Toradiur

Patient Information Leaflet

Toradiur, 10 mg, tablets
Torasemidum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Toradiur is and what it is used for

Toradiur is a diuretic medicine. It also lowers blood pressure. It belongs to a group of medicines called loop diuretics.
Toradiur is used to treat and prevent recurrence of:

• fluid retention in tissues (oedema) and/or
• fluid accumulation in body cavities (effusions), which may occur due to heart dysfunction (weakened heart muscle), and in the treatment of essential hypertension, renal or hepatic oedema, and pulmonary oedema.

2. Important information before taking Toradiur

When not to take Toradiur:

• if the patient is allergic to torasemide or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines with a chemical structure similar to torasemide (sulfonamide derivatives);
• in renal failure (with anuria);
• in severe liver function disorders (hepatic coma or pre-coma state);
• in case of low blood pressure (hypotension);
• in case of reduced circulating blood volume (hypovolemia);
• in case of low sodium and potassium levels in the blood (hyponatremia, hypokalemia);
• in disorders of bladder emptying (e.g. caused by benign prostatic hyperplasia);
• during breastfeeding.

Warnings and precautions
Before starting treatment with Toradiur, discuss this with your doctor or pharmacist.
Due to lack of adequate study data, Toradiur should not be used in the following cases:

• gout;
• severe cardiac arrhythmias, when heartbeats are slowed;
• acid-base balance disorders;
• patients concurrently taking lithium salts (medicines used in mood disorders and depression);
• patients taking certain antibiotics for infections, such as aminoglycosides, cephalosporins;
• patients with blood morphology disorders, e.g. thrombocytopenia or anemia in patients without kidney dysfunction;
• patients with kidney function disorders caused by nephrotoxic substances.

During long-term treatment with torasemide, the following are recommended:

• regular monitoring of fluid and electrolyte balance, potassium, glucose, uric acid, creatinine, and lipid levels in blood;
• in patients with overt or latent diabetes, careful monitoring of carbohydrate metabolism is required due to the risk of increased blood glucose levels.

Children and adolescents
Toradiur should not be used in children and adolescents under 18 years of age due to insufficient data on the use of Toradiur in this population.

Impact on doping tests
Use of Toradiur may result in positive anti-doping test results.
The effects of using Toradiur as a doping aid cannot be predicted. Health risks cannot be excluded.

Toradiur and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Use of Toradiur may affect the action of the following medicines:

• Blood pressure-lowering medicines, especially angiotensin-converting enzyme (ACE) inhibitors: concomitant administration of ACE inhibitors with or immediately after torasemide treatment may cause a sudden drop in blood pressure. If uncertain whether a medicine belongs to ACE inhibitors, consult your doctor or pharmacist.
• Theophylline (a medicine used in asthma treatment): Toradiur may enhance the effects of theophylline.
• Neuromuscular blocking agents: increased muscle-relaxing effect.
• Antidiabetic medicines: Toradiur may reduce the effectiveness of antidiabetic drugs.
• Analgesics and anti-rheumatic medicines: when high doses of salicylates are used, torasemide may enhance their toxic effects on the central nervous system.
• Medicines used in circulatory disorders (epinephrine and norepinephrine): Toradiur may reduce the effectiveness of these medicines.

The following medicines may affect the action of Toradiur:

• Probenecid (a medicine used in the treatment of gout): may inhibit the diuretic and antihypertensive effects of torasemide.
• Certain anti-inflammatory medicines (e.g. indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effects of torasemide.
• Cholestyramine (a cholesterol-lowering medicine): concomitant use of cholestyramine may reduce the gastrointestinal absorption of Toradiur and thus weaken its effect.

During treatment with high doses (see section 3), Toradiur may lead to an increase in the following adverse effects:

• Hearing and kidney damage caused by aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin) used to treat infections.
• Hearing and kidney damage caused by cisplatin (used in cancer treatment).
• Kidney damage caused by cephalosporins (antibiotics used to treat infections).

Other interactions of Toradiur with other medicines:

• Low potassium levels caused by Toradiur may enhance the adverse effects of concurrently administered digitalis glycosides (used in heart failure treatment).
• Laxatives may increase potassium loss caused by Toradiur.
• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g. cortisone), when used concomitantly with Toradiur, may increase potassium loss.
• Concurrent use of Toradiur with lithium salts (used in the treatment of acute mood disorders and various types of depression) may increase serum lithium levels and thereby enhance its cardiotoxic and nephrotoxic effects.

Taking Toradiur with food, drink, and alcohol
Eating food does not affect the action of Toradiur.
During treatment with Toradiur, alcohol consumption should be avoided.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Toradiur may be used during pregnancy only if the doctor considers it necessary. Only the lowest possible dose should be used.
There is insufficient knowledge regarding the effects of Toradiur on unborn children.
If the patient plans pregnancy or becomes pregnant during treatment with Toradiur, she should immediately inform her doctor. If the patient is unsure whether she is pregnant, a pregnancy test should be performed.

Breastfeeding
Toradiur should not be used during breastfeeding, as it is unknown whether it passes into breast milk. If use of this medicine during lactation is necessary, breastfeeding should be discontinued.

Driving and operating machinery
Toradiur may alter reaction time and impair the ability to drive vehicles, operate machinery, or work at heights.
This especially applies to:

• the initial period of treatment;
• the time after dose increase;
• the period after switching medicines;
• the period after starting additional treatment with another medicine.

Toradiur contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Toradiur

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Dosage
Essential hypertension
The recommended initial dose is 2.5 mg once daily (products containing torasemide in the appropriate strength should be used, as Toradiur 10 mg tablets do not allow for accurate administration of a 2.5 mg dose).
The antihypertensive effect begins within the first week of treatment, with full therapeutic effect achieved after up to 12 weeks of treatment.
If blood pressure has not normalized after 12 weeks, the dose may be increased to half a tablet (5 mg torasemide) once daily.
The dose should not be increased beyond half a tablet (more than 5 mg torasemide) per day, as this will not result in further blood pressure reduction.
Edema and fluid retention
Unless otherwise directed by the doctor, treatment should be initiated with half a tablet (5 mg torasemide) once daily. The initial dose is usually maintained as the maintenance dose.
If the response to treatment is inadequate and depending on the patient's condition, the doctor may increase the dose to 1 tablet (10 mg torasemide) daily or up to a maximum of 2 tablets (20 mg torasemide) daily.
Patients with hepatic impairment
Treatment should be conducted with particular caution due to the possibility of increased blood concentration of torasemide.
Elderly patients
Dose adjustment is not required in elderly patients.
Administration method
Tablets should be taken in the morning, with a small amount of fluid. The medicine may be taken with or without food. The tablet has a score line and can be divided into equal doses.
Duration of treatment
The duration of Toradiur therapy is determined by the treating physician.
Use in children and adolescents
Toradiur must not be used in children and adolescents under 18 years of age.
Taking more Toradiur than recommended
Taking more than the recommended dose of Toradiur may cause:

• excessive diuresis, potentially dangerous, with loss of fluids and electrolytes;
• disturbances in consciousness;
• confusion;
• drop in blood pressure;
• circulatory collapse;
• gastrointestinal disturbances.
  You should contact your doctor immediately, who will advise on appropriate management.

Missed dose of Toradiur
Taking a lower than recommended dose reduces the effectiveness of the medicine. Missing a dose of Toradiur also reduces its effectiveness. This may manifest as:

• weight gain;
• increased fluid retention in the body (edema).
  The missed dose should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should not be taken. A double dose must not be taken to make up for a missed dose.

Stopping Toradiur treatment
Discontinuation or premature termination of treatment may lead to worsening of symptoms.
Under no circumstances should the prescribed treatment be changed or stopped without consulting your doctor.
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 not everybody will experience them.
If any of the adverse effects listed below occur, inform your doctor immediately. The doctor will assess the severity of the symptoms and decide which tests are necessary.
In the event of a sudden and severe adverse effect, contact your doctor immediately. This is very important because some adverse effects may be life-threatening. The doctor will decide which tests are required and whether treatment should continue.
If any hypersensitivity reactions occur (e.g. severe allergic skin reaction), Toradiur must not be used again.

Common (occur in 1 to 10 people out of 100)

• disturbances in acid-base balance (metabolic alkalosis);
• muscle cramps (especially at the beginning of treatment);
• increased levels of uric acid, glucose and lipids (triglycerides, cholesterol) in blood;
• potassium deficiency (hypokalaemia), particularly when combined with a low-potassium diet, vomiting, diarrhoea, laxative abuse, or in patients with chronic liver dysfunction;
• disturbances in water and electrolyte balance, depending on the dose and duration of treatment, especially reduction in circulating blood volume (hypovolaemia), loss of potassium and sodium: hypokalaemia and (or) hyponatraemia;
• gastrointestinal disturbances (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation), especially at the beginning of treatment;
• increased activity of certain liver enzymes (gamma-GT) in blood;
• headache and dizziness, feeling of fatigue, weakness (especially at the beginning of treatment).

Uncommon (occur in 1 to 10 people out of 1,000)

• elevated levels of urea, creatinine (a muscle component) and urea in blood;
• in patients with urinary voiding disorders (e.g. due to benign prostatic hyperplasia), urinary retention may occur. In such cases, urination becomes difficult or impossible;
• dryness of the mouth;
• numbness and cold sensation in the extremities (paraesthesia).

Very rare (occur in less than 1 person out of 10,000)

• reduced number of blood cells (red and white blood cells) and platelets;
• allergic reactions, for example itching, rash, photosensitivity, severe allergic skin reactions;
• in case of intravenous administration, acute, even potentially fatal, hypersensitivity reactions (anaphylactic shock) cannot be excluded in isolated cases;
• formation of blood clots in blood vessels (thromboembolic complications);
• confusion;
• low blood pressure (hypotension);
• disturbances in coronary or cerebral circulation (including myocardial and cerebral ischaemia). These conditions may lead to cardiac arrhythmia, chest tightness (angina pectoris), acute myocardial infarction, or sudden loss of consciousness (syncope);
• pancreatitis;
• visual disturbances;
• tinnitus;
• hearing loss.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warszawa
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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Toradiur

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 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 no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Toradiur contains

• The active substance is torasemide in a dose of 10 mg.
• The other ingredients are: monohydrate lactose, maize starch, colloidal anhydrous silica, magnesium stearate.

What Toradiur looks like and contents of the pack
Toradiur is a white, oval, biconvex tablet with a division line on one side. The tablet can be divided into equal doses.
One pack contains 30 tablets in blisters, packed in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów