Package leaflet: Information for the patient

Furosemide Mylan Generics 25 mg tablets

Generic 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Furosemide Mylan Generics is and what it is used for
What you need to know before taking Furosemide Mylan Generics
How to take Furosemide Mylan Generics
Possible side effects
How to store Furosemide Mylan Generics
Contents of the pack and other information

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

Furosemide Mylan Generics contains the active substance furosemide, which belongs to a group of medicines called diuretics. These help increase urine production, thereby helping to relieve conditions caused by excessive fluid accumulation in the body (oedema).
Furosemide Mylan Generics 25 mg is indicated to treat:

fluid retention (oedema) in people with heart problems,
ascites, an accumulation of fluid in the abdominal cavity (caused by hepatic cirrhosis),
fluid accumulation due to kidney disorders (nephrotic syndrome; in this case Furosemide Mylan Generics may also be used in combination with other medicines such as ACTH or corticosteroids),
obstruction of organs and blood vessels or heart failure,
fluid retention in the extremities (peripheral oedema),
mild to moderate high blood pressure.

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

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

Do not take Furosemide Mylan Generics if:

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

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

you have difficulty passing urine (for example, due to prostate enlargement or urethral stricture). In people in whom urinary flow is obstructed, careful monitoring is required, especially at the beginning of treatment.
you suffer from low blood pressure or are at risk of excessive drop in blood pressure due to circulatory problems (significant narrowing of the coronary arteries or blood vessels supplying the brain);
you have diabetes. During treatment, your doctor must monitor your blood and urine sugar levels.
you suffer from a condition called “gout,” caused by accumulation of uric acid.
you have severe liver or kidney problems.
you have low levels of protein in your blood.
you are at risk of electrolyte imbalances in the blood or have lost large amounts of fluids (e.g., due to vomiting, diarrhea, or excessive sweating). In such cases, 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.
you suffer from “hypertension,” i.e., high blood pressure, because in more severe cases of hypertension you may need to take other medicines together with Furosemide Mylan Generics to prevent excessive lowering of blood pressure.
if you are elderly, taking other medicines that may lower blood pressure, or have other conditions that increase the risk of low blood pressure.
you have a disease of the adrenal glands (see section 2 “What you need to know before taking Furosemide Mylan Generics”).

To reduce the risk of low potassium levels in the blood, during treatment with
Furosemide Mylan Generics follow a potassium-rich diet (potatoes, bananas, oranges, tomatoes, spinach, and
dried fruit). Your doctor may prescribe potassium supplements to restore normal potassium levels in the
blood, if necessary.
You are at risk of low potassium levels and require appropriate monitoring and supplementation if:

you suffer from hepatic cirrhosis (a liver disease);
you suffer from chronic diarrhea;
you are in a condition with increased fluid loss (vomiting, diarrhea, excessive sweating);
you use laxatives for prolonged periods;
you follow a diet low in potassium;
you are taking medicines called mineralocorticoids, which regulate water and salt levels in the blood. In case of edema due to liver problems (hepatic cirrhosis with ascites), Furosemide Mylan Generics should be administered in hospital under strict medical supervision. Your doctor may also regularly monitor your blood glucose, glycosuria, and uric acid metabolism. Your doctor should also correct any reduction in circulating blood volume, dehydration, and any significant disturbances in mineral balance and blood pH (acid-base balance). This may require temporary discontinuation of the medicine. If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body, called systemic lupus erythematosus, taking this medicine could worsen your condition. The use of this drug may also trigger the onset of this disease in individuals in whom it was not previously established (see section 4 “Possible side effects”).

For athletes: using this medicine without medical need constitutes doping and may result in a positive
anti-doping test.
Children
This medicine may cause kidney problems in premature newborns. Therefore, during treatment with
Furosemide Mylan Generics, your doctor should closely monitor your child’s kidney function.
Other medicines and Furosemide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Furosemide Mylan Generics in combination with any of the following medicines:

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

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

cisplatin, used for certain cancers. When taken together with furosemide, it may cause damage to the ears and kidneys.
sucralfate, used for ulcers. Take sucralfate at least two hours apart from furosemide, as simultaneous administration may reduce its effect.
lithium salts, used for depression. Furosemide may increase the toxic effects of lithium. Therefore, if both medicines are taken together, your doctor must carefully monitor lithium blood levels.
ACE inhibitors or angiotensin II receptor antagonists, used to lower blood pressure. Your doctor must determine the correct dose of furosemide and may advise you to discontinue its use.
risperidone, an antipsychotic medicine used to treat mental disorders. Your doctor will consider the risks and benefits before prescribing furosemide together with this medicine due to increased mortality risk, especially in elderly patients with dementia.
levothyroxine, a medicine used to stimulate the thyroid gland. High doses of furosemide may lead to an overall decrease in thyroid hormone levels.
non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, and other salicylates used for inflammation: they may reduce the effect of furosemide, and furosemide may increase the toxicity of salicylates;
phenytoin, used for epilepsy: may reduce the effect of furosemide;
probenecid, used for gout: may reduce the effects of furosemide and simultaneously increase its side effects;
methotrexate, used to treat certain cancers: may reduce the effects of furosemide and simultaneously increase its side effects;
medicines toxic to the kidneys (nephrotoxic), such as certain antibiotics (cephalosporins);
corticosteroids, used for inflammation, carbenoxolone, a medicine for ulcers, liquorice, and long-term use of laxatives, 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, used to treat high blood pressure, and diuretics, which promote urine elimination, because a marked drop in blood pressure may occur;
antidiabetic medicines, used to treat diabetes: furosemide may reduce their effectiveness;
sympathomimetics such as adrenaline and noradrenaline;
curare-like muscle relaxants (tubocurarine), used in anesthesia: furosemide may enhance their effect;
theophylline: furosemide may enhance its effect;
ciclosporin A, used to prevent transplant rejection. Taking it with furosemide increases the risk of developing gouty arthritis (a form of acute inflammatory arthritis);
contrast media, substances used in certain radiological examinations. Furosemide may increase the harmful effects of these substances on the kidneys;
aliskiren (used in the treatment of high blood pressure): may reduce blood concentrations of orally administered furosemide.

Furosemide Mylan Generics and food
If you consume large amounts of liquorice during treatment with this medicine, you may experience a
decrease in potassium levels in the blood.
Furosemide Mylan Generics rarely may lead to decreased potassium in the blood; however, it is important
that you follow a potassium-rich diet, including potatoes, bananas, oranges, tomatoes, spinach, and dried
fruit, while taking this medicine.
In addition, the therapeutic effect of Furosemide Mylan Generics may be reduced if taken with food: always
take the medicine on an empty stomach (see also section “How to take Furosemide Mylan Generics”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor
or pharmacist before taking this medicine.
Pregnancy
You must not take this medicine during the first three months of pregnancy, as furosemide crosses the
placental barrier. You may take Furosemide Mylan Generics during the second and third trimesters of
pregnancy only if strictly necessary, as determined by your doctor, who will monitor your baby’s growth
periodically.
Breastfeeding
Do not take Furosemide Mylan Generics if you are breastfeeding, as furosemide passes into breast milk.
Driving and using machines
This medicine may affect your ability to concentrate and your reaction time. Do not drive or operate
machinery requiring special attention while taking this medicine, as it may cause low blood pressure and
therefore reduce reflex responsiveness and level of alertness.
Furosemide Mylan Generics 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 Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment of oedema (swelling due to fluid accumulation in the body)
The recommended dose is 1–3 tablets of 25 mg, taken as a single dose,
preferably in the morning or at the time when you wish to achieve the effect.
Depending on your health condition, you may repeat the dose every 4 hours.
If sufficient effect is not achieved, the dose may be increased by 1 or 2 tablets
every 4 hours until the desired effect is obtained. If necessary, the dose may be
further increased at the doctor’s discretion.
Treatment of high blood pressure (hypertension)
The recommended dose is 1–3 tablets per day.
If you are already taking other medicines for high blood pressure, consult your doctor, as your dosage may need to be adjusted.
Patients with kidney or liver disorders
In case of kidney disease (low glomerular filtration rate) or liver disease (hepatic cirrhosis), or if both kidney and liver functions are impaired, your doctor may adjust the dose.
In more severe cases, the doctor may decide to initiate treatment in hospital to adequately monitor for possible adverse effects (e.g. hepatic encephalopathy).
Instructions for use
Furosemide Mylan Generics should be taken on an empty stomach.
If you take more Furosemide Mylan Generics than you should
Overdose may cause: reduced blood volume (hypovolemia), dehydration, increased concentration of blood (haemoconcentration), irregular heartbeat (arrhythmias). Symptoms may include: severe drop in blood pressure (up to shock), serious kidney problems (acute renal failure), circulatory problems (thrombosis), muscle paralysis (flaccid paralysis), delirium, apathy, confusion.
If you have taken an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
If you forget to take Furosemide Mylan Generics
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Furosemide Mylan Generics
Consult your doctor if you intend to stop treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Stop taking this medicine immediately and contact your doctor if you experience any of the following side effects:

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

The side effects that may occur with furosemide are listed below.
Very common (may affect more than 1 in 10 people)

electrolyte disturbances (imbalance of salts in the blood);
dehydration;
reduction in blood volume (hypovolemia), especially in elderly patients;
increased levels of certain blood test values (creatinine and triglycerides).

Common (may affect up to 1 in 10 people)

increased concentration of blood (haemoconcentration);
reduced sodium levels in the blood (hyponatraemia);
reduced chloride levels in the blood (hypochloraemia);
reduced potassium levels in the blood (hypokalaemia);
increased cholesterol levels in blood tests;
increased levels of uric acid in the blood (hyperuricaemia);
gout (joint inflammation causing pain and swelling);
brain disturbances as a consequence of liver disorders (hepatic encephalopathy);
production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

reduced number of blood cells called platelets (thrombocytopenia);
diabetes and worsening of pre-existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
drowsiness;
headache;
dizziness;
confusion;
visual disturbances;
hearing disorders, sometimes irreversible (deafness);
changes in heart rhythm (cardiac arrhythmias);
dry mouth;
nausea;
intestinal motility disorders;
itching, urticaria, skin irritation, blister formation on the skin and mucous membranes (symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
appearance of small red or purplish spots spread across the skin, with or without joint and muscle pain, weakness and fever (may be symptoms of inflammation of blood vessel walls, known as purpura);
allergic reaction to sunlight manifested as skin irritation accompanied by itching (photosensitivity reaction);
sudden, severe muscle pain caused by involuntary contraction of one or more muscles (cramps);
muscle weakness (myasthenia);
cramps, muscle spasms, involuntary muscle contractions and tremors (symptoms of a condition known as tetany);
fatigue.

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

reduced white blood cells in the blood (leucopenia);
increased white blood cells in the blood (eosinophilia);
altered sensation in limbs or other parts of the body (paraesthesia);
inflammation of blood vessels (vasculitis);
vomiting and diarrhoea;
kidney disease called interstitial nephritis;
fever.

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

inadequate production in the bone marrow of all types of blood cells (aplastic anaemia);
severe reduction in the number of white blood cells called granulocytes (agranulocytosis);
excessive reduction in haemoglobin concentration in the blood due to abnormal destruction of red blood cells (haemolytic anaemia);
ringing in the ears (tinnitus);
severe inflammation of the pancreas (acute pancreatitis);
impairment of normal bile flow (cholestasis);
increased levels of certain liver enzymes in the blood (transaminases).

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

reduced calcium levels in the blood (hypocalcaemia);
reduced magnesium levels in the blood (hypomagnesaemia);
alteration of blood acidity (metabolic alkalosis);
increased urea levels in blood tests;
Bartter syndrome (a rare kidney disease) in case of abuse or prolonged use of furosemide;
formation of blood clots within blood vessels (thrombosis);
skin diseases such as urticaria, development of red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, sometimes accompanied by fever. These may be symptoms of serious skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption) or DRESS syndrome;
lichenoid reactions characterised by small, itchy, reddish-purple, polygonal lesions on the skin, genitals or in the mouth;
increased sodium levels in urine tests;
increased chloride levels in urine tests;
difficulty emptying the bladder (urinary retention, in patients with prostatic hypertrophy, urethral stenosis or other bladder emptying difficulties);
impaired kidney function (renal failure);
onset or worsening of a chronic autoimmune disease affecting various organs and tissues of the body, known as systemic lupus erythematosus;
dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
severe damage to skeletal muscle and release into the blood of substances contained in muscles (rhabdomyolysis), usually in the context of severe potassium deficiency in the blood.

Additional side effects in children

kidney stones (nephrolithiasis) or kidney calcifications (nephrocalcinosis) in preterm infants;
increased risk of heart abnormalities (patent ductus arteriosus) in premature infants receiving furosemide during the first weeks of life.

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

5. How to store Furosemide Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from light.
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 Mylan Generics contains

The active substance is furosemide. One tablet contains 25 mg of furosemide.
The other components are: monohydrate lactose, maize starch, pregelatinized starch, talc, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Furosemide Mylan Generics and contents of the pack
Pack containing 30 tablets or 60 tablets of 25 mg.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI)
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)

Patient Information Leaflet

Furosemide Mylan Generics 500 mg tablets (scored)

Generic 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Furosemide Mylan Generics is and what it is used for
What you need to know before taking Furosemide Mylan Generics
How to take Furosemide Mylan Generics
Possible side effects
How to store Furosemide Mylan Generics
Contents of the pack and other information

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

Furosemide Mylan Generics contains the active substance furosemide, which belongs to a group of
medicines called diuretics, which help produce more urine, thereby helping to relieve disorders
caused by excessive fluid accumulation in the body ( edema ).
Furosemide Mylan Generics 500 mg is indicated when:

you have severe kidney problems such as markedly impaired glomerular filtration (glomerular filtration rate ≤ 20 ml/min)
acute renal failure (oliguria)
chronic renal failure in the pre-dialysis and dialysis stages with fluid retention (especially in cases of fluid retention in the lungs)
nephrotic syndrome (characterized by low levels of protein in the blood, fluid accumulation known as “edema”, and increased blood fats) with severely reduced kidney function (when anti-inflammatory medicines called corticosteroids are not sufficient to control the edema)
chronic renal failure without fluid retention
you are in shock, a dangerous drop in blood pressure which, if untreated, may lead to collapse, coma, and death.

Furosemide Mylan Generics 500 mg tablets may 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 should know before taking Furosemide Mylan Generics

Do not take Furosemide Mylan Generics if:

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

you have difficulty passing urine (for example, due to an enlarged prostate or urethral stricture). In patients where urinary flow is obstructed, careful monitoring is required, especially at the beginning of treatment.
you suffer from low blood pressure or are at risk of excessive blood pressure drop due to circulatory problems (significant narrowing of coronary arteries or blood vessels supplying the brain)
you have diabetes. During treatment, your doctor must monitor your blood and urine sugar levels.
you suffer from a condition called “gout”, caused by accumulation of uric acid. During treatment, your doctor must monitor your blood uric acid levels.
you have severe liver or kidney problems
you have low levels of protein in your blood
you are at risk of electrolyte imbalances or have lost large amounts of fluids (e.g. due to vomiting, diarrhoea, or excessive sweating). In such cases, your doctor should 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.
you suffer from “hypertension” (high blood pressure), because in severe cases you may need to take other medicines together with Furosemide Mylan Generics to prevent excessive blood pressure reduction
if you are elderly, taking other medicines that may lower blood pressure, or have other conditions that increase the risk of low blood pressure
you have a disease of the adrenal glands (see section 2 “What you should know before taking Furosemide Mylan Generics”)

To reduce the risk of low potassium levels in the blood, during treatment with
Furosemide Mylan Generics follow a potassium-rich diet (potatoes, bananas, oranges, tomatoes, spinach, and
dried fruit). Your doctor may prescribe potassium supplements if needed.
You are at risk of low potassium levels if:

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

In case of oedema due to liver problems (cirrhotic ascites), Furosemide Mylan
Generics should be administered in hospital under strict medical supervision.
Your doctor may also regularly monitor your blood glucose, glycosuria, and uric acid metabolism as needed.
Your doctor should also correct any reduction in circulating blood volume, dehydration,
and any significant disturbances in mineral balance and blood pH (acid-base balance).
This may require a temporary interruption of the medicine.
If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body,
called systemic lupus erythematosus, taking this medicine could worsen your condition.
After using the medicine, this disease may also develop in individuals in whom it was not previously present (see section 4 “Possible side effects”).
For athletes: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
This medicine may cause kidney problems in premature infants. Therefore, during treatment with
Furosemide Mylan Generics, your doctor should monitor your child’s kidney function.
Other medicines and Furosemide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Do not take Furosemide Mylan Generics in combination with any of the following medicines:

chloral hydrate, a sedative: skin flushing, sudden sweating, agitation, nausea, increased blood pressure, and increased heart rate (tachycardia) may occur if furosemide is taken less than 24 hours after chloral hydrate; concomitant use is not recommended
aminoglycosides (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin), used to treat bacterial infections
medicines that may cause ear damage (ototoxic medicines). Take Furosemide Mylan Generics with caution if you are taking any of the following medicines:
cisplatin, used for certain cancers. When taken together with furosemide, it may cause damage to the ears and kidneys.
sucralfate, used for ulcers. Take sucralfate at least two hours apart from furosemide, as simultaneous use may reduce its effectiveness.
lithium salts, used for depression. Furosemide may increase lithium’s toxic effects. Therefore, if both medicines are taken together, your doctor must closely monitor your blood lithium levels.
ACE inhibitors or angiotensin II receptor antagonists, used to lower blood pressure. Your doctor must determine the correct furosemide dose and may advise you to discontinue its use.
risperidone, an antipsychotic medicine used to treat mental disorders. Your doctor will consider risks and benefits before prescribing furosemide together with this medicine due to increased mortality risk, especially in elderly patients with dementia
levothyroxine, a medicine used to stimulate the thyroid gland. High doses of furosemide may lead to an overall decrease in thyroid hormone levels
non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, and other salicylates used for inflammation: they may reduce the effect of furosemide and furosemide may increase salicylate toxicity
phenytoin, used for epilepsy: may reduce the effect of furosemide
probenecid, used for gout: may reduce the effect of furosemide and simultaneously increase side effects
methotrexate, used to treat certain cancers: may reduce the effects of furosemide and simultaneously increase side effects
medicines toxic to the kidneys (nephrotoxic), such as certain antibiotics (e.g. cephalosporins)
corticosteroids, used for inflammation, carbenoxolone, a medicine for ulcers, liquorice, and laxatives used over prolonged periods, as they may increase the risk of low potassium levels in the blood
digitalis-containing medicines, used for heart conditions. Furosemide may increase their toxic effects by altering magnesium and potassium levels in the blood
antihypertensives, used to treat high blood pressure, and diuretics, which promote urine elimination, as a marked drop in blood pressure may occur
antidiabetics, used to treat diabetes: furosemide may reduce their effectiveness
sympathomimetics such as adrenaline and noradrenaline
curare-like muscle relaxants (tubocurarine), used in anaesthesia: furosemide may enhance their effect
theophylline: furosemide may enhance its effect
ciclosporin A, used to prevent transplant rejection. Taking it with furosemide increases the risk of developing gouty arthritis (a form of acute inflammatory arthritis)
contrast media, substances used in certain radiological examinations. Furosemide may increase the kidney-damaging effects of these substances
aliskiren (used to treat high blood pressure): may reduce blood concentrations of orally administered furosemide.

Furosemide Mylan Generics and food
If you consume large amounts of liquorice during treatment with this medicine, you may experience
low potassium levels in the blood.
Furosemide Mylan Generics rarely may lead to low blood potassium levels; it is nevertheless
important that you follow a diet rich in this mineral by consuming potatoes, bananas, oranges, tomatoes,
spinach, and dried fruit during treatment.
Moreover, the therapeutic effect of Furosemide Mylan Generics may be reduced if taken
with food: always take the medicine on an empty stomach (see also section “How to take
Furosemide Mylan Generics”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not take this medicine during the first three months of pregnancy, as furosemide crosses the placental barrier.
You may take Furosemide Mylan Generics during the second and third trimesters of pregnancy only if strictly necessary, as determined by your doctor, who will monitor your baby’s growth regularly.
Breastfeeding
Do not take Furosemide Mylan Generics if you are breastfeeding, as furosemide passes into breast milk.
Driving and using machines
This medicine may affect your concentration and reaction time. Do not drive or operate
machinery requiring special attention while taking this medicine, as it may cause low blood pressure and thereby reduce reflex speed and alertness.
Furosemide Mylan Generics contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Furosemide Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you
have
any doubts, consult your doctor or pharmacist. The dose used should be the lowest sufficient to achieve
the desired effect.
Treatment of kidney problems (chronic renal failure)
Your doctor will determine the most suitable dose for you based on your response to treatment (the effective
dose will allow elimination of approximately 2.5 litres of urine).
Begin treatment with half a tablet (250 mg). If you do not notice an effect within 4–6 hours after administration,
increase the dose you initially took by another half tablet every 4–6 hours. Continue treatment in this way until
the desired effect is achieved, bearing in mind that the total daily dose may range between 250 mg and 2000 mg (from half a tablet to 4 tablets).
Maintenance therapy
After receiving intravenous furosemide injection treatment, you may continue taking furosemide orally. The recommended initial dose is equal to the dose you received intravenously.
If you do not notice an effect within 4–6 hours after administration, increase the dose by one or half a tablet every
4–6 hours (for example, if the initial dose was 1 tablet, the second dose could be 1.5 tablets or 2 tablets).
Method of administration
Take the tablets with some liquid, preferably at breakfast.
If you take more Furosemide Mylan Generics than you should
In case of overdose, the following may occur: reduction in blood volume (hypovolemia),
dehydration, increased blood concentration (haemoconcentration), irregular heartbeat (arrhythmias). Symptoms
may include severe drop in blood pressure (up to shock),
severe kidney problems (acute renal failure), circulatory problems (thrombosis), muscle paralysis (flaccid paralysis), delirium, apathy, confusion.
If you have taken an excessive dose of this medicine, contact your doctor immediately or go
to the nearest hospital emergency department.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist or nurse.
If you forget to take Furosemide Mylan Generics
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Furosemide Mylan Generics
Ask your doctor for advice if you intend to stop treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking this medicine immediately and contact your doctor if you experience any of the following side effects:

