FUROSEMIDE 500 мг Таблетка

Содержание инструкции

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

FUROSEMIDE DOC Generici 25 mg tablets

Equivalent Medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is FUROSEMIDE DOC Generici and what it is used for

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

FUROSEMIDE DOC Generici 25 mg tablets is indicated for the treatment of:
all forms of swelling due to fluid accumulation (edema and peripheral edema) caused by
problems with the heart (for example due to heart failure), liver (hepatic cirrhosis), kidneys
(as in nephrotic syndrome, where it can be taken together with other medicines ACTH or
corticosteroids) or problems with obstruction of an organ or blood vessels
mild to moderately high blood pressure.

2. What you need to know before taking FUROSEMIDE DOC Generici

Do not take FUROSEMIDE DOC Generici:
if you are allergic (hypersensitive) to furosemide or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to other medicines called sulfonamides (such as sulfonamide antibiotics used to treat infections or like “sulfonylureas” used to treat diabetes)
if you have a very low blood volume (hypovolemia) or are dehydrated
if you do not produce urine (anuria) due to serious kidney problems (renal failure)
if you have low levels of potassium (hypokalemia) or sodium (hyponatremia) in the blood
if the person taking the medicine is in a pre-comatose or comatose state and has brain problems caused by liver damage (hepatic encephalopathy)
if you have taken high doses of heart medications called digitalis
if you are in the first three months of pregnancy or if you are breastfeeding (see the “Pregnancy and breastfeeding” section)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking FUROSEMIDE DOC Generici
Take this medicine under the direct supervision of your doctor.
Take FUROSEMIDE DOC Generici 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, in fact, 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 blood circulation problems (significant stenosis of the coronary arteries or blood vessels that irrigate the brain);
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 suffer from diabetes (latent or manifest diabetes mellitus). During treatment, the doctor will need to check 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 check uric acid levels in the blood;
if you have serious liver or kidney problems (hepato-renal syndrome, functional renal failure associated with severe liver disease);
if you have low levels of proteins in the blood (hypoproteinemia);
if you are at risk of changes in the levels of salts (electrolytes) 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 to follow appropriate therapy to restore electrolyte levels to normal;
if you suffer from dementia and are being treated with a medicine called risperidone. In this case, the doctor will carefully evaluate the risks and benefits of this combination and co-administration with other potent diuretics.
To reduce the risk of lowering potassium levels in the blood, during treatment with FUROSEMIDE DOC Generici follow a diet rich in potassium (potatoes, bananas, oranges, tomatoes, spinach and dried fruit). The doctor will indicate whether it is necessary to take medicines to restore normal potassium levels in the blood.
You are at risk of lowering potassium levels:
if you suffer from liver problems (liver cirrhosis);
if you have suffered from chronic diarrhea;
if you are in a condition in which fluid loss is increased (vomiting, diarrhea, heavy sweating);
if you use laxative medicines 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.
In case of treatment of swelling caused by fluid accumulation due to liver problems (liver cirrhosis with ascites), FUROSEMIDE DOC Generici must be administered to you only in hospital.
FUROSEMIDE DOC Generici does not change the pressure in those who are normotensive, while it reduces the pressure in hypertensive patients; in severe forms of hypertension, it is recommended to use it in association with other medicines.
During treatment with furosemide, the possibility of worsening or activation of systemic lupus erythematosus, a disease in which the immune system produces antibodies that mainly attack the skin and joints, has been reported (see section 4).
For those who play sports, the use of the drug without therapeutic necessity constitutes doping and may still result in positive doping tests.

Children
This medicine can cause the formation of stones (nephrocalcinosis/nephrolithiasis) in the kidneys in premature infants. Therefore, during treatment with FUROSEMIDE DOC Generici, the doctor will need to monitor the function of your child’s kidneys.

Other medicines and FUROSEMIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking FUROSEMIDE DOC Generici if you are taking any of the following medicines:

aminoglycosides, medicines used against bacterial infections and other medicines that can cause damage to the ear. FUROSEMIDE DOC Generici can increase the toxic effects on the ear in this case.
Take FUROSEMIDE DOC Generici with cautionif you are taking one of the following medicines:

cisplatin, a medicine used for some tumors. If taken together with furosemide, it can produce damage to the ear and kidneys;

sucralfate, a medicine for ulcers. Take sucralfate two hours apart from furosemide because if taken at the same time, it can reduce its effect;

lithium salts, medicines used for depression. Furosemide can increase the toxic effects of lithium, including an increased risk of cardiotoxic and neurotoxic effects. Therefore, 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. Use with furosemide can cause an excessive drop in pressure and compromise kidney function. The doctor will in this case establish the appropriate dose of furosemide and may possibly advise you to suspend its intake 3 days before starting treatment with the ACE inhibitor or increasing the dose of the ACE inhibitor;

risperidone, a medicine used for mental problems, as an increase in mortality has been reported in elderly patients. In this case, the doctor will carefully evaluate the risks and benefits of this combination and co-administration with other potent diuretics. (see the “Warnings and precautions” section).
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, such as acetylsalicylic acid, medicines used for inflammation whose use, together with furosemide, can also increase their toxic effects. If you are dehydrated or have a low blood volume, you may also experience kidney problems;

phenytoin, a medicine for epilepsy; probenecid, a medicine used for gout and

methotrexate, a medicine for the treatment of some tumors and psoriasis.
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) such as cephalosporins (antibiotics used against bacterial infections) and for the ear (ototoxic) such as aminoglycoside antibiotics;

corticosteroids, medicines used 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 can occur;

antidiabetics, medicines used to treat diabetes;

sympathomimeticssuch as adrenaline and noradrenaline, used in anaphylactic shock and cardiac arrest;

curare-like muscle relaxants, used for anesthesia;

theophyllineused for asthma;

cyclosporine A, a medicine used after a transplant;

contrast agents, medicines used for some examinations, because kidney damage can occur.

FUROSEMIDE DOC Generici with food
If you take a lot of licorice during treatment with this medicine, you may have an excessive decrease in potassium levels in the blood.
In addition, taking it with food can change the amount of furosemide absorbed, so
FUROSEMIDE DOC Generici should be taken on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
You should not take FUROSEMIDE DOC Generici during the first three months of pregnancy.
In the second and third trimester of pregnancy, furosemide can be used, but only in cases of urgent clinical need. If treatment is during pregnancy, the doctor will carefully monitor fetal growth.
During treatment with FUROSEMIDE DOC Generici, stop breastfeeding because furosemide passes into breast milk.

Driving and operating machinery
This medicine can alter your ability to concentrate and your reactivity. Therefore, if this happens to you, avoid driving vehicles and using machinery.

FUROSEMIDE DOC Generici contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.

3. How to take FUROSEMIDE DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doctor will establish the dose, the duration of treatment depending on the disease to be treated and according to
your health conditions.
Take the tablets with some liquid on an empty stomach.

Treatment of swelling due to fluid accumulation
The recommended dose is 1-3 tablets at once, to be repeated at intervals of 4 hours, if
necessary.
The dose may be increased by 1-2 tablets at intervals of 4 hours, until the desired
diuretic effect is achieved.

Treatment of high blood pressure
The recommended dose is 1-3 tablets distributed over 24 hours. In case of administration of
more drugs for the reduction of pressure (hypotensives) your doctor may suggest you to reduce the
dose of FUROSEMIDE DOC Generici.

If you take more FUROSEMIDE DOC Generici than you should
In case of overdose of this medicine, a decrease in blood volume (hypovolemia), dehydration, increased blood concentration
(hemoconcentration), heart problems (arrhythmias, including A-V block and ventricular fibrillation) may occur. The
symptoms may be a severe decrease in blood pressure (up to shock), serious
kidney problems (acute renal failure), blood circulation problems (thrombosis),
delirium, paralysis of the muscles (flaccid paralysis), apathy, confused state.
Depending on your condition, the doctor will establish an adequate therapy.
In case of taking an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take FUROSEMIDE DOC Generici
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:

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

• alterations in the concentrations of mineral salts (electrolytes) in the blood;
• dehydration;
• decreased blood volume (hypovolemia) especially in elderly patients;
• increased levels of triglycerides and creatinine.

Common(may affect up to 1 in 10 people)

• increased blood concentration (hemoconcentration);
• decreased levels of sodium, chlorine and potassium in the blood (hyponatremia, hypochloremia, and hypokalemia);
• increased cholesterol levels;
• increased uric acid levels in the blood with possible gout attacks;
• brain problems caused by liver damage (hepatic encephalopathy) in patients with severe liver dysfunction;
• increased urine production.

Uncommon(may affect up to 1 in 100 people)

• decreased levels of platelets in the blood (thrombocytopenia);
• impaired glucose tolerance;
• manifestation of latent diabetes mellitus;
• drowsiness, headache, dizziness, confusion;
• vision disorders;
• lowering of protein levels in the blood (hypoproteinemia);
• hearing problems usually transient, especially in patients with impaired kidney function;
• alterations in heart rate (arrhythmias);
• dry mouth, nausea, stomach and intestinal problems;
• skin and mucous membrane reactions such as: urticaria, itching, rash, blister formation, red skin spots and bleeding (purpura), erythema multiforme, appearance of blisters and small hemorrhages (pemphigoid) exfoliative dermatitis,
• increased sensitivity to light (photosensitivity reactions);
• muscle problems (muscle cramps, tetany, myasthenia);
• deafness (sometimes irreversible).

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

• reduction in the number of white blood cells and white blood cells in the blood (leukopenia and eosinophilia);
• allergic reactions, sometimes severe (anaphylactic or anaphylactoid reactions, e.g. accompanied by shock);
• loss of sensation (paresthesia);
• inflammation of blood vessels (vasculitis);
• vomiting, diarrhea;
• acute or chronic kidney inflammation (interstitial nephritis).

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

• blood problems (aplastic anemia, agranulocytosis, hemolytic anemia);
• ringing in the ears (tinnitus);
• acute inflammation of the pancreas (pancreatitis);
• liver problems, including impaired bile flow (cholestasis) and increased levels of transaminases.

Not known(the frequency of which cannot be estimated on the basis of available data)

• systemic lupus erythematosus (a disease in which the immune system produces antibodies that primarily attack the skin and joints);
• decreased levels of calcium or magnesium in the blood (hypocalcemia or hypomagnesemia);
• increased blood pH (metabolic alkalosis);
• increased urea in the blood;
• in the case of abuse or prolonged use of furosemide, pseudo-Bartter syndrome may occur (a disease in which there are simultaneously an increase in blood pH, a decrease in potassium levels in the blood, a severe decrease in blood pressure and an abnormal increase in calcium in the urine);
• blood circulation problems (thrombosis);
• skin rash and redness, which can evolve into potentially life-threatening skin reactions including widespread rash with blisters and skin detachment, which appear particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread skin detachment (more than 30% of the body surface - toxic epidermal necrolysis) or extensive rash involving the liver, blood and other body organs (DRESS);
• increased sodium and chlorine in the urine;
• acute generalized exanthematous pustulosis (AGEP) (acute drug-induced febrile skin eruption);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension)

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
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store FUROSEMIDE DOC Generici

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, tightly closed, to protect the medicine from light. No
special storage conditions are required regarding temperature.
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 DOC Generici contains
FUROSEMIDE DOC Generici 25 mg tablets
The active ingredient is furosemide. Each tablet contains 25 mg of furosemide.
The other ingredients are: corn starch, lactose, talc, colloidal silicon dioxide and magnesium stearate.
Description of the appearance of FUROSEMIDE DOC Generici and contents of the pack
Pack of 30 tablets.
Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano

Manufacturers
DOPPEL Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de Stampi - Rozzano (Mi)
Fulton Medicinali S.p.A. – Via Marconi, 28/9 – Arese (MI)
Lachifarma S.r.l. - Laboratorio Chimico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)

FUROSEMIDE DOC Generici 500mg tablets

Equivalent Medicine

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

1. What is FUROSEMIDE DOC Generici and what is it used for

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

FUROSEMIDE DOC Generici is indicated if one of the following conditions applies to you:
if you suffer from severe problems in kidney function such as acute renal failure,
chronic renal failure (especially in the case of chronic pulmonary edema), nephrotic syndrome
(when anti-inflammatory drugs called corticosteroids are not sufficient to control edema), and in the
case of a renal complication of diabetes called Kimmelstiel-Wilson syndrome

2. What you need to know before taking FUROSEMIDE DOC Generici

Do not take FUROSEMIDE DOC Generici:
if you are allergic (hypersensitive) to furosemide or to any of the other ingredients of this
medicine (listed in section 6)
if you are allergic to other medicines called sulfonamides (such as sulfonamide antibiotics used to
treat infections or like “sulfonylureas” used to treat diabetes)
if your kidney function is normal or moderately reduced
if you have a very low blood volume (hypovolemia) or are dehydrated
if you do not produce urine (anuria) due to serious kidney problems (renal failure)
if you have low levels of potassium (hypokalemia) or sodium (hyponatremia) in the blood
if the person taking the medicine is in a pre-comatose or comatose state and has brain problems
caused by liver damage (hepatic encephalopathy)
if you have taken high doses of heart medications called digitalis
if you are in the first three months of pregnancy or if you are breastfeeding (see the “Pregnancy and
breastfeeding” section)

Warnings and precautions
Talk to your doctor or pharmacist before taking FUROSEMIDE DOC Generici
Take this medicine under the direct supervision of your doctor.
Take FUROSEMIDE DOC Generici with cautionin the following cases:
if you have problems emptying the bladder or if you suffer from diseases that cause difficulty
urinating (prostatic hyperplasia or urethral stenosis). In people in whom the 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 blood circulation problems (e.g. significant narrowing of the coronary
arteries or blood vessels that irrigate the brain);
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 low
blood pressure; if you suffer from diabetes (latent or manifest diabetes mellitus). During
treatment, the doctor will need to monitor blood sugar 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 serious liver or kidney problems (hepatorenal syndrome, 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 alterations in the levels of
salts (electrolytes) in the blood or if you have lost a lot of fluids (e.g. following vomiting, diarrhea or intense
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 to follow appropriate therapy to restore electrolyte levels to normal;
if you suffer from dementia and are being treated with a medicine called risperidone. In this case, the
doctor will carefully assess the risks and benefits of this combination and co-administration
with other potent diuretics.
To reduce the risk of lowering potassium levels in the blood, during treatment with
FUROSEMIDE DOC Generici, 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.
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, intense
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.
In case of treatment of swelling caused by fluid accumulation due to liver problems
(liver cirrhosis with ascites), FUROSEMIDE DOC Generici must be administered to you only in
hospital.
FUROSEMIDE DOC Generici does not change the pressure in people with normal pressure, while it reduces
pressure in hypertensive patients; in severe forms of hypertension, it is recommended to use it in
association with other medicines.
During treatment with furosemide, the possibility of worsening or activation of systemic lupus erythematosus, a disease in which the immune system produces
antibodies that attack mainly the skin and joints has been reported (see section 4).
For those who engage in sports, the use of the drug without therapeutic necessity constitutes doping and
may still result in positive doping tests.

