Diured

Patient Information Leaflet

Diured
20 mg, tablets
Torasemide
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of Contents

1. What Diured is and what it is used for
2. Important information before taking Diured
3. How to take Diured
4. Possible side effects
5. How to store Diured
6. Contents of the pack and other information

1. What Diured is and what it is used for

Diured contains the active substance torasemide, which belongs to a group of medicines called loop diuretics.
Indications:

• Edema caused by congestive heart failure, pulmonary edema, hepatic edema, and renal edema.

2. Important information before using Diured

When not to use Diured

• if the patient is allergic to torasemide, other sulfonylurea derivatives (medicines used in diabetes), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has kidney function disorders with anuria;
• if the patient has kidney function disorders caused by medicines that may damage the kidneys;
• if the patient has hepatic coma or pre-coma condition;
• if the patient has hypotension;
• if the patient has reduced intravascular volume (hypovolemia);
• if the patient has cardiac arrhythmias;
• if the patient is taking aminoglycoside and cephalosporin antibiotics;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Diured, discuss this with your doctor or pharmacist:

• if the patient has disorders of urination, including benign prostatic hyperplasia;
• if the patient has low blood potassium or sodium levels (detected in blood tests);
• if the patient has elevated uric acid levels in the blood or gout;
• if the patient has diabetes.

Children and adolescents
There is no clinical experience with the use of torasemide in this age group.
Diured and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This especially includes:

• certain antibiotics (aminoglycosides and cephalosporins) – Diured is contraindicated in such cases;
• cardiac glycosides (e.g. digoxin);
• muscle relaxants, curare derivatives;
• theophylline (used in the treatment of asthma);
• antihypertensive medicines, especially so-called angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, ramipril);
• cisplatin (used in cancer treatment);
• salicylates (e.g. acetylsalicylic acid);
• lithium salts (used in the treatment of psychiatric disorders);
• antidiabetic medicines;
• non-steroidal anti-inflammatory drugs (e.g. indomethacin, ibuprofen, naproxen);
• probenecid (used in the treatment of gout);
• cholestyramine (used in the treatment of high cholesterol levels);
• corticosteroids (used as anti-inflammatory and antiallergic agents and in the treatment of hormonal disorders);
• laxatives;
• medicines that increase blood pressure, e.g. adrenaline and noradrenaline.

Diured with food and drink
Diured should be taken in the morning, with a small amount of liquid (e.g. water), with or without food.
Pregnancy and breastfeeding
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:
Diured is contraindicated during pregnancy.
Breastfeeding:
Diured is contraindicated during breastfeeding.
Driving and operating machinery
As with other medicines affecting blood pressure, the patient may experience dizziness, headache, or fatigue. If such symptoms occur, the patient should not drive or operate machinery. Contact your doctor.
Diured contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered "sodium-free".

3. How to use Diured

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Edema
The recommended dose is 5 mg of torasemide, taken orally once daily. This dose cannot be achieved using
Diured tablets with a strength of 20 mg. Your doctor will recommend other medicines with the appropriate strength.
If necessary, your doctor may gradually increase the dose up to 20 mg once daily.
The tablet may be divided into two equal doses.
Use of Diured in elderly patients
Dosage adjustment is not required in elderly patients.
Taking more Diured than recommended
If you take more Diured than recommended, seek immediate medical advice from your doctor or go to the
nearest hospital emergency department.
Symptoms of overdose may include excessive urination, which could lead to drowsiness, confusion, hypotension, and circulatory collapse. Gastrointestinal disturbances may also occur.
Missed dose of Diured
Do not take a double dose to make up for a missed dose.
Stopping Diured
This medicine should be taken for as long as prescribed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
The frequency of adverse effects is defined as follows:
Very common (affects at least 1 in 10 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Rare (affects less than 1 in 1 000 people)
Very rare (affects less than 1 in 10 000 people)
Frequency not known (frequency cannot be estimated from the available data)

Common adverse effects:

• metabolic alkalosis (increased blood pH),
• muscle cramps,
• water and electrolyte disturbances, e.g. hypovolemia (reduced intravascular volume), hyponatremia (decreased sodium concentration in blood), hypokalemia (decreased potassium concentration in blood),
• gastrointestinal disturbances (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation),
• headache, dizziness,
• fatigue, weakness.

Uncommon adverse effects:

• increased activity of liver enzymes (e.g. gamma-glutamyl transferase - GGT) in blood,
• urinary retention, bladder dilation,
• increased concentration of uric acid in blood, increased glucose concentration in blood, increased lipid concentration (triglycerides and cholesterol) in blood.

Rare adverse effects:

• increased concentration of urea and creatinine in blood.

Very rare adverse effects:

• allergic skin reactions (e.g. itching, rash), photosensitivity reactions.

Frequency not known:

• decreased platelet count, decreased white blood cell count, anaemia,
• severe skin reactions (purple skin spots, blister formation, skin peeling, skin and mucous membrane erosions – Stevens-Johnson syndrome, toxic epidermal necrolysis),
• cerebral circulation disorders, paresthesia (tingling or numbness of limbs), confusion (disorientation),
• visual disturbances,
• tinnitus, hearing loss,
• acute myocardial infarction, myocardial ischemia, angina pectoris (chest pain due to insufficient blood supply to the heart muscle), fainting, hypotension,
• thromboembolic complications due to blood concentration,
• dryness of the oral mucosa, pancreatitis.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell 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 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 of adverse effects helps to collect more information on the safety of the medicine.

5. How to store Diured

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack.
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 you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Diured contains

• The active substance is torasemide. One tablet contains 20 mg of torasemide.
• The other ingredients are: microcrystalline cellulose, maize starch, sodium croscarmellose, colloidal anhydrous silica and magnesium stearate.

What Diured looks like and contents of the pack
Oblong, white, biconvex tablets with a single-score line, measuring 7.3 mm – 7.7 mm in width and 17.3 mm – 17.7 mm in length.
Diured tablets are packed in PVC/Aluminium blisters, placed in a cardboard box.
The pack contains:
10, 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań