Furosemide Aurobindo Italia: detailed information

Package leaflet: Information for the user

Furosemide Aurobindo Italia 500 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 they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Furosemide Aurobindo Italia contains furosemide, a substance that 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 Aurobindo Italia should be used in adults at this high dosage only if kidney function is
severely impaired (glomerular filtration rate (GFR) < 20 ml/min).

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

Do not take Furosemide Aurobindo Italia

If you are allergic to furosemide, to any of the antibiotics belonging to the sulfonamide class (or sulfonylureas: you might also be allergic to these substances), or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from renal failure and your kidneys do not produce any urine at all (oliguria or anuria).
If you have low levels of potassium in your blood (hypokalaemia).
If you have low levels of sodium in your blood (hyponatraemia).
If you have too little fluid in your body (dehydration).
If your body is unable to produce adequate amounts of adrenal hormones (Addison's disease).
If you are in the first trimester of pregnancy or are breastfeeding.
In case of poisoning with cardiac glycosides. Cardiac glycosides (e.g. digoxin, digitoxin) are medicines used to treat heart failure and heart rhythm disorders.

Furosemide Aurobindo Italia must not be used also under the following conditions:

in case of precoma (a condition characterized by mental confusion, apathy, muscle weakness);
in case of coma due to impaired liver function (hepatic encephalopathy);
in case of hypovolemia (severe reduction in blood volume).

Warnings and precautions
Furosemide Aurobindo Italia may be used in cases of advanced or end-stage renal failure (when dialysis is or may become necessary) with fluid retention (oedema) and/or high blood pressure, and to maintain residual urine production (with regular monitoring).
Consult your doctor or pharmacist before taking Furosemide Aurobindo Italia:

if you suffer from low blood pressure (hypotension);
if you have diabetes;
if you have gout;
if you have urinary tract obstruction problems (for example, if you have difficulty emptying your bladder due to an enlarged prostate or urethral strictures); since Furosemide Aurobindo Italia is a medicine that increases diuresis, adequate urine outflow must be ensured;
if your blood protein levels are low (hypoproteinaemia);
if you suffer from liver cirrhosis (tiredness, weakness, fluid retention, feeling unwell, weight loss or loss of appetite, yellowing of the skin or eyes, itching) and reduced kidney function;
if you experience sudden drops in blood pressure, especially if you are a patient with narrowing (stenosis) of the heart (coronary) arteries or blood vessels supplying the brain;
if you have severe liver and kidney problems (hepatorenal syndrome);
if you are elderly, if you are taking other medicines that may cause hypotension, or if you suffer from other diseases that involve a risk of low blood pressure.

Your doctor may also regularly prescribe tests to monitor blood and urine sugar levels, creatinine or uric acid levels in the blood, as well as to check levels of certain electrolytes such as potassium and sodium, which are particularly important especially if you suffer from conditions affecting electrolyte balance or following vomiting, diarrhoea or excessive sweating.
Your doctor may decide to adjust the dose of Furosemide Aurobindo Italia based on the results of clinical tests.
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 medicine could also trigger the onset of this disease in individuals in whom it has not yet been established.

Children
Administration of Furosemide Aurobindo Italia in premature infants should be accompanied by appropriate medical monitoring to prevent the development of kidney complications (nephrolithiasis or nephrocalcinosis).

Athletes
For those engaged in sports activity: the use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test. The use of Furosemide Aurobindo Italia as a substance to enhance performance may endanger your health.

Other medicines and Furosemide Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose and/or take other precautions if you are taking any of the following medicines:

aliskiren – used to treat high blood pressure.

