly and almost completely absorbed, with maximum plasma concentration occurring within 1 to 2 hours. Approximately 80% of the administered dose is excreted in the urine.
Indications:

• Oedema caused by congestive heart failure, pulmonary oedema, hepatic oedema, renal oedema. Diuver is used in adults.

2. Important information before using Diuver

When not to use Diuver:

• if the patient is allergic to torasemide, sulfonylurea derivatives (medicines used in diabetes), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has kidney dysfunction with anuria;
• if the patient has hepatic coma or pre-comatose conditions;
• if the patient has hypotension;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Diuver, discuss this with a doctor or pharmacist.

• if the patient has disturbances in urine excretion, the cause of these disturbances should be eliminated and water-electrolyte balance restored before starting treatment (especially in patients receiving concomitant treatment 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;
• if the patient has irregular heart rhythm.

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;
• kidney failure caused by nephrotoxic agents;
• children and adolescents under 18 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 lack of clinical experience with the use of torasemide in this age group.
Diuver and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
When torasemide is used concomitantly with cardiac glycosides (medicines that stimulate heart function, increase myocardial contractility, and simultaneously reduce heart rate), increased sensitivity of the heart muscle to these medicines may occur due to reduced potassium and/or magnesium levels in plasma.
When used together with mineralocorticosteroids (hormones regulating mineral and ionic balance in the body) and glucocorticosteroids (hormones regulating protein, carbohydrate, and fat metabolism) or laxatives, increased potassium excretion in urine may occur.
As with other diuretics (also known as diuretic agents, medicines increasing urine volume), an enhanced blood pressure-lowering effect may occur when used together with other antihypertensive medicines.
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 muscle-relaxing effect of curare-like agents and the effect of theophylline may be enhanced during concomitant use with torasemide.
Since torasemide inhibits renal excretion of salicylates, toxicity may increase in patients receiving high doses of salicylates.
The effect of antidiabetic medicines may be reduced.
Administration of angiotensin-converting enzyme (ACE) inhibitors after treatment with torasemide, or initiation of combination therapy with these medicines, 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 an ACE inhibitor.
Torasemide may reduce arterial responsiveness to vasoconstrictor medicines (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 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 dysfunction
Patients with impaired liver function should be under special monitoring during treatment with Diuver due to the risk of increased blood levels of torasemide.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy:
Diuver is contraindicated during pregnancy.
Breastfeeding:
There is no data on 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 medicines affecting blood pressure, patients treated with torasemide who experience dizziness or similar symptoms should not drive or operate machinery.
Diuver contains lactose monohydrate.
This medicine contains the sugar lactose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Diuver

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose
Adults:
Oedema
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, 40 mg daily has been used.
The tablet may be divided into equal doses.
Diuver is usually used for long-term treatment or until oedema resolves.
Use in elderly patients
Dosage adjustment is not required in elderly patients.
Use in children and adolescents
Due to insufficient experience with the use of torasemide in children and adolescents,
the use of Diuver is not recommended in patients under 18 years of age.
Method of administration
Oral administration.
Diuver tablets should be taken in the morning with a small amount of fluid, regardless of meals.
Taking more Diuver than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
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,
together with administration of fluids and electrolytes.
Missed dose of Diuver
Take the missed dose 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.
Stopping Diuver
Do not stop taking this medicine without consulting your doctor, as this may cause harmful effects
for the patient and reduce the effectiveness of treatment.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects may occur with the following frequency:
Common (may affect less than 1 in 10 people):

• electrolyte and fluid balance disturbances dependent on dose and duration of treatment, especially when following a low-sodium diet
• decreased potassium blood levels (hypokalaemia), particularly in patients on a low-potassium 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 also in elderly patients, symptoms of fluid and electrolyte loss may occur, such as pain and dizziness, hypotension, weakness, drowsiness, confusion, loss of appetite, muscle cramps. A dose adjustment of the medicine may be necessary.
• worsening of metabolic alkalosis
• gastrointestinal disturbances, e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation
• increased serum levels of uric acid, glucose and lipids
• increased activity of certain liver enzymes (e.g. gamma-glutamyl transferase)

Uncommon (may affect less than 1 in 100 people):

• in patients with impaired urinary outflow, sudden urinary retention may occur. Increased blood serum levels of urea and creatinine may appear.

Rare (may affect less than 1 in 1,000 people):

• limb paresthesia (numbness or tingling)

Very rare (may affect less than 1 in 10,000 people, including single cases):

• decreased number of red and white blood cells and platelets
• disturbances of vision and hearing (tinnitus, hearing loss)
• thrombotic complications and disturbances of cardiac and cerebral circulation caused by blood thickening (including myocardial and cerebral ischaemia), leading, for example, to cardiac arrhythmias, angina pectoris, acute myocardial infarction or fainting
• pancreatitis
• allergic reactions (such as itching, rash, photosensitivity), severe skin reactions

Frequency not known (cannot be estimated from the available data):

• dryness of oral mucous membranes

Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diuver

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the outer packaging after "Expiry date". The expiry date refers to the last day of the specified month.
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 20 mg of torasemide.
• The other ingredients are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Diuver looks like and contents of the pack
Diuver is white or almost white, round, biconvex tablets with a score line on one side and the imprint T20 on the other side of the tablet.
Pack sizes:
30 or 60 tablets in a cardboard box. The tablets are packed in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
Pliva Croatia Ltd.
Prilaz Baruna Filipovića 25
10000 Zagreb
Croatia
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
Tel.: (22) 345 93 00