Toradiur

Package leaflet: information for the patient

Toradiur, 5 mg, tablets
Torasemide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Toradiur is and what it is 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 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 impaired heart function (heart muscle weakness); and for 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 dysfunction (hepatic coma or pre-coma state);
• in low blood pressure (hypotension);
• in reduced circulating blood volume (hypovolemia);
• in low levels of sodium or potassium in the blood (hyponatremia, hypokalemia);
• in urinary bladder emptying disorders (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 clinical data, Toradiur should not be used in the following cases:

• gout;
• severe cardiac arrhythmias, particularly when heart rate is slow;
• 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 dysfunction caused by nephrotoxic substances.

Children and adolescents
Toradiur should not be used in children and adolescents under 18 years of age due to insufficient data on its use 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 ruled out.

Toradiur and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
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 may cause a sudden drop in blood pressure. If uncertain whether a medicine belongs to the ACE inhibitor class, consult your doctor or pharmacist.
• Theophylline (a medicine used to treat asthma): Toradiur may enhance the effects of theophylline.
• Muscle relaxants (curare-like agents): increased muscle-relaxing effect.
• Antidiabetic medicines: Toradiur may reduce the effectiveness of antidiabetic medicines.
• Analgesic and anti-rheumatic medicines: when high doses of salicylates are used, torasemide may enhance their toxic effects on the central nervous system.
• Medicines used to treat 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 to treat 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 medicine that lowers cholesterol levels): concomitant use of cholestyramine may reduce the gastrointestinal absorption of Toradiur, thereby weakening its effect.

During high-dose treatment (see section 3), Toradiur may intensify 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 between Toradiur and other medicines:

• Low potassium levels caused by Toradiur may increase the risk of adverse effects from concurrently administered cardiac 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.
• Concomitant use of Toradiur with lithium salts (used in the treatment of acute mood disorders and various types of depression) may increase serum lithium concentration, thereby enhancing its toxic effects on the heart and kidneys.

Toradiur with food, drink, and alcohol
Food intake does not affect the action of Toradiur.
Alcohol should not be consumed during treatment with Toradiur.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 the unborn child.
If a patient plans pregnancy or becomes pregnant during treatment with Toradiur, she should inform her doctor immediately. If pregnancy is uncertain, 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 must 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 particularly applies to:

• the initial period of treatment;
• the period following dose increase;
• the period after switching medicines;
• the period after starting additional treatment with another medicine;
• when alcohol is consumed concurrently.

Toradiur contains monohydrate 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 exactly as directed by your doctor or pharmacist.
If you are unsure, please consult your doctor or pharmacist.

Dosage

Primary hypertension
The recommended starting dose is ½ tablet (2.5 mg of torasemide) of Toradiur once daily.
The antihypertensive effect begins within the first week of treatment, while the full therapeutic effect
is achieved after up to 12 weeks of treatment.

If blood pressure has not normalized after 12 weeks of treatment with a dose of ½ tablet (2.5 mg
torasemide) per day, the dose may be increased to 1 tablet (5 mg torasemide) daily.

The dose should not exceed 1 tablet (5 mg torasemide) of Toradiur per day, as this will not result in
further reduction of blood pressure.

Edema and fluid retention
The recommended initial dose is 1 tablet (5 mg torasemide) once daily. This dose is usually also used
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 2 tablets (10 mg torasemide) daily or up to a maximum of 4 tablets (20 mg
torasemide) daily.

Patients with hepatic impairment
Treatment should be carried out with particular caution due to the potential for increased
torasemide blood concentration.

Elderly patients
Dosage adjustment is not required in elderly patients.

Method of administration
Tablets should be taken in the morning, with a small amount of liquid. Toradiur 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 Toradiur than recommended 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. Similarly, missing
a dose of Toradiur leads to reduced efficacy, which may manifest as:

• weight gain;
• increased fluid retention in the body (edema).

You should take the missed dose as soon as possible. However, do not take a missed dose if it is almost
time for the next scheduled dose. Do not take a double dose 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 you change or stop the prescribed treatment without consulting your
doctor.

If you have any further questions about the use of this medicine, please 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 symptoms and decide which tests are necessary.
In the event of a sudden and severe adverse reaction, seek medical advice immediately. This is very important, as some adverse effects may be life-threatening. The doctor will decide which tests are required and whether treatment should be continued.
If any hypersensitivity reactions occur (e.g. severe allergic skin reaction), Toradiur must not be used again.

Common (occur in 1 to 10 users 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 blood lipids (triglycerides, cholesterol);
• potassium deficiency (hypokalaemia), particularly when combined with a low-potassium diet, vomiting, diarrhoea, or overuse of laxatives, as well as in patients with chronic liver dysfunction;
• disturbances in water and electrolyte balance, depending on the dose and duration of treatment, especially reduced 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), particularly 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 users out of 1,000)

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

Rare (occur in fewer than 1 user out of 10,000)

• decreased number of blood cells (red and white blood cells) and platelets;
• allergic reactions, such as itching, rash, photosensitivity, severe allergic skin reactions;
• during intravenous administration, acute, even potentially fatal, hypersensitivity reactions (anaphylactic shock) cannot be excluded in isolated cases;
• formation of blood clots in 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 arrhythmias, chest tightness (angina pectoris), acute myocardial infarction, or sudden loss of consciousness (fainting);
• 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 of Adverse Drug Reactions at the 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 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. 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 5 mg.
• The other ingredients are: monohydrate lactose, corn starch, colloidal anhydrous silica, magnesium stearate.

What Toradiur looks like and contents of the pack
Toradiur is a white, round, biconvex tablet with a diameter of 6.0 mm ± 0.2 mm, 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