Diured

Patient Information Leaflet

Diured, 5 mg, tablets
Diured, 10 mg, tablets
Torasemidum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• 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 reactions, including those 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 is a diuretic medicine belonging to the group of loop diuretics.
Indications:

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

2. Important information before using Diured

When not to use Diured

• 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 function disorders with anuria;
• if the patient has hepatic coma or pre-coma conditions;
• if the patient has hypotension;
• if the patient has cardiac arrhythmias;
• if the patient is taking aminoglycoside antibiotics and cephalosporins;
• 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 in urine excretion. The cause of these disorders should be eliminated and water-electrolyte balance restored before starting treatment;
• if torasemide therapy is long-term. During prolonged treatment, regular monitoring of water-electrolyte balance, blood glucose, uric acid, creatinine, and lipid levels is recommended;
• if the patient has a tendency towards increased blood uric acid levels;
• if the patient has latent or overt diabetes. In such patients, carbohydrate metabolism should be monitored.

Children and adolescents
There is no clinical experience with the use of torasemide in this age group.

Diured with 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.

• When torasemide is used concomitantly with cardiac glycosides (medicines that enhance heart function by increasing myocardial contractility while reducing heart rate), increased myocardial sensitivity to these medicines may occur due to decreased serum potassium and/or magnesium levels.
• In combination with mineralocorticosteroids (hormones regulating mineral and electrolyte balance), glucocorticosteroids (hormones regulating protein, carbohydrate, and fat metabolism), and laxatives, increased urinary potassium excretion may occur.
• As with other diuretic medicines (also known as diuretics or drugs that increase urine volume), an enhanced blood pressure-lowering effect may occur when used concomitantly with other antihypertensive medicines.
• Torasemide, especially in high doses, may increase the toxicity of aminoglycoside antibiotics, cisplatin (a medicine used in cancer chemotherapy), the neurotoxicity of cephalosporins (a class of antibiotics), and the cardio- and neurotoxicity of lithium (a medicine used in psychiatry).
• The effect of muscle relaxants containing curare and the effect of theophylline (a medicine used in respiratory diseases) may be enhanced when used concomitantly with torasemide.
• In patients receiving high doses of salicylates (analgesic, anti-inflammatory, and antipyretic medicines), their toxicity may increase.
• The effect of antidiabetic medicines may be reduced.
• The use of angiotensin-converting enzyme inhibitors (medicines used to treat hypertension) after torasemide treatment, or initiation of combined therapy with these medicines, may cause transient drops in blood pressure. 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 arterial reactivity to vasoconstrictor medicines (e.g., adrenaline, noradrenaline).
• Non-steroidal anti-inflammatory drugs (e.g., indomethacin – a non-steroidal anti-inflammatory drug) and probenecid (which increases uric acid excretion) may reduce the diuretic and blood pressure-lowering effects of torasemide.
• Concomitant administration of torasemide and cholestyramine (a medicine that binds bile acids in the gastrointestinal tract and increases their excretion) has not been studied in humans, but animal studies have shown reduced absorption of torasemide.

Diured with food and drink
Diured should be taken in the morning, with a small amount of fluid (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 her 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, patients experiencing dizziness or similar symptoms should not drive or operate machinery.

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 used as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Primary hypertension
The recommended dose is 2.5 mg (half a Diured 5 mg tablet), taken orally once daily.
If necessary, the dose may be increased to 5 mg once daily. Clinical studies indicate that doses greater 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 Diured 5 mg tablet or half a Diured 10 mg tablet), taken orally once daily. If necessary, the dose may be gradually increased up to 20 mg once daily.
The Diured 5 mg and Diured 10 mg tablets may be divided into two equal doses.
Use of Diured in patients with hepatic impairment
Patients with impaired liver function should be closely monitored during torasemide treatment due to the risk of increased blood concentrations of torasemide.
Use of Diured in elderly patients
Dosage adjustment is not required in elderly patients.
How to split a Diured 5 mg tablet into two equal doses
To split a Diured 5 mg tablet in half, place it on a hard, smooth surface with the groove facing downwards, and press firmly with your finger, as shown in the figure below:

Use of a higher than recommended dose of Diured
If you take more Diured than prescribed, contact your doctor or pharmacist immediately.
There is no specific antidote.
Patients showing symptoms of overdose require dose reduction or discontinuation of the drug, along with administration of fluids and electrolytes.
Missed dose of Diured
Do not take a double dose to make up for a missed dose.
Stopping Diured
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, 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 more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)

Common adverse 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 blood, hypokalaemia (reduced potassium levels in blood) – especially with a potassium-deficient diet, concomitant vomiting, diarrhoea, use of large amounts of laxatives, and in case of liver function disorders, gastrointestinal disturbances (e.g. decreased appetite, stomach pain, nausea, vomiting, diarrhoea, constipation), particularly at the beginning of treatment,
• Increased activity of liver enzymes (e.g. gamma-GT) in blood,
• Headache, dizziness,
• Fatigue, weakness (especially at the beginning of treatment).

Uncommon adverse effects:

• Increased levels of urea and creatinine in plasma,
• Dryness of the mouth,
• Paresthesia (sensation of pricking, burning, and tingling in limbs).

In patients with impaired urine outflow (e.g. due to prostate enlargement), urine retention and bladder damage may occur.
Very rare adverse effects:

• Thrombotic complications due to blood concentration,
• Circulatory disturbances in coronary vessels and central nervous system (including myocardial and cerebral ischaemia), which may lead to, for example, irregular heartbeat, angina pectoris, myocardial infarction or fainting,
• Disorientation,
• Pancreatitis,
• Allergic reactions (e.g. itching, rash, photosensitivity),
• Severe skin reactions,
• Decreased platelet count, red and (or) white blood cells,
• Visual disturbances,
• 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 volume of circulating blood),
• Hypokalaemia and (or)
• Hyponatraemia (reduced sodium concentration in blood).

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 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 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.
Store 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 stated month.
Medicines should 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 packaging and other information

What Diured contains

• The active substance is torasemide.

Diured 5 mg tablets
Each tablet contains 5 mg of torasemide.
Diured 10 mg tablets
Each tablet contains 10 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
Diured 5 mg tablets: white, round tablets with a score line on one side.
Diured 10 mg tablets: white, round tablets with a score line on one side.
Diured tablets are packed in PVC/Aluminium blisters placed in a cardboard box.
Pack sizes:
10 tablets (1 blister containing 10 tablets)
30 tablets (3 blisters containing 10 tablets each)
60 tablets (6 blisters containing 10 tablets each)
Not all pack sizes may be marketed.

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