PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TORASEMIDE MYLAN GENERICS 10 mg tablets

Torasemide
Generic Medicine
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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TORASEMIDE MYLAN GENERICS is and what it is used for

TORASEMIDE MYLAN GENERICS contains the active substance torasemide, which belongs to a group of medicines called diuretics that increase the production and elimination of urine.
This medicine is indicated to reduce swelling caused by fluid retention (edema) in people with severe heart problems (heart failure).

2. What you need to know before taking TORASEMIDE MYLAN GENERICS

Do not take TORASEMIDE MYLAN GENERICS

if you are allergic to torasemide, to similar substances (sulphonamides) or to any of the other ingredients of this medicine (listed in section 6);
if you are unable to produce urine (anuria) due to severe kidney problems (renal failure);
if you are in a coma caused by liver problems (hepatic coma) or in the stage preceding coma (pre-coma);
if you have low blood pressure (hypotension);
if you are breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking TORASEMIDE MYLAN GENERICS.
Take this medicine with caution and inform your doctor in the following cases:

if you have low levels of potassium and sodium in your blood (hypokalaemia, hyponatraemia) or if you have reduced blood volume (hypovolaemia);
if you have problems urinating (urinary disorders) or suffer from prostate problems (benign prostatic hyperplasia);
if you suffer from heart rhythm disorders (cardiac arrhythmias, sino-atrial block, second- or third-degree atrioventricular block);
if you suffer from diseases causing disturbances in the acid-base balance of the body;
if you are taking lithium, used to treat certain psychiatric disorders, and aminoglycosides or cephalosporins, antibiotics used to treat infections (See section “Other medicines and TORASEMIDE MYLAN GENERICS”);
if you suffer from kidney problems (renal failure) caused by substances that may damage the kidneys (nephrotoxic agents).

During treatment with TORASEMIDE MYLAN GENERICS, especially during prolonged treatment, your doctor should perform periodic blood tests to monitor:

fluid and electrolyte balance in the body, especially if you are taking medicines used to treat heart conditions (digitalis glycosides), inflammation (glucocorticoids), to control blood pressure and urine elimination (mineralocorticoids), or to facilitate bowel movements (laxatives) (See section “Other medicines and TORASEMIDE MYLAN GENERICS”);
blood sugar levels, especially if you have diabetes;
uric acid levels, especially if you are prone to high levels of uric acid in the blood (hyperuricaemia) and in the joints (gout);
creatinine levels, to assess kidney function;
levels of fats in the blood.
Attention for athletes: The active ingredient contained in this preparation is included in the list of substances prohibited for doping.

Children
This medicine is not recommended for children under 12 years of age.
Elderly
If you are elderly, your doctor should monitor you closely during treatment with this medicine, especially during prolonged treatment.
Other medicines and TORASEMIDE MYLAN GENERICS
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

cardiac glycosides, used to treat heart conditions, mineralocorticoids (which regulate blood pressure and urine elimination), glucocorticoids (for the treatment of inflammation), and laxatives (to facilitate bowel movements). These medicines, when taken together with TORASEMIDE MYLAN GENERICS, may cause increased loss of electrolytes in the urine.
antihypertensives, particularly ACE inhibitors, used to treat high blood pressure. In this case, to avoid excessive lowering of blood pressure, your doctor may decide to reduce the doses of these medicines or to discontinue treatment with TORASEMIDE MYLAN GENERICS 2 or 3 days before starting therapy with an ACE inhibitor.
adrenaline and noradrenaline, used to increase blood pressure, and antidiabetic medicines, used to treat diabetes, as torasemide may reduce the effects of these medicines;
aminoglycoside and cephalosporin antibiotics, used to treat infections, cisplatin, used to treat certain tumours, and salicylates, used to treat inflammation, as TORASEMIDE MYLAN GENERICS may increase their toxicity;
lithium, used for certain psychiatric disorders, as TORASEMIDE MYLAN GENERICS may increase its concentration and toxicity;
curare (curarizing agents), used to reduce muscle contraction, and theophylline, used for asthma and certain breathing disorders, as torasemide increases their effectiveness;
non-steroidal anti-inflammatory drugs, such as indomethacin, used to treat inflammation, probenecid for the treatment of gout, and cholestyramine, used to lower cholesterol levels in the blood, as they may reduce the effectiveness of TORASEMIDE MYLAN GENERICS.

