Diuresix

Patient Information Leaflet: Information for the User

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

Torasemide
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult 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 taking 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 DIURESIX is and what it is used for

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

• Oedema (fluid accumulation) of cardiac, hepatic (liver), and renal origin.
• Acute pulmonary oedema (fluid accumulation in the lungs).
• Ascites (fluid accumulation in the abdomen).
• Congestive heart failure (the heart’s inability to deliver an adequate blood supply to meet the body’s normal requirements).
• Acute renal failure (oliguria, i.e. reduced urine output), chronic renal failure (long-term kidney dysfunction), nephrotic syndrome (a kidney disorder resulting in loss of proteins in the urine). The use of DIURESIX 200 mg/20 ml solution for infusion is indicated only in patients with renal failure in non-anuric phase (kidney dysfunction not accompanied by complete inability to excrete urine).

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

2. What you should know before taking DIURESIX

Do not take DIURESIX

• If you are allergic to the active substance, to sulphonamides (a family of drugs used in the treatment of diabetes), or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from anuric renal failure (kidney dysfunction accompanied by inability to excrete urine).
• In pre-hepatic coma or hepatic coma.
• During pregnancy and breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking DIURESIX.
If you are being treated with DIURESIX or any other diuretic, especially for prolonged periods, appropriate monitoring of serum potassium levels (potassium concentration in the blood) should be performed. Similarly, at regular intervals and whenever necessary, your blood glucose (blood sugar levels), uric acid levels (uricemia), creatinine levels (creatininemia), and blood lipid levels (lipidemia) should also be monitored.
If you have latent (not yet apparent) or overt diabetes mellitus, careful monitoring of sugar metabolism is recommended, as an increase in blood glucose levels cannot be ruled out during treatment with torasemide.
Before starting treatment with torasemide, ensure that conditions such as hypokalemia (low potassium levels in the blood), hyponatremia (low sodium levels in the blood), hypovolemia (reduced blood volume), and urinary disorders (urination problems) have been resolved (see section 4, "Possible side effects").
Torasemide, even when used correctly, may affect your reaction ability. Therefore, if you are taking this medicine, you should exercise caution when driving or operating machinery, especially during the first days of treatment or when the medicine is taken together with alcohol (see "DIURESIX and alcohol" and "Driving and use of machinery").

For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children
There are no data on the use of torasemide in the pediatric population.

Other medicines and DIURESIX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of DIURESIX with:

• Cardiac glycosides (digitalis drugs) such as digoxin and digitoxin (medicines that stimulate heart activity) may lead to disturbances in heart rhythm if potassium and/or magnesium deficiency is present (which may be caused by DIURESIX). If DIURESIX is taken together with cardiac glycosides, your doctor may periodically check your blood levels of potassium and magnesium.
• NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, such as indomethacin) may reduce the effect of torasemide.
• Laxatives (substances that stimulate intestinal motility and bowel movements), mineralocorticoids (substances regulating water and electrolyte balance), and glucocorticoids (important in glucose metabolism) may increase their kaliuretic effect (increased excretion of potassium in urine).
• Antihypertensive medicines (drugs that lower blood pressure) may have an enhanced effect. If treatment with torasemide is combined with an ACE inhibitor (a drug used to treat hypertension), excessive lowering of blood pressure may occur.
• Antidiabetic medicines may result in reduced effectiveness of these medicines.
• Aminoglycoside antibiotics (e.g., kanamycin, gentamicin, tobramycin), cisplatin preparations, and cephalosporins (antibiotic drugs), especially when high doses are administered, may lead to increased toxicity (ear and kidney damage).
• Lithium may lead to increased lithium toxicity at the level of the heart and neurons.
• Curare and theophylline (a drug used in the treatment of various respiratory diseases) may enhance their muscle-relaxing (myorelaxant) effects.
• Salicylates (anti-inflammatory drugs derived from acetylsalicylic acid) at high doses may increase their toxicity.
• Pressor agents (substances that increase blood pressure, such as epinephrine, norepinephrine) may reduce arterial responsiveness to these agents.
• Cholestyramine (a drug that lowers blood cholesterol levels) reduces the bioavailability (amount of drug reaching the target organ), thereby reducing the effectiveness of torasemide.

DIURESIX and alcohol
If you are taking this medicine, you should exercise caution when driving or operating machinery, particularly when the medicine is taken together with alcohol (see "Driving and use of machinery").

Pregnancy and breastfeeding
You must not take DIURESIX during pregnancy or breastfeeding (see "Do not take DIURESIX").

Driving and use of machinery
Torasemide, even when used correctly, may affect your reaction ability. Therefore, if you are taking this medicine, you should exercise caution when driving or operating machinery, especially during the first days of treatment or when the medicine is taken together with alcohol (see "DIURESIX and alcohol").

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

3. How to take DIURESIX

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

DIURESIX 10 mg tablets
The recommended dose may range from half a tablet to a maximum of 2 tablets daily, depending on the severity of the disease. Take the tablets with some liquid during meals.
The tablet may be divided into equal parts.

DIURESIX 10 mg/2 ml injectable solution
Unless otherwise prescribed by the physician, administration of 1 or 2 vials per day as a single intravenous dose is sufficient.
In acute clinical situations (with rapid onset of severe symptoms), for example in pulmonary edema, 2 vials may be administered as an initial dose. If necessary, this dose may be repeated after 30 minutes.

DIURESIX 200 mg/20 ml infusion solution
The 200 mg infusion vials are indicated only in patients with non-anuric renal insufficiency (kidney dysfunction not accompanied by complete inability to excrete urine).
Using an infusion pump (a medical device allowing slow intravenous administration of a drug), 200 mg of torasemide (one 20 ml vial) may be administered as a slow intravenous infusion.
Further infusions should be given at intervals of 6–12 hours, depending on diuresis. The maximum daily dose is 400 mg.
The infusion rate should not exceed 4 mg/min of torasemide (0.4 ml/min). If needed, the 200 mg DIURESIX vial can be diluted in 30 ml, 125 ml, 250 ml, or 500 ml of physiological saline, 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 may occur, leading to loss of fluids and electrolytes. In such cases, blood electrolyte concentrations (particles present in the body such as sodium, potassium, chloride, etc.) must be restored. There is no specific antidote for torasemide (i.e., a substance capable of neutralizing the effect of torasemide).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Depending on the dosage and duration of treatment, disturbances in the water-electrolyte balance (the ratio between minerals and water in the body) may occur, especially if salt intake is reduced. Particularly at the beginning of treatment and especially in elderly patients or in case of high diuresis, symptoms of electrolyte deficiency and reduced blood volume may occur, such as headache, dizziness, asthenia (lack of strength), loss of appetite and cramps; in rare cases circulatory disturbances and thromboembolic complications (problems with blood circulation leading to blood clot formation) due to haemoconcentration (increased blood concentration) may occur. These side effects disappear by adjusting the dosage according to individual needs.

Occasionally, treatment with torasemide at the recommended doses may reduce potassium levels in the blood; hypokalaemia may also occur in case of a diet low in potassium, persistent vomiting, profuse diarrhoea, or excessive use of laxatives (see “Warnings and precautions” and “Other medicines and DIURESIX”).

Occasionally, gastrointestinal disturbances such as nausea, vomiting, diarrhoea and constipation may occur.

If you suffer from urinary tract obstruction (blockage or narrowing) (e.g. due to prostate enlargement), increased urine production may lead to urinary retention, thus causing bladder distension.

Rarely, treatment with torasemide may lead to a reversible decrease in blood cellular components (erythrocytes, leucocytes, platelets).

Isolated cases of increased blood urea nitrogen (azotaemia), creatinine levels, gamma-GT (substances whose blood levels may indicate liver abnormalities), alterations in blood glucose levels, fat metabolism, and increased levels of uric acid have been reported.

Individual cases of allergic skin reactions such as itching or erythema may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after 'Exp'. The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 tablet contains:
Active substance: Torasemide 10 mg.
Other components: Lactose, maize starch, precipitated silica, magnesium stearate.

DIURESIX 10 mg/2 ml injectable solution
1 vial contains:
Active substance: Torasemide 10 mg (equivalent to 10.631 mg of sodium salt).
Other components: Sodium hydroxide, trometamol, polyethylene glycol 400, water for injections.

DIURESIX 200 mg/20 ml infusion solution
1 vial contains:
Active substance: 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 score line for oral use – 14 tablets of 10 mg in blister packs.
DIURESIX 10 mg/2 ml injectable solution: colourless injectable solution for intravenous use – 5 vials of 10 mg in 2 ml, colourless glass.
DIURESIX 200 mg/20 ml infusion solution: colourless solution for intravenous infusion – 1 vial of 200 mg in 20 ml, colourless glass.

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

Manufacturer
DIURESIX 10 mg/2 ml injectable solution and DIURESIX 200 mg/20 ml infusion solution
A. Menarini Manufacturing Logistics and Services s.r.l., via Sette Santi, 3 – Florence, Italy.

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