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

Other medicines and FUROSEMIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid taking FUROSEMIDE DOC Generici if you are taking any of the following medicines:

aminoglycosides, medicines used against bacterial infections and other medicinesthat can
cause damage to the ear. FUROSEMIDE DOC Generici can increase the toxic effects
to the ear in this case.
Take FUROSEMIDE DOC Generici with cautionif you are taking any of the following medicines:

cisplatin, a medicine used for some tumors. If taken together with furosemide, it can
produce damage to the ear and kidneys;

sucralfate, a medicine for 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 depression. Furosemide can increase the toxic effects
of lithium, including an increased risk of cardiotoxic and neurotoxic effects. Therefore, 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. Use with furosemide can cause an excessive drop in
pressure and compromise kidney function. The doctor in this case will need to establish the appropriate dose
of furosemide and may possibly advise you to suspend its use 3 days
before starting treatment with the ACE inhibitor or increasing the dose of the ACE inhibitor.

risperidone,a medicine for the treatment of the mind as an increase in
mortality has been reported in elderly patients. In this case, the doctor will carefully assess the risks and benefits of
this combination and co-administration with other potent diuretics.(see the section
“Warnings and precautions”).
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, such as acetylsalicylic acid, medicines used for
inflammation whose use, together with furosemide, can also increase their toxic effects. If you are
dehydrated or have low blood volume, you may also experience kidney problems;

phenytoin, a medicine for epilepsy; probenecid, a medicine used for gout and

methotrexate, a medicine for the treatment of some tumors and psoriasis.
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) such as cephalosporins (antibiotics used against
bacterial infections) and for the ear (ototoxic) such as aminoglycoside antibiotics;

corticosteroids, medicines used for inflammation, carbenoxolone, a medicine for
ulcers and laxativesfor prolonged use because it can increase the risk of lowering
potassium levels in the blood;

digitalis-based medicines, used for the heart. Furosemide can increase their toxic effects
because it alters magnesium and potassium levels in the blood;

antihypertensives, medicines for treating high blood pressure, diuretics, medicines that promote
urine elimination because a strong drop in blood pressure may occur;

antidiabetics, medicines used to treat diabetes;

sympathomimeticssuch as adrenaline and noradrenaline, used in anaphylactic shock and
cardiac arrest;

curaro-like muscle relaxants, used for anesthesia;

theophyllineused for asthma;

cyclosporine A, a medicine used following a transplant;

contrast agents, medicines used for some examinations, because kidney damage may occur.

FUROSEMIDE DOC Generici with food
If you take a lot of licorice during treatment with this medicine, you may have a
excessive decrease in potassium levels in the blood.
In addition, taking it with food may change the amount of furosemide absorbed, so
FUROSEMIDE DOC Generici should be taken on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine.
Do not take FUROSEMIDE DOC Generici during the first three months of pregnancy.
In the second and third trimesters of pregnancy, furosemide can be used, but only in cases of
urgent clinical need. If treatment is during pregnancy, the doctor will need to
carefully monitor fetal growth.
During treatment with FUROSEMIDE DOC Generici, discontinue breastfeeding because
furosemide passes into breast milk.

Driving and using machines
This medicine can alter your ability to concentrate and your reactivity. Therefore, if
this happens to you, avoid driving vehicles and using machinery.

FUROSEMIDE DOC Generici 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 DOC Generici

This medicine must be administered to you always following exactly the instructions of the
doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
The doctor will establish the dose, and the duration of treatment depending on the disease to be treated and
according to your health conditions.
The recommended initial dose is half a tablet (250 mg). The initial dose may be increased
by half a tablet every 4-6 hours.
This procedure should be repeated until reaching the effective dose, which may range between
250 and 2000 mg (half - 4 tablets).
Take the tablets with some liquid on an empty stomach, preferably in the morning.

If you take more FUROSEMIDE DOC Generici than you should
In case of overdose with this medicine, a decrease in blood volume (hypovolemia), dehydration, increased blood concentration
(hemoconcentration), heart problems (arrhythmias, including A-V block and ventricular fibrillation) may occur. The
symptoms may be a severe decrease in blood pressure (up to shock), serious
kidney problems (acute renal failure), blood circulation problems (thrombosis),
delirium, paralysis of the muscles (flaccid paralysis), apathy, confused state.
Depending on your condition, the doctor will establish an adequate therapy.
In case of taking an excessive dose of this medicine, contact your doctor immediately or
go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:

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

• alterations in the concentrations of mineral salts (electrolytes) in the blood;
• dehydration;
• decrease in blood volume (hypovolemia) especially in elderly patients;
• increased levels of triglycerides and creatinine.

