DIURESIX 10 mg Coated Tablet

Зміст інструкції

1. DIURESIX 10 mg tablets, 10 mg/2 ml injectable solution, 200 mg/20 ml solution for infusion
   1. What is DIURESIX and what is it used for
   2. What you need to know before taking DIURESIX
   3. How to take DIURESIX
   4. Possible side effects
   5. How to store DIURESIX
   6. Package Contents and Other Information

DIURESIX 10 mg tablets, 10 mg/2 ml injectable solution, 200 mg/20 ml solution for infusion

Torasemide

Read this leaflet carefully before you start 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 DIURESIX is and what it is used for
• 2. What you need to know before you take DIURESIX
• 3. How to take DIURESIX
• 4. Possible side effects
• 5. How to store DIURESIX
• 6. Contents of the pack and other information

1. What is DIURESIX and what is it used for

DIURESIX contains torasemide and belongs to the class of diuretic drugs (i.e. drugs that increase
the amount of urine excreted).
This medicine is used in adults for the treatment of:

• Edema (fluid accumulation) of cardiac, hepatic (liver) and renal origin.
• 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 in the amount of urine eliminated), chronic renal failure (long-term kidney malfunction), nephrotic syndrome (an alteration at the level of the kidneys that involves the elimination of proteins in the urine). The use of DIURESIX 200 mg/20 ml solution for infusion is indicated only in patients with non-anuric renal failure (kidney malfunction not accompanied by complete inability to eliminate urine).

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking DIURESIX

Do not take DIURESIX

• If you are allergic to the active ingredient, to sulphonamides (a class of drugs used to treat diabetes) or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from anuric renal failure (kidney malfunction accompanied by an inability to eliminate urine).
• In pre-coma and hepatic coma.
• During pregnancy and breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking DIURESIX.
If you are being treated with DIURESIX or with any other diuretic, especially in case of prolonged treatment, adequate monitoring of potassium levels (concentration of potassium in the blood) should be performed. Similarly, at regular intervals and if necessary, your blood sugar levels (glucose levels in the blood), uric acid levels (amount of uric acid in the blood), creatinine levels (creatinine levels in the blood) and lipid levels (amount of fat in the blood) should be monitored.
If you suffer from latent (not yet manifested) or already manifest diabetes mellitus, careful monitoring of sugar metabolism is recommended, as an increase in blood sugar cannot be ruled out following treatment with torasemide.
Before starting treatment with torasemide, make sure that situations of hypokalaemia (potassium deficiency in the blood), hyponatraemia (sodium deficiency in the blood), hypovolaemia (decreased blood volume) and urinary disorders (urine emission) have been resolved (see section 4 “Possible side effects”).
Torasemide, even when used correctly, can affect your ability to react. Therefore, if you are taking this medicine, you should be careful when driving or operating machinery, especially during the first few days of treatment or when the medicine is taken simultaneously with alcohol (see “DIURESIX and alcohol” and “Driving and using machines”).
For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still result in positive anti-doping tests.

Children
There is no data on the use of torasemide in paediatric age.

Other medicines and DIURESIX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The simultaneous intake of DIURESIX with:

• Cardiac glycosides such as digoxin and digitoxin (drugs that stimulate heart activity) may cause cardiac rhythm disturbances if a potassium and/or magnesium deficiency is present (which may be caused by DIURESIX). If you are taking DIURESIX and cardiac glycosides at the same time, your doctor may have your potassium and magnesium levels checked periodically.
• NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, such as indometacin) may reduce the effect of torasemide.
• Laxatives (substances that stimulate intestinal motility and bowel movements), mineralocorticoids (substances that regulate water and salt balance in the body) and glucocorticoids (substances important in glucose metabolism) may lead to an increase in their kaliuretic effect (increased excretion of potassium in the urine).
• Antihypertensive drugs (drugs that lower blood pressure) lead to an increase in the effect of the latter. If treatment with torasemide is associated with an ACE inhibitor (a drug used to treat hypertension), an excessive drop in blood pressure may occur.
• Antidiabetic drugs lead to a decrease in the effectiveness of the latter.
• Aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin), cisplatin and cephalosporin preparations (antibiotic drugs), especially when taken in high doses, may potentiate their harmful effects (toxicity to the ears and kidneys).
• Lithium, may lead to an increase in the toxicity of lithium itself at the level of the heart and neurons.
• Curare and theophylline (a drug used in the therapy of numerous respiratory diseases) may potentiate their muscle relaxant action (reduction of muscle tone).
• Salicylates (anti-inflammatory drugs derived from acetylsalicylic acid) at high doses, may lead to an increase in the toxicity of the latter.
• Pressor agents (substances that increase blood pressure such as epinephrine, norepinephrine) may lead to a decrease in the arteries' response to them.
• Cholestyramine (a drug that reduces cholesterol levels in the blood) reduces bioavailability, i.e. (the amount of drug that reaches the organ on which it must act and this consequently causes a reduction in the effectiveness of torasemide.

DIURESIX with alcohol
If you are taking this medicine, you should be careful when driving or operating machinery, when the medicine is taken simultaneously with alcohol (see “Driving and using machines”).

Pregnancy and breastfeeding
You should not take DIURESIX during pregnancy and breastfeeding (see “Do not take DIURESIX”).

Driving and using machines
Torasemide, even when used correctly, can affect your ability to react. Therefore, if you are taking this medicine, you should be careful when driving or operating machinery, especially during the first few days of treatment or when the medicine is taken simultaneously with alcohol (see “DIURESIX with alcohol”).

DIURESIX 10 mg tablets contains lactose.If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, contact him before taking this medicine.

3. How to take DIURESIX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
DIURESIX 10 mg tablets
The recommended dose may vary from half to a maximum of 2 tablets per day depending on the
severity of the disease. Take the tablets with some liquid during meals.
The tablet can be divided into equal parts.
DIURESIX 10 mg/2 ml injectable solution
Unless otherwise prescribed by your doctor, the use of 1 or 2 vials per day in a single administration
into a vein is sufficient.
In case of acute clinical situations (with rapid onset of severe symptoms), for example in pulmonary
edema, 2 vials can be administered as an initial dose. If necessary, this dose can be
repeated after 30 minutes.
DIURESIX 200 mg/20 ml solution for infusion
The 200 mg vials for infusion are only indicated in patients with renal insufficiency in a non-anuric phase
(kidney malfunction not accompanied by total inability to eliminate urine).
Using an infusion pump (medical device that allows the slow injection of a drug into a vein), 200 mg of torasemide (20 ml vial) can be administered in a slow intravenous infusion.
Further infusions must be carried out at intervals of 6-12 hours depending on diuresis. The maximum
daily dose is 400 mg.
The rate of infusion should not exceed 4 mg/min of torasemide (0.4 ml/min). If necessary, the
DIURESIX 200 mg vial can be diluted in 30 ml, 125 ml, 250 ml or 500 ml of physiological saline solution,
5% glucose solution, 5% fructose solution or water for injectable preparations. The resulting
solution must be used immediately.

If you take more DIURESIX than you should
In case of overdose, marked diuresis with loss of fluids and electrolytes may occur. In this case,
electrolyte concentrations in the blood (particles present within
the body, such as sodium, potassium, chlorine, etc.) will have to be restored. There is no specific antidote to torasemide (i.e.
a substance capable of neutralizing the action of torasemide).
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.
In relation to the dosage and duration of treatment, disturbances of the hydro-electrolyte balance (ratio
between mineral salts and water in our body) may occur, especially in case of reduced salt intake.
Especially at the beginning of treatment and if you are elderly, in case of high diuresis, symptoms of
electrolyte deficiency and reduction of blood volume may manifest, such as migraine, dizziness, asthenia
(lack of strength), loss of appetite and cramps, and in rare cases circulatory disorders and
thromboembolic complications (difficulty in blood circulation with consequent formation of
coaguli) due to hemoconcentration (increased blood concentration). These side effects
disappear by adjusting the dosage to individual needs.
Occasionally, the concentration of potassium in the blood may be reduced by treatment with
torasemide at the recommended doses; hypokalemia may also occur in case of a diet poor in potassium,
continuous vomiting, profuse diarrhea and excessive use of laxatives (see “Warnings and precautions” and
“Other medicines and DIURESIX”).
Occasionally, gastrointestinal disorders such as nausea, vomiting, diarrhea and constipation may occur.
If you suffer from obstruction (closure or narrowing) of the urinary tract (e.g. due to prostatic
hypertrophy) the increased urine production may lead to its retention, causing therefore bladder
dilation.
In rare cases, treatment with torasemide may lead to a reversible decrease in the formed elements of the
blood (erythrocytes, leukocytes, platelets).
Isolated cases of increased azotemia (nitrogen concentration in the blood), creatinine and gamma-GT
(substances whose level in the blood may indicate a liver abnormality), alterations in blood glucose, fat
metabolism and increased uric acid levels have been reported.
Individual cases of allergic skin reactions such as itching or erythema may occur.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store DIURESIX

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 which is stated on the packaging 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. Package Contents and Other Information

What DIURESIX contains
DIURESIX 10 mg tablets
1 divisible tablet contains:

Active ingredient: Torasemide 10 mg.

Other components: Lactose, corn starch, precipitated silica, magnesium stearate.
DIURESIX 10mg/2 ml injectable solution
1 vial contains:

Active ingredient: Torasemide 10 mg (equivalent to 10.631 mg of sodium salt).

Other components: Sodium hydroxide, trometamol, polyethylene glycol 400, water for injections
DIURESIX 200mg/20 ml solution for infusion
1 vial contains:

Active ingredient: Torasemide 200 mg (equivalent to 212.62 mg of sodium salt).

Other components: Sodium hydroxide, trometamol, polyethylene glycol 400, water for injections.

Description of the appearance of DIURESIX and package contents
DIURESIX 10 mg tablets: white tablets with a fracture line for oral use - 14 tablets
of 10 mg in blisters.
DIURESIX 10mg/2 ml injectable solution: colorless injectable solution for intravenous use - 5 vials of 10
mg in 2 ml, of colorless glass.
DIURESIX 200mg/20 ml solution for infusion: colorless solution for intravenous infusion - 1 vial of
200 mg in 20 ml, of colorless glass.

Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. – 1, Avenue de la Gare, Luxembourg .

Manufacturer
DIURESIX 10mg/2 ml injectable solution and DIURESIX 200mg/20ml solution for infusion

• A. Menarini Manufacturing Logistics and Services s.r.l., via Sette Santi, 3 – Firenze. DIURESIX 10 mg tablets
• A. Menarini Manufacturing Logistics and Services s.r.l., via Sette Santi, 3 – Firenze.
• A. Menarini Manufacturing Logistics and Services s.r.l., Campo di Pile, L'Aquila. Berlin Chemie AG, Glienicker Weg, 125 - 12489 Berlin – Germany.