FUROSEMIDE 25 mg Tablet

Зміст інструкції

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

Furosemide Teva Generics 25 mg tablets

Generic medicine

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is FUROSEMIDE TEVA GENERICS and what is it used for

FUROSEMIDE TEVA GENERICS contains the active ingredient furosemide, which belongs to the category of
medicines called diuretics, which help to produce more urine, thus contributing to relieve the disorders caused by an
excessive accumulation of fluids in the body.
FUROSEMIDE TEVA GENERICS is indicated for the treatment of edema caused by heart or kidney diseases
(in nephrotic syndrome also in combination with ACTH or corticosteroids); ascites (fluid collection
in the abdomen) following liver cirrhosis (liver disease), mechanical obstruction or heart failure; peripheral
edema (for example in the ankles and legs); mild or moderate high blood pressure.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking FUROSEMIDE TEVA GENERICS

Do not take FUROSEMIDE TEVA GENERICS

• if you are allergic to furosemide or to any of the other ingredients of this medicine (listed in section 6). If you are allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas, medicines used in diabetes), you may experience cross-sensitivity to furosemide;
• if you have dehydration or hypovolemia (decreased blood volume);
• if you have a severe decrease in blood pressure;
• if you do not urinate or your urine output is significantly reduced (kidney failure with oliguria or anuria) and do not respond to treatment with medicines containing furosemide;
• if you have hypokalemia (decreased potassium in the blood);
• if you have hyponatremia (decreased sodium in the blood);
• if your body is unable to produce an adequate amount of adrenal hormones (Addison's disease);
• in states of precoma or coma, associated with hepatic encephalopathy (a brain disorder due to a liver problem);
• in case of digitalis overdose (a medicine used in some heart conditions);
• if you are pregnant, confirmed or suspected, or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking FUROSEMIDE TEVA GENERICS:
if you are elderly, if you are taking other medicines that can cause a lowering of blood pressure and if
you suffer from other diseases that involve risks of lowering blood pressure.
It is necessary to ensure free urine flow.
If you have a partial obstruction of urine flow (for example if your bladder emptying is impaired, if you suffer from
prostate tumor or conditions that involve a narrowing of the urethra), this requires particularly careful monitoring, especially during the initial phases of treatment.
Treatment with FUROSEMIDE TEVA GENERICS requires regular medical check-ups.
In particular, careful monitoring is necessary in the following cases:

• if you suffer from low blood pressure (hypotension) or high blood pressure (hypertension);
• if you are particularly at risk following an excessive drop in blood pressure, e.g. if you have significant obstructions of the coronary arteries (heart vessels) or blood vessels that supply the brain;
• if you suffer from latent (not yet symptomatic) or manifest diabetes mellitus;
• if you suffer from gout;
• if you have severe liver and kidney problems (hepatorenal syndrome);
• if you have hypoproteinemia (decreased proteins in the blood), e.g. associated with nephrotic syndrome, a kidney disease (the action of furosemide may be weakened and its toxicity to the ear potentiated). Particular caution is required in determining the dosage;
• in the case of premature newborns (for the possible development of nephrocalcinosis/nephrolithiasis, calcium precipitation with the formation of kidney stones); renal ultrasound and monitoring of kidney function are necessary;
• if you have a disease of the adrenal glands (see section 2 “Do not take FUROSEMIDE TEVA GENERICS”);
• if you are taking antipsychotics (e.g. risperidone). Generally, regular monitoring of sodium, potassium and creatinine (kidney function test) is recommended during therapy with furosemide; particularly rigorous monitoring is required if you are at high risk of electrolyte imbalance (salts) or when there is a further significant loss of fluids (e.g. following vomiting, diarrhea or heavy sweating). Although the use of FUROSEMIDE TEVA GENERICS only rarely leads to a decrease in potassium, a potassium-rich diet (potatoes, bananas, oranges, tomatoes, spinach and dried fruit) is recommended. Sometimes adequate pharmacological correction may also be necessary. In particular, predisposing conditions to potassium deficiency such as cirrhosis of the liver, chronic diarrhea, prolonged use of laxatives, a potassium-poor diet, concomitant use of mineralocorticoids (hormones that regulate water-salt balance) require appropriate checks and supplementation. Decreased blood volume, dehydration and any significant alteration of salt balance and blood acidity must be corrected. This may require temporary suspension of furosemide administration. Regular checks of blood sugar (glucose), glycosuria (sugar in the urine) and, where necessary, uric acid metabolism (a substance produced by protein metabolism that increases in gout) are also recommended. If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body called Systemic Lupus erythematosus, taking this medicine may worsen the condition of your illness, making it worse. Following the use of the drug, this disease may begin in subjects in whom it is not yet established (see section 4 “Possible side effects”).

Use this medicine under direct medical supervision.

Other medicines and FUROSEMIDE TEVA GENERICS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, you need to be careful if you take FUROSEMIDE TEVA GENERICS with:

• Chloral hydrate (a sedative): in isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may cause skin flushing, sudden sweating, agitation, nausea, increased blood pressure and increased heart rate (tachycardia). Therefore, the simultaneous administration of furosemide and chloral hydrate is not recommended.
• Aminoglycosides (a class of antibiotics) and other medicines toxic to the ear: furosemide may potentiate the ear toxicity of aminoglycosides and other medicines toxic to the ear. Since this can lead to irreversible damage, these medicines can only be used in combination with furosemide if there is a clear clinical need.
• Cisplatin (an antineoplastic agent):the simultaneous administration of furosemide and cisplatin involves the risk of toxic effects on the ear. In addition, the renal toxicity of cisplatin may be potentiated if furosemide is not administered at small doses (e.g. 40 mg in patients with normal kidney function) and in the presence of a positive fluid balance, when furosemide is used to achieve forced diuresis during cisplatin treatment.
• Sucralfate (an anti-ulcer): oral administration of furosemide should be spaced at least 2 hours from that of sucralfate, as sucralfate reduces the intestinal absorption of furosemide, thereby reducing its effect.
• Lithium salts (used in the therapy of bipolar disorder):furosemide reduces the elimination of lithium salts and can cause an increase in their concentration in the blood and related toxicity, resulting in an increased risk of adverse effects on the heart or nervous system. Therefore, careful monitoring of lithium concentrations is recommended if the two medicines are administered simultaneously.
• ACE inhibitors (used in the therapy of high blood pressure):if you are on diuretic therapy, you may experience a severe drop in blood pressure and impaired kidney function upon first administration of an ACE inhibitor, an angiotensin II receptor antagonist or the first time the dose is increased (“first-dose hypotension”). Therefore, it is advisable to temporarily suspend the administration of furosemide or, at least, to reduce the dose 3 days before starting treatment with an ACE inhibitor, an angiotensin II receptor antagonist or before increasing the dose of these latter.
• Risperidone (antipsychotic drug, for treating mental disorders):caution should be exercised, considering the risks and benefits of combining furosemide with this medicine.
• Levothyroxine (used to stimulate the thyroid):high doses of furosemide may inhibit the binding of thyroid hormones to blood proteins. Thyroid hormone levels should be monitored.
• Non-steroidal anti-inflammatory drugs, including acetylsalicylic acid: the simultaneous administration of non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, may reduce the effect of furosemide. If you have dehydration or decreased blood volume, non-steroidal anti-inflammatory drugs may induce acute renal failure. Furosemide may exacerbate the toxicity of salicylates.
• Phenytoin (an antiepileptic): a reduction in the effect of furosemide may occur in case of concomitant administration of phenytoin.
• Antibiotics with renal toxicity: the harmful effects of antibiotics toxic to the kidney may be increased.
• Corticosteroids (cortisone and similar), carbenoxolone (an anti-ulcer), high doses of licorice and prolonged use oflaxatives: the administration of corticosteroids, carbenoxolone and high doses of licorice, as well as the prolonged use of laxatives may increase the risk of decreased potassium in the blood.
• Some salt alterations (e.g. decrease in potassium and magnesium) may increase the toxicity of some medicines (e.g. preparations based on digitalis, used in some heart conditionsand medicines thatinduce the QT prolongation syndrome, an alteration of the electrocardiogram).
• Antihypertensive medicines (used in the therapy of high blood pressure):in case of simultaneous administration of furosemide and antihypertensive medicines or other drugs with potentially antihypertensive action, a more pronounced drop in blood pressure is to be expected.
• Probenecid (used in the therapy of gout, an inflammatory disease of the joints), methotrexate (animmunosuppressant) and other medicines that, like furosemide, are predominantly eliminated via thekidney,may reduce the effect of furosemide. Conversely, furosemide may reduce the renal elimination of these substances. In case of treatment with high doses (both of furosemide and other drugs), an increase in the concentrations in the blood of one and the others may occur. Consequently, the risk of adverse effects due to furosemide or other concomitant therapies increases.
• Antidiabetic medicines and sympathomimetics: the effects of antidiabetic medicines and sympathomimetics(e.g. adrenaline, noradrenaline) may be decreased.
• Curare-like muscle relaxants or theophylline (used in asthma):the effects of curare-like muscle relaxants (tubocurarine) or theophylline may be increased.
• Cephalosporins (an antibiotic):in patients undergoing concomitant therapy with furosemide and high doses of certain cephalosporins, impaired kidney function may develop.
• Cyclosporine A (prevention of organ rejection in organ transplantation):concomitant use with furosemide is associated with an increased risk of gouty arthritis secondary to hyperuricemia.
• Contrast media (substances used in some radiological examinations): furosemide may increase the harmful effects exerted by these substances on the kidneys.
• Aliskiren (used in the treatment of high blood pressure): may reduce blood concentrations of orally administered furosemide.

FUROSEMIDE TEVA GENERICS with food
It is recommended to take the medicine on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, confirmed or suspected, you should not take FUROSEMIDE TEVA GENERICS (see
section “Do not take Furosemide Teva Generics”).
Breastfeeding
If you are breastfeeding, you should not take FUROSEMIDE TEVA GENERICS, as furosemide passes into
breast milk and may block lactation, therefore breastfeeding should be discontinued during treatment with furosemide.

Driving and using machines
Some side effects (e.g. an unexpected and severe drop in blood pressure) may
impair your ability to concentrate and react and, therefore, pose a risk in situations in
which these abilities are particularly important (e.g. driving vehicles or using machinery).

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

For athletes:the use of the drug without therapeutic need constitutes doping and may in any case result in positive doping tests.

3. How to take FUROSEMIDE TEVA GENERICS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
For the treatment of edema, in most cases the recommended dose is 1-3 tablets of 25 mg to be
taken in a single dose, preferably in the morning or, in any case, choosing the time most suitable when you want to
obtain the effect. Depending on the response obtained, the same dose can be readministered after 4 hours.
If the diuretic effect (elimination of salts and, consequently, fluids through urine) is not
sufficient, your doctor will advise you to increase the dose by 1-2 tablets at intervals of 4 hours until the
desired diuretic effect is achieved.
For the treatment of high blood pressure, 1-3 tablets distributed over 24 hours may be sufficient.
In case of association with drugs that lower blood pressure, the doctor will carefully define the
dose of furosemide that you must take based on your health condition in order to avoid excessive
lowering of your blood pressure, and will decide whether to advise you to supplement the therapy with potassium intake.
Patients with kidney or liver disorders
In case of kidney disease (low glomerular filtration) or liver (hepatic cirrhosis) or in case of insufficient
functioning of the kidneys and liver simultaneously, the doctor may modify the dose.
Method of administration
FUROSEMIDE TEVA GENERICS should be taken on an empty stomach (see “FUROSEMIDE TEVA GENERICS with
food”).

