Toradiur

Package Leaflet: Information for the Patient

Toradiur, 10 mg, Tablets

Torasemidum

Read the Leaflet Carefully Before Taking the Medication, 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Toradiur and what is it used for
• 2. Important information 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 is Toradiur and what is it used for

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

• fluid retention in tissues (edema) and (or)
• fluid retention in body cavities (effusions) that may occur in connection with heart function disorders (heart failure), as well as in the treatment of primary hypertension, edema of renal or hepatic origin, and pulmonary edema.

2. Important information before taking Toradiur

When not to take Toradiur:

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

Warnings and precautions

Before starting to take Toradiur, discuss it with your doctor or pharmacist.
Due to the lack of adequate study results, Toradiur should not be used in the following cases:

• gout;
• severe heart rhythm disorders, when heartbeats are slowed down;
• acid-base balance disorders;
• patients taking lithium salts (medicines used in mood and depression disorders) at the same time;
• patients taking certain antibiotics for infection treatment, such as aminoglycosides, cephalosporins;
• patients with blood morphology disorders, e.g. thrombocytopenia or anemia in patients without kidney function disorders;
• patients with kidney function disorders caused by nephrotoxic substances.

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

• regular monitoring of water and electrolyte balance, potassium, glucose, uric acid, creatinine, and lipid levels in the blood;
• in patients with overt or latent diabetes, careful monitoring of carbohydrate metabolism is necessary 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 children and adolescents.

Impact on doping tests

Taking Toradiur may result in positive doping test results.
The consequences of using Toradiur as a doping aid cannot be predicted. A threat to health cannot be ruled out.

Toradiur and other medicines

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

Toradiur may affect the action of the following medicines

• Blood pressure lowering medicines, especially angiotensin-converting enzyme inhibitors: taking angiotensin-converting enzyme inhibitors at the same time or immediately after torasemide treatment may cause a sudden drop in blood pressure. If in doubt whether the medicine belongs to ACE inhibitors, ask your doctor or pharmacist.
• Theophylline (a medicine used to treat asthma): Toradiur may enhance the effect of theophylline.
• Muscle relaxants: increased muscle relaxant effect.
• Antidiabetic medicines: Toradiur may reduce the effect of antidiabetic medicines.
• Pain and anti-rheumatic medicines: in case of high doses of salicylates, torasemide may increase their toxic effect on the central nervous system.
• Medicines used to treat circulation disorders (epinephrine and norepinephrine): Toradiur may reduce the effect of these medicines.

Medicines that affect Toradiur

• Probenecid (a medicine used to treat gout): may inhibit the diuretic and antihypertensive effect of torasemide.
• Certain anti-inflammatory medicines (e.g. indomethacin, acetylsalicylic acid): these medicines may inhibit the diuretic and antihypertensive effect of torasemide.
• Cholestyramine (a medicine that lowers cholesterol levels): concurrent use of cholestyramine may reduce the absorption of Toradiur from the gastrointestinal tract and thus weaken its effect.

During treatment with high doses (see section 3), Toradiur may lead to an increase in the following side 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 to treat tumors).
• Kidney damage caused by cephalosporins (antibiotics used to treat infections).

Other interactions of Toradiur with other medicines

• Potassium level reduction caused by Toradiur may increase the side effects of concurrently taken digitalis glycosides (used to treat heart failure).
• Laxatives may increase potassium loss caused by Toradiur.
• Adrenal cortex hormones (mineralo- and glucocorticoids, e.g. cortisone), taken concurrently with Toradiur, may increase potassium loss.
• Concurrent use of Toradiur with lithium salts (used to treat mood swings and depression) may cause an increase in lithium levels in the serum, thus increasing the cardiotoxic and nephrotoxic effect.

Taking Toradiur with food, drinks, and alcohol

Meal consumption does not affect the action of Toradiur.
During treatment with Toradiur, do not consume alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Toradiur should only be used during pregnancy if your doctor considers it necessary. Only the lowest dose should be used.
There is insufficient knowledge about the effect of Toradiur on the unborn child.
If you plan to become pregnant or become pregnant during treatment with Toradiur, inform your doctor immediately. If you are unsure whether you are 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 the use of this medicine is necessary during lactation, breastfeeding should be discontinued.

Driving and operating machinery

Toradiur may change your reaction time and impair your ability to drive vehicles, operate machinery, or work at heights.
This applies especially to:

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

Toradiur contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Toradiur

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

Primary hypertension

The recommended initial dose is 2.5 mg once a day (you should use products containing torasemide as the active substance with the appropriate strength, as Toradiur 10 mg tablets do not allow for a 2.5 mg dose).
The antihypertensive effect starts in the first week of use, and the full therapeutic effect is achieved after up to 12 weeks of treatment.
If blood pressure does not normalize after 12 weeks, the dose can be increased to half a tablet (5 mg of torasemide) per day.
The dose should not be increased to more than half a tablet (more than 5 mg of torasemide) per day, as it will not cause further blood pressure reduction.

Edema and effusions

Unless your doctor has told you otherwise, treatment should be started with half a tablet (5 mg of torasemide) per day. The initial dose can usually be used as a maintenance dose.
If the effect of the medicine is not satisfactory and depending on the patient's condition, your doctor may increase the dose to 1 tablet (10 mg of torasemide) per day or up to a maximum of 2 tablets (20 mg of torasemide) per day.

Patients with liver failure

Treatment should be carried out with special caution, due to the possibility of increased torasemide levels in the blood.

Patients of advanced age

No dose adjustment is required in patients of advanced age.

Method of administration

Tablets should be taken in the morning, with a small amount of liquid. The medicine can be taken with or without food. The tablet has a dividing line and can be divided into equal doses.

Duration of treatment

The duration of treatment with Toradiur is determined by your doctor.

Use in children and adolescents

Toradiur should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Toradiur than recommended

Taking a higher dose of Toradiur than recommended may cause:

• increased urine production, potentially life-threatening, with fluid and electrolyte loss;
• disorders of consciousness;
• confusion;
• blood pressure drop;
• circulatory collapse;
• gastrointestinal disorders. You should immediatelycontact your doctor, who will recommend the appropriate course of action.

Missing a dose of Toradiur

Taking a lower dose reduces the effectiveness of the medicine. Also, missing a dose of Toradiur leads to reduced effectiveness. This may manifest in the following symptoms:

• weight gain;
• increased fluid retention in the body (edema). You should take the missed dose as soon as possible. However, do not take the missed dose if it is close to the time of the next dose. Do not take a double dose to make up for the missed dose.

Stopping Toradiur treatment

Stopping or prematurely ending treatment may lead to worsening of symptoms.
In no case should the prescribed treatment be changed or stopped without consulting your doctor.
If you have any further doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Toradiur can cause side effects, although not everybody gets them.
If you experience any of the following side effects, inform your doctor immediately. The doctor will assess the severity of the symptoms and decide what tests to perform.
In case of a side effect that occurs suddenly and has a severe course, immediatelycontactyour doctor. This is very important, as some side effects can be life-threatening. The doctor will decide what tests to perform and whether to continue treatment.
If you experience any allergic reactions (e.g. severe allergic skin reaction), Toradiur should not be used again.
Common(occurring in 1 to 10 people out of 100)

• acid-base balance disorders (metabolic alkalosis);
• muscle cramps (especially at the beginning of treatment);
• increased levels of uric acid, glucose, and lipids in the blood (triglycerides, cholesterol);
• potassium deficiency (hypokalemia), especially when taking a low-potassium diet, vomiting, diarrhea, abusing laxatives, as well as in patients with chronic liver function disorders);
• depending on the dose and duration of treatment, water and electrolyte balance disorders may occur, in particular reduced blood volume (hypovolemia), potassium and sodium loss: hypokalemia and (or) hyponatremia;
• gastrointestinal disorders (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), especially at the beginning of treatment;
• increased activity of certain liver enzymes (gamma-GT) in the blood;
• headache and dizziness, feeling of fatigue, weakness (especially at the beginning of treatment).

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

• increased levels of urea, creatinine (a muscle component), and uric acid in the blood;
• in patients with urinary disorders (e.g. due to prostate enlargement), urine retention may occur. In such cases, urination is difficult or impossible;
• dry mouth;
• numbness and feeling of cold in the limbs (paresthesia).

Rare(occurring in less than 1 person out of 10,000)

• reduced number of blood cells (red and white blood cells) and platelets;
• allergic reactions, e.g. itching, rash, hypersensitivity to light, severe allergic skin reactions;
• in the case of intravenous administration, it cannot be excluded that acute, even potentially life-threatening, allergic reactions (anaphylactic shock) may occur;
• formation of blood clots in blood vessels (thromboembolic complications);
• confusion;
• low blood pressure (hypotension);
• disorders of coronary or cerebral circulation (including myocardial ischemia and cerebral ischemia). These conditions may lead to arrhythmias, feeling of chest pressure (angina pectoris), acute myocardial infarction, or sudden loss of consciousness (syncope);
• pancreatitis;
• vision disorders;
• tinnitus;
• hearing loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Toradiur

Keep this medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Toradiur contains

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

What Toradiur looks like and contents of the pack

Toradiur is a white, oval, biconvex tablet with a dividing line on one side. The tablet can be divided into equal doses.
One pack contains 30 tablets in blisters, in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka Street 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Szkolna Street 31
95-054 Ksawerów

Date of last revision of the leaflet: