Diured

Package Leaflet: Information for the Patient

Diured

20 mg, tablets

Torasemide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your 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 contains the active substance torasemide, which belongs to a group of so-called loop diuretics.

Indications:

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

2. Important information before taking Diured

When not to take Diured

• if you are allergic to torasemide, other sulfonylurea derivatives (used in diabetes) or any of the other ingredients of this medicine (listed in section 6);
• if you have renal impairment with anuria;
• if you have renal impairment caused by drugs that can damage the kidneys;
• if you have hepatic coma or pre-coma;
• if you have hypotension;
• if you have decreased intravascular volume (hypovolemia);
• if you have cardiac arrhythmias;
• if you are taking aminoglycoside antibiotics and cephalosporins,
• if you are pregnant or breastfeeding.

Warnings and precautions

Before taking Diured, discuss with your doctor or pharmacist:

• if you have urinary disorders, including prostatic hyperplasia;
• if you have low potassium or sodium levels in the blood (detected in blood tests);
• if you have increased uric acid levels in the blood or gout;
• if you have diabetes.

Children and adolescents

There is no clinical experience with torasemide in this age group.

Diured and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about the medicines you plan to take. This is especially important for:

• certain antibiotics (aminoglycosides and cephalosporins) - taking Diured is contraindicated in this case;
• cardiac glycosides (e.g. digoxin);
• muscle relaxants, curare derivatives;
• theophylline (used in asthma treatment);
• antihypertensive drugs, especially so-called angiotensin-converting enzyme inhibitors (e.g. enalapril, ramipril);
• cisplatin (used in cancer treatment);
• salicylates (e.g. acetylsalicylic acid);
• lithium salts (used in psychiatric disorders);
• antidiabetic drugs;
• non-steroidal anti-inflammatory drugs (e.g. indomethacin, ibuprofen, naproxen);
• probenecid (used in gout treatment);
• cholestyramine (used in high cholesterol treatment);
• corticosteroids (used as anti-inflammatory and antiallergic drugs, as well as in hormonal disorders);
• laxatives;
• drugs 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 you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your 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 medicines that affect blood pressure, you may experience dizziness, headache, or fatigue. If you experience such symptoms, do not drive or operate machinery. Contact your doctor.

Diured contains sodium

The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means that the medicine is considered "sodium-free".

3. How to take Diured

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Edema
The recommended dose is 5 mg of torasemide, orally, once a day. This dose cannot be achieved with Diured 20 mg tablets. Your doctor will prescribe other medicines with the appropriate strength.
If necessary, your doctor may gradually increase the dose to 20 mg once a day.
The tablet can be divided into two equal doses.

Taking Diured in elderly patients

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

Taking more than the recommended dose of Diured

If you take more than the recommended dose of Diured, contact your doctor or go to the emergency department of the nearest hospital immediately.
A symptom of overdose may be increased urine production, which can lead to drowsiness, confusion, hypotension, and circulatory collapse. Gastrointestinal disorders may also occur.

Missing a dose of Diured

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

Stopping Diured treatment

This medicine should be taken for as long as your doctor recommends.
If you have any further questions about taking this medicine, ask your 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 at least 1 in 10 people)
Common (occurring in less than 1 in 10 people)
Uncommon (occurring in less than 1 in 100 people)
Rare (occurring in less than 1 in 1000 people)
Very rare (occurring in less than 1 in 10,000 people)
Frequency not known (frequency cannot be estimated from the available data)

Common side effects:

• metabolic alkalosis (increased blood pH),
• muscle cramps,
• water and electrolyte disorders, e.g. hypovolemia (decreased intravascular volume), hyponatremia (decreased sodium levels in the blood), hypokalemia (decreased potassium levels in the blood),
• gastrointestinal disorders (e.g. decreased appetite, stomach pain, nausea, vomiting, diarrhea, constipation),
• headache, dizziness,
• fatigue, weakness.

Uncommon side effects:

• increased liver enzyme activity (e.g. gamma-glutamyl transferase - GGT) in the blood,
• urinary retention, bladder enlargement,
• increased uric acid levels in the blood, increased glucose levels in the blood, increased lipid levels (triglycerides and cholesterol) in the blood.

Rare side effects:

• increased urea and creatinine levels in the blood.

Very rare side effects:

• allergic skin reactions (e.g. itching, rash), hypersensitivity reactions to light.

Frequency not known:

• decreased platelet count, decreased white blood cell count, anemia,
• severe skin reactions (purple spots on the skin, blistering, skin peeling, ulcers on the skin and mucous membranes - Stevens-Johnson syndrome, toxic epidermal necrolysis),
• cerebral blood flow disorders, paresthesia (tingling or numbness of the limbs), confusion,
• vision disorders,
• tinnitus, hearing loss,
• acute myocardial infarction, myocardial ischemia, angina pectoris (chest pain due to insufficient blood flow to the heart muscle), fainting, hypotension,
• thromboembolic complications due to blood thickening,
• dryness of the mucous membranes of the mouth, pancreatitis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the
Department for the Monitoring of Adverse Reactions to Medicinal Products
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, you can help provide more information on the safety of this medicine.

5. How to store Diured

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
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. Ask your 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. One tablet contains 20 mg of torasemide.
• The other ingredients of the medicine are: microcrystalline cellulose, maize starch, sodium carmellose, colloidal anhydrous silica, and magnesium stearate.

What Diured looks like and contents of the pack

Oval, white, biconvex tablets with a single break line, 7.3 mm - 7.7 mm wide and 17.3 mm - 17.7 mm long.
Diured tablets are packaged in PVC/Aluminum blisters, placed in a cardboard box.
The pack contains:
10, 30, or 60 tablets.
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: