Package leaflet: Information for the user

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

Torasemide
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DIUREMID is and what it is used for
What you need to know before taking DIUREMID
How to take DIUREMID
Possible side effects
How to store DIUREMID
Contents of the pack and other information

1. What DIUREMID is and what it is used for

DIUREMID contains torasemide and belongs to a class of medicines called diuretics (i.e. drugs that increase the amount of urine produced).
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 supply adequate blood flow 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 causing loss of protein in the urine). The use of DIUREMID 200 mg/20 ml solution for infusion is indicated only in patients with renal failure in the non-anuric phase (kidney dysfunction not accompanied by complete inability to excrete urine).

Talk to your doctor if you do not feel better or if you feel worse.
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2. What you should know before taking DIUREMID

Do not take DIUREMID

If you are allergic to the active substance, to sulfonamides (a class 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 renal failure in the anuric phase (kidney dysfunction accompanied by inability to excrete urine).
In pre-hepatic coma and hepatic coma.
During pregnancy and breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking DIUREMID.
If you are being treated with DIUREMID or any other diuretic, particularly if treatment is prolonged, appropriate monitoring of serum potassium levels (blood potassium concentration) should be performed. Similarly, at regular intervals and whenever necessary, your blood glucose levels (blood sugar), uric acid levels (blood uric acid), creatinine levels (blood creatinine), and lipid levels (blood fats) should also be monitored.
If you have latent (not yet apparent) or overt diabetes mellitus, careful monitoring of sugar metabolism is recommended, since an increase in blood glucose levels cannot be ruled out during treatment with torasemide.
Before starting treatment with torasemide, ensure that conditions such as hypokalaemia (low blood potassium), hyponatraemia (low blood sodium), hypovolaemia (reduced blood volume), and urinary disorders (urination problems) have been resolved (see section 4 "Possible side effects").

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

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

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

Cardiac glycosides (digitalis-type drugs such as digoxin and digitoxin—medicines that stimulate heart activity) may lead to cardiac rhythm disturbances if there is a deficiency of potassium and/or magnesium (which may be caused by DIUREMID). If DIUREMID and cardiac glycosides are taken together, your doctor may periodically check your blood levels of potassium and magnesium.

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NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, such as indomethacin) may reduce the effect of torasemide.
Laxatives (substances that stimulate intestinal motility and faecal excretion), mineralocorticoids (substances regulating water and electrolyte balance in the body), and glucocorticoids (important in glucose metabolism) may enhance their kaliuretic effect (increased excretion of potassium in urine).
Antihypertensive medicines (drugs that lower blood pressure) may result in an enhanced effect of these medicines. If treatment with torasemide is combined with an ACE inhibitor (a medicine 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 medicines), especially when high doses are administered, may lead to increased harmful effects (ototoxicity and nephrotoxicity).
Lithium may lead to increased lithium toxicity affecting the heart and neurons.
Curare and theophylline (a medicine used in the treatment of various respiratory diseases) may result in enhanced muscle-relaxant effects.
Salicylates (anti-inflammatory drugs derived from acetylsalicylic acid) at high doses may lead to increased toxicity of these drugs.
Pressor agents (substances that increase blood pressure, such as epinephrine, norepinephrine) may lead to reduced arterial response to these agents.
Cholestyramine (a medicine that reduces blood cholesterol levels) reduces bioavailability—i.e., the amount of drug reaching its target organ—resulting in reduced efficacy of torasemide.

DIUREMID 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 machines").

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

Driving and use of machines
Torasemide, even when used correctly, may affect 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 "DIUREMID and alcohol").

DIUREMID 10 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take DIUREMID

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

DIUREMID 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.

DIUREMID 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 cases of acute clinical conditions (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.

DIUREMID 200 mg/20 ml infusion solution
The 200 mg infusion vials are indicated only in patients with renal insufficiency in non-anuric phase (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 (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 DIUREMID vial may 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 DIUREMID than you should
In case of overdose, pronounced 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 action of torasemide).
If you have any doubts about the use of 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 water and electrolyte balance (the ratio between minerals and water in the body) may occur, particularly if salt intake is reduced. Especially at the beginning of treatment and if you are elderly, or if you experience 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, and, in rare cases, circulatory disturbances and thromboembolic complications (problems with blood circulation leading to blood clot formation) due to haemoconcentration (increased concentration of the blood). These side effects disappear by adjusting the dosage according to individual needs.
Occasionally, treatment with torasemide at the recommended doses may reduce blood potassium levels; hypokalaemia may also occur with a potassium-poor diet, persistent vomiting, profuse diarrhoea, or excessive use of laxatives (see "Warnings and precautions" and "Other medicines and DIUREMID").
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 prostatic hypertrophy), increased urine production may lead to urinary retention, thus causing bladder distension.
In rare cases, treatment with torasemide may lead to a reversible decrease in blood cellular components (red blood cells, white blood cells, platelets).
Isolated cases have been reported of increased blood urea nitrogen, serum creatinine and gamma-GT (substances whose blood levels may indicate liver abnormalities), changes in blood glucose, fat metabolism, and increased uric acid levels.
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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://
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 DIUREMID

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. Contents of the pack and other information

What DIUREMID contains
DIUREMID 10 mg tablets
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1 tablet contains:
Active substance: Torasemide 10 mg.
Other components: Lactose, corn starch, precipitated silica, magnesium stearate.

DIUREMID 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, tromethamine, polyethylene glycol 400, water for injectable preparations.

DIUREMID 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, tromethamine, polyethylene glycol 400, water for injectable preparations.

Description of the appearance of DIUREMID and contents of the pack
DIUREMID 10 mg tablets: white tablets with a score line for oral use – 14 tablets of 10 mg in blister packs.
DIUREMID 10 mg/2 ml injectable solution: colourless injectable solution for intravenous use – 5 vials of 10 mg in 2 ml, in colourless glass.
DIUREMID 200 mg/20 ml infusion solution: colourless solution for intravenous infusion – 1 vial of 200 mg in 20 ml, in colourless glass.

Marketing Authorization Holder
Menarini International Operations Luxembourg S.A. – 1, Avenue de la Gare, Luxembourg.
Sales Licensee: Istituto Luso Farmaco d’Italia S.p.A., Milanofiori – Strada 6 – Edificio L – 20089 Rozzano (MI)

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

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