TORASEMIDE MYLAN GENERICS and alcohol
TORASEMIDE MYLAN GENERICS may cause dizziness or similar symptoms, especially if you consume alcohol at the same time. Avoid drinking alcoholic beverages during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During pregnancy, take TORASEMIDE MYLAN GENERICS only if clearly needed and under direct medical supervision. If necessary, your doctor will prescribe the lowest possible dose.
Breastfeeding
Do not take TORASEMIDE MYLAN GENERICS if you are breastfeeding.
Driving and using machines
The use of TORASEMIDE MYLAN GENERICS may cause dizziness or similar symptoms, especially at the beginning of treatment or when the dose is increased. If you experience these symptoms, do not drive or operate machinery.
TORASEMIDE MYLAN GENERICS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take TORASEMIDE MYLAN GENERICS

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole in the morning, without chewing, with a glass of water.
The tablet may be divided into two equal halves.
TORASEMIDE MYLAN GENERICS is usually prescribed for long-term treatment or until
disappearance of swelling caused by fluid accumulation (edema).
The recommended dose in adults is 5 mg once daily (maintenance dose). If necessary, your
doctor may gradually increase the dose up to 20 mg once daily.
Use in the elderly
If necessary, your doctor may decide to adjust the dose to reduce the risk of adverse effects.
Use in patients with liver problems (hepatic impairment)
Take this medicine with caution if you suffer from liver problems, as in such cases the effect of TORASEMIDE MYLAN GENERICS may be increased.
If you take more TORASEMIDE MYLAN GENERICS than you should
If you (or someone else) have taken an excessive dose of TORASEMIDE MYLAN GENERICS, or if you suspect that a child has taken an excessive dose, contact a doctor immediately.
After taking an excessive dose of this medicine, the following symptoms may occur:
increased urine production (diuresis) leading to loss of fluids and salts (electrolytes) from the body,
drowsiness, confusion, severe and sudden drop in blood pressure (hypotension and circulatory collapse), stomach and intestinal problems.
In case of accidental overdose of this medicine, contact a doctor immediately or go to the nearest hospital emergency department.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so that they know which medicine has been taken.
If you forget to take TORASEMIDE MYLAN GENERICS
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
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 everyone experiences them.
The side effects that may occur are listed below:
Very rare (may affect up to 1 in 10,000 people)

severe skin reactions. Frequency not known (frequency cannot be estimated from the available data)
disturbances in the balance of water and dissolved salts in the body (fluid and electrolyte balance), especially if you consume low amounts of salt in your diet;
decreased levels of potassium in the blood (hypokalaemia), particularly if you follow a potassium-poor diet, have vomiting or diarrhoea, use laxatives or medicines that increase bowel movements, use high doses for prolonged periods, or suffer from severe liver problems (hepatic insufficiency);
headache (cephalalgia), dizziness, low blood pressure (hypotension), weakness, drowsiness, confusion, loss of appetite, and muscle cramps. These are symptoms of loss of salts (electrolytes) or reduction in blood volume (hypovolemia) and may occur with excessive urine production, especially at the beginning of treatment and in elderly patients.
increased levels of uric acid, blood sugar (glucose), and fats (lipids) in the blood;
worsening of metabolic alkalosis, a condition in which blood acidity is reduced;
loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation;
worsening of inability of the bladder to empty (urinary retention) in patients with kidney problems (urinary flow obstruction), changes in certain blood test results (increased blood urea and creatinine levels);
increased levels of certain liver enzymes;
dry mouth;
formation of blood clots in the veins (thromboembolism), circulation problems affecting the heart and brain (cardiac and cerebral ischemia), which may lead to disturbances in heart rhythm (cardiac arrhythmias), chest pain (angina pectoris), heart attack, or fainting with loss of consciousness (syncope);
inflammation of the pancreas (pancreatitis);
decreased number of red blood cells, white blood cells, and platelets;
itching, skin rash, and sensitivity to light (photosensitivity);
vision disorders;
perception of ringing in the ears (tinnitus);
hearing loss;
tingling sensation (paraesthesia) in the limbs.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You may 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 TORASEMIDE MYLAN GENERICS

Keep this medicine out of the sight and reach of children.
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 store above 25°C.
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 TORASEMIDE MYLAN GENERICS contains

The active substance is torasemide. Each tablet contains 10 mg of torasemide.
The other components are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica.

Description of the appearance of TORASEMIDE MYLAN GENERICS and package contents
Blister packs containing 10, 14, 20, 28, 30, 50, 56, 100, 400 (20x20) tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee, 39179 Barleben, Germany
Mylan S.p.A., Viale dell'Innovazione 3, 20126 Milano, Italy
Lek S.A., Ul. Domaniewska 50C, Warszawa, 02-672, Poland