Common(may affect up to 1 in 10 people)

• increase in blood concentration (hemoconcentration);
• decrease in levels of sodium, chlorine and potassium in the blood (hyponatremia, hypochloremia, and hypokalemia);
• increased levels of cholesterol;
• increased amount of uric acid in the blood with possible gout attacks;
• brain problems caused by liver damage (hepatic encephalopathy) in patients with severe liver dysfunction;
• increased urine production.

Uncommon(may affect up to 1 in 100 people)

• decrease in the levels of platelets in the blood (thrombocytopenia);
• altered glucose tolerance;
• manifestation of a latent diabetes mellitus;
• drowsiness, headache, dizziness, confusion;
• visual disturbances;
• lowering of protein levels in the blood (hypoproteinemia);
• hearing problems usually transient, especially in patients with kidney dysfunction;
• alterations in heart rate (arrhythmias);
• dry mouth, nausea, stomach and intestinal problems;
• skin and mucous membrane reactions such as: urticaria, itching, skin rash, blister formation, formation of red spots on the skin and bleeding (purpura), erythema multiforme, appearance of blisters and small hemorrhages (pemphigoid) exfoliative dermatitis,
• excessive sensitivity to light (photosensitivity reactions);
• muscle problems (muscle cramps, tetany, myasthenia);
• deafness (sometimes irreversible).

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

• reduction in the number of white blood cells and white cells in the blood (leukopenia and eosinophilia);
• allergic reactions, sometimes severe (anaphylactic or anaphylactoid reactions, e.g. accompanied by shock);
• loss of sensation (paresthesia);
• inflammation of blood vessels (vasculitis);
• vomiting, diarrhea;
• acute or chronic inflammation of the kidneys (interstitial nephritis).

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

• blood problems (aplastic anemia, agranulocytosis, hemolytic anemia);
• ringing in the ears (tinnitus);
• acute inflammation of the pancreas (pancreatitis);
• liver problems, including alterations in bile flow (cholestasis) and increased levels of transaminases.

Not known(the frequency of which cannot be estimated on the basis of available data)

• systemic lupus erythematosus (a disease in which the immune system produces antibodies that attack mainly the skin and joints);
• decrease in calcium or magnesium levels in the blood (hypocalcemia or hypomagnesemia);
• increase in blood pH (metabolic alkalosis);
• increased urea in the blood;
• in the case of abuse or prolonged use of furosemide, pseudo-Bartter syndrome may occur (a disease in which there are simultaneously an increase in blood pH, a decrease in potassium levels in the blood, a severe decrease in blood pressure and an abnormal increase in calcium in the urine);
• blood circulation problems (thrombosis);
• skin rash and redness, which can evolve into potentially life-threatening skin reactions including widespread rash with blisters and skin detachment, which appear particularly around the mouth, nose, eyes and genitals (Stevens-

Johnson syndrome), widespread skin detachment (more than 30% of the body surface area – toxic epidermal necrolysis) or extensive rash involving the liver, blood and other organs of the body (DRESS);

• increased sodium and chlorine in the urine;
• acute generalized exanthematous pustulosis (AGEP) (acute febrile drug-induced skin rash);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store FUROSEMIDE DOC Generici

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, tightly closed, to protect the medicine from light. No
special storage conditions are required regarding temperature.
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 DOC Generici contains
The active ingredient is furosemide. One tablet contains 500 mg of furosemide.
The other ingredients are: lactose, corn starch, microcrystalline cellulose, sodium croscarmellose,
talc, colloidal silicon dioxide, vegetable magnesium stearate.
Description of the appearance of FUROSEMIDE DOC Generici and contents of the pack
Pack of 20 tablets.
Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan

Manufacturers
Fulton medicinali S.p.A. – Via Marconi, 28/9 – 20020 Arese (MI)
Lachifarma S.r.l. - Laboratorio Chimico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)