Furosemide Aurobindo Italia may affect the action of the following medicines:

chloral hydrate (a sedative medicine): 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;
aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin) and other medicines toxic to the ear (ototoxic), such as cisplatin (an anticancer medicine): Furosemide Aurobindo Italia may enhance the toxic, even irreversible, effects that all these medicines have on the ear (auditory system). The combination of these medicines should therefore occur only if strictly necessary;
sucralfate (a medicine used to treat stomach ulcers): this medicine should be taken at least 2 hours apart, as sucralfate may reduce the effect of Furosemide Aurobindo Italia;
lithium salts (used to treat mental disorders): Furosemide Aurobindo Italia may enhance the toxic effects of lithium on the heart and nervous system;
ACE inhibitors and angiotensin II antagonists (medicines used to lower blood pressure): due to the risk of developing severe hypotension and impaired kidney function; if you take these medicines with Furosemide Aurobindo Italia, carefully follow your doctor's instructions;
phenytoin (an antiepileptic medicine): may reduce the effect of Furosemide Aurobindo Italia;
corticosteroids, carbenoxolone, liquorice, and prolonged use of laxatives: concomitant use with Furosemide Aurobindo Italia may increase the risk of excessively reducing potassium levels in the blood (hypokalaemia);
diuretics: taking Furosemide Aurobindo Italia together with other medicines of the same class leads to a greater reduction in blood pressure;
probenecid (a medicine used to treat gout) and methotrexate (a medicine used to treat certain types of cancer and some severe inflammatory diseases): may reduce the effects of furosemide and simultaneously increase its adverse effects;
peripheral muscle relaxants (curarising agents) and theophylline (a medicine used in certain respiratory diseases): Furosemide Aurobindo Italia may increase their action;
antidiabetic medicines (such as biguanides, sulfonylureas and thiazolidinediones) and sympathomimetics (such as adrenaline and noradrenaline): Furosemide Aurobindo Italia may reduce their action;
risperidone (an antipsychotic medicine, used to treat mental disorders): your doctor will consider the risks and benefits before prescribing Furosemide Aurobindo Italia together with this medicine, due to increased mortality, particularly in elderly patients with dementia;
levothyroxine (a medicine used to stimulate the thyroid gland): high doses of Furosemide Aurobindo Italia may lead to an overall decrease in thyroid hormone levels;
non-steroidal anti-inflammatory drugs (NSAIDs; including acetylsalicylic acid): may reduce the effect of Furosemide Aurobindo Italia, and Furosemide Aurobindo Italia may increase the toxicity of salicylates;
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.

Furosemide Aurobindo Italia and food
Furosemide Aurobindo Italia rarely may lead to a decrease in potassium levels in the blood; however, it is important that you follow a diet rich in this mineral by consuming potatoes, bananas, oranges, tomatoes, spinach, and dried fruit during treatment with this medicine.
Moreover, the therapeutic effect of Furosemide Aurobindo Italia may be reduced if taken during meals: always take the medicine on an empty stomach (see also section “How to take Furosemide Aurobindo Italia”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are in the first three months of pregnancy, you must not take this medicine, as furosemide crosses the placental barrier. You may take Furosemide Aurobindo Italia during the second and third trimesters of pregnancy only if your doctor considers it strictly necessary, and your doctor will periodically monitor your baby's growth.

Breastfeeding
If you are breastfeeding, you must not take Furosemide Aurobindo Italia, as furosemide passes into breast milk and may reduce milk production.
Consult your doctor or pharmacist before using any medicine.

Driving and using machines
Furosemide Aurobindo Italia may affect your ability to drive or use machinery.
Do not drive or operate machinery requiring particular attention while taking this medicine, as it may cause low blood pressure and thus reduce your reflexes and level of attention.

Excipients:
Furosemide Aurobindo Italia contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.
Furosemide Aurobindo Italia contains lactose monohydrate:
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Furosemide Aurobindo Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine must always be taken under medical supervision.

Adults
The initial dose of Furosemide Aurobindo Italia is half a tablet (250 mg of furosemide).
Your doctor will gradually adjust the dose, increasing by half a tablet (250 mg) at intervals of 4–6 hours, up to the usual maximum dose of 2 tablets (1,000 mg). Your doctor will periodically monitor your urine output and your fluid and electrolyte balance.
In case