FUROSEMIDE 500 mg Tablet

Зміст інструкції

1. Furosemide Mylan Generics 25 mg tablets
   1. What is Furosemide Mylan Generics and what is it used for
   2. What you need to know before taking Furosemide Mylan Generics
   3. How to take Furosemide Mylan Generics
   4. Possible side effects
   5. How to store Furosemide Mylan Generics
   6. Contents of the pack and other information
2. Furosemide Mylan Generics 500 mg divisible tablets
   1. What is Furosemide Mylan Generics and what it is used for
   2. What you need to know before taking Furosemide Mylan Generics
   3. How to take Furosemide Mylan Generics
   4. Possible side effects
   5. How to store Furosemide Mylan Generics
   6. Contents of the pack and other information

Furosemide Mylan Generics 25 mg tablets

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 they have the same symptoms as you, as it may 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 Furosemide Mylan Generics is and what it is used for
• 2. What you need to know before you take Furosemide Mylan Generics
• 3. How to take Furosemide Mylan Generics
• 4. Possible side effects
• 5. How to store Furosemide Mylan Generics
• 6. Contents of the pack and other information

1. What is Furosemide Mylan Generics and what is it used for

Furosemide Mylan Generics contains the active ingredient furosemide, which belongs to a group of
medicines called diuretics, which help to produce more urine, thus helping to relieve discomfort
caused by an excessive accumulation of fluids in the body (edema).
Furosemide Mylan Generics 25 mg is indicated for the treatment of:

• fluid retention (edema) in people with heart problems,
• ascites, an accumulation of fluid in the abdomen (caused by liver cirrhosis),
• fluid accumulation in the kidneys (nephrotic syndrome; in this case Furosemide Mylan Generics can also be used in association with other medicines, such as ACTH or corticosteroids)
• obstruction of organs and blood vessels or heart failure;
• fluid retention in the extremities (peripheral edema)
• mild to moderate high blood pressure.

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

2. What you need to know before taking Furosemide Mylan Generics

Do not take Furosemide Mylan Generics if:

• you are allergic to furosemide or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to certain medicines called “sulphonamides” (such as sulphonamide antibiotics or “sulphonylureas” used to treat diabetes);
• you have a very low blood volume (hypovolaemia) or are dehydrated;
• you do not produce urine or your amount of urine is significantly reduced due to severe kidney problems (renal failure with oliguria or anuria) and do not respond to treatment with medicines containing a substance called furosemide;
• you have low levels of potassium or sodium in your blood (hypokalaemia or hyponatraemia);
• if your body is unable to produce an adequate amount of adrenal hormones (Addison's disease);
• you are in a pre-coma state (characterized by mental confusion, apathy, muscle weakness) or coma, associated with hepatic encephalopathy, a condition of the brain caused by liver damage;
• you have taken high doses of digitalis;
• you have very low blood pressure;
• you are in the first trimester of pregnancy or if you are breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking Furosemide Mylan Generics
Take this medicine under the direct supervision of your doctor.
Furosemide Mylan Generics must be administered with caution in the following cases:

• you have difficulty emptying your bladder (for example if you have problems emptying your bladder due to an enlarged prostate or narrowing of the urethra). In people in whom the urinary flow is obstructed, careful monitoring is necessary, especially at the beginning of therapy.
• you suffer from low blood pressure or are at risk of excessive lowering of blood pressure due to circulatory problems (significant narrowing of the coronary arteries or blood vessels that irrigate the brain);
• you suffer from diabetes. During treatment, the doctor must monitor blood sugar and urine sugar levels.
• you suffer from a disease called “gout”, caused by an accumulation of uric acid.
• you have severe liver and kidney problems.
• you have low levels of protein in your blood.
• you are at risk of changes in blood salt (electrolyte) levels or have lost a lot of fluids (e.g. following vomiting, diarrhoea or heavy sweating). In this case, the doctor must check your sodium, potassium and creatinine levels in the blood and, if necessary, may advise you to temporarily suspend treatment with furosemide and follow appropriate therapy to restore normal salt levels.
• you suffer from “hypertension”, i.e. high blood pressure, because in the most severe cases of hypertension you will need to take, together with Furosemide Mylan Generics, other medicines to avoid excessive lowering of blood pressure.
• if you are elderly, if you are taking other medicines that can cause a lowering of blood pressure and if you suffer from other diseases that entail risks of lowering blood pressure.
• you have a disease of the adrenal glands (see section 2 “What you need to know before taking Furosemide Mylan Generics”).

To reduce the risk of lowering potassium levels in the blood, during treatment with
Furosemide Mylan Generics, follow a diet rich in potassium (potatoes, bananas, oranges, tomatoes, spinach and
dried fruit). Your doctor will advise you to take medicines to restore normal potassium levels in
your blood, if necessary.
You are at risk of lowering potassium levels and need appropriate monitoring and supplementation if:

• you suffer from hepatic cirrhosis (a liver disease);
• you suffer from chronic diarrhoea;
• you are in a condition in which fluid loss is increased (vomiting, diarrhoea, heavy sweating);
• you use laxatives for prolonged periods;
• you follow a diet low in potassium;
• you are taking medicines called mineralocorticoids that regulate water and salt levels in the blood. In case of treatment of edema due to liver problems (hepatic cirrhosis with ascites), Furosemide Mylan Generics must be administered in hospital under strict medical supervision. The doctor will also likely subject you to regular checks of blood sugar, glycosuria and uric acid metabolism, if necessary. The doctor must also correct any decrease in circulating blood volume, dehydration and any significant alteration in the balance of mineral salts and the degree of acidity and basicity of the blood. This may require a temporary suspension of the administration of the medicine. If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body called Systemic Lupus Erythematosus, taking this medicine could worsen the state of your illness, making it worse. Following the use of the medicine, this disease could begin in subjects in whom it is not yet established (see section 4 “Possible side effects”).

For those who play sports: the use of the medicine without therapeutic need constitutes doping and may
still result in positive anti-doping tests.
Children
This medicine can cause kidney problems in premature babies. Therefore, during treatment with
Furosemide Mylan Generics, the doctor must monitor the function of your child's kidneys.

Other medicines and Furosemide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Furosemide Mylan Generics in association with any of the following medicines:

• chloral hydrate, a sedative: skin flushing, sudden sweating, agitation, nausea, increased blood pressure and increased heart rate (tachycardia) may occur if furosemide is taken less than 24 hours after taking chloral hydrate; taking furosemide with chloral hydrate is not recommended
• aminoglycosides (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin), used against bacterial infections
• medicines that can damage the ear (ototoxic)

Take Furosemide Mylan Generics with caution if you are taking any of the following medicines:

• cisplatin, used for some tumors. If taken together with furosemide it can cause damage to the ear and kidneys.
• sucralfate, used for ulcers. Take sucralfate two hours apart from furosemide because if taken at the same time it can reduce its effect.
• lithium salts, used for depression. Furosemide may increase the toxic effects of lithium. Therefore, if the two medicines are taken together, the doctor must carefully check the levels of lithium in the blood.
• ACE inhibitors or angiotensin II receptor antagonists, used to lower blood pressure. The doctor must establish the correct dose of furosemide and may advise you to discontinue it.
• risperidone, an antipsychotic drug used to treat mental disorders. The doctor will consider the risks and benefits before having you take furosemide together with this medicine for the increased risk of death that can occur, especially in elderly patients with dementia.
• levothyroxine, a medicine used to stimulate the thyroid. High doses of furosemide can lead to an overall decrease in thyroid hormone.
• non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, and other salicylates used for inflammation: they can reduce the effect of furosemide and furosemide can increase the toxicity of salicylates;
• phenytoin, used for epilepsy: it can reduce the effect of furosemide;
• probenecid, used for gout: it can reduce the effects of furosemide and at the same time increase its side effects;
• methotrexate, for the treatment of some tumors: it can reduce the effects of furosemide and at the same time increase its side effects;
• medicines toxic to the kidneys (nephrotoxic) such as some antibiotics (cephalosporins);
• corticosteroids, used for inflammation, carbenoxolone, a medicine for ulcers, liquorice and laxatives for prolonged use because they can increase the risk of lowering potassium levels in the blood;
• medicines based on digitalis, used for the heart. Furosemide can increase their toxic effects because it alters the levels of magnesium and potassium in the blood.
• antihypertensives, used to treat high blood pressure, and diuretics, which promote the elimination of urine, because a strong lowering of blood pressure may occur;
• antidiabetics, used for the treatment of diabetes: furosemide can reduce their action;
• sympathomimetics such as adrenaline and noradrenaline;
• curaro-like muscle relaxants (tubocurarine), used for anesthesia: furosemide can increase their action;
• theophylline: furosemide can increase its action;
• cyclosporine A, used to prevent transplant rejection. Taking it with furosemide increases the risk of developing gouty arthritis (an acute inflammatory form of arthritis);
• contrast media, substances used in some radiological examinations. Furosemide can increase the harmful effects exerted by these substances on the kidneys;
• aliskiren (used in the treatment of high blood pressure): it can reduce the concentrations of furosemide in the blood, administered orally.

Furosemide Mylan Generics with food
If you take high amounts of liquorice during treatment with this medicine, you may experience a
decrease in potassium levels in the blood.
Furosemide Mylan Generics can rarely lead to a decrease in potassium in the blood; it is still
important that you follow a diet rich in this mineral by taking potatoes, bananas, oranges, tomatoes,
spinach and dried fruit, during the taking of the medicine.
Furthermore, the therapeutic action of Furosemide Mylan Generics may decrease if the medicine is taken
during meals: always take the medicine on an empty stomach (see also section “How to take
Furosemide Mylan Generics”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are in the first three months of pregnancy, you must absolutely not take this medicine as
furosemide crosses the placental barrier. You can take Furosemide Mylan Generics in the second and
third trimester of pregnancy only if deemed strictly necessary by your doctor, who will periodically monitor
the growth of your baby.
Breastfeeding
Do not take Furosemide Mylan Generics if you are breastfeeding as furosemide passes into
breast milk.

Driving and using machines
This medicine can alter your ability to concentrate and your reactivity. Do not drive and do not use
machines that require particular attention while taking this medicine, as it may
cause a decrease in blood pressure and therefore decrease the promptness of reflexes and the degree of
attention.

Furosemide Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Furosemide Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Treatment of edema (swelling due to fluid retention in the body)
The recommended dose is 1-3 tablets of 25 mg, to be taken in a single administration,
preferably in the morning or choosing the time when you want to obtain the effect.
Depending on your health conditions, you can repeat the dose every 4 hours.
If you do not obtain a sufficient effect, it is recommended to increase the dose by 1 or 2 tablets
at intervals of 4 hours until the desired effect is achieved. If necessary, the dose may be
further increased at the doctor's discretion.

Treatment of high blood pressure (hypertension)
The recommended dose is 1-3 tablets per day.
If you are already taking other medicines for high blood pressure, consult your doctor because it may be
necessary to adjust the dose.

Patients with kidney and liver disorders
In case of kidney disease (low glomerular filtration rate) or liver disease (hepatic cirrhosis) or in case of insufficient
functioning of the kidneys and liver simultaneously, the doctor may adjust the dose.
In the most serious situations, the doctor may decide to start treatment in hospital to adequately control
any undesirable effects (hepatic coma).
Method of administration
Furosemide Mylan Generics should be taken on an empty stomach.

If you take more Furosemide Mylan Generics than you should
In case of overdose, the following may occur: decrease in blood volume (hypovolemia),
dehydration, increased blood concentration (hemoconcentration), irregular heartbeat (arrhythmias). Symptoms may include: severe decrease in blood pressure (up to shock),
serious kidney problems (acute renal failure), blood circulation problems (thrombosis), paralysis
of the muscles (flaccid paralysis), states of delirium, apathy, confusion.
If you have taken an excessive dose of this medicine, contact your doctor immediately or
go to the Emergency Room of the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to take Furosemide Mylan Generics
Do not take a double dose to compensate for the missed tablet.

If you stop taking Furosemide Mylan Generics
Ask your doctor for advice if you intend to stop treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment with this medicine and contact your doctor immediatelyif you experience the following side effects:

• difficulty breathing or swallowing, swelling of the face, eyes, lips and/or tongue, skin irritation: these may be symptoms of a severe allergic reaction (anaphylactic shock), which is rare.

The side effects that may occur with furosemide are as follows.

Very common (may affect more than 1 in 10 people)

• electrolyte disturbances (alteration of the balance of salts in the blood);
• dehydration;
• decreased blood volume (hypovolemia), especially in elderly patients;
• increased values of some blood tests (creatinine and triglycerides).

Common (may affect up to 1 in 10 people)

• increased blood concentration (hemoconcentration);
• decreased sodium in the blood (hyponatremia);
• decreased chlorine in the blood (hypochloremia);
• decreased potassium in the blood (hypokalemia);
• increased cholesterol levels in the blood test;
• increased uric acid levels in the blood (hyperuricemia);
• gout (inflammation of the joints causing pain and swelling);
• brain alterations as a result of liver disorders (hepatic encephalopathy);
• production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

• decreased number of blood cells called platelets (thrombocytopenia);
• diabetes and worsening of initial diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
• drowsiness;
• headache;
• dizziness;
• confusional state;
• vision impairment;
• hearing disorders, sometimes irreversible (deafness);
• alterations of the heartbeat (cardiac arrhythmias);
• dry mouth;
• nausea;
• disorders of intestinal motility;
• itching, urticaria, skin irritation, formation of blisters on the skin and mucous membranes (these are disorders of
• skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
• appearance of small red or purple spots spread over the skin, associated or not with joint pain, muscle pain, weakness and fever (these may be disorders of inflammation of the blood vessel walls, called purpura);
• allergic reaction to sunlight which manifests as skin irritation accompanied by itching
• (photosensitivity reaction);
• severe sudden muscle pain, caused by the involuntary contraction of one or more muscles (cramps);
• muscle weakness (myasthenia);
• cramps, muscle spasms, involuntary muscle contraction and tremors (these are disorders of a disease known as tetany);
• fatigue.

Rare (may affect up to 1 in 1,000 people)

• decreased white blood cells in the blood (leukopenia);
• increased white blood cells in the blood (eosinophilia);
• alteration of the sensitivity of the limbs or other parts of the body (paresthesia);
• inflammation of the blood vessels (vasculitis);
• vomiting and diarrhea;
• kidney disease called interstitial nephritis;
• fever.

Very rare (may affect up to 1 in 10,000 people)

• insufficient production in the bone marrow of all types of blood cells (aplastic anemia);
• severe decrease in the number of white blood cells called granulocytes (agranulocytosis);
• excessive reduction of hemoglobin concentration in the blood caused by abnormal destruction of red blood cells (hemolytic anemia);
• ringing in the ears (tinnitus);
• severe inflammation of the pancreas (acute pancreatitis);
• impaired correct flow of bile (cholestasis);
• increased values of some liver enzymes in the blood (transaminases).

Not known (frequency cannot be estimated based on available data):

• decreased levels of calcium in the blood (hypocalcemia);
• decreased levels of magnesium in the blood (hypomagnesemia);
• alteration of blood acidity (metabolic alkalosis);
• increased urea value in the blood test;
• Bartter's syndrome (a rare disease that affects the kidneys) in case of abuse or prolonged use of furosemide;
• formation of blood clots inside the blood vessels (thrombosis);
• skin diseases, such as urticaria, formation of red or blister-like papules spread and scaling in
• particular on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever. These may be symptoms of severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP) (acute febrile drug eruption) or Dress syndrome;
• lichenoid reactions characterized by small, itchy, reddish-purple, polygonal lesions on the skin, genitals or in the mouth;
• increased sodium value in the urine test;
• increased chlorine value in the urine test;
• difficulty emptying the bladder (urinary retention, in patients with prostatic hypertrophy, urethral stenosis or other difficulty emptying the bladder);
• impaired kidney function (renal failure);
• appearance or worsening of a chronic autoimmune disease, which can affect various organs and tissues of the body called systemic lupus erythematosus;
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
• severe damage to skeletal muscle and release into the blood of substances contained in the muscles (rhabdomyolysis), generally in the context of severe potassium deficiency in the blood.

Additional side effects in children

• kidney stones (nephrolithiasis) or calcifications at the level of the kidneys (nephrocalcinosis) in premature newborns;
• increased risk of heart alterations (patent ductus arteriosus) in premature infants to whom furosemide is administered during the first weeks of life.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Furosemide 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.
Store in the original packaging to protect the medicine from light.
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. Contents of the pack and other information

What Furosemide Mylan Generics contains

• The active ingredient is furosemide. One tablet contains 25 mg of furosemide.
• The other ingredients are: lactose monohydrate, corn starch, pregelatinized starch, talc, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Furosemide Mylan Generics and contents of the pack
Pack containing 30 tablets or 60 tablets of 25 mg.

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

Manufacturers
Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI)
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)

Furosemide Mylan Generics 500 mg divisible tablets

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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Furosemide Mylan Generics is and what it is used for
• 2. What you need to know before you take Furosemide Mylan Generics
• 3. How to take Furosemide Mylan Generics
• 4. Possible side effects
• 5. How to store Furosemide Mylan Generics
• 6. Contents of the pack and other information

1. What is Furosemide Mylan Generics and what it is used for

Furosemide Mylan Generics contains the active ingredient furosemide, which belongs to a group of
medicines called diuretics, which help to produce more urine, thus helping to relieve discomfort
caused by an excessive build-up of fluid in the body ( edema)..
Furosemide Mylan Generics 500 mg is indicated if:

• you suffer from severe kidney problems such as severely impaired glomerular filtration (glomerular filtration rate ≤ 20 ml/min)
• acute renal failure (oligoanuria)
• chronic renal failure in the pre-dialytic and dialytic stage with fluid retention (especially in the case of fluid retention in the lungs)
• nephrotic syndrome (which consists of a reduction in blood proteins, fluid accumulation called “edema” and an increase in blood fats) with severely limited kidney function (when anti-inflammatory drugs called corticosteroids are not sufficient to control the edema)
• chronic renal failure without fluid retention
• you are in a state of shock, a dangerous drop in blood pressure which, if left untreated, can lead to collapse, coma and death.

Furosemide Mylan Generics 500 mg tablets can also be used as maintenance therapy in
patients who have responded positively to treatment with high doses of furosemide administered for
infusion.

2. What you need to know before taking Furosemide Mylan Generics

Do not take Furosemide Mylan Generics if:

• you are allergic to furosemide or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic to certain medicines called “sulphonamides” (such as sulphonamide antibiotics or “sulphonylureas” used to treat diabetes);
• you have a very low blood volume (hypovolaemia) or are dehydrated
• you do not produce urine or your amount of urine is significantly reduced due to severe kidney problems (renal failure with oliguria or anuria) and do not respond to treatment with medicines containing a substance called furosemide
• you have low levels of potassium or sodium in your blood (hypokalaemia or hyponatraemia)
• your body is unable to produce an adequate amount of adrenal hormones (Addison's disease)
• you are in a pre-comatose state (a condition characterised by mental confusion, apathy, muscle weakness) or coma associated with hepatic encephalopathy, a brain condition caused by liver damage
• you have taken high doses of digitalis
• you have very low blood pressure
• you are in the first trimester of pregnancy or if you are breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking Furosemide Mylan Generics.
Take this medicine under the direct supervision of your doctor.
Furosemide Mylan Generics must be administered with caution in the following cases:

• you have difficulty emptying your bladder (for example if you have problems emptying your bladder due to an enlarged prostate or narrowing of the urethra). In people in whom the urinary flow is obstructed, careful monitoring is necessary, especially at the beginning of therapy.
• you suffer from low blood pressure or are at risk of a severe drop in blood pressure due to circulatory problems (significant narrowing of the coronary arteries or blood vessels that supply the brain);
• you suffer from diabetes. During treatment, the doctor must monitor blood sugar and urine levels.
• you suffer from a disease called “gout”, caused by a build-up of uric acid. During treatment, the doctor must monitor uric acid levels in the blood.
• you have severe liver and kidney problems;
• you have low levels of protein in your blood;
• you are at risk of changes in the concentrations of salts (electrolytes) in your blood or have lost a lot of fluids (for example following vomiting, diarrhoea or heavy sweating). In this case, the doctor must check your sodium, potassium and creatinine levels in the blood and, if necessary, may advise you to temporarily stop treatment with furosemide and follow appropriate therapy to restore normal salt levels.
• you suffer from “hypertension” i.e. high blood pressure, because in the most severe cases you will need to take other medicines together with Furosemide Mylan Generics to avoid an excessive drop in blood pressure.
• if you are elderly, if you are taking other medicines that can cause a drop in blood pressure and if you suffer from other diseases that involve a risk of low blood pressure
• you have a disease of the adrenal glands (see section 2 “What you need to know before taking Furosemide Mylan Generics”)

To reduce the risk of low potassium levels in the blood, during treatment with
Furosemide Mylan Generics, follow a diet rich in potassium (potatoes, bananas, oranges, tomatoes, spinach and
dried fruit). Your doctor will advise you to take medicines to restore normal potassium levels in
your blood, if necessary.
You are at risk of low potassium levels if:

• you suffer from hepatic cirrhosis (a liver disease)
• you suffer from chronic diarrhoea;
• you are in a condition in which fluid loss is increased (vomiting, diarrhoea, heavy sweating);
• you use laxatives for prolonged periods;
• you follow a diet low in potassium;
• you are taking medicines called mineralocorticoids that regulate water and salt levels in the blood.

In case of treatment of oedema due to liver problems (hepatic cirrhosis with ascites), Furosemide Mylan
Generics must be administered in hospital under strict medical supervision.
It is also likely that the doctor, if necessary, will subject you to regular checks of blood sugar, glycosuria and
uric acid metabolism.
The doctor must also correct any decrease in circulating blood volume, dehydration
and any significant changes in the balance of mineral salts and the degree of acidity and basicity of the blood.
This may require a temporary suspension of the administration of the medicine.
If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body
called Systemic Lupus Erythematosus, taking this medicine may worsen the condition of your
disease, making it worse. Following the use of the medicine, this disease may begin in subjects in whom
it is not yet established (see section 4 “Possible side effects”).

For those who play sports: the use of the medicine without therapeutic need constitutes doping and may
still result in positive anti-doping tests.
Children
This medicine can cause kidney problems in premature babies. Therefore, during treatment with
Furosemide Mylan Generics, the doctor must monitor the function of your child's kidneys.

Other medicines and Furosemide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Furosemide Mylan Generics in association with any of the following medicines:

• chloral hydrate, a sedative: redness of the skin, sudden sweating, agitation, nausea, increased blood pressure and increased heart rate (tachycardia) may occur if furosemide is taken less than 24 hours after taking chloral hydrate; taking furosemide with chloral hydrate is not recommended
• aminoglycosides (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin),used against bacterial infections
• medicines that can cause damage to the ear (ototoxic). Take Furosemide Mylan Generics with caution if you are taking any of the following medicines:
• cisplatin, used for some cancers. If taken together with furosemide, it can cause damage to the ear and kidneys.
• sucralfate, used for ulcers. Take sucralfate 2 hours apart from furosemide because if taken at the same time it can reduce its effect.
• lithium salts, used for depression. Furosemide may increase the toxic effects of lithium. Therefore, if the two medicines are taken together, the doctor must carefully check the lithium levels in the blood.
• ACE inhibitors or angiotensin II receptor antagonists, used to lower blood pressure. The doctor must establish the correct dose of furosemide and may advise you to stop taking it.
• risperidone, an antipsychotic drug used to treat mental disorders. The doctor will consider the risks and benefits before having you take furosemide together with this medicine for the increased risk of death that can occur, especially in elderly patients with dementia;
• levothyroxine, a medicine used to stimulate the thyroid. High doses of furosemide can lead to an overall decrease in thyroid hormone;
• non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, and other salicylates used for inflammation: they can reduce the effect of furosemide and furosemide can increase the toxicity of salicylates;
• phenytoin, used for epilepsy: it can reduce the effect of furosemide;
• probenecid, used for gout: it can reduce the effect of furosemide and at the same time increase the side effects;
• methotrexate, for the treatment of some cancers: it can reduce the effects of furosemide and at the same time increase the side effects;
• medicines toxic to the kidneys (nephrotoxic) such as some antibiotics (such as cephalosporins);
• corticosteroids, used for inflammation, carbenoxolone, a medicine for ulcers, liquorice and laxatives for prolonged use because they can increase the risk of low potassium levels in the blood;
• medicines based on digitalis, used for the heart. Furosemide can increase their toxic effects because it alters the levels of magnesium and potassium in the blood.
• antihypertensives, used to treat high blood pressure, and diuretics, which promote the elimination of urine, because a severe drop in blood pressure may occur;
• antidiabetics, used to treat diabetes: furosemide can reduce their action;
• sympathomimetics such as adrenaline and noradrenaline;
• curare-like muscle relaxants (tubocurarine), used for anaesthesia: furosemide can increase their action;
• theophylline: furosemide can increase its action;
• cyclosporine A, used to prevent transplant rejection. Taking it with furosemide increases the risk of developing gouty arthritis (an acute inflammatory form of arthritis);
• contrast media, substances used in some radiological examinations. Furosemide can increase the harmful effects exerted by these substances on the kidneys;
• aliskiren (used in the treatment of high blood pressure): it can reduce the concentrations of furosemide in the blood, when administered orally.

Furosemide Mylan Generics with food
If you take high amounts of liquorice during treatment with this medicine, you may experience a
decrease in potassium levels in the blood.
Furosemide Mylan Generics can rarely lead to a decrease in potassium in the blood; it is nevertheless
important that you follow a diet rich in this mineral by taking potatoes, bananas, oranges, tomatoes,
spinach and dried fruit, during the intake of the medicine.
Furthermore, the therapeutic action of Furosemide Mylan Generics may decrease if the medicine is taken
during meals: always take the medicine on an empty stomach (see also section “How to take
Furosemide Mylan Generics”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are in the first three months of pregnancy, you must absolutely not take this medicine as
furosemide crosses the placental barrier. You can take Furosemide Mylan Generics in the second and
third trimester of pregnancy only if considered strictly necessary by your doctor, who will periodically monitor
the growth of your baby.
Breastfeeding
Do not take Furosemide Mylan Generics if you are breastfeeding as furosemide passes into breast
milk.

Driving and using machines
This medicine can alter your ability to concentrate and your reactivity. Do not drive and do not use
machines that require particular attention while taking this medicine, as it may
cause a decrease in blood pressure and therefore decrease the promptness of reflexes and the degree of
attention.

Furosemide Mylan Generics contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Furosemide Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. The dose used must be the lowest sufficient to achieve
the desired effect.

Treatment of kidney problems (chronic renal insufficiency)
The doctor will establish the most suitable dose for you based on your response to treatment (the effective
dose will allow a urine output of approximately 2.5 liters of urine).
Start treatment with half a tablet (250 mg). If within 4-6 hours of administration you do not notice an
effect, increase the dose you initially took by another half tablet every 4-6 hours. Continue the
treatment in this way until the desired effect is achieved and keeping in mind that the total
dose may vary between 250 mg and 2000 mg (from half a tablet to 4 tablets).

Maintenance therapy
After receiving treatment with direct intravenous injection of furosemide, you may continue to take
furosemide orally. The recommended initial dose is equal to the one that was administered to you intravenously.
If within 4-6 hours of administration you do not notice an effect, increase the dose by 1 or half a tablet every
4-6 hours (for example, if the initial dose was 1 tablet; the second dose could be 1 and a
half or 2 tablets).
Method of administration
Take the tablets with some liquid, preferably with breakfast.

If you take more Furosemide Mylan Generics than you should
In case of overdose, the following may occur: decrease in blood volume (hypovolemia),
dehydration, increase in blood concentration (hemoconcentration), irregular heartbeat (arrhythmias). Symptoms may include: severe decrease in blood pressure (up to shock),
serious kidney problems (acute renal failure), blood circulation problems (thrombosis), paralysis
of the muscles (flaccid paralysis), states of delirium, apathy, confusion.
If you have taken an excessive dose of this medicine, contact your doctor immediately or
go to the Emergency Room of the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

If you forget to take Furosemide Mylan Generics
Do not take a double dose to make up for a missed tablet.

If you stop taking Furosemide Mylan Generics
Ask your doctor for advice if you intend to stop treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment with this medicine and immediately contact your doctorif you experience the following side effects:

• difficulty breathing or swallowing, swelling of the face, eyes, lips and/or tongue, skin irritation: these may be symptoms of a severe allergic reaction (anaphylactic shock), which occurs rarely.

The side effects that may occur with furosemide are as follows.

