Diured

Leaflet attached to the packaging: patient information

Diured, 5 mg, tablets

Diured, 10 mg, tablets

Torasemide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Diured and what is it 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 is Diured and what is it used for

Diured is a diuretic medicine belonging to the group of loop diuretics.

Indications for use:

• primary hypertension;
• edema caused by congestive heart failure, pulmonary edema, hepatic edema, and renal edema.

2. Important information before taking Diured

When not to take Diured

Warnings and precautions

Before starting Diured, the patient should discuss it with their doctor or pharmacist:

Children and adolescents

There is a lack of clinical experience with torasemide in this age group.

Diured and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or
have recently taken, as well as any medicines they plan to take.

• In the case of concomitant use of torasemide with cardiac glycosides(drugs that stimulate heart function, increasing the strength of heart muscle contraction, while often reducing the frequency of this contraction), there may be an increased sensitivity of the heart muscle to these drugs, due to decreased potassium and (or) magnesium levels in the serum.
• In combination with mineralocorticosteroids(hormones regulating mineral and ion metabolism) and glucocorticosteroids(hormones regulating protein, carbohydrate, and fat metabolism) and laxatives, it may cause increased potassium excretion in the urine.
• Similarly to other diuretic drugs (also known as diuretics, drugs that increase urine output), there may be an enhancement of the blood pressure-lowering effect when administered concomitantly with other antihypertensive drugs.
• Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibioticsand cisplatin(a drug used in cancer chemotherapy), neurotoxicity of cephalosporins, and cardiotoxicity and neurotoxicity of lithium(a drug used in psychiatry).
• The action of muscle relaxantscontaining curareand the action of theophylline(a drug used in respiratory diseases) may be enhanced during concomitant use with torasemide.
• In patients receiving high doses of salicylates(pain-relieving, anti-inflammatory, and antipyretic drugs), their toxicity may increase.
• The action of antidiabetic drugsmay be weakened.
• The use of angiotensin-converting enzyme inhibitors(drugs used to treat hypertension) after torasemide treatment, or the initiation of combined therapy with these drugs, may cause transient blood pressure drops. This effect can be minimized by reducing the initial dose of the angiotensin inhibitor and (or) reducing the dose or temporarily discontinuing torasemide.
• Torasemide may increase the reactivity of blood vessels to vasoconstrictor drugs(e.g., adrenaline, noradrenaline).
• Non-steroidal anti-inflammatory drugs(e.g., indomethacin - a non-steroidal anti-inflammatory drug) and probenecid(increasing uric acid excretion) may reduce the diuretic and blood pressure-lowering effect of torasemide.
• The concomitant administration of torasemide and cholestyramine (a drug binding bile acids in the gastrointestinal tract and increasing their excretion) has not been studied in humans, but in animal studies, a decrease in torasemide absorption has been observed.

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, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy:
Diured is contraindicated during pregnancy.
Breastfeeding:
Diured is contraindicated during breastfeeding.

Driving and using machines

As with other blood pressure-lowering drugs, patients who experience dizziness or similar symptoms should not drive vehicles or operate machines.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, which means that the medicine is considered "sodium-free".

3. How to take Diured

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Primary hypertension
The recommended dose is 2.5 mg (half a tablet of Diured 5 mg), orally, once a day.
If necessary, the dose can be increased to 5 mg once a day. Studies have shown 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 recommended dose is 5 mg (one tablet of Diured, 5 mg or half a tablet of Diured, 10 mg), orally, once a day. If necessary, the dose can be gradually increased to 20 mg once a day.
The Diured, 5 mg and Diured, 10 mg tablets can be divided into two equal doses.

Using Diured in patients with liver function disorders

During torasemide treatment, patients with liver function disorders should be under special supervision due to the risk of increased torasemide levels in the blood.

Using Diured in elderly patients

In elderly patients, there is no need to change the dosage.

How to divide a Diured, 5 mg tablet into two equal doses

To divide the Diured, 5 mg tablet into two equal doses, place it on a hard, smooth surface, with the groove facing down, and press firmly with your finger, as shown in the diagram below:

Taking a higher dose of Diured than recommended

In case of taking a higher dose of Diured than recommended, consult a doctor or pharmacist immediately.
There is no specific antidote.
Patients with symptoms of overdose require dose reduction or discontinuation of the medicine with concurrent administration of fluids and electrolytes.

Missing a dose of Diured

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

Stopping Diured treatment

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Diured can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common (occurring in more than 1 in 10 people)
Common (occurring in 1 to 10 in 100 people)
Uncommon (occurring in 1 to 10 in 1,000 people)
Rare (occurring in 1 to 10 in 10,000 people)
Very rare (occurring in less than 1 in 10,000 people)

Common side effects:

• worsening of metabolic acidosis symptoms (excessive blood acidification),
• muscle cramps (especially at the beginning of therapy),
• increased levels of uric acid and glucose, as well as lipids (triglycerides and cholesterol) in the blood, hypokalemia (decreased potassium levels in the blood) - especially with a low-potassium diet, with accompanying vomiting, diarrhea, use of large amounts of laxatives, and in cases of liver function disorders, gastrointestinal disorders (e.g., decreased appetite, stomach pain, nausea, vomiting, diarrhea, constipation), especially at the beginning of treatment,
• increased activity of liver enzymes (e.g., gamma-GT) in the blood,
• headaches, dizziness,
• fatigue, weakness (especially at the beginning of treatment).

Uncommon side effects:

• increased levels of urea and creatinine in the serum,
• dry mouth,
• paresthesia (tingling, burning, and numbness in the limbs).

In patients with urinary excretion disorders (e.g., in the case of prostate enlargement), there may be urinary retention and bladder damage.

Very rare side effects:

• thrombotic complications caused by blood thickening,
• circulatory disorders in the coronary and central nervous system (including heart failure and brain damage), which may lead to, for example, irregular heart rhythm, angina pectoris, heart attack, or fainting,
• disorientation,
• pancreatitis,
• allergic reactions (e.g., itching, rash, hypersensitivity to light),
• severe skin reactions,
• decreased platelet, red, and (or) white blood cell count,
• vision disorders,
• tinnitus, hearing loss.

Diagnostic tests
Depending on the dose and duration of treatment, symptoms of fluid and electrolyte loss may occur, and in particular:

• oligemia (reduced blood volume in the vessels),
• hypokalemia and (or)
• hyponatremia (decreased sodium levels in the blood).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diured

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Diured contains

• The active substance of the medicine is torasemide.

Diured, 5 mg, tablets
One tablet contains 5 mg of torasemide.
Diured, 10 mg, tablets
One tablet contains 10 mg of torasemide.

• The other ingredients of the medicine are: microcrystalline cellulose, corn starch, sodium croscarmellose, colloidal silica, and magnesium stearate.

What Diured looks like and what the pack contains

Diured, 5 mg, tablets: white, round tablets with a groove on one side.
Diured, 10 mg, tablets: white, round tablets with a groove on one side.
Diured tablets are packaged in PVC/Aluminum blisters, placed in a cardboard box.
The pack contains:
10 tablets (1 blister of 10)
30 tablets (3 blisters of 10)
60 tablets (6 blisters of 10)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Date of last revision of the leaflet: