TORADIUR 10 mg Tablets

Зміст інструкції

1. Toradiur 10 mg tablets
   1. What is Toradiur and what is it 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

Toradiur 10 mg tablets

torasemide

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Toradiur is and what it is used for
• 2. What you need to know before you take 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 contains the active substance torasemide, belonging to the class of “diuretics”, medicines that
increase the formation and elimination of urine.
Toradiur is used in adultsand adolescents over 12 years of agefor the treatment of:

• edema (fluid accumulation) originating from the heart, liver and kidneys;
• acute pulmonary edema (fluid accumulation in the lungs);
• ascites (fluid accumulation in the abdomen);
• congestive heart failure (the heart's inability to provide an adequate amount of blood in relation to the body's normal needs);
• acute renal failure (oliguria, i.e. reduction of the amount of urine eliminated);
• chronic renal failure (long-term kidney dysfunction);
• nephrotic syndrome (kidney alteration that causes protein elimination in the urine). If you do not feel better or if you feel worse, please consult your doctor.

2. What you need to know before taking Toradiur

Do not 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 sulphonamides (medicines used to treat diabetes);
• if you suffer from anuria (marked reduction in urine production);
• if you are in a coma caused by liver problems (hepatic coma);
• if you suffer from hypotension (low blood pressure);
• if you have hypovolemia (reduced blood volume);
• if you have hyponatremia (low sodium levels in the blood) and hypokalaemia (low potassium levels in the blood);
• if you have severe urinary problems, such as for example in case of prostatic hypertrophy (enlarged prostate);
• if you suffer from gout (a disease that causes inflammation and pain in the joints);
• if you have sinoatrial block or a second and third degree atrioventricular block (if the heart has irregular heartbeats);
• if you are being treated with aminoglycosides or cephalosporins (antibiotics);
• if you suffer from kidney problems due to drugs that can cause kidney damage (nephrotoxic);
• if the child to be treated is under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Toradiur.
In particular, talk to your doctor or pharmacist if you think that any of the following conditions apply to you:

• if you suffer from kidney problems (nephrotic syndrome);
• if you suffer from liver problems (e.g. hepatic cirrhosis, ascites and hepatic encephalopathy);
• if you suffer from urinary retention;
• if you suffer from hypotension. During prolonged treatment with Toradiur, the doctor will perform periodic blood tests to monitor:
• the amount of water and salts present in the body (electrolyte balance), especially potassium levels (high potassium levels can cause disturbances in heart and atrial rhythm);
• the levels of sugar, uric acid, creatinine and fats in the blood. For those who play sports The use of the drug without a therapeutic need constitutes doping and can still result in positive doping tests.

Children
Safety and efficacy in children under 12 years of age have not been established.

Other medicines and Toradiur
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• cardiac glycosides(used to stimulate heart activity);
• mineralocorticoids(used to regulate blood pressure and urine elimination);
• glucocorticoids(used for the treatment of inflammation);
• laxatives(used to facilitate bowel movements);
• NSAIDs such as salicylates and indometacin(anti-inflammatory drugs);
• kanamycin, gentamicin, tobramycinand cephalosporins(antibiotics, used to treat infections caused by bacteria);
• platinum derivatives(used for the treatment of some tumors);
• lithium(used for some mental disorders);
• probenecid(used for the treatment of gout);
• coumarin derivatives(used to delay blood clotting);
• ACE inhibitors and AT2 antagonists(used for the treatment of high blood pressure);
• cholestyramine(used to lower cholesterol levels in the blood);
• antidiabetic drugs(used for the treatment of diabetes);
• noradrenaline and adrenaline(medicines that increase blood pressure);
• muscle relaxants(used to decrease muscle contraction);
• theophylline(used for asthma and some breathing problems)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
No clinical data are available for the risk in pregnancy with the use of Toradiur.
The doctor will prescribe Toradiur to you only if it is absolutely necessary.

Breastfeeding
There is insufficient data on the excretion of Toradiur into human milk.
A risk to the infant cannot be excluded.
If you are breastfeeding, the doctor will prescribe Toradiur to you only if it is absolutely necessary.

Driving and operating machinery
This medicine can impair the ability to drive and operate machinery. Therefore, if you are
taking this medicine, you should be careful when driving vehicles or operating machinery,
especially in the first few days of treatment or if you take alcohol at the same time.

Toradiur contains lactose
If your doctor has diagnosed you with lactose intolerance, contact him before taking this
medicine.

3. How to take Toradiur

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is from ½ to 2 tablets per day depending on the severity of the condition.
The tablet can be divided into equal parts.
Take the tablets by mouth.
Swallow without chewing, with a little liquid during meals.

If you take more Toradiur than you should
In case of accidental ingestion/intake of an excessive dose of Toradiur, immediately inform your doctor or go to the nearest hospital.
The symptoms you may experience in case of accidental ingestion/intake of an excessive dose of Toradiur are:

• drowsiness;
• confusion;
• hypotension (low blood pressure);
• cardiovascular collapse (sudden drop in blood pressure);
• symptoms affecting the stomach and intestines (such as abdominal pain, nausea, vomiting, diarrhea, constipation);
• dehydration (loss of fluids);
• hypovolemia (reduction in blood volume);
• reduction of sodium, potassium and chlorides in the blood (hyponatremia, hypokalemia, hypochloremic alkalosis);
• hemoconcentration (increase in blood concentration).

If you forget to take Toradiur
Do not take a double dose to make up for the missed tablet.

If you stop taking Toradiur
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during therapy:
alteration of the electrolyte balance (depletion of water, sodium, potassium, chlorine).
Occasionally, worsening of metabolic alkalosis (increased bicarbonate in the blood).
In isolated cases, hypotension (reduction of blood pressure), confusion, thromboembolic complications (formation
of thrombi or emboli) may occur, which can cause serious damage to the heart and brain.
Especially at the beginning of treatment, headache, dizziness and drowsiness may occur.
In addition, the following may occur:
feeling of weakness, muscle cramps, loss of appetite, stomach pain, nausea, vomiting, diarrhoea
or constipation, especially at the beginning of treatment.
In isolated cases, pancreatitis.
In patients who present with obstruction of the urinary tract, such as in the case of prostatic hypertrophy,
urinary retention and bladder distension may occur due to increased urine production.
Changes in some blood tests may occur: gamma-GT, uricemia, glycaemia, triglycerides,
cholesterol, azotemia, creatinine, blood count.
In isolated cases, allergic reactions such as itching, rash, severe skin reactions or photosensitization; following
intravenous administration, acute hypersensitivity reactions, potentially fatal, cannot be excluded.
Rarely dry mouth and paraesthesia of the limbs; in isolated cases, visual disturbances, tinnitus (perception of noises
in the ears) and hearing loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Toradiur

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Toradiur contains

• The active ingredient is torasemide. Each tablet contains 10 mg of torasemide.
• The other ingredients are: lactose monohydrate, corn starch, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Toradiur and contents of the pack
Tablets, for oral use, pack in a carton of 14 divisible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
Madaus GmbH - Lütticher Straße 5 - 53842 Troisdorf - Germany