FUROSEMIDE 500 мг Таблетка

Содержание инструкции

1. Furosemide Hexal 500 mg tablets
   1. What is Furosemide Hexal and what is it used for
   2. What you need to know before taking Furosemide Hexal
   3. How to take Furosemide Hexal
   4. Possible side effects
   5. How to store Furosemide Hexal
   6. Contents of the pack and other information
2. Furosemide Hexal 20 mg/2 ml injectable solution
   1. What is Furosemide Hexal and what is it used for
   2. What you need to know before using Furosemide Hexal
   3. How to use Furosemide Hexal
   4. Possible side effects
   5. How to store Furosemide Hexal
   6. Package Contents and Other Information
3. Furosemide Hexal 250 mg/25 ml solution for infusion
   1. What is Furosemide Hexal and what is it used for
   2. What you need to know before using Furosemide Hexal
   3. How to use Furosemide Hexal
   4. Possible side effects
   5. How to store Furosemide Hexal
   6. Package Contents and Other Information

Furosemide Hexal 500 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 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 Furosemide Hexal is and what it is used for
• 2. What you need to know before you take Furosemide Hexal
• 3. How to take Furosemide Hexal
• 4. Possible side effects
• 5. How to store Furosemide Hexal
• 6. Contents of the pack and other information

1. What is Furosemide Hexal and what is it used for

Furosemide Hexal contains the active ingredient furosemide, which belongs to a group of
medicines called diuretics used to promote the elimination of excess fluids.

Furosemide Hexalis indicated if one of the following conditions applies to you:

• if you suffer from severe problems in kidney function (for example, acute renal failure in the postoperative phase and in case of septicemia, chronic renal failure in the predialytic and dialytic stage with fluid retention, chronic renal failure without fluid retention, severely limited renal function for example in chronic glomerulonephritis and lupus erythematosus, Kimmelstiel-Wilson syndrome);
• if you are in a state of shock characterized by severe problems with blood circulation;
• poor urine elimination (glomerular filtration severely impaired).

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

2. What you need to know before taking Furosemide Hexal

Do not take Furosemide Hexal:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines called sulfonamides used for infections or to medicines called sulfonylureas used for the treatment of diabetes;
• if you have a very low blood volume (hypovolemia) or are dehydrated;
• if you do not urinate or your urine output is significantly reduced (renal insufficiency with oliguria or anuria) and do not respond to treatment with medicines containing a substance called furosemide;
• if you have low levels of potassium (hypokalemia) or sodium (hyponatremia) in your blood;
• if you are in a pre-coma or coma and have brain problems caused by liver damage (hepatic encephalopathy);
• if you have taken high doses of a heart medicine called digitalis;
• if you are in the first three months of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if your body is unable to produce an adequate amount of adrenal hormones (Addison's disease).

If your kidney function is good, do not take Furosemide Hexal because you may be
subject to significant fluid loss.

Warnings and precautions
Talk to your doctor or pharmacist before taking Furosemide Hexal.
Take this medicine under the direct supervision of your doctor.
Take Furosemide Hexal with caution and inform your doctor in the following cases:

• if you have problems emptying your bladder or if you suffer from diseases that cause difficulty eliminating urine (prostatic hyperplasia or urethral stenosis). In people in whom the urinary flow is obstructed, in fact, careful monitoring is necessary, especially at the beginning of therapy;
• if you suffer from low blood pressure (hypotension) or if you are at risk of an excessive drop in blood pressure caused by problems with blood circulation (significant narrowing of the coronary arteries or blood vessels that supply the brain);
• if you suffer from diabetes (latent or manifest diabetes mellitus). During treatment, the doctor will need to monitor blood sugar and urine levels;
• if you suffer from a disease called gout, caused by an accumulation of uric acid. During treatment, the doctor will need to monitor uric acid levels in the blood;
• if you have severe liver or kidney problems (hepatorenal syndrome, for example, with functional renal failure associated with severe liver disease);
• if you have low levels of protein in your blood (hypoproteinemia);
• if you are at risk of changes in electrolyte levels in the blood or if you have lost a lot of fluids (e.g. following vomiting, diarrhea or heavy sweating). In this case, the doctor will need to 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 electrolyte levels to normal;
• if you are taking a medicine called risperidone, used to treat psychiatric disorders. Cases of death in elderly people with dementia taking risperidone together with furosemide have been reported (see section “Other medicines and Furosemide Hexal”);
• 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. After using the medicine, this disease may begin in subjects in whom it is not yet established;
• if you suffer from a severe high blood pressure problem (severe forms of hypertension), because in this case you will need to take, together with furosemide, other medicines to control 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 risks of lowering blood pressure;
• if you have a disease of the adrenal glands (see section 2 “What you need to know before taking Furosemide Hexal”).

To reduce the risk of lowering potassium levels in the blood, during treatment with
Furosemide Hexal, follow a diet rich in potassium (potatoes, bananas, oranges, tomatoes, spinach and
dried fruit). Your doctor will advise you if necessary to take medicines to restore normal
potassium levels in the blood.
The doctor will monitor the values of blood sugar, sugars in the urine and, if necessary, the
metabolism of uric acids.
The doctor will also correct any decrease in circulating blood volume, dehydration and any significant change in the balance of mineral salts and the degree of
acidity and alkalinity of the blood. This may require a temporary suspension of
administration of the medicine.
You are at risk of lowering potassium levels:

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

For those who practice sports, the use of the medicine without therapeutic need constitutes doping
and may in any case determine positivity to doping tests.

Children
This medicine can cause kidney problems (nephrocalcinosis/nephrolithiasis) in premature infants.
Therefore, during treatment with Furosemide Hexal, the doctor will need to monitor the
function of your child's kidneys.

Other medicines and Furosemide Hexal
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicine.
Do not take this medicine if you are taking:

• chloral hydrate, a sedative medicine. If furosemide is administered intravenously within 24 hours of taking chloral hydrate, it can cause skin redness, sudden sweating, agitation, nausea, increased blood pressure and increased heart rate (tachycardia);
• aminoglycoside antibiotics, medicines used against bacterial infections and other medicines that can cause damage to the ear. Furosemide Hexal can increase the toxic effects on the ear in this case.

Take Furosemide Hexal with caution and consult your doctor if you are taking any of the following
medicines:

• cisplatin, a medicine used to treat some cancers. If taken together with furosemide, it can produce damage to the ear and kidneys;
• sucralfate, a medicine for the treatment of ulcers. Take sucralfate 2 hours apart from furosemide because if taken at the same time, it can reduce its effect;
• lithium salts, medicines used to treat depression. Furosemide can increase the toxic effects of lithium, so if the two medicines are taken together, the doctor will need to carefully monitor lithium levels in the blood;
• ACE inhibitors or angiotensin II receptor antagonists, medicines used to lower blood pressure. The doctor in this case will need to establish the appropriate dose of furosemide and may advise you to stop taking it;
• risperidone, a medicine used to treat psychiatric disorders (see section “Warnings and precautions”).
• levothyroxine(a medicine used to stimulate the thyroid): high doses of furosemide can lead to an overall decrease in thyroid hormone.

Taking the following medicines together with furosemide must be carefully evaluated
by the doctor because they can reduce the effect of furosemide:

• Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, medicines used to treat inflammation. If you are dehydrated or have low blood volume (hypovolemia), you may also experience kidney problems (acute renal failure);
• phenytoin, a medicine for the treatment of epilepsy;
• probenecid, a medicine for the treatment of gout;
• methotrexate, a medicine for the treatment of some cancers.

Taking the following medicines together with furosemide must be carefully evaluated
by the doctor because they can increase the toxic effects of these medicines or their effectiveness may be altered:

• medicines toxic to the kidneys(nephrotoxic);
• corticosteroids, medicines for inflammation, carbenoxolone, a medicine for ulcers and laxativesfor prolonged use because it 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, medicines to treat high blood pressure, diuretics, medicines that promote the elimination of urine because a strong drop in blood pressure may occur;
• antidiabetics, medicines used to treat diabetes;
• sympathomimeticssuch as adrenaline and noradrenaline;
• curare-like muscle relaxants, used for anesthesia;
• theophylline,used to treat asthma;
• antibiotics belonging to the cephalosporin class, medicines used against bacteria, because kidney damage may occur;
• cyclosporine A, a medicine used after a transplant, because it can increase the risk of uric acid accumulation;
• contrast agents, medicines used for some examinations, because kidney damage may occur;
• aliskiren(used in the treatment of high blood pressure), may reduce furosemide concentrations in the blood, when administered orally.

Furosemide Hexalwith food
Furosemide Hexal can rarely lead to a decrease in potassium levels 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 intake of the medicine. Furthermore
the therapeutic action of Furosemide Hexal may decrease if the medicine is taken
during meals; always take the medicine on an empty stomach (see also section “How
to take Furosemide Hexal”).
If you take high amounts of licorice during treatment with this medicine, you may
experience a decrease in potassium levels in the blood.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take Furosemide Hexal 500 mg tablets in the first three months of pregnancy. You can take it
instead during the second and third trimester of pregnancy but only if necessary
and under the direct supervision of your doctor.
Breastfeeding
Furosemide is excreted in breast milk, therefore discontinue breastfeeding during
treatment with Furosemide Hexal.

Driving and using machines
This medicine can alter the ability to drive vehicles or use machines.
Do not drive and do not use machinery that requires particular attention while taking
this medicine, because it can cause a decrease in blood pressure and therefore
decrease the promptness of reflexes and the degree of attention.

Furosemide Hexalcontains lactose and sodium
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take Furosemide Hexal

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The dose used must be the lowest sufficient to achieve the desired effect.
The doctor will establish the dose and duration of treatment depending on the disease to be treated and according to your health conditions.
Treatment in case of 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).
The recommended dose at the beginning of treatment is ½ 500 mg tablet.
If, within 4 - 6 hours, a satisfactory increase in urine production (diuresis) does not occur, the doctor will increase the initial dose by ½ tablet to be taken every 4 - 6 hours until the desired effect is achieved.
The maximum dose to be taken, which will be established by the doctor, may range from 250 mg to 2 g (from ½ tablet to 4 tablets).
Maintenance therapy
The recommended dose in maintenance therapy, in patients who have responded positively to treatment with high doses of furosemide administered parenterally (by intravenous infusion), is equal to the effective dose that was administered to them by infusion.
If, within 4 - 6 hours, a satisfactory increase in diuresis does not occur, the doctor will increase the dose by ½ - 1 tablet.
Method of administration
Lasix 500 mg tablets should be taken with some water in the morning during breakfast.

If you take more Furosemide Hexalthan you should
In case of taking an excessive dose of this medicine, contact your doctor immediately or go to the Emergency Room of the nearest hospital.
In case of an overdose of this medicine, a decrease in blood volume (hypovolemia), dehydration, alteration of the blood (hemoconcentration), heart problems, cardiac arrhythmias (including A-V block and ventricular fibrillation) may occur. 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.
Depending on your condition, the doctor will establish an adequate therapy.

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

If you stop taking Furosemide Hexal
Ask your doctor for advice if you intend to stop the treatment.
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.

Stop taking this medicine and contact your doctor or nurse immediatelyif you experience the following symptoms: 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 following side effects may occur:

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

• dehydration;
• electrolyte imbalances;
• decreased blood volume (hypovolemia), especially in elderly patients;
• increased levels of certain blood tests (creatinine and triglycerides).

Common(may affect up to 1 in 10 people):

• high number of red blood cells in the blood (hemoconcentration);
• decreased levels of sodium, chloride, potassium in the blood (hyponatremia, hypochloremia, hypokalemia);
• increased uric acid in the blood (hyperuricemia);
• increased cholesterol levels in blood tests;
• gout (inflammation of the joints causing pain and swelling);
• brain changes as a result of liver problems (hepatic encephalopathy in patients with hepatocellular insufficiency);
• production of large amounts of urine (polyuria).

Uncommon(may affect up to 1 in 100 people):

• reduced number of platelets (thrombocytopenia);
• diabetes and worsening of existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
• problems with the heart rate (cardiac arrhythmias);
• drowsiness, headache, dizziness, confusion;
• vision impairment;
• dry mouth, nausea, intestinal problems (intestinal motility disorders);
• severe, sudden muscle pain caused by involuntary contraction of one or more muscles (cramps);
• muscle weakness (myasthenia);
• cramps, muscle spasms, involuntary muscle contractions and tremors (these are symptoms of a condition known as tetany);
• fatigue;
• itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (these are symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
• appearance of small, red or purple spots on the skin, with or without 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);
• hearing disorders (usually transient);
• deafness (sometimes irreversible).

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

• reduced number of white blood cells (leukopenia), increased number of eosinophils (eosinophilia);
• altered sensitivity of the limbs or other parts of the body (paresthesia);
• allergic reactions, including severe ones including shock (anaphylactic and anaphylactoid reactions);
• serious kidney problems (interstitial nephritis);
• inflammation of the blood vessels (vasculitis);
• vomiting;
• diarrhea;
• fever.