If you take more FUROSEMIDE TEVA GENERICS than you should
In case of taking a dose higher than that prescribed, immediately inform your doctor or go to the nearest
hospital. The symptoms of overdose are: severe decrease in pressure (up to shock), acute renal failure, thrombosis (formation of blood clots), states of delirium, flaccid paralysis (muscle paralysis, with
decreased tone), apathy and confused state and depend, primarily, on the extent and consequences of fluid and electrolyte loss (of fluids and salts), e.g. decreased blood volume, dehydration, blood concentration, cardiac arrhythmias (blood concentration, including A-V block and ventricular fibrillation).
If you have just taken an excessive dose of the medicine, the doctor will limit absorption by means of
measures to reduce absorption (such as gastric lavage or, for example, administration of activated charcoal) and will monitor your
clinical conditions, as well as administer adequate therapeutic measures.
If you have urinary disorders, such as in the case of prostatic hypertrophy or unconsciousness, it is necessary to provide for
restoration of free urinary flow.

If you forget to take FUROSEMIDE TEVA GENERICS
Do not take a double dose to make up for a missed dose.

If you stop taking FUROSEMIDE TEVA GENERICS
If you have any doubts about the use of this medicine, consult your doctor or pharmacist. 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 everybody gets them.
Stop treatment with this medicine and contact your doctor or nurse immediately if you
experience the following symptoms:
difficulty breathing or swallowing, swelling of the face, eyes, lips and/or tongue, skin irritation;
these may be symptoms of a severe allergic reaction (anaphylactic shock), which is rare.
Side effects may include:

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

• Electrolyte disturbances (alteration of the balance of salts in the blood);
• dehydration;
• decreased blood volume (hypovolemia), especially in elderly patients;
• decreased blood pressure (hypotension);
• decreased blood pressure when moving from a sitting to a standing position (orthostatic hypotension);
• increased levels of some blood tests (creatinine and triglycerides).

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Decreased white blood cells in the blood (leukopenia);
• increased white blood cells in the blood (eosinophilia);
• severe allergic reaction (anaphylactic shock);
• altered sensitivity of the limbs or other parts of the body (paresthesia);
• inflammation of the blood vessels (vasculitis);
• vomiting and diarrhea;
• kidney disease called tubulo-interstitial nephritis;
• fever.

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

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

Not known (frequency cannot be estimated from available data)

• Decreased levels of calcium in the blood (hypocalcemia);
• decreased levels of magnesium in the blood (hypomagnesemia);
• alteration of blood acidity (metabolic alkalosis);
• pseudo-Bartter syndrome (a rare disease affecting the kidneys) in case of abuse or prolonged use of furosemide;
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
• attention impairment;
• difficulty remaining upright (abnormal coordination);
• formation of blood clots inside blood vessels (thrombosis);
• skin diseases, such as hives, formation of red papules or blisters spread and scaling particularly on legs, arms, hands and feet, which may extend to the face and la bbr a , occasionally accompanied by fever. These may be symptoms of severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome);
• lichenoid reactions, characterized by small, itchy, reddish-purple, polygonal lesions on the skin, genitals or in the mouth;
• severe damage to skeletal muscle and release into the blood of substances contained in the muscles (rhabdomyolysis), generally in the context of severe potassium deficiency in the blood;
• appearance or worsening of a chronic autoimmune disease, which can affect various organs and tissues of the body called Systemic Lupus Erythematosus;
• difficulty emptying the bladder (urinary retention, in patients with prostatic hypertrophy, urethral stenosis or other difficulty emptying the bladder);
• impaired kidney function (renal failure);
• physical exhaustion (asthenia);
• increased thirst;
• increased urea in the blood;
• increased sodium in the urine;
• increased chlorine in the urine.

Additional side effects in children
In premature infants, furosemide may worsen nephrocalcinosis/nephrolithiasis (precipitation of calcium in the kidney, with formation of stones). Therefore, if administered to premature infants during the first few weeks of life, it may increase the risk of delayed closure of the ductus arteriosus (a blood vessel in the heart that normally closes at birth).

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

5. How to store Furosemide Teva 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. The period of validity refers to the product in
intact packaging, correctly stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FUROSEMIDE TEVA GENERICS contains

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

Description of the appearance of FUROSEMIDE TEVA GENERICS and contents of the pack
Tablets.
Pack of 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
Industria Farmaceutica Nova Argentia S.r.l. - Via G. Pascoli, 1 - 20064 Gorgonzola (MI)