FUROSEMIDE 500 mg Tabletka

Treść ulotki

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

Furosemide Teva 500 mg tablets

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

Contents of this leaflet

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

1. What is Furosemide Teva and what is it used for?

Furosemide Teva belongs to a group of medicines known as diuretics.
You should only use this high-dose formulation if your kidney function is
severely impaired (glomerular filtration rate (GFR) < 20 ml/min.).
Furosemide Teva is used for the treatment of reduced urine production (oliguria)
in chronic renal failure.

2. What you need to know before you take Furosemide Teva

Do not take Furosemide Teva
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 some medicines that inhibit bacterial growth (sulfonamide antibiotics)
or to medicines used for diabetes (sulfonylureas),
If you have normal kidney function or mildly to moderately reduced kidney function with a GFR
greater than 20 ml/min, due to the risk of severe fluid and salt (electrolyte) loss.
If you suffer from kidney failure and your kidneys do not produce any urine at all (anuria).
If you suffer from liver failure with altered consciousness (hepatic coma and precoma).
If you have a potassium deficiency.
If you have a sodium deficiency.
If you have too little blood (hypovolemia) or water in your body (dehydration).
If you are breastfeeding (see the section below “Pregnancy and breastfeeding”).
If you have glycosidic cardiac poisoning. Cardiac glycosides (e.g. digoxin and
digitoxin) are medicines used for heart failure and heart rhythm disturbances.

Warnings and precautions
Furosemide Teva can be used in advanced or end-stage renal failure
(when dialysis is or may become necessary), with fluid retention (edema) and/or
hypertension, and to preserve the remaining urine production (with regular monitoring).
Talk to your doctor or pharmacist before taking Furosemide Teva:
if you suffer from hypotension;
if you have or suspect you have diabetes: in this case, regular monitoring of
blood sugar levels is necessary;
if you suffer from gout: in this case, regular monitoring of blood uric acid levels is necessary;
if you suffer from an obstruction of the urinary tract (e.g. if you have an enlarged prostate;
urine accumulation in the kidneys; a narrowing of the ureter, the tract connecting the kidney and
bladder; kidney stones or bladder disorders): in this case, the doctor will need to monitor your
condition;
if you have low levels of proteins in your blood (hypoproteinemia), for example if you suffer from nephrotic syndrome (protein loss, altered fat metabolism and fluid retention):
in this case, the doctor will need to adjust the dose carefully and you must follow
their instructions exactly;
if you suffer from liver cirrhosis (fatigue, weakness, fluid retention, nausea or
vomiting, weight loss or loss of appetite, yellowing of the skin or eyes, itching) and your
kidney function is impaired;
if you have circulatory problems in the brain (cerebrovascular circulatory disorders) or in the
heart vessels (coronary artery disease): in this case, the risks associated with a possible drop
in blood pressure are higher;
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;
The doctor will monitor you and may perform some blood tests during
taking this medicine.
Careful monitoring is necessary if you have a high risk of developing electrolyte disturbances
(e.g. if you suffer from liver cirrhosis, take corticosteroid medicines or take many laxatives or if
you follow a controlled diet) or if you lose a lot of fluids (e.g. if you have severe vomiting, diarrhea or
excessive sweating). Any blood or fluid loss (hypovolemia or dehydration), or electrolyte imbalance, or acid-base imbalance in your body must be corrected; for this reason
the doctor may need to temporarily interrupt the treatment with
Furosemide Teva.
When using high doses of furosemide, it is recommended to monitor thyroid hormone levels.
Regardless of the amount of urine produced, your body weight should not decrease by more than 1 kg
per day due to the increased urine production caused by Furosemide Teva.
The doctor may need to periodically check the effect of Furosemide treatment
Teva by temporarily interrupting therapy.
If you take, together with Furosemide Teva, another medicine called risperidone, it is very
important that you avoid dehydration. In clinical studies conducted on elderly patients with
dementia, more patients treated with risperidone and furosemide died than patients treated
with either medicine alone.
Tell your doctor if you need to undergo an X-ray examination with contrast medium.
Children
Furosemide Teva can cause the formation of calcium deposits, or stones, in the kidneys of premature infants
and increase the risk that a fetal blood vessel, called the ductus arteriosus, remains open
after birth, instead of closing normally, in premature infants with breathing problems. The
doctor will therefore need to monitor the child very carefully.
Athletes
Furosemide Teva can cause positive results in toxicology tests.
The use of Furosemide Teva as a doping substance can endanger your health.

For those who engage in sports: the use of the medicine without therapeutic necessity constitutes doping

and may still result in positive anti-doping tests.

Other medicines and Furosemide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The medicines listed below can alter the effect of Furosemide Teva:
Glucocorticoids (“cortisone”), carbenoxolone, high alcohol consumption or abuse of
laxatives can increase potassium loss and, consequently, the risk of potassium deficiency;
Anti-inflammatory medicines (NSAIDs, e.g. indometacin and acetylsalicylic acid) can
reduce the effect of Furosemide Teva and increase the risk of acute kidney failure in
case of blood or fluid loss (hypovolemia or dehydration);
Probenecid (for gout), methotrexate (for arthritis and immune system suppression) and other medicines excreted by the kidneys can reduce the effect of Furosemide Teva;
Phenytoin (for epilepsy and some forms of pain) can reduce the effect of Furosemide
Teva;
Carbamazepine (for epilepsy and some psychiatric illnesses) can increase the loss of
sodium and, consequently, the risk of sodium deficiency;
Sucralfate (an antacid) reduces the absorption of Furosemide Teva from the intestine and
can therefore attenuate its effect; for this reason, sucralfate and furosemide should be
taken at least 2 hours apart.
Aliskiren (used to treat high blood pressure) can reduce the effect of Furosemide Teva.
Furosemide Teva can alter the effect of the following medicines:
Some heart medicines (glycosides) may have a stronger effect due to
potassium and magnesium deficiency that may be caused by Furosemide Teva. Medicines that
affect the heart rhythm (e.g. terfenadine for allergies and some medicines used for
treating heart rhythm disturbances) have a greater risk of causing heart rhythm disturbances if they are taken together with Furosemide Teva or in case of electrolyte disturbances;
The undesirable effects of salicylates at high doses (for pain) may worsen due to
Furosemide Teva;
The undesirable effects of some medicines on the kidneys may worsen (e.g. antibiotics
such as aminoglycosides, cephalosporins and polymyxins). Together with high doses of some
cephalosporins, Furosemide Teva can cause worsening of kidney function;
Furosemide Teva can worsen the undesirable effects of some medicines (e.g. aminoglycosides such as kanamycin, gentamicin and tobramycin) on hearing. These undesirable effects are not always reversible; for this reason Furosemide Teva should not
be used together with these medicines;
The risk of hearing damage may increase if Furosemide Teva is administered together
with cisplatin (for the treatment of tumors). Caution is required as the undesirable effects of cisplatin on the kidneys may also worsen;
The undesirable effects of lithium (used for some forms of depression) on the heart and
nervous system may be worse if taken simultaneously with Furosemide
Teva. The doctor must monitor your lithium levels in the blood if you take these medicines
together;
Blood pressure may decrease if you take Furosemide Teva together with other
medicines capable of lowering it, such as other diuretics. In particular, medicines
called ACE inhibitors and angiotensin II receptor blockers can cause a sharp
drop in pressure, to the point of causing collapse, and worsening of
kidney function (in isolated cases to the point of causing kidney failure) when taking the first dose or the first time a higher dose is taken. The
doctor may ask you to stop taking Furosemide Teva for at least 3 days before
starting to take an ACE inhibitor or an angiotensin II receptor blocker or
before the dose of these medicines is increased;
Furosemide Teva can reduce the elimination of probenecid, methotrexate or other medicines from
the kidneys; this can determine the increase of the levels of the drugs in the blood and
lead to possible undesirable effects;
The effect of theophylline (for asthma) or curariform muscle relaxants may increase in
case of taking together with Furosemide Teva;
Antidiabetic medicines and products that increase blood pressure (pressor amines, e.g. adrenaline and noradrenaline) may not work well together with
Furosemide Teva;
Caution is required when using risperidone together with Furosemide Teva (see
“Warnings and precautions”).
In case of taking Furosemide Teva together with cyclosporine A, joint inflammation and gout may occur.
The side effects on the kidneys due to the contrast agents used in some X-ray examinations may
worsen with Furosemide Teva.
In isolated cases, the use of chloral hydrate within 24 hours of intravenous administration
of furosemide has resulted in hot flashes, sweating, agitation, nausea and increased
heart rate. Chloral hydrate should not be used together with Furosemide Teva.

Furosemide Teva with food and drink
During the intake of Furosemide Teva, large amounts of licorice should not be consumed,
as licorice may increase its potassium loss.

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.
Furosemide Teva should not be taken during pregnancy unless your doctor considers the
treatment essential, as Furosemide Teva crosses the placenta.
You should not take Furosemide Teva if you are breastfeeding, as the medicine is secreted into
breast milk and prevents its production. You must stop breastfeeding to be able to take Furosemide Teva.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Furosemide Teva can impair your ability to react to such an extent as to affect your
ability to drive and operate machinery. This happens especially at the beginning of treatment,
when increasing the dose or changing medicine, and if you consume alcohol during treatment.

Furosemide Teva contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking
this medicine.

3. How to take Furosemide Teva

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doctor will decide the correct dose for you, based mainly on your response to
treatment. The dose must correspond to the minimum dose capable of producing the
desired effect.
Adults
The initial dose of Furosemide Teva is half a tablet (250 mg of furosemide).
The doctor will gradually adjust the dose, in increments of half a tablet (250 mg) and intervals of
4-6 hours, up to a usual maximum dose of 2 tablets (1000 mg). The doctor will periodically check
your urine production and electrolyte and fluid balance.
If you suffer from chronic kidney damage, the doctor will carefully adjust the dose in order to reduce fluid
retention (edema).

Use in children and adolescents
The 500 mg dose is not recommended in children and adolescents under 18 years of age
due to the scarcity of data available on the safety and efficacy of the product. Other pharmaceutical
forms, or dosages, may be more appropriate for administration to
these patients.
Elderly patients and patients with hepatic impairment
The doctor will carefully adjust the dose based on your response to treatment.
Method of administration
The tablets should be taken in the morning without food, without chewing them and together with a
sufficient amount of liquid (e.g. a glass of water).
The doctor will decide how long you should take Furosemide Teva based on the nature and
severity of your illness.

If you take more Furosemide Teva than you should
If you take an excessive amount of Furosemide Teva, or suspect an overdose, contact
your doctor immediately. The signs of acute overdose are related to the loss of salts and
liquids: hypotension, dizziness or lightheadedness when standing up (orthostatic regulation problems), electrolyte
disorders (low levels of potassium, sodium and chloride) or an increase in the value
of blood pH (alkalosis). Severe fluid loss can lead to dehydration and collapse due to reduced blood volume, as well as blood concentration and
increased risk of clots. In case of rapid loss of fluids and electrolytes, confusion and delirium may
occur.

If you forget to take Furosemide Teva
Continue to take the usual dose at the usual time. Do not take a double dose to
compensate for missing the dose.

If you stop taking Furosemide Teva
Do not stop Furosemide Teva unless your doctor tells you to, otherwise the treatment
may not be effective.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people)
Electrolyte or fluid imbalances, which can lead to:

• sodium deficiency (hyponatremia, mainly characterized by apathy, leg cramps, loss of appetite, weakness, drowsiness, vomiting and confusion);
• potassium deficiency (hypokalemia, mainly characterized by muscle weakness, tingling, mild paralysis, vomiting, constipation, flatulence, frequent urination, excessive thirst, abnormal heart rhythm and, in severe cases, intestinal obstruction or altered consciousness, including coma);
• calcium deficiency, sometimes resulting in muscle spasms and cramps (tetany);
• magnesium deficiency, which in rare cases causes muscle spasms and cramps (tetany) or abnormal heart rhythm;
• significant loss of fluids, which can cause circulatory disorders mainly associated with headache, dizziness, visual disturbances, dry mouth and thirst, hypotension and a feeling of dizziness or lightheadedness when getting up (orthostatic regulation problems), especially in the elderly and children; severe fluid loss that can lead to dehydration and collapse due to reduced blood volume, as well as blood concentration and increased risk of blood clots.
• increased creatinine and triglycerides

Common side effects (may affect up to 1 in 10 people)
Thickening of the blood.
Decreased minerals (sodium, chloride and/or potassium) in the blood, gout attacks.
Disorders of the brain characterized, for example, by convulsions and loss of consciousness
due to insufficient liver function (hepatic encephalopathy).
Feeling unwell
Increased cholesterol in the blood, increased uric acid in the blood, increased
urine volume.

Uncommon side effects (may affect up to 1 in 100 people)
Low number of platelets in the blood (thrombocytopenia).
Itching and skin and mucous membrane reactions: redness, blisters,
scaling (e.g. bullous rash, urticaria, purpura, erythema multiforme,
bullous pemphigoid, exfoliative dermatitis), increased sensitivity to light (photosensitivity).
Hearing disorders, deafness (sometimes irreversible)
Increased urea in the blood

Rare side effects (may affect up to 1 in 1,000 people)
High or low number of white blood cells (eosinophilia or leukopenia).
Fever.
Inflammation of blood vessels (vasculitis).
Inflammation of the kidneys (interstitial nephritis).
Severe allergic reaction (anaphylactic shock): the first signs are a skin reaction with
flushing or urticaria, restlessness, headache, sweating, nausea and bluish discoloration of the skin (cyanosis).
Tingling (paresthesia), life-threatening form of unconsciousness (hyperosmolar coma)
Hearing disorders and/or ringing or whistling in the ears (tinnitus) generally reversible.
Digestive problems (e.g., nausea or vomiting, diarrhea).

Very rare side effects (may affect up to 1 in 10,000 people)
Anemia due to a decrease (hemolytic anemia) or reduced production (aplastic anemia) of red blood cells, very low levels of certain white blood cells with increased risk of infection and severe
general symptoms (agranulocytosis).
Inflammation of the pancreas, inhibition of bile flow (intrahepatic cholestasis), increased
results of liver function tests (transaminases).

Not known (frequency cannot be estimated from available data)
Decreased calcium and/or magnesium in the blood, increased blood pH (metabolic alkalosis), Pseudo-Bartter syndrome which can cause fluid retention in the body tissues.
Thrombosis

• Acute generalized exanthematous pustulosis (AGEP) (acute febrile drug eruption) Skin eruption with eosinophilia and systemic symptoms "(DRESS)" (drug reaction with eosinophilia and systemic symptoms)
• Lichenoid reactions characterized by small, polygonal, itchy, reddish-purple lesions on the skin, genitals or in the mouth.
• Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension), headache
• Blood glucose levels may increase during treatment with Furosemide Teva; this may lead to a worsening of diabetes control, or the clear manifestation of previously silent diabetes.
• Sudden retention of urine in the bladder due to insufficient emptying of the bladder (urinary retention) in patients with partial blockage of the urinary tract, kidney failure.
• Calcium deposits or kidney stones in premature babies.
• Increased risk of failure to close the ductus arteriosus (aorta in the fetus) after birth in premature babies with certain respiratory disorders ("respiratory distress syndrome").

Symptoms of urinary tract obstruction (e.g. enlargement of the
prostate or narrowing of the ureter, the tract connecting the kidney and bladder) may occur or worsen, with the risk of
urine retention and associated complications.
If you develop any of these side effects, contact your doctor as soon as possible. If an
side effect occurs suddenly, or worsens, consult a doctor immediately
as, in certain circumstances, some side effects may be
potentially life-threatening.
You should stop taking Furosemide Teva at the first signs of an allergic reaction
(hypersensitivity).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://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

• 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 cartons and blister after “EXP”. The expiry date refers to the last day of that month.
• Store in the original package 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 contains
The active ingredient is furosemide. Each tablet contains 500 mg of furosemide.
The other ingredients are: lactose monohydrate, corn starch, anhydrous colloidal silica, talc,
magnesium stearate and yellow iron oxide (E172).

Description of the appearance of Furosemide Teva and contents of the pack
Circular, flat tablets, 13 mm in diameter, light yellow in color, with beveled edges
and the inscription “FUS” imprinted on one side and scoring lines into quarters on the other. The
tablet can be divided into halves or equal quarters.
Furosemide Teva is available in packs of 20, 28, 30, 50, 60, 90 and 100 tablets. Not all
pack sizes may be marketed.

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

Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
Pharmachemie BV
Swensweg 5, 2031 GA Haarlem (Netherlands)
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, 747 70 Opava-Komarov (Czech Republic)