Very rare(may affect less than 1 in 10,000 people):

• decreased concentrations of hemoglobin (hemolytic anemia), impaired production of blood cells (aplastic anemia), severe reduction in the number of white blood cells (agranulocytosis);
• ringing in the ears (tinnitus);
• inflammation of the pancreas (acute pancreatitis);
• impaired correct flow of bile (cholestasis);
• increased levels of certain liver enzymes in the blood (transaminases).

Not known(frequency cannot be estimated from the available data):

• formation of blood clots inside blood vessels (thrombosis);
• occurrence or worsening of a chronic autoimmune disease, which can affect various organs and tissues of the body called Systemic Lupus Erythematosus;
• serious skin damage (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• decreased levels of calcium and magnesium in the blood (hypocalcemia, hypomagnesemia);
• febrile acute drug eruption (acute generalized exanthematous pustulosis (AGEP);
• skin rash caused by hypersensitivity (DRESS syndrome);
• problems with urination (urinary retention in patients with prostatic hypertrophy, urethral stenosis or difficulty emptying the bladder);
• increased value of sodium in the urine test;
• increased value of chlorine in the urine test;
• increased pH of the blood (metabolic alkalosis);
• impaired kidney function (renal failure);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension);
• kidney stones (nephrolithiasis) or calcifications at the kidney level (nephrocalcinosis) in premature infants;
• abnormal blood test values, fatigue, muscle weakness, diarrhea, dehydration, increased thirst, increased urination, low blood pressure, irregular heartbeat (pseudo-Bartter syndrome);
• increased risk of heart changes (patent ductus arteriosus) in premature infants who are given furosemide during the first weeks of life;
• increased value of urea in the blood test;
• severe damage to skeletal muscle cells and release into the blood of substances contained in the muscles (rhabdomyolysis), generally in the context of a severe potassium deficiency in the blood;
• lichenoid reactions, characterized by small, itchy, reddish-purple polygonal lesions on the skin, genitals or in the mouth.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 Hexal

Keep this medicine out of the sight and reach of children.
Do not take 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 Hexal 500 mg tablets contains

• The active ingredient is furosemide. One tablet contains 500 mg of furosemide.
• The other ingredients are: microcrystalline cellulose, corn starch, sodium carboxymethylamide, hydroxypropylcellulose, lactose monohydrate, magnesium stearate.

Description of the appearance of Furosemide Hexal and contents of the pack
Pack of 20 tablets of 500 mg.

Marketing Authorisation Holder
Sandoz S.p.A. -
Viale Luigi Sturzo 43
20154 Milano - Italy

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke-Allee, 1 - 39179 Barleben (Germany)

Furosemide Hexal 20 mg/2 ml injectable solution

Equivalent Medicinal Product

Read this leaflet carefully before you start to use 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Furosemide Hexal and what is it used for

Furosemide Hexal contains the active ingredient furosemide, which belongs to a group of medicines
called diuretics used to promote the elimination of excess fluids.

Furosemide Hexal is indicated for the treatment of:

• all forms of swelling due to fluid retention (edema and peripheral edema) caused by problems with the heart, liver, kidneys or obstruction of any organ or blood vessels;
• mild to moderately high blood pressure.

2. What you need to know before using Furosemide Hexal

Do not use Furosemide Hexal:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines called sulfonamides used for infections or to medicines called sulfonylureas used for the treatment of diabetes;
• if your body is unable to produce an adequate amount of adrenal hormones (Addison's disease);
• if you have a very low blood volume (hypovolemia) or are dehydrated;
• if you do not urinate or your urine output is significantly reduced (renal failure with oliguria or anuria) and do not respond to treatment with medicines containing a substance called furosemide;
• if you have low levels of potassium (hypokalemia) or sodium (hyponatremia) in your blood;
• if you are in a pre-comatose or comatose state and have brain problems caused by liver damage (hepatic encephalopathy);
• if you have taken high doses of a heart medicine called digitalis;
• if you are in the first three months of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Furosemide Hexal.
Take this medicine under the direct supervision of your doctor.
Furosemide Hexal should be administered with cautionin the following cases:

• if you have problems emptying your bladder or if you suffer from diseases that cause difficulty in eliminating urine (prostatic hyperplasia or urethral stenosis). In people in whom urinary flow is obstructed, careful monitoring is necessary, especially at the beginning of therapy;
• if you suffer from low blood pressure or if you are at risk of an excessive drop in blood pressure caused by problems with blood circulation (significant narrowing of the coronary arteries or blood vessels that supply the brain);
• if you suffer from diabetes (latent or manifest diabetes mellitus). During treatment, the doctor will need to monitor blood and urine sugar levels;
• if you suffer from a disease called gout, caused by an accumulation of uric acid. During treatment, the doctor will need to monitor uric acid levels in the blood;
• if you have severe liver or kidney problems (hepatorenal syndrome, for example, with functional renal failure associated with severe liver disease);
• if you have low levels of protein in your blood (hypoproteinemia);
• if you are at risk of changes in salt (electrolyte) levels in your blood or if you have lost a lot of fluids (e.g. following vomiting, diarrhea or heavy sweating). In this case, the doctor will need to check your sodium, potassium and creatinine levels in your blood and, if necessary, may advise you to temporarily stop treatment with furosemide and follow appropriate therapy to restore normal electrolyte levels;
• if you are taking a medicine called risperidone, used for the treatment of psychiatric disorders. Cases of death in elderly people with dementia taking risperidone together with furosemide have been reported (see section “Other medicines and Furosemide Hexal”);
• 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 illness, making it worse. Following the use of the medicine, this disease may begin in subjects in whom it is not already established;
• if you suffer from a severe high blood pressure problem (severe forms of hypertension), because in this case you will need to take other medicines together with furosemide to control 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 risks of lowering blood pressure;
• if you have a disease of the adrenal glands (see section 2 “What you need to know before taking Furosemide Hexal”).

To reduce the risk of low potassium levels in the blood, during treatment with
Furosemide Hexal, follow a diet rich in potassium (potatoes, bananas, oranges, tomatoes, spinach and
dried fruit). The doctor will advise you if necessary to take medicines to restore normal
potassium levels in the blood.
The doctor must also correct any decrease in circulating blood volume, dehydration and any significant imbalance in mineral salts and the degree of acidity
and basicity of the blood. This may require a temporary suspension of the administration of
the medicine.
The doctor will monitor blood glucose levels, sugar in the urine and, if necessary, uric acid metabolism.
You are at risk of low potassium levels:

• if you suffer from liver problems (liver cirrhosis);
• if you suffer from chronic diarrhea;
• if you are in a condition where fluid loss is increased (vomiting, diarrhea, heavy sweating);
• if you use laxative medicines for prolonged periods;
• if you follow a low-potassium diet;
• if you are taking medicines called mineralocorticoids that regulate water and salt levels in the blood.