Very common (may affect more than 1 in 10 people)

• electrolyte disturbances (alteration of the balance of salts in the blood);
• dehydration;
• decreased blood volume (hypovolemia), especially in elderly patients; increased values of some blood tests (creatinine and triglycerides). Common (may affect up to 1 in 10 people)
• increased blood concentration (hemoconcentration);
• reduced sodium in the blood (hyponatremia);
• reduced chlorine in the blood (hypochloremia);
• reduced potassium in the blood (hypokalemia);
• increased cholesterol value in the blood test;
• increased uric acid levels in the blood (hyperuricemia);
• gout (inflammation of the joints causing pain and swelling);
• brain alterations as a result of liver disorders (hepatic encephalopathy);
• production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

• reduction in the number of blood cells called platelets (thrombocytopenia);
• diabetes and worsening of initial diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
• drowsiness;
• headache;
• dizziness;
• confusional state;
• visual impairment;
• hearing disorders, sometimes irreversible (deafness);
• alterations in heart rate (cardiac arrhythmias);
• dry mouth;
• nausea;
• motility disorders of the intestine;
• itching, urticaria, skin irritation, formation of blisters on the skin and mucous membranes (these are the symptoms of
• skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
• appearance of small red or purple spots spread over the skin, associated or not with joint pain, muscle pain, weakness and fever (these may be symptoms of inflammation of the blood vessel walls, called purpura);
• allergic reaction to sunlight that manifests as skin irritation accompanied by itching
• (photosensitivity reaction);
• severe sudden muscle pain, caused by the involuntary contraction of one or more muscles (cramps);
• muscle weakness (myasthenia);
• cramps, muscle spasms, involuntary muscle contraction and tremors (these are the symptoms of a disease
• known as tetany);
• fatigue.

Rare (may affect up to 1 in 1,000 people)

• reduction of white blood cells in the blood (leukopenia);
• increase of white blood cells in the blood (eosinophilia);
• alteration of the sensitivity of the limbs or other parts of the body (paresthesia);
• inflammation of the blood vessels (vasculitis);
• vomiting and diarrhea;
• kidney disease called interstitial nephritis;
• fever.

Very rare (may affect up to 1 in 10,000 people)

• insufficient production in the bone marrow of all types of blood cells (aplastic anemia);
• severe reduction in the number of white blood cells called granulocytes (agranulocytosis);
• excessive reduction in hemoglobin concentration in the blood caused by abnormal destruction of red blood cells (hemolytic anemia);
• ringing in the ears (tinnitus);
• severe inflammation of the pancreas (acute pancreatitis);
• impaired correct flow of bile (cholestasis);
• increased values of some liver enzymes in the blood (transaminases).

Not known (frequency cannot be estimated based on available data):

• decreased levels of calcium in the blood (hypocalcemia);
• decreased levels of magnesium in the blood (hypomagnesemia);
• alteration of blood acidity (metabolic alkalosis);
• increased urea value in the blood test;
• Bartter's syndrome (a rare disease affecting the kidneys) in case of abuse or prolonged use of furosemide;
• formation of blood clots inside blood vessels (thrombosis);
• skin diseases, such as urticaria, formation of red or blister-like papules spread out and scaling in
• particular on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied
• by fever. These may be symptoms of severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP) (acute drug-induced febrile skin eruption) or Dress syndrome;
• lichenoid reactions characterized by small, itchy, reddish-purple, polygonal lesions on the skin, genitals or in the mouth;
• increased sodium value in the urine test;
• increased chlorine value in the urine test;
• difficulty emptying the bladder (urinary retention, in patients with prostatic hypertrophy, urethral stenosis or other difficulty emptying the bladder);
• impaired kidney function (renal failure);
• appearance or worsening of a chronic autoimmune disease, which can affect various organs and tissues of the body called systemic lupus erythematosus
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes).
• severe skeletal muscle damage and release into the blood of substances contained in the muscles (rhabdomyolysis), generally in the context of a severe potassium deficiency in the blood.

Additional side effects in children

• kidney stones (nephrolithiasis) or calcifications at the level of the kidneys (nephrocalcinosis) in premature newborns;
• increased risk of heart alterations (patent ductus arteriosus) in premature newborns to whom
• furosemide is administered during the first weeks of life.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can contribute to providing more information on the safety of
this medicine.

5. How to store Furosemide 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.
Store in the original package to protect the medicine from light.
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. Contents of the pack and other information

What Furosemide Mylan Generics contains

• The active ingredient is furosemide. One tablet contains 500 mg of furosemide.
• The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica and vegetable magnesium stearate.

Description of the appearance of Furosemide Mylan Generics and contents of the pack
Pack containing 20 divisible tablets of 500 mg.
The tablet can be divided into equal doses.

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

Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI)
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)