TORASEMIDE 10 mg Tablet

Зміст інструкції

1. TORASEMIDE MYLAN GENERICS10 mg tablets
   1. What is TORASEMIDE MYLAN GENERICS and what it is used for
   2. What you need to know before you take TORASEMIDE MYLAN GENERICS
2. TORASEMIDE MYLAN GENERICS may cause dizziness or similar symptoms, especially if
   1. How to take TORASEMIDE MYLAN GENERICS
   2. Possible side effects
   3. How to store TORASEMIDE MYLAN GENERICS
   4. Package Contents and Other Information

TORASEMIDE MYLAN GENERICS10 mg tablets

Torasemide

Equivalent Medicinal Product
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 their symptoms are the same as yours, 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 TORASEMIDE MYLAN GENERICS is and what it is used for
• 2. What you need to know before you take TORASEMIDE MYLAN GENERICS
• 3. How to take TORASEMIDE MYLAN GENERICS
• 4. Possible side effects
• 5. How to store TORASEMIDE MYLAN GENERICS
• 6. Contents of the pack and other information

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

TORASEMIDE MYLAN GENERICS contains the active ingredient 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
suffering from severe heart problems (heart failure).

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

Do not take TORASEMIDE MYLAN GENERICS

• if you are allergic to torasemide, to similar substances (sulfonamides) or to any of the other ingredients of this medicine (listed in section 6);
• if you are unable to produce urine (anuria) because you suffer from severe kidney problems (renal failure);
• if you are in a coma caused by liver problems (hepatic coma) or are in the stage preceding the coma (pre-coma);
• if you suffer from 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 (hypokalemia, hyponatremia) or if you have a decrease in blood volume (hypovolemia);
• if you have problems with urination (urinary disorders) or suffer from prostate problems (benign prostatic hyperplasia);
• if you suffer from heart rhythm disturbances (cardiac arrhythmias, sinoatrial block, second or third degree atrioventricular block);
• if you suffer from diseases that cause an alteration of the acidic substances present in the body (acid-base balance);
• if you are taking lithium, used to treat some mental 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 can damage the kidneys (nephrotoxic).

During treatment with TORASEMIDE MYLAN GENERICS, especially in case of prolonged
treatments, your doctor will need to perform periodic blood tests to monitor:

• the amount of water and salts present in the body (electrolyte balance), especially if you are taking medicines used to treat heart disorders (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 suffer from diabetes;
• uric acid levels, especially if you are predisposed to having high levels of uric acid in the blood (hyperuricemia) and in the joints (gout);
• creatinine levels, to assess your kidney function;
• fat levels in the blood. Attention, for those who practice sports: the active ingredient contained in this preparation is included in the list of prohibited substances for doping.

Children
This medicine is not recommended for children under the age of 12 years.

Elderly
If you are elderly, your doctor will need to monitor you during treatment with this medicine especially
in case of prolonged treatments.

Other medicines and TORASEMIDE MYLAN GENERICS
Tell 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 disorders, mineralocorticoids, which regulate blood pressure and urine elimination, glucocorticoids, for the treatment of inflammation, laxatives, to facilitate bowel movements. These medicines, if taken together with TORASEMIDE MYLAN GENERICS, can cause increased loss of salts with the urine.
• antihypertensives, particularly ACE inhibitors, used to treat high blood pressure. In this case, to avoid excessive reduction of blood pressure, the doctor may decide to reduce the doses of the medicines or to stop treatment with TORASEMIDE MYLAN GENERICS 2 or 3 days before starting therapy with the ACE inhibitor.
• adrenaline and noradrenaline, used to increase blood pressure and antidiabetics, 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 some cancers, and salicylates, for the treatment of inflammation, as TORASEMIDE MYLAN GENERICS can increase their toxicity;
• lithium, used for some mental disorders, as TORASEMIDE MYLAN GENERICS can increase its concentration and toxicity;
• curare, used to decrease muscle contraction, and theophylline, used for asthma and some breathing disorders, as torasemide increases their effectiveness;
• non-steroidal anti-inflammatory drugs, such as indomethacin, for the treatment of inflammation, probenecid for the treatment of gout, and cholestiramine, to lower cholesterol levels in the blood, as they may reduce the effectiveness of TORASEMIDE MYLAN GENERICS.

