Furosemide Doc Generici

Package leaflet: Information for the patient

FUROSEMIDE DOC Generici 25 mg tablets

Equivalent Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

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

FUROSEMIDE DOC Generici contains the active substance furosemide, which belongs to a group of
medicines called diuretics used to promote the elimination of excess fluid.
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
heart problems (e.g. due to heart failure), liver (liver cirrhosis), kidney (such as nephrotic syndrome, where it may be taken together with other medicines such as ACTH or
corticosteroids), or problems due to obstruction of an organ or blood vessels
slightly or 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 "sulfonylureas" used to treat diabetes)
if you have very low blood volume (hypovolemia) or are dehydrated
if you are not producing urine (anuria) due to severe kidney problems (renal failure)
if you have low levels of potassium (hypokalemia) or sodium (hyponatremia) in your blood
if the person taking the medicine is in a pre-coma or coma state and has brain problems caused by
liver damage (hepatic encephalopathy)
if you have taken high doses of heart medicines 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 taking FUROSEMIDE DOC Generici.
Take this medicine under direct medical supervision.
Take FUROSEMIDE DOC Generici with caution in the following cases:
if you have problems emptying your bladder or suffer from conditions causing difficulty in eliminating
urine (prostatic hyperplasia or urethral stenosis). In people where urinary flow is obstructed, careful
monitoring is required, especially at the beginning of treatment;
if you have low blood pressure or are at risk of excessive drop in arterial blood pressure due to
circulatory problems (significant stenosis of coronary arteries or blood vessels supplying the brain);
if you are elderly, if you are taking other medicines that may lower blood pressure, or if you suffer
from other conditions that increase the risk of low blood pressure;
if you have diabetes (latent or overt diabetes mellitus). During treatment, your doctor must monitor
your blood and urine sugar levels;
if you suffer from gout, a condition caused by uric acid accumulation. During treatment, your doctor
must monitor your blood uric acid levels;
if you have severe liver or kidney problems (hepatorenal syndrome, functional renal failure
associated with severe liver disease);
if you have low protein levels in the blood (hypoproteinemia);
if you are at risk of electrolyte imbalances in the blood or if you have lost large amounts of fluids (e.g.
due to vomiting, diarrhea, or excessive sweating). In this case, your doctor should monitor your blood
levels of sodium, potassium, and creatinine and may advise you to temporarily stop treatment with
furosemide and follow appropriate therapy to restore normal electrolyte levels;
if you have dementia and are being treated with a medicine called risperidone. In this case, your
doctor will carefully evaluate the risks and benefits of this combination and co-administration with
other potent diuretics.

To reduce the risk of low potassium levels in the blood during treatment with FUROSEMIDE DOC
Generici, follow a potassium-rich diet (potatoes, bananas, oranges, tomatoes, spinach, and dried
fruits). Your doctor may recommend potassium supplements if necessary to restore normal blood
potassium levels.

You are at risk of low potassium levels if:
you have liver problems (hepatic cirrhosis);
you have had chronic diarrhea;
you are in a condition with increased fluid loss (vomiting, diarrhea, excessive sweating);
you use laxatives for prolonged periods;
you follow a potassium-poor diet;
you are taking medicines called mineralocorticoids that regulate water and salt levels in the blood.

In the treatment of swelling caused by fluid accumulation due to liver problems (hepatic cirrhosis with
ascites), FUROSEMIDE DOC Generici should only be administered in a hospital setting.

FUROSEMIDE DOC Generici does not affect blood pressure in normotensive individuals, but reduces
blood pressure in hypertensive patients; in severe forms of hypertension, it is recommended to use it
in combination with other medicines.

During treatment with furosemide, there have been reports of worsening or activation of systemic
lupus erythematosus, a disease in which the immune system produces antibodies that mainly attack
the skin and joints (see section 4).

For individuals engaged in sports, using this medicine without therapeutic need constitutes doping
and may result in a positive anti-doping test.

Children
This medicine may cause kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature
newborns. Therefore, during treatment with FUROSEMIDE DOC Generici, your doctor must closely
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
medicine.

Avoid taking FUROSEMIDE DOC Generici if you are taking any of the following medicines:
aminoglycosides, antibiotics used to treat bacterial infections and other medicines that may cause
ear damage. FUROSEMIDE DOC Generici may increase ototoxic effects in this case.

Take FUROSEMIDE DOC Generici with caution if you are taking any of the following medicines:
cisplatin, a medicine used for certain cancers. When taken together with furosemide, it may cause
damage to the ears and kidneys;
sucralfate, a medicine for ulcers. Take sucralfate at least two hours apart from furosemide, as
concurrent use may reduce its effect;
lithium salts, medicines used for depression. Furosemide may increase lithium’s toxic effects,
including increased risk of cardiotoxic and neurotoxic effects. Therefore, if both medicines are taken
together, your doctor must closely monitor blood lithium levels;
ACE inhibitors or angiotensin II receptor antagonists, medicines used to lower blood pressure.
Combining them with furosemide may cause excessive drop in blood pressure and impair kidney
function. In this case, your doctor will determine the appropriate furosemide dose and may advise
you to stop taking furosemide 3 days before starting or increasing the dose of an ACE inhibitor;
risperidone, a medicine used for mental disorders, as increased mortality has been reported in
elderly patients. In this case, your doctor will carefully evaluate the risks and benefits of this
combination and co-administration with other potent diuretics (see section “Warnings and
precautions”).

The concomitant use of the following medicines with furosemide should be carefully evaluated by
your doctor, as they may reduce the effect of furosemide:
non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, used for inflammation,
whose use together with furosemide may also increase its toxic effects. If you are dehydrated or have
low blood volume, you may also develop kidney problems;
phenytoin, a medicine for epilepsy; probenecid, a medicine used for gout; and methotrexate, a
medicine used to treat certain cancers and psoriasis.

The concomitant use of the following medicines with furosemide should be carefully evaluated by
your doctor, as they may increase the toxic effects of these medicines or alter their effectiveness:
nephrotoxic medicines (toxic to kidneys), such as cephalosporins (antibiotics used for bacterial
infections), and ototoxic medicines (toxic to hearing), such as aminoglycoside antibiotics;
corticosteroids, medicines used for inflammation, carbenoxolone, a medicine for ulcers, and
laxatives used long-term, as they may increase the risk of low potassium levels in the blood;
digitalis-based medicines, used for heart conditions. Furosemide may increase their toxic effects by
altering magnesium and potassium levels in the blood;
antihypertensives, medicines for high blood pressure, and diuretics, medicines that promote urine
elimination, as a marked drop in blood pressure may occur;
antidiabetics, medicines used to treat diabetes;
sympathomimetics such as adrenaline and noradrenaline, used in anaphylactic shock and cardiac
arrest;
curare-like muscle relaxants, used in anesthesia;
theophylline, used for asthma;
cyclosporine A, a medicine used after organ transplantation;
contrast media, medicines used for certain imaging tests, as kidney damage may occur.

FUROSEMIDE DOC Generici with food
If you consume large amounts of licorice during treatment with this medicine, you may experience an
excessive drop in blood potassium levels.
Moreover, taking this medicine with food may alter the amount of furosemide absorbed; therefore,
FUROSEMIDE DOC Generici should be taken on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor
or pharmacist before taking this medicine.
You must not take FUROSEMIDE DOC Generici during the first three months of pregnancy.
During the second and third trimesters of pregnancy, furosemide may be used only if there is an
urgent clinical need. If treatment is required during pregnancy, your doctor must carefully monitor
fetal growth.
During treatment with FUROSEMIDE DOC Generici, stop breastfeeding because furosemide passes
into breast milk.

Driving and using machines
This medicine may affect your ability to concentrate and your reaction times. Therefore, if this occurs,
avoid driving vehicles or operating machinery.

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

3. How to take FUROSEMIDE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment depending on the condition being treated and your individual health status.
Take the tablets with some liquid on an empty stomach.

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

Treatment of high blood pressure
The recommended dose is 1–3 tablets distributed over 24 hours. If you are taking other antihypertensive medicines, your doctor may advise you to reduce the dose of FUROSEMIDE DOC Generici.

If you take more FUROSEMIDE DOC Generici than you should
Overdose with this medicine may cause reduced blood volume (hypovolemia), dehydration, increased blood concentration (haemoconcentration), heart problems (arrhythmias, including A-V block and ventricular fibrillation). Symptoms may include severe drop in blood pressure (up to shock), serious kidney problems (acute renal failure), circulatory problems (thrombosis), delirium, muscle paralysis (flaccid paralysis), apathy, and confusion.
Depending on your condition, your doctor will decide on appropriate treatment.
If you have taken an excessive amount 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

The following side effects may occur:

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

• changes in blood levels of salts (electrolytes);
• dehydration;
• reduction in blood volume (hypovolaemia), particularly in elderly patients;
• increased levels of triglycerides and creatinine.

Common (may affect up to 1 in 10 people)

• increased concentration of blood (haemoconcentration);
• decreased levels of sodium, chloride and potassium in the blood (hyponatraemia, hypochloraemia, and hypokalaemia);
• increased cholesterol levels;
• increased levels of uric acid in the blood, possibly leading to 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;
• visual disturbances;
• decreased levels of proteins in the blood (hypoproteinaemia);
• hearing problems, usually temporary, especially in patients with kidney dysfunction;
• changes in heart rate (arrhythmias);
• dry mouth, nausea, gastrointestinal disturbances;
• skin and mucous membrane reactions such as: urticaria, itching, rash, blistering, red spots on the skin and bleeding (purpura), erythema multiforme, development of blisters and small haemorrhages (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)

• reduced number of white blood cells and white blood cell types in the blood (leucopenia and eosinophilia);
• allergic reactions, sometimes severe (anaphylactic or anaphylactoid reactions, sometimes accompanied by shock);
• loss of sensation (paraesthesiae);
• inflammation of blood vessels (vasculitis);
• vomiting, diarrhoea;
• acute or chronic inflammation of the kidneys (interstitial nephritis).

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

• blood disorders (aplastic anaemia, agranulocytosis, haemolytic anaemia);
• ringing in the ears (tinnitus);
• acute inflammation of the pancreas (pancreatitis);
• liver problems, including disturbances in bile flow (cholestasis) and increased transaminase levels.

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

• systemic lupus erythematosus (a disease in which the immune system produces antibodies that attack mainly the skin and joints);
• decreased levels of calcium or magnesium in the blood (hypocalcaemia or hypomagnesaemia);
• increased blood pH (metabolic alkalosis);
• increased blood urea levels;
• in cases of abuse or prolonged use of furosemide, pseudo-Bartter syndrome may occur (a condition characterized by increased blood pH, decreased potassium levels in the blood, severe drop in blood pressure, and abnormal increase of calcium in the urine);
• circulatory problems (thrombosis);
• skin rash and redness, which may progress to potentially life-threatening skin reactions including widespread rash with blisters and skin detachment, particularly affecting the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread skin detachment (more than 30% of body surface area – toxic epidermal necrolysis), or extensive rash with involvement of the liver, blood and other organs (DRESS);
• increased levels of sodium and chloride in urine;
• acute generalised exanthematous pustulosis (AGEP) (acute febrile drug rash);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FUROSEMIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging, tightly closed, to protect the medicine from light.
No special storage conditions regarding temperature are required.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FUROSEMIDE DOC Generici contains
FUROSEMIDE DOC Generici 25 mg tablets
The active substance is furosemide. Each tablet contains 25 mg of furosemide.
The other components are: maize starch, lactose, talc, colloidal silicon dioxide and magnesium stearate.
Description of the appearance of FUROSEMIDE DOC Generici and contents of the pack
Carton pack containing 30 tablets.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan
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)
Package leaflet: Information for the patient

FUROSEMIDE DOC Generics 500mg tablets

Equivalent Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FUROSEMIDE DOC Generics is and what it is used for
2. What you need to know before taking FUROSEMIDE DOC Generics
3. How to take FUROSEMIDE DOC Generics
4. Possible side effects
5. How to store FUROSEMIDE DOC Generics
6. Package contents and other information

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

FUROSEMIDE DOC Generici contains the active substance furosemide, which belongs to a group of
medicines called diuretics used to promote the elimination of excess fluids.
FUROSEMIDE DOC Generici is indicated if you have any of the following conditions:
if you suffer from severe kidney function problems such as acute renal failure,
chronic renal failure (especially in the case of chronic pulmonary edema), nephrotic syndrome
(when anti-inflammatory medicines called corticosteroids are not sufficient to control the edema), and in the case of a diabetic kidney complication called Kimmelstiel-Wilson syndrome

2. What you should 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
medicinal product (listed in section 6)
if you are allergic to other medicines called sulfonamides (such as sulfonamide antibiotics used to
treat infections or sulfonylureas used to treat diabetes)
if kidney function is normal or only moderately reduced
if you have severely reduced blood volume (hypovolemia) or are dehydrated
if you are not producing urine (anuria) due to severe kidney problems (renal failure)
if you have low levels of potassium (hypokalaemia) or sodium (hyponatraemia) 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 medicines 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 or pharmacist before taking FUROSEMIDE DOC Generici.
Take this medicine under direct medical supervision.
Take FUROSEMIDE DOC Generici with caution in the following cases:
if you have problems emptying your bladder or suffer from conditions causing difficulty in passing urine (prostatic hyperplasia or urethral stenosis). In individuals where urinary flow is obstructed, careful monitoring is required, especially at the beginning of treatment;
if you suffer from low blood pressure or are at risk of excessive drop in arterial blood pressure due to circulatory problems (e.g. significant narrowing of coronary arteries or blood vessels supplying the brain);
if you are elderly, if you are taking other medicines that may lower blood pressure, or if you suffer from other conditions that increase the risk of low blood pressure;
if you suffer from diabetes (latent or overt diabetes mellitus). During treatment, your doctor must monitor sugar levels in your blood and urine;
if you suffer from gout, a disease caused by accumulation of uric acid. During treatment, your doctor must monitor uric acid levels in your blood;
if you have severe liver or kidney problems (hepatorenal syndrome, functional renal failure associated with severe liver disease);
if you have low levels of protein in the blood (hypoproteinaemia);
if you are at risk of electrolyte imbalance or have lost large amounts of fluids (e.g. due to vomiting, diarrhoea, or excessive sweating). In this case, your doctor must monitor your blood levels of sodium, potassium, and creatinine and, if necessary, may advise you to temporarily stop treatment with furosemide and initiate appropriate therapy to restore normal electrolyte levels;
if you suffer from dementia and are being treated with a medicine called risperidone. In this case, your doctor will carefully evaluate the risks and benefits of this combination and of co-administration with other potent diuretics.

To reduce the risk of low 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). Your doctor may also recommend potassium supplements if necessary to restore normal potassium levels.

You are at risk of low potassium levels:
if you suffer from liver problems (hepatic cirrhosis);
if you suffer from chronic diarrhoea;
if you are in a condition with increased fluid loss (vomiting, diarrhoea, excessive sweating);
if you use laxatives for prolonged periods;
if you follow a diet low in potassium;
if you are taking medicines called mineralocorticoids, which regulate water and salt levels in the blood.

In the treatment of swelling caused by fluid accumulation due to liver problems (cirrhosis with ascites), FUROSEMIDE DOC Generici should only be administered in hospital.

FUROSEMIDE DOC Generici does not alter blood pressure in normotensive individuals, but reduces blood pressure in hypertensive patients; in severe forms of hypertension, it is recommended to use it in combination with other medicines.

During treatment with furosemide, worsening or activation of systemic lupus erythematosus has been reported, a disease in which the immune system produces antibodies that primarily attack the skin and joints (see section 4).

For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children
This medicine may cause kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature newborns. Therefore, during treatment with FUROSEMIDE DOC Generici, your doctor must closely monitor your child’s kidney function.

Other medicines and FUROSEMIDE DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Avoid taking FUROSEMIDE DOC Generici if you are taking any of the following medicines:
Aminoglycosides, antibiotics used against bacterial infections, and other medicines that may cause ear damage. FUROSEMIDE DOC Generici may increase ototoxic effects in such cases.

Take FUROSEMIDE DOC Generici with caution if you are taking any of the following medicines:
Cisplatin, a medicine used for certain cancers. When taken together with furosemide, it may cause damage to the ears and kidneys;
Sucralfate, a medicine for ulcers. Take sucralfate at least two hours apart from furosemide, as concomitant use may reduce its effect;
Lithium salts, medicines used for depression. Furosemide may increase lithium toxicity, including increased risk of cardiotoxic and neurotoxic effects. Therefore, if both medicines are taken together, your doctor must closely monitor blood lithium levels;
ACE inhibitors or angiotensin II receptor antagonists, medicines used to lower blood pressure. Use with furosemide may cause excessive drop in blood pressure and impair kidney function. In such cases, your doctor must determine the appropriate furosemide dose and may advise you to discontinue furosemide three days before starting ACE inhibitor treatment or increasing its dose.
Risperidone, a medicine for mental disorders, as increased mortality has been reported in elderly patients. In this case, your doctor will carefully evaluate the risks and benefits of this combination and of co-administration with other potent diuretics (see section “Warnings and precautions”).

The concomitant use of the following medicines with furosemide must be carefully evaluated by your doctor, as they may reduce the effect of furosemide:
Non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, used for inflammation; their use together with furosemide may also increase furosemide’s toxic effects. If you are dehydrated or have low blood volume, you may also develop kidney problems;
Phenytoin, an antiepileptic medicine; probenecid, a medicine used for gout; and methotrexate, a medicine used to treat certain cancers and psoriasis.

The concomitant use of the following medicines with furosemide must be carefully evaluated by your doctor, as they may increase the toxic effects of these medicines or alter their efficacy:
Nephrotoxic medicines (e.g. cephalosporins, antibiotics used against bacterial infections) and ototoxic medicines (e.g. aminoglycoside antibiotics);
Corticosteroids, medicines used for inflammation; carbenoxolone, a medicine for ulcers; and laxatives used long-term, as they may increase the risk of low potassium levels;
Digitalis-based medicines, used for heart conditions. Furosemide may increase their toxicity by altering magnesium and potassium levels in the blood;
Antihypertensives, medicines for high blood pressure; diuretics, medicines that promote urine elimination, as a marked drop in blood pressure may occur;
Antidiabetics, medicines used to treat diabetes;
Sympathomimetics such as adrenaline and noradrenaline, used in anaphylactic shock and cardiac arrest;
Curare-like muscle relaxants, used in anaesthesia;
Theophylline, used for asthma;
Cyclosporin A, a medicine used after organ transplantation;
Contrast media, medicines used in certain imaging procedures, as they may cause kidney damage.

FUROSEMIDE DOC Generici with food
Consuming large amounts of liquorice during treatment with this medicine may cause excessive reduction in blood potassium levels.
Moreover, taking the medicine with food may alter the amount of furosemide absorbed; therefore, FUROSEMIDE DOC Generici should be taken on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Do not take FUROSEMIDE DOC Generici during the first three months of pregnancy.
During the second and third trimesters of pregnancy, furosemide may be used only if there is a clear clinical need. If treatment during pregnancy is required, your doctor must carefully monitor fetal growth.
During treatment with FUROSEMIDE DOC Generici, breastfeeding must be discontinued because furosemide passes into breast milk.

