FUROSEMIDE TEVA ITALIA

Package leaflet: Information for the patient

Furosemide Teva Italia 500 mg tablets

equivalent medicine
Please read all of 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Furosemide Teva Italia belongs to a group of medicines known as diuretics. Diuretics increase the
production of urine.
Furosemide Teva Italia should only be used in adult patients with fluid retention (oedema) and
severely reduced glomerular filtration (glomerular filtration rate [GFR] < 20 mL/min).

2. What you need to know before taking Furosemide Teva Italia

Do not take Furosemide Teva Italia

• if you are allergic to furosemide, sulfonamides (used to treat bacterial infections, diabetes, increased intraocular pressure, or to increase urine production), or to any of the other ingredients of this medicine (listed in section 6);
• if you have normal or mildly to moderately reduced kidney function with a GFR above 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 urine (anuria);
• if you have severe liver disease (pre-coma or coma associated with liver-related brain damage [hepatic encephalopathy]);
• if you have a potassium deficiency;
• if you have a sodium deficiency;
• if you have been told that you have a reduced amount of blood (hypovolemia) or body water (dehydration);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if your body is unable to produce adequate amounts of adrenal hormones (Addison’s disease);
• if you have taken an excessive amount (overdose) of cardiac glycosides (e.g., digoxin, digitoxin).

Warnings and precautions
Talk to your doctor or pharmacist before taking Furosemide Teva Italia:

• if you have low blood pressure (hypotension);
• if you have or suspect you have diabetes: regular monitoring of blood sugar levels is necessary;
• if you have gout: regular monitoring of uric acid levels in the blood is necessary;
• if you have low levels of protein in the blood (hypoproteinemia), for example if you suffer from nephrotic syndrome (protein loss, fat metabolism disorder, and fluid retention): your doctor will need to carefully adjust the dose and you must follow instructions exactly;
• if you have liver cirrhosis (fatigue, weakness, fluid retention, nausea or vomiting, weight or appetite loss, yellowing of the skin or eyes, itching) and reduced kidney function;
• if you have circulatory problems in the brain (cerebrovascular circulatory disorders) or in the heart vessels (coronary heart disease): the risks associated with a possible drop in blood pressure are higher;
• if you are elderly, if you are taking other medicines that can lower blood pressure, or if you have other medical conditions that pose risks of low blood pressure;
• if you have significant difficulty urinating due to a blockage in urine flow (urinary tract obstruction). Your doctor will monitor you and may prescribe blood tests during treatment with this medicine.

Patients with impaired kidney function but frequent urine production should ensure they drink enough fluids.
In patients with problems emptying the bladder (e.g., enlarged prostate), Furosemide Teva Italia may only be used if free urinary flow is ensured, as a sudden increase in urine flow may cause urinary blockage (urinary retention), leading to excessive bladder distension.
In patients with pre-existing reduction in blood acidity (increased pH) due to acid loss (metabolic alkalosis), furosemide may worsen this existing condition. If you use furosemide for a long time, your doctor will monitor you regularly.
Careful monitoring is necessary if you are at high risk of developing electrolyte imbalances (e.g., if you have liver cirrhosis, are taking corticosteroids, or use many laxatives, or if you follow a restricted diet) or if you lose large amounts of fluids (e.g., due to severe vomiting, diarrhea, or heavy sweating): any loss of blood or fluids (hypovolemia or dehydration) or any electrolyte or acid-base imbalance in the body will require correction, for which your doctor may need to temporarily stop treatment with Furosemide Teva Italia. Your doctor will perform regular blood tests. If you use furosemide long-term, your doctor may recommend a potassium-rich diet (potatoes, bananas, tomatoes, citrus fruits, fruit juices, dried fruits, cauliflowers, and spinach).
Regardless of the amount of urine produced, your body weight should not decrease by more than 1 kg per day due to increased urine production.
Your doctor may need to periodically check the effect of treatment with Furosemide Teva Italia by temporarily stopping therapy.
Inform your doctor if you are scheduled for a radiographic examination with contrast medium. The undesirable renal effects of contrast agents used in some radiographic examinations may worsen with Furosemide Teva Italia.
Exposure to sunlight or UV rays: inform your doctor if you develop an excessive skin reaction after exposure to sunlight or UV rays (photosensitivity), as treatment interruption may be necessary.

Children
Furosemide Teva Italia may cause calcium deposits or kidney stones in premature infants and increase the risk that a fetal blood vessel called the ductus arteriosus remains open after birth rather than closing normally in premature infants with respiratory difficulties. The 500 mg dosage is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Furosemide Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Furosemide Teva Italia can affect the action of certain other medicines. Likewise, some medicines can affect the action of Furosemide Teva Italia.
It is particularly important to inform your doctor if you are taking the following medicines:

• glucocorticoids (“cortisone”), carbenoxolone, or laxatives may increase potassium loss and thus the risk of potassium deficiency;
• anti-inflammatory drugs (NSAIDs, e.g., indomethacin, acetylsalicylic acid) may reduce the effect of Furosemide Teva Italia 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 immunosuppression), and other medicines excreted by the kidneys may reduce the effect of Furosemide Teva Italia;
• phenytoin (for epilepsy and certain types of pain) may reduce the effect of Furosemide Teva Italia;
• carbamazepine (for epilepsy and certain psychiatric conditions) may increase sodium loss and thus the risk of sodium deficiency;
• sucralfate (an antacid) reduces the intestinal absorption of Furosemide Teva Italia and may therefore weaken its effect: sucralfate and Furosemide Teva Italia should be taken at least 2 hours apart;
• aliskiren (for high blood pressure).

Furosemide Teva Italia can affect the action of the following medicines:

• certain heart medicines (glycosides) may have a stronger effect due to potassium and magnesium deficiency that may be caused by Furosemide Teva Italia. Medicines affecting heart rhythm (e.g., terfenadine for allergies, certain medicines used to treat heart rhythm disorders) are more likely to cause heart rhythm abnormalities when used concomitantly with Furosemide Teva Italia or in case of electrolyte imbalances;
• undesirable effects of high-dose salicylates (for pain) may worsen due to Furosemide Teva Italia;
• undesirable effects of certain medicines on the kidneys may worsen (e.g., antibiotics such as aminoglycosides, cephalosporins, polymyxins). Furosemide Teva Italia, together with high doses of certain cephalosporins, may cause worsening of kidney function;
• Furosemide Teva Italia may worsen undesirable effects of certain medicines (e.g., aminoglicosides such as kanamycin, gentamicin, tobramycin) on hearing. These side effects are not always reversible. Therefore, Furosemide Teva Italia should not be used together with these medicines;
• the risk of hearing damage may increase when cisplatin (for cancer) and Furosemide Teva Italia are used together. Caution is required, as the undesirable renal effects of cisplatin may increase;
• undesirable effects of lithium (for certain types of depression) on the heart and nervous system may worsen if used together with Furosemide Teva Italia. Your doctor must monitor lithium levels in the blood if these medicines are taken together;
• blood pressure may decrease if Furosemide Teva Italia is taken with other medicines that lower it, such as blood pressure medicines or other diuretics. In particular, medicines called ACE inhibitors and angiotensin II receptor antagonists may cause a marked drop in blood pressure, potentially leading to shock and worsening kidney function (in isolated cases, up to kidney failure) when starting the first dose or increasing the dose. Your doctor may advise you to stop treatment with Furosemide Teva Italia for at least 3 days before

starting to take an ACE inhibitor or an angiotensin II receptor antagonist, or
before increasing the dose of these medicines;

• Furosemide Teva Italia may reduce the renal elimination of probenecid, methotrexate, or other medicines, which may cause increased levels of these medicines in the blood and possible adverse effects;
• the effect of theophylline (for asthma) or curare-type muscle relaxants may increase if used concomitantly with Furosemide Teva Italia;
• antidiabetic medicines and blood pressure-raising products (sympathomimetics, e.g., adrenaline, noradrenaline) may be less effective with Furosemide Teva Italia;
• caution is required when using risperidone together with Furosemide Teva Italia in elderly patients with dementia. It is very important to avoid dehydration. In clinical studies on elderly patients with dementia, deaths observed among patients treated with risperidone concomitantly with furosemide were higher than those recorded among patients treated with the individual medicines alone;
• concomitant use of thyroid hormones (e.g., L-thyroxine) and high doses of furosemide may affect thyroid hormone levels. Your doctor must monitor thyroid hormone levels if these medicines are taken together;
• concomitant use of cyclosporine A (a medicine used to prevent transplant rejection) and furosemide is associated with an increased risk of gout-induced arthritis, due to furosemide-induced increases in blood uric acid levels and cyclosporine’s interference with renal uric acid excretion;
• in isolated cases, after intravenous administration of furosemide within 24 hours following ingestion of chloral hydrate (a drug with sedative properties), flushing, sweating, restlessness, nausea, and increased blood pressure and heart rate (tachycardia) may occur. Concomitant use of furosemide and chloral hydrate should therefore be avoided.

Furosemide Teva Italia with food and drinks
During treatment with Furosemide Teva Italia, avoid consuming large amounts of liquorice-containing products, as this may lead to increased potassium loss.

Pregnancy and breastfeeding
Pregnancy
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.
Do not take Furosemide Teva Italia during pregnancy unless your doctor considers it essential, as furosemide crosses the placenta.

Breastfeeding
Do not take Furosemide Teva Italia if you are breastfeeding, as the medicine passes into breast milk and reduces milk production. To take Furosemide Teva Italia, you must stop breastfeeding.
Consult your doctor or pharmacist before using any medicine.

Driving and using machines
This medicine may impair reaction ability to the extent that it affects your ability to drive vehicles and operate machinery, especially at the beginning of treatment, when the dose is increased, when changing medicines, and when combined with alcohol.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Furosemide Teva Italia contains lactose 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., it is essentially “sodium-free”.

3. How to take Furosemide Teva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The initial dose of Furosemide Teva Italia is 250 mg of furosemide.
Subsequently, your doctor will gradually adjust the dose at intervals of 4–6 hours. Your doctor will
periodically monitor your urine output and fluid and electrolyte balance.
The maximum recommended daily dose of furosemide in adults is 1500 mg when the medicine is taken
orally.
In case of chronic renal impairment, your doctor will carefully adjust the dose to reduce fluid retention (edema).
Use in children and adolescents
The safety and efficacy of Furosemide Teva Italia in children and adolescents under 18 years of age
have not been established. No data are available: other pharmaceutical forms/dosages might be more
appropriate for administration to these patients.
Elderly patients and patients with hepatic impairment
Your doctor will carefully adjust the dose according to your response to treatment.
Method of administration
The tablets should be taken in the morning, without food, without chewing, and with sufficient fluid (e.g. a glass of water).
Your doctor will decide for how long you should take Furosemide Teva Italia based on the nature and
severity of your condition.
If you take more Furosemide Teva Italia than you should
If you take an excessive amount of Furosemide Teva Italia or suspect an overdose, contact a doctor
immediately. Signs of acute overdose are related to loss of salts and fluids:
low blood pressure (hypotension), dizziness or lightheadedness when standing up (orthostatic regulation problems), electrolyte disturbances (reduction in potassium, sodium, and chloride levels), or an increase in blood pH (alkalosis).
Severe fluid loss may lead to dehydration and circulatory collapse due to reduced blood volume,
resulting in hemoconcentration and an increased risk of blood clots. Rapid loss of fluids and electrolytes may cause confusion and delirium.
If you forget to take Furosemide Teva Italia
Continue taking your usual dose at the regular time. Do not take a double dose to make up for a
missed dose.
If you stop taking Furosemide Teva Italia
Do not stop treatment with Furosemide Teva Italia unless your doctor tells you to do so, otherwise
the treatment may not be effective.
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 everybody gets them.
Stop taking Furosemide Teva Italia and contact a doctor immediately if you notice any of the following
serious side effects, as you may need urgent medical treatment:

• hair loss, sudden appearance of a swollen and red area on the skin with numerous small pustules (acute generalized exanthematous pustulosis [AGEP]);
• widespread skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome);
• severe allergic reaction (anaphylactic shock): early signs include skin reaction with redness or hives, restlessness, headache, sweating, nausea and bluish discoloration of the skin (cyanosis);
• tingling sensation (paraesthesia); life-threatening form of unconsciousness (hyperosmolar coma);
• some severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Discontinue treatment with Furosemide Teva Italia at the first signs of an allergic (hypersensitivity) reaction.
Blood glucose levels may increase during treatment with Furosemide Teva Italia, which may lead to worsening of diabetes control or clear manifestation of previously silent diabetes.
Furosemide Teva Italia may cause calcium deposits or kidney stones in premature infants and increases the risk that a fetal blood vessel called the ductus arteriosus remains open after birth instead of closing normally in premature infants with respiratory distress.
If you experience any of these side effects, contact your doctor as soon as possible. If a side effect occurs suddenly or worsens, seek immediate medical attention; under certain circumstances, some side effects may be life-threatening.

Very common side effects (may affect more than 1 in 10 people):
electrolyte or fluid disturbances that may cause:

• low sodium levels (hyponatremia, mainly characterized by apathy, leg cramps, loss of appetite, weakness, drowsiness, vomiting and confusion);
• low potassium levels (hypokalemia, mainly characterized by muscle weakness, tingling, mild paralysis, vomiting, constipation, bloating, frequent need to urinate, excessive thirst, heart rhythm abnormalities and, in severe cases, intestinal obstruction or altered state of consciousness including coma);
• low calcium levels, sometimes causing muscle spasms and cramps (tetany);
• low magnesium levels, which in rare cases may cause muscle spasms and cramps (tetany) or heart rhythm abnormalities;
• increased blood pH (metabolic alkalosis);
• significant fluid loss, which may cause circulatory disturbances mainly associated with headache, dizziness, visual disturbances, dry mouth and thirst, low blood pressure (hypotension), and dizziness or lightheadedness upon standing (orthostatic regulation problems), especially in elderly people and children. Severe fluid loss may lead to dehydration and circulatory collapse due to reduced blood volume, blood concentration, and increased risk of blood clots;
• increased blood creatinine levels;
• increased blood triglyceride levels.

Common side effects (may affect up to 1 in 10 people):
increased blood concentration (haemoconcentration);
reduced levels of sodium, chloride and potassium in the blood (hyponatremia, hypochloremia, hypokalemia);
increased blood cholesterol levels;
increased blood uric acid levels, which in some patients may trigger gout;
increased urine volume;
liver-related brain disorder characterized, for example, by seizures and reduced consciousness due to impaired liver function (hepatic encephalopathy).

Uncommon side effects (may affect up to 1 in 100 people):

• low platelet count in the blood (thrombocytopenia);
• itching, mucosal skin reactions: redness, blistering, peeling (e.g. bullous rash, urticaria, purpura, erythema multiforme, bullous pemphigoid, exfoliative dermatitis), increased sensitivity to light (photosensitivity);
• deafness (sometimes irreversible);
• hearing impairment (usually reversible);
• feeling unwell (nausea).

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

• high or low white blood cell count (eosinophilia or leucopenia);
• fever;
• inflammation of blood vessels (vasculitis);
• kidney inflammation (interstitial nephritis);
• ringing or buzzing in the ears (tinnitus);
• digestive problems (e.g. vomiting, diarrhoea).

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

• anaemia due to destruction (haemolytic anaemia) or reduced production (aplastic anaemia) of red blood cells; very low levels of certain white blood cells, increasing the risk of infection and severe general symptoms (agranulocytosis);
• inflammation of the pancreas, inhibition of bile flow (intrahepatic cholestasis), increased liver function test results (transaminases).

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

• dizziness, fainting and loss of consciousness (caused by symptomatic hypotension);
• worsening or onset of systemic lupus erythematosus (a disease in which the immune system attacks the body), headache;
• decreased levels of calcium and/or magnesium in the blood;
• decreased acidity (increased pH) in the blood due to acid loss (metabolic alkalosis);
• pseudo-Bartter syndrome, which may cause fluid retention in body tissues;
• lichenoid reactions characterized by small, itchy, red-purple polygonal lesions on the skin, genitals or in the mouth;
• muscle breakdown often leading to kidney damage (rhabdomyolysis), frequently associated with severe reduction in blood potassium levels;
• increased sodium levels in urine;
• increased chloride levels in urine;
• increased blood urea levels;
• sudden urinary retention due to difficulty emptying the bladder (urinary retention) in patients with partial urinary tract obstruction (e.g. in case of prostate enlargement, hydronephrosis, ureteral stenosis);
• kidney failure;
• formation of blood clots in blood vessels (thrombosis), particularly in elderly patients.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. Keep the blisters in the outer carton.
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 Teva Italia contains

• The active substance is furosemide.
• Each tablet contains 500 mg of furosemide.
• The other components are microcrystalline cellulose E460, monohydrate lactose, povidone K90 E1201, sodium starch glycolate type A and magnesium stearate E470b.

Description of the appearance of Furosemide Teva Italia and package contents
Furosemide Teva Italia 500 mg tablets appear as white or almost white, round, biconvex tablets of approximately 14 mm in diameter, with two crossed score lines on one side and smooth on the other.
Furosemide Teva Italia 500 mg tablets are available in blisters containing 20, 30, 50 or 100 tablets and in bottles containing 50, 100, 105 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer:
Teva Operations Poland Sp. z.o.o
Mogilska Str. 80
Krakow 31-546
Poland