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

The side effects that may occur with furosemide are listed below.
Very common (may affect more than 1 in 10 people)

electrolyte disturbances (imbalance of salts in the blood);
dehydration;
decreased blood volume (hypovolemia), especially in elderly patients;
increased levels of certain blood test values (creatinine and triglycerides).

Common (may affect up to 1 in 10 people)

increased concentration of the blood (haemoconcentration);
low sodium levels in the blood (hyponatraemia);
low chloride levels in the blood (hypochloraemia);
low potassium levels in the blood (hypokalaemia);
increased cholesterol levels in blood tests;
increased levels of uric acid in the blood (hyperuricaemia);
gout (joint inflammation causing pain and swelling);
brain disturbances as a consequence of liver disorders (hepatic encephalopathy);
production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

reduced number of blood cells called platelets (thrombocytopenia);
diabetes and worsening of pre-existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
drowsiness;
headache;
dizziness;
confusion;
visual disturbances;
hearing disorders, sometimes irreversible (deafness);
changes in heart rhythm (cardiac arrhythmias);
dry mouth;
nausea;
intestinal motility disorders;
itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
appearance of small red or purple spots spread across the skin, with or without joint pain, muscle pain, weakness and fever (may be symptoms of inflammation of blood vessel walls, known as purpura);
allergic reaction to sunlight, manifesting as skin irritation accompanied by itching (photosensitivity reaction);
sudden, severe muscle pain caused by involuntary contraction of one or more muscles (cramps);
muscle weakness (myasthenia);
cramps, muscle spasms, involuntary muscle contractions and tremors (symptoms of a condition known as tetany);
fatigue.

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

reduced white blood cell count (leucopenia);
increased white blood cell count (eosinophilia);
altered sensation in limbs or other parts of the body (paraesthesia);
inflammation of blood vessels (vasculitis);
vomiting and diarrhoea;
kidney disease known as interstitial nephritis;
fever.

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

inadequate production in the bone marrow of all types of blood cells (aplastic anaemia);
severe reduction in the number of white blood cells called granulocytes (agranulocytosis);
excessive reduction in haemoglobin concentration in the blood due to abnormal destruction of red blood cells (haemolytic anaemia);
ringing in the ears (tinnitus);
severe 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):

decreased calcium levels in the blood (hypocalcaemia);
decreased magnesium levels in the blood (hypomagnesaemia);
alteration of blood acidity (metabolic alkalosis);
increased urea levels in blood tests;
Bartter syndrome (a rare kidney disease) in cases of abuse or prolonged use of furosemide;
formation of blood clots within blood vessels (thrombosis);
skin diseases such as hives, development of red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever. These may be symptoms of severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP) (acute febrile drug eruption) or DRESS syndrome;
lichenoid reactions characterised by small, itchy, reddish-purple, polygon-shaped lesions on the skin, genitals or in the mouth;
increased sodium levels in urine tests;
increased chloride levels in urine tests;
difficulty emptying the bladder (urinary retention, in patients with prostate enlargement, urethral stenosis or other bladder emptying difficulties);
impaired kidney function (renal failure);
onset or worsening of a chronic autoimmune disease affecting various organs and tissues of the body, known as systemic lupus erythematosus;
dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
severe damage to skeletal muscle and release into the blood of substances contained in muscle cells (rhabdomyolysis), usually in the context of severe potassium deficiency in the blood.

Additional side effects in children

kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis) in preterm newborns;
increased risk of heart abnormalities (patent ductus arteriosus) in premature infants receiving furosemide during the first weeks of life.

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

5. How to store Furosemide Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container 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 this medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Furosemide Mylan Generics contains

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

Description of the appearance of Furosemide Mylan Generics and contents of the pack
Pack containing 20 divisible tablets of 500 mg.
The tablet can be divided into equal doses.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI)
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)