Driving and using machines
This medicine may affect your concentration and reaction time. Therefore, if this occurs, avoid driving vehicles or operating machinery.

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

3. How to take FUROSEMIDE DOC Generici

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment according to the condition being treated and your individual health status.
The recommended starting 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 the effective dose is reached, which may range between 250 and 2000 mg (half to 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
Overdose with this medicine may cause reduced blood volume (hypovolemia), dehydration, increased blood concentration (hemoconcentration), heart problems (arrhythmias, including A-V block and ventricular fibrillation). Symptoms may include severe drop in blood pressure (up to shock), serious kidney problems (acute renal failure), circulatory problems (thrombosis), delirium, muscle paralysis (flaccid paralysis), apathy, and confusion.
Depending on your condition, your doctor will decide on appropriate treatment.
If you have taken an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you have any questions 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)

• changes in blood levels of minerals (electrolytes);
• dehydration;
• reduction in blood volume (hypovolemia), especially in elderly patients;
• increased levels of triglycerides and creatinine.

Common (may affect up to 1 in 10 people)

• increased concentration of blood (haemoconcentration);
• decreased levels of sodium, chloride, and potassium in the blood (hyponatraemia, hypochloraemia, and hypokalaemia);
• increased cholesterol levels;
• increased levels of uric acid in the blood, possibly leading to 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;
• onset of latent diabetes mellitus;
• drowsiness, headache, dizziness, confusion;
• vision disturbances;
• decreased levels of proteins in the blood (hypoproteinaemia);
• hearing problems, usually temporary, especially in patients with kidney dysfunction;
• changes in heart rate (arrhythmias);
• dry mouth, nausea, stomach and intestinal problems;
• skin and mucous membrane reactions such as: urticaria, itching, rash, blistering, red skin spots and bleeding (purpura), erythema multiforme, development of blisters and small haemorrhages (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)

• reduced number of white blood cells and white blood cell types in the blood (leucopenia and eosinophilia);
• allergic reactions, sometimes severe (anaphylactic or anaphylactoid reactions, sometimes accompanied by shock);
• loss of sensation (paraesthesiae);
• inflammation of blood vessels (vasculitis);
• vomiting, diarrhoea;
• acute or chronic inflammation of the kidneys (interstitial nephritis).

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

• blood disorders (aplastic anaemia, agranulocytosis, haemolytic anaemia);
• ringing in the ears (tinnitus);
• acute inflammation of the pancreas (pancreatitis);
• liver problems, including disturbances in bile flow (cholestasis) and increased transaminase levels.

Not known (frequency cannot be estimated from 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 (hypocalcaemia or hypomagnesaemia);
• increased blood pH (metabolic alkalosis);
• increased blood urea levels;
• in cases of abuse or prolonged use of furosemide, pseudo-Bartter syndrome may occur (a condition characterized by increased blood pH, decreased potassium levels, severe drop in blood pressure, and abnormal increase in calcium in the urine);
• blood circulation problems (thrombosis);
• skin rash and redness, which may progress to potentially life-threatening skin reactions including widespread rash with blisters and skin detachment, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis), or widespread rash involving the liver, blood, and other organs (DRESS syndrome);
• increased excretion of sodium and chloride in urine;
• acute generalised exanthematous pustulosis (AGEP) (acute febrile rash due to medication);
• dizziness, fainting, and loss of consciousness (due to symptomatic hypotension).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 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 regarding temperature are required.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FUROSEMIDE DOC Generici contains
The active substance is furosemide. One tablet contains 500 mg of furosemide.
The other components are: lactose, maize starch, microcrystalline cellulose, sodium croscarmellose,
talc, colloidal silica, vegetable magnesium stearate.

Description of the appearance of FUROSEMIDE DOC Generici and package contents
Carton pack containing 20 tablets.

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan, Italy

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)