TORASEMIDE MYLAN GENERICS with alcohol

TORASEMIDE MYLAN GENERICS may cause dizziness or similar symptoms, especially if

you are simultaneously taking alcohol .Avoid drinking alcoholic beverages during treatment with this
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During pregnancy, take TORASEMIDE MYLAN GENERICS only when absolutely necessary and
under the direct supervision of your doctor. If necessary, your doctor will prescribe the lowest dosage.
Breastfeeding
Do not take TORASEMIDE MYLAN GENERICS if you are breastfeeding.

Driving and operating machinery
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 vehicles or
operate machinery.

TORASEMIDE MYLAN GENERICS contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

3. How to take TORASEMIDE MYLAN GENERICS

Take this medicine following exactly the instructions of 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 sip of water.
The tablet can be divided into two equal halves.
TORASEMIDE MYLAN GENERICS is usually prescribed for long-term therapy or until the
disappearance of swelling caused by fluid accumulation (edema).
The recommended dose in adults is 5 mg, once a day (maintenance dose). If necessary, the
doctor may increase the dose, gradually, up to 20 mg, once a day.

Use in the elderly
The doctor may decide to adjust the dose, if necessary, to reduce the risk of undesirable effects.

Use in people with liver problems (hepatic insufficiency)
Take this medicine with caution if you suffer from liver problems, because in these cases it may increase
the effectiveness of TORASEMIDE MYLAN GENERICS.

If you take more TORASEMIDE MYLAN GENERICS than you should
If you (or someone else) have ingested an excessive dose of TORASEMIDE MYLAN GENERICS, or if you think
that a child has ingested an excessive dose, consult a doctor immediately.
Following the intake of an excessive dose of this medicine, the following symptoms may occur:
increased urine production (diuresis) which determines loss of fluids and salts (electrolytes) from the body,
drowsiness, confusion, severe and sudden lowering of blood pressure (hypotension and circulatory collapse),
problems with the stomach and intestines.
In case of accidental intake/ingestion of an excessive dose of this medicine, warn
your doctor immediately or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the remaining medicine and its container to the hospital or doctor so
they know which medicine was 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 to take
the next dose. Do not take a double dose to make up for the missed dose.
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 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(the frequency of which cannot be estimated based on available data)
• disturbances in the balance of water and dissolved salts in the body (water and electrolyte balance), especially if you take in few salts with your diet;
• reduction of potassium levels in the blood (hypokalemia), especially if you follow a low-potassium diet, if you have vomiting, diarrhea, if you use laxatives, medicines that facilitate bowel movements, at high doses and for a long time or if you suffer from severe liver problems (hepatic insufficiency);
• headache, dizziness, low blood pressure (hypotension), weakness, drowsiness, confusion, loss of appetite and cramps. These are the symptoms of loss of salts (electrolytes) or reduction of blood volume (volemia) and occur when there is excessive urine excretion, especially at the beginning of therapy and in the elderly.
• increase in uric acid, sugar (glucose) and fat (lipid) levels in the blood;
• worsening of metabolic alkalosis, a condition in which a reduction in blood acidity occurs;
• loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation;
• worsening of the bladder's inability to empty (urinary retention) in patients suffering from kidney problems (obstruction of urine flow), alteration of the values of some blood tests (increase in blood urea levels and creatinine);
• increase in some liver enzymes;
• dry mouth
• formation of blood clots in the veins (thromboembolism), problems with the circulation of the heart and brain (cardiac and cerebral ischemia), which can lead to heart rhythm disturbances (cardiac arrhythmias), chest pain (angina pectoris), heart attack or fainting with loss of consciousness (syncope);
• inflammation of the pancreas (pancreatitis);
• decrease in the number of red blood cells, white blood cells and platelets;
• itching, rash and sensitivity to light (photosensitivity);
• vision disturbances;
• perception of ringing inside the ear (tinnitus);
• hearing loss;
• sensation of tingling (paresthesia) in the limbs.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 TORASEMIDE MYLAN GENERICS

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

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

Description of the appearance of TORASEMIDE MYLAN GENERICS and package contents
Packs in blisters of 10, 14, 20, 28, 30, 50, 56, 100, 400 (20x20) tablets.

Marketing Authorisation Holder
Mylan S.p.A.,Via Vittor Pisani 20,20124 Milano

Manufacturers
SalutasPharmaGmbH,Otto-von-Guericke-Allee,39179 Barleben, Germany
Mylan S.p.A.,Viale dell'Innovazione 3,20126 Milano, Italy
Lek S.A.,UI. Domaniewska 50C,Warszawa, 02-672, Poland