For those who engage in sports activities, the use of the drug without therapeutic need constitutes doping
and may still result in positive doping tests.

Children
This medicine can cause kidney problems (nephrocalcinosis/nephrolithiasis) in premature babies.
Therefore, during treatment with Furosemide Hexal, the doctor will need to monitor
your child's kidney function.

Other medicines and Furosemide Hexal
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicine.
Furosemide Hexal must not be administeredif you are taking any of the following
medicines:

• chloral hydrate, a sedative medicine. If furosemide is injected intravenously within 24 hours of taking chloral hydrate, it can cause skin redness, sudden sweating, agitation, nausea, increased blood pressure and increased heart rate (tachycardia);
• aminoglycosides, medicines used against bacterial infections and other medicines that can cause damage to the ear. Furosemide Hexal can increase the toxic effects on the ear in this case.

Furosemide Hexal must be administered with cautionif you are taking any of the following
medicines:

• cisplatin, a medicine used for the treatment of some cancers. If taken together with furosemide, it can produce damage to the ear and kidneys;
• sucralfate, a medicine for the treatment of ulcers. Take sucralfate 2 hours apart from furosemide because if taken at the same time, it can reduce its effect;
• lithium salts, medicines used for the treatment of depression. Furosemide can increase the toxic effects of lithium, so if the two medicines are taken together, the doctor will need to carefully check lithium levels in the blood;
• ACE inhibitors or angiotensin II receptor antagonists, medicines used to lower blood pressure. The doctor in this case will need to establish the appropriate dose of furosemide and may possibly advise you to stop taking it;
• risperidone, a medicine used for the treatment of psychiatric disorders (see section “Warnings and precautions”);
• levothyroxine(a medicine used to stimulate the thyroid): high doses of furosemide can lead to an overall decrease in thyroid hormone.

Taking the following medicines together with furosemide must be carefully evaluated by
the doctor because they can reduce the effect of furosemide:

• Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, medicines used for the treatment of inflammation. If you are dehydrated or have low blood volume (hypovolemia), you may also experience kidney problems (renal failure);
• phenytoin, a medicine for the treatment of epilepsy;
• probenecid, a medicine used for the treatment of gout;
• methotrexate, a medicine for the treatment of some cancers.

Taking the following medicines together with furosemide must be carefully evaluated by
the doctor because they can increase the toxic effects of these medicines or their
effectiveness may be altered:

• medicines toxic to the kidneys(nephrotoxic);
• corticosteroids, medicines for inflammation, carbenoxolone, a medicine for ulcers and laxativesfor prolonged use because it 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, medicines for treating high blood pressure, diuretics, medicines that promote the elimination of urine, because a strong drop in blood pressure can occur;
• antidiabetics, medicines used for the treatment of diabetes;
• sympathomimeticssuch as adrenaline and noradrenaline;
• curare-like muscle relaxants, used for anesthesia;
• theophylline, used for the treatment of asthma;
• antibiotics belonging to the cephalosporin class, medicines used against bacteria, because kidney damage may occur;
• cyclosporine A, a medicine used after a transplant, because it can increase the risk of uric acid accumulation;
• contrast agents, medicines used for some examinations, because kidney damage may occur;
• aliskiren(used in the treatment of high blood pressure): may reduce blood concentrations of orally administered furosemide. The effects of aliskiren on intravenous furosemide have not been studied.

Furosemide Hexal with food
If you consume large amounts of licorice during treatment with this medicine, you may
experience a decrease in potassium levels in the blood. It is nevertheless important that you follow
a diet rich in this mineral by consuming potatoes, bananas, oranges, tomatoes, spinach and
dried fruit during the intake of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not take Furosemide Hexal 20 mg/2 ml injectable solution in the first three months of pregnancy. In
the second and third trimesters of pregnancy, however, it may be administered only if absolutely
necessary and under the direct supervision of a doctor.
Breastfeeding
Furosemide is excreted in breast milk, so stop breastfeeding during
treatment with Furosemide Hexal.

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

Furosemide Hexal contains sodium
1 vial of Furosemide Hexal 20 mg/2 ml contains less than 1 mmol (23 mg) of sodium, which is
practically “sodium-free”.

3. How to use Furosemide Hexal

This medicine must be administered to you always following the instructions of your doctor, pharmacist or nurse exactly. If you have any doubts, consult your doctor, pharmacist or nurse.
The doctor will establish the dose, the duration of treatment, the method and the speed of injection depending on
the disease to be treated and according to your health conditions.
The recommended dose is 20 mg (1 vial), 1 - 2 times a day, as prescribed by your doctor.
The dose used must be the lowest sufficient to achieve the desired effect.

Method of administration
Furosemide Hexal is normally administered by intravenous injection or slow infusion; the rate of
infusion will be carefully established by the doctor or nurse, particularly in patients with severe
kidney disorders.

Patients with kidney or 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
modify the dose.
In exceptional cases (i.e. when it is not possible to administer the medicine either by
intravenous route or by oral route) Furosemide Hexal may be administered to you by
intramuscular injection.

If you are given more Furosemide Hexal than you should
If you believe that you have been given an excessive dose of this medicine, contact
your doctor immediately or go to the Emergency Room of the nearest hospital.
In case of overdose of this medicine, a decrease in blood volume (hypovolemia), dehydration, alteration of the blood (hemoconcentration), heart problems, cardiac arrhythmias (including A-V block and ventricular fibrillation) may occur. Symptoms may include
severe decrease in blood pressure (up to shock), severe kidney problems (acute renal failure), blood circulation problems (thrombosis), paralysis of the muscles (flaccid paralysis),
states of delirium, apathy, confusion.
Depending on your condition, the doctor will establish an appropriate therapy.

If you stop taking Furosemide Hexal
Ask your doctor for advice if you intend to stop the treatment.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

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

Stop treatment with this medicine and contact your doctor or nurse immediatelyif you experience the following symptoms: 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 following side effects may occur:

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

• dehydration;
• electrolyte imbalances;
• decreased blood volume (hypovolemia);
• increased levels of certain blood tests (creatinine and triglycerides);
• low blood pressure (hypotension) or dizziness when standing up due to low blood pressure (orthostatic hypotension).

Common(may affect up to 1 in 10 people):

• high number of red blood cells in the blood (hemoconcentration);
• decreased levels of sodium, chloride, potassium in the blood (hyponatremia, hypochloremia, hypokalemia);
• increased uric acid in the blood (hyperuricemia);
• increased cholesterol levels in blood tests;
• gout (inflammation of the joints causing pain and swelling);
• brain changes as a result of liver disorders (hepatic encephalopathy);
• increased urine production (polyuria).

Uncommon(may affect up to 1 in 100 people):

• reduced number of platelets (thrombocytopenia);
• diabetes and worsening of existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
• problems with the heart rate (cardiac arrhythmias);
• sleepiness, headache, dizziness, confusion;
• vision impairment;
• dry mouth, nausea, intestinal problems (intestinal motility disorders);
• severe, sudden muscle pain caused by involuntary contraction of one or more muscles (cramps);
• muscle weakness (myasthenia);
• cramps, muscle spasms, involuntary muscle contractions and tremors (these are symptoms of a condition known as tetany);
• fatigue;
• itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (these are symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
• appearance of small red or purple spots on the skin, with or without 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);
• hearing problems (usually transient);
• low levels of proteins in the blood (hypoproteinemia);
• deafness (sometimes irreversible).

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

• reduced number of white blood cells (leukopenia), increased number of eosinophils (eosinophilia);
• altered sensation in the limbs or other parts of the body (paresthesia);
• allergic reactions, including severe reactions including shock (anaphylactic and anaphylactoid reactions);
• serious kidney problems (interstitial nephritis);
• inflammation of the blood vessels (vasculitis);
• vomiting;
• diarrhea;
• fever.

Very rare(may affect less than 1 in 10,000 people):

• reduced concentrations of hemoglobin (hemolytic anemia), impaired production of blood cells (aplastic anemia), severe reduction in the number of white blood cells (agranulocytosis);
• ringing in the ears (tinnitus);
• inflammation of the pancreas (acute pancreatitis);
• impaired proper flow of bile (cholestasis);
• increased levels of certain liver enzymes in the blood (transaminases).

Not known(frequency cannot be estimated from available data):

• formation of blood clots inside blood vessels (thrombosis);
• onset or worsening of a chronic autoimmune disease that can affect various organs and tissues of the body called Systemic Lupus Erythematosus;
• severe skin damage (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• decreased levels of calcium and magnesium in the blood (hypocalcemia, hypomagnesemia);
• febrile acute drug eruption (acute generalized exanthematous pustulosis (AGEP);
• skin rash caused by hypersensitivity (DRESS syndrome);
• problems with urination (urinary retention in patients with prostatic hypertrophy, urethral stenosis or difficulty emptying the bladder);
• increased sodium levels in urine tests;
• increased chloride levels in urine tests;
• increased blood pH (metabolic alkalosis);
• impaired kidney function (renal insufficiency);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension);
• kidney stones (nephrolithiasis) or calcifications in the kidneys (nephrocalcinosis) in premature infants;
• abnormal blood test results, fatigue, muscle weakness, diarrhea, dehydration, increased thirst, increased urination, low blood pressure, irregular heartbeat (pseudo-Bartter syndrome);
• increased risk of heart changes (patent ductus arteriosus) in premature infants who are given furosemide during the first weeks of life;
• increased urea levels in blood tests;
• severe damage to skeletal muscle cells and release into the blood of substances contained in the muscles (rhabdomyolysis), usually in the context of severe potassium deficiency in the blood;
• local reactions such as pain at the injection site;
• lichenoid reactions, characterized by small, itchy, reddish-purple, polygonal lesions on the skin, genitals or in the mouth.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://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 Hexal

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 refrigerate or freeze
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 Furosemide Hexal 20 mg/2 ml injectable solution contains

• The active ingredient is furosemide. One 2 ml vial contains 20 mg of furosemide.
• The other ingredients are: sodium hydroxide, sodium chloride, sodium hydroxide solution 5 N, water for injections.

Description of the appearance of Furosemide Hexal and package contents
Pack of 5 vials of 2 ml.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke Allee, 1 - D-39179 Barleben (Germany)
Lek farmacevtska družba d.d. (Lek Pharmaceuticals d.d.) Verovskova 57 - SI-1526 Ljubljana (Slovenia)
------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:

Route of administration
Injection/infusion
Intravenous furosemide must be injected or infused slowly, without exceeding a rate of
4 mg/minute. In patients with severe renal impairment
(serum creatinine > 5 mg/dL), it is recommended not to exceed an infusion rate of 2.5 mg
per minute.
Intramuscular injection
Intramuscular administration should be limited to exceptional cases, when administration of the medicinal product is not possible either intravenously or orally. It is
emphasized that intramuscular injection is not suitable for the treatment of acute situations, such as
pulmonary edema.

Incompatibilities
Furosemide, as a derivative of anthranilic acid, dissolves in an alkaline environment with the formation
of a salt. The solution has a pH of approximately 9 and has no buffering effect; below pH 7 the active ingredient
precipitates. Therefore, it should be noted that Furosemide Hexal can be mixed with
alkaline or neutral or weakly acidic solutions with modest buffering capacity, for example
isotonic saline and Ringer's solution, strophanthine solution and neutral glucose solution.
Acidic solutions, especially those with
high buffering capacity, must not be mixed with Furosemide Hexal.
In addition, salts of organic bases in solution (e.g. local anesthetics, alkaloids, sedatives and
antihistamines) may precipitate if combined with Furosemide Hexal solution
Furosemide Hexal should not be combined with other drugs in the same syringe.
Once diluted, it is recommended to use the solution as soon as possible. Infusion solutions
should be used immediately after preparation.

Furosemide Hexal 250 mg/25 ml solution for infusion

Equivalent Medicinal Product

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, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Furosemide Hexal and what is it used for

Furosemide Hexal contains the active ingredient furosemide, which belongs to a group of medicines
called diuretics used to promote the elimination of excess fluids.

Furosemide Hexal is indicated if one of the following conditions applies to you:

• if you suffer from severe problems in kidney function (for example, acute renal failure in the postoperative phase and in cases of septicemia, chronic renal failure in the pre-dialytic and dialytic stage with fluid retention, chronic renal failure without fluid retention, severely impaired renal function for example in chronic glomerulonephritis and lupus erythematosus, Kimmelstiel-Wilson syndrome);
• if you are in a state of shock characterized by severe problems with blood circulation.

2. What you need to know before using Furosemide Hexal

Do not use Furosemide Hexal:

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if your body is unable to produce an adequate amount of adrenal hormones (Addison's disease);
• if you are allergic to medicines called sulfonamides used for infections or medicines called sulfonylureas used for the treatment of diabetes;
• if you have a very low blood volume (hypovolemia) or are dehydrated;
• if you do not urinate or your urine output is significantly reduced (kidney failure with oliguria or anuria) and do not respond to treatment with medicines containing a substance called furosemide;
• if you have low levels of potassium (hypokalemia) or sodium (hyponatremia) in the blood;
• if you are in a pre-coma or coma and have brain problems caused by liver damage (hepatic encephalopathy);
• if you have taken high doses of a heart medicine called digitalis;
• if you are in the first three months of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

If your kidney function is good, do not take Furosemide Hexal because you may be
subject to significant fluid loss.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Furosemide Hexal.
Take this medicine under the direct supervision of your doctor.
Furosemide Hexal should be administered to you with cautionin the following cases:

• if you have problems emptying your bladder or if you suffer from diseases that cause difficulty in eliminating urine (prostatic hyperplasia or urethral stenosis). In people in whom the urinary flow is obstructed, careful monitoring is required, especially at the beginning of therapy;
• if you suffer from low blood pressure or if you are at risk of an excessive drop in blood pressure caused by problems with blood circulation (significant narrowing of the coronary arteries or blood vessels that irrigate the brain);
• if you suffer from diabetes (latent or manifest diabetes mellitus). During treatment, the doctor will need to monitor blood sugar and urine levels;
• if you suffer from a disease called gout, caused by an accumulation of uric acid. During treatment, the doctor will need to monitor uric acid levels in the blood;
• if you have severe liver or kidney problems (hepatorenal syndrome, for example, with functional renal failure associated with severe liver disease);
• if you have low levels of protein in the blood (hypoproteinemia);
• if you are at risk of changes in salt (electrolyte) levels in the blood or if you have lost a lot of fluids (e.g. following vomiting, diarrhea or heavy sweating). In this case, the doctor will need to 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 electrolyte levels;
• if you are taking a medicine called risperidone, used for the treatment of psychiatric disorders. Cases of death in elderly people with dementia who were taking risperidone together with furosemide have been reported (see section “Other medicines and Furosemide Hexal”);
• 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 already established;
• if you suffer from a severe problem of high blood pressure (severe forms of hypertension), because in this case you will need to take, together with furosemide, other medicines to control the 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 risks of lowering blood pressure;
• if you have a disease of the adrenal glands (see section 2 “What you need to know before taking Furosemide Hexal”).

To reduce the risk of lowering potassium levels in the blood, during treatment with
Furosemide Hexal, follow a diet rich in potassium (potatoes, bananas, oranges, tomatoes, spinach and
dried fruit). The doctor will indicate to you if necessary to take medicines to restore normal
potassium levels in the blood.
The doctor will monitor the values of blood sugar, sugars in the urine and, if necessary, the
metabolism of uric acids.
The doctor will 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.
You are at risk of lowering potassium levels:

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

For those who engage in sports activities, the use of the drug without therapeutic need constitutes doping
and may still result in positive doping tests.

Children
This medicine can cause kidney problems (nephrocalcinosis/nephrolithiasis) in premature babies.
Therefore, during treatment with Furosemide Hexal, the doctor will need to monitor the
function of your child's kidneys.

Other medicines and Furosemide Hexal
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines.
Furosemide Hexal must not be administeredto you if you are taking any of the following
medicines:

• chloral hydrate, a sedative medicine. If furosemide is administered intravenously within 24 hours of taking chloral hydrate, it can cause skin flushing, sudden sweating, agitation, nausea, increased blood pressure and increased heart rate (tachycardia);
• aminoglycosides, medicines used against bacterial infections and other medicines that can cause damage to the ear. Furosemide Hexal can increase the toxic effects on the ear in this case.

Furosemide Hexal must be administered to you with cautionif you are taking one of the following
medicines:

• cisplatin, a medicine used for the treatment of some cancers. If taken together with furosemide, it can produce damage to the ear and kidneys;
• sucralfate, a medicine for the treatment of ulcers. Take sucralfate at a distance of two hours from furosemide because if taken simultaneously, it can reduce its effect;
• lithium salts, medicines used for the treatment of depression. Furosemide can increase the toxic effects of lithium, so if the two medicines are taken together, the doctor will need to carefully monitor lithium levels in the blood;
• ACE inhibitors or angiotensin II receptor antagonists, medicines used to lower blood pressure. The doctor in this case will need to establish the appropriate dose of furosemide and may possibly advise you to suspend its administration;
• risperidone, a medicine used for mental problems (see section “Warnings and precautions”);
• levothyroxine(a medicine used to stimulate the thyroid): high doses of furosemide can lead to an overall decrease in thyroid hormone.

The taking of the following medicines together with furosemide must be carefully evaluated by the
doctor because they can reduce the effect of furosemide:

• Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, medicines used for the treatment of inflammation. If you are dehydrated or have low blood volume (hypovolemia), you may also experience kidney problems (acute renal failure);
• phenytoin, a medicine for the treatment of epilepsy;
• probenecid, a medicine used for the treatment of gout;
• methotrexate, a medicine for the treatment of some cancers.

The taking of the following medicines together with furosemide must be carefully evaluated by the
doctor because they can increase the toxic effects of these medicines or their efficacy may be altered:

• medicines toxic to the kidneys(nephrotoxic);
• corticosteroids, medicines for inflammation, carbenoxolone, a medicine for ulcers and laxativesfor prolonged use because it 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, medicines for treating high blood pressure, diuretics, medicines that promote the elimination of urine because a strong drop in blood pressure may occur;
• antidiabetics, medicines used for the treatment of diabetes;
• sympathomimeticssuch as adrenaline and noradrenaline;
• curare-like muscle relaxants, used for anesthesia;
• theophylline, used for the treatment of asthma;
• antibiotics belonging to the cephalosporin category, medicines used against bacteria, because kidney damage may occur;
• cyclosporine A, a medicine used after a transplant, because it can increase the risk of uric acid accumulation;
• contrast agents, medicines used for some examinations, because kidney damage may occur,
• aliskiren(used in the treatment of high blood pressure), may reduce concentrations of furosemide in the blood, when administered orally.

Furosemide Hexalwith food
If you take large amounts of licorice during treatment with this medicine, you may
experience a decrease in potassium levels 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 taking of the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not take Furosemide Hexal 250 mg/25 ml solution for infusion in the first three months of
pregnancy. In the second and third trimester of pregnancy, however, it may be administered to you in case
of actual need and under the direct supervision of your doctor.
Breastfeeding
Furosemide is excreted in breast milk, so stop breastfeeding during
treatment with Furosemide Hexal.

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

Furosemide Hexal contains sodium
This medicine contains 35.65 mg of sodium (the main component of table salt) per vial.
This is equivalent to 1.82% of the recommended daily intake of salt with the diet of a
adult.

3. How to use Furosemide Hexal

This medicine must be administered to you always following the instructions of your doctor, pharmacist or nurse exactly. If you have any doubts, consult your doctor, pharmacist or nurse. The dose used must be the lowest sufficient to achieve the desired effect. The doctor will establish the dose, duration of treatment, method and speed of injection depending on the disease to be treated and depending on your health conditions. The medicine must be infused into a vein through a special device. The recommended dose at the beginning of treatment is 1 vial appropriately diluted in 250 ml of infusion solution. An increase in urine output (diuresis) should be obtained already during the infusion, which will last about 1 hour. If you do not obtain a satisfactory increase in diuresis, one hour after the end of the first administration it is possible to perform a second infusion with 2 vials of Lasix appropriately diluted in infusion solution. The duration of this administration will be decided by healthcare personnel based on your condition. If, even following the second administration, the desired effect is not obtained, one hour after the end of the second administration it is possible to proceed with a third infusion with 4 vials of Furosemide Hexal appropriately diluted in infusion solution. If, even following the third administration, no undesirable effects are obtained, the doctor will consider the possibility of subjecting you to dialysis. If you are a hypervolemic patient (excessive blood volume), it is possible that Furosemide Hexal 250 mg/25 ml solution for infusion will be administered to you without first being diluted in infusion solution, to avoid administering an excessive amount of liquid (hyperhydration). The duration of this administration must be carefully regulated by healthcare personnel. Patients with renal insufficiency In case of kidney disease, the doctor may modify the dose. Method of administration Furosemide Hexal 250 mg/25 ml solution for infusion is administered intravenously (administration into a vein) for slow infusion only by healthcare personnel, who will regulate the infusion rate and dilute the contents of the vial in appropriate infusion solution, to which no other drugs must be added. Lasix infusion solutions must be used immediately after dilution.

If you are given more Furosemide Hexal than you should
If you think you have been given an excessive dose of this medicine, contact your doctor immediately or go to the Emergency Room of the nearest hospital. In case of overdose of this medicine, a decrease in blood volume (hypovolemia), dehydration, alteration of the blood (hemoconcentration), heart problems, cardiac arrhythmias (including A-V block and ventricular fibrillation) may occur. Symptoms may include a 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, confused state. Depending on your condition, the doctor will establish an adequate therapy. If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

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 or nurse immediatelyif you experience the following symptoms: 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 following side effects may occur:

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

• dehydration;
• electrolyte imbalances;
• decreased blood volume (hypovolemia);
• increased levels of certain blood tests (creatinine and triglycerides);
• decreased blood pressure (hypotension) or feeling dizzy when getting up due to low blood pressure (orthostatic hypotension).

Common(may affect up to 1 in 10 people):

• elevated red blood cell count (hemoconcentration);
• decreased levels of sodium, chloride, potassium in the blood (hyponatremia, hypochloremia, hypokalemia);
• increased uric acid in the blood (hyperuricemia);
• increased cholesterol levels in blood tests;
• gout (inflammation of the joints causing pain and swelling);
• brain changes as a result of liver disorders (hepatic encephalopathy);
• production of large amounts of urine (polyuria).

Uncommon(may affect up to 1 in 100 people):

• reduced number of platelets (thrombocytopenia);
• diabetes and worsening of existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
• problems with heart rate (cardiac arrhythmias);
• sleepiness, headache, dizziness, confusion;
• vision impairment;
• dry mouth, nausea, intestinal problems (intestinal motility disorders);
• severe, sudden muscle pain caused by involuntary contraction of one or more muscles (cramps);
• muscle weakness (myasthenia);
• cramps, muscle spasms, involuntary muscle contractions and tremors (these are symptoms of a condition known as tetany);
• fatigue;
• itching, hives, skin irritation, blistering of the skin and mucous membranes (these are symptoms of skin conditions such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
• appearance of small, red or purple spots spread over the skin, with or without joint, muscle pain, weakness and fever (these may be symptoms of inflammation of the blood vessel walls, called purpura);
• allergic reaction to sunlight manifesting as skin irritation accompanied by itching (photosensitivity reaction);
• hearing problems (usually transient);
• low levels of proteins in the blood (hypoproteinemia);
• deafness (sometimes irreversible).

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

• reduced number of white blood cells (leukopenia), increased number of eosinophils (eosinophilia);
• altered sensitivity of the limbs or other parts of the body (paresthesia);
• allergic reactions, including severe ones including shock (anaphylactic and anaphylactoid reactions);
• serious kidney problems (interstitial nephritis);
• inflammation of the blood vessels (vasculitis);
• vomiting;
• diarrhea;
• fever.

Very rare(may affect less than 1 in 10,000 people):

• reduced concentrations of hemoglobin (hemolytic anemia), impaired production of blood cells (aplastic anemia), severe reduction in the number of white blood cells (agranulocytosis);
• ringing in the ears (tinnitus);
• inflammation of the pancreas (acute pancreatitis);
• impaired bile flow (cholestasis);
• increased levels of certain liver enzymes in the blood (transaminases).

Not known(frequency cannot be estimated from available data):

• formation of blood clots inside blood vessels (thrombosis);
• onset or worsening of a chronic autoimmune disease, which can affect various organs and tissues of the body called Systemic Lupus Erythematosus;
• severe skin damage (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• decreased levels of calcium and magnesium in the blood (hypocalcemia, hypomagnesemia);
• febrile acute drug eruption (acute generalized exanthematous pustulosis (AGEP);
• skin rash caused by hypersensitivity (DRESS syndrome);
• problems with urination (urinary retention in patients with prostatic hypertrophy, urethral stenosis or difficulty emptying the bladder);
• increased value of sodium in the urine test;
• increased value of chlorine in the urine test;
• increased pH of the blood (metabolic alkalosis);
• impaired kidney function (renal failure);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension);
• kidney stones (nephrolithiasis) or calcifications at the kidney level (nephrocalcinosis) in premature infants;
• abnormal blood test values, fatigue, muscle weakness, diarrhea, dehydration, increased thirst, increased urination, low blood pressure, irregular heartbeat (pseudo-Bartter syndrome);
• increased risk of heart changes (patent ductus arteriosus) in premature infants to whom furosemide is administered during the first weeks of life;
• increased value of urea in the blood test;
• severe damage to skeletal muscle cells and release into the blood of substances contained in the muscles (rhabdomyolysis), generally in the context of severe potassium deficiency in the blood;
• local reactions such as pain at the injection site.
• lichenoid reactions, characterized by small, itchy, reddish-purple polygonal lesions on the skin, genitals or in the mouth.

Reporting of side effects
If you experience any side effects, including 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
https://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 Hexal

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. Package Contents and Other Information

What Furosemide Hexal 250 mg/25 ml solution for infusion contains

• The active ingredient is: furosemide. One 25 ml vial contains 250 mg of furosemide.
• The other ingredients are: sodium hydroxide, mannitol, sodium hydroxide solution 5N, water for injections.

Description of the appearance of Furosemide Hexal and package contents
Pack of 5 vials of 25 ml.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke Allee, 1 – 39179 Barleben (Germany)
Sandoz GmbH - Biochemiestraße 10 - 6250 Kundl (Austria)
EVER Pharma Jena GmbH- Otto-Schott-Straße 15 - 07745 Jena (Germany)

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The following information is intended exclusively for healthcare professionals:
Therapeutic indications:
The use of Lasix 250 mg/25 ml solution for infusion preparations is indicated
exclusively in patients with:

• severely impaired glomerular filtration rate (GFR < 0.33 ml/s = 20 ml/min.);
• acute renal failure (oligoanuria), for example in the postoperative phase in septic processes;
• chronic renal failure in the predialytic and dialytic stage with fluid retention, in particular in chronic pulmonary edema;
• nephrotic syndrome with severely limited renal function, for example in chronic glomerulonephritis and lupus erythematosus; Kimmelstiel-Wilson syndrome. In nephrotic syndrome, therapy with corticosteroids is of paramount importance. Lasix is still indicated in case of insufficient control of edema, in patients refractory to corticosteroid therapy or in cases where the latter is contraindicated;
• chronic renal failure without fluid retention. In these patients, therapeutic attempt with Lasix is possible; if diuresis remains insufficient (less than 2.5 l/day) the patient should be considered for the dialysis program;
• shock state; before starting diuretic therapy, hypovolemia and hypotension must be resolved with appropriate measures. Severe disturbances of serum electrolytes and acid-base balance must also be corrected beforehand.

Furosemide, due to its high therapeutic reserve, can induce a significant increase in
diuresis even in clinical situations where other diuretic measures are ineffective (marked
renal impairment, hypoalbuminemia, metabolic acidosis).

Special warnings and precautions for use
Furosemide Hexal 250 mg/25 ml solution for infusion must not be used for injections
i.v., but only for slow venous infusion using pumps for controlling the volume or infusion rate, in order to reduce the risk of accidental overdose.

Dosage and method of administration
Lasix 250 mg/25 ml solution for infusion
The rate of infusion must always be adjusted so that no more than
4 mg of furosemide/min are administered. In patients in whom there is a severe impairment of renal function
(serum creatinine > 5 mg/dL) it is recommended not to exceed an infusion rate of 2.5 mg
per minute.
The pH of the infusion solution ready for use must not be less than 7, because in acidic solution
furosemide may precipitate.
The furosemide solution must not be infused together with other drugs.
If the test dose of 40 - 80 mg of furosemide, administered slowly i.v. (about 2 - 5 min.), does not
determine a significant increase in diuresis within 30 min., the infusion treatment with Furosemide Hexal 250 mg can be started.
The contents of 1 vial of Furosemide Hexal 250 mg/25 ml solution for infusion must be diluted
in 250 ml of isotonic Ringer's solution or another isotonic neutral or alkaline solution.
Considering the prescribed infusion rate, in this case (250 mg in 275 ml) the duration
of the infusion is approximately 1 hour. If the patient responds to this dose, an increase in
diuresis should be detected during the infusion. From a therapeutic point of view, an increase in
diuresis of at least 40 - 50 ml/hour will be sought.
If a satisfactory increase in diuresis is not obtained with the first dose of Furosemide Hexal, one hour
after the end of the first infusion, a second one with 2 vials of Furosemide Hexal 250
mg/25 ml solution for infusion (500 mg in 50 ml) will be performed, diluting the contents with appropriate
infusion solution and adjusting the volume of the infusion to the patient's hydration status.
The duration of the infusion will always be regulated by the possibility of infusing a maximum of 4 mg/min.
of active ingredient.
If even with this dose the diuresis is not what is desired, one hour after the end
of the second infusion, a third one can be performed with 4 vials of Furosemide Hexal 250 mg/25
ml solution for infusion (1000 mg in 100 ml). For the total volume of the infusion solution,
as well as for the rate of administration, the previously indicated directives apply. If even
with this dose a satisfactory diuretic effect is not obtained, the possibility of
switching to dialysis should be considered.
In hypervolemic patients, it is preferable, if the test dose of 40 - 80 mg i.v. has proved ineffective,
to administer the Furosemide Hexal 250 mg/25 ml solution for infusion without
diluting it or adding it to the volume of infusion solution compatible with the patient's hydration status in order to avoid hyperhydration. Direct infusion of the vial contents can be
carried out only if the administration rate not exceeding 4 mg of
furosemide/min. (= 0.4 ml/min.) is guaranteed.
Infusion solutions containing furosemide must be used immediately after
preparation.

Water retention associated with chronic renal failure
The natriuretic response to furosemide depends on a number of factors, including the severity
of renal failure and sodium balance, and therefore the effect of a dose cannot be
predicted with accuracy. In patients with chronic renal failure, the dose must be
carefully titrated so that the initial fluid loss is gradual.

Maintenance of fluid excretion in acute renal failure
Hypovolemia, hypotension and significant electrolyte and acid-base imbalances must be corrected before
starting therapy with furosemide. It is recommended that transfer from the intravenous route to the oral route be effected as soon as possible.
Incompatibilities

Lasix 250 mg/25 ml solution for infusion
Furosemide, as a derivative of anthranilic acid, is soluble in an alkaline environment. The solution of
Furosemide Hexal 250 mg/25 ml solution for infusion contains in fact the sodium salt of furosemide;
this solution has a pH of about 9 and has no buffering effect.
At pH values below 7, the active ingredient may precipitate and therefore, for administration by
infusion, the Furosemide Hexal 250 mg/25 ml solution for infusion solution can be
mixed only with weakly alkaline or neutral solutions, with modest buffering capacity: for
example, isotonic sodium chloride solution or Ringer's solution.
Acidic solutions, especially those with
high buffering capacity, must not be mixed with Furosemide Hexal.
Furosemide Hexal must not be combined with other drugs in the same syringe.
Once diluted, it is recommended to use the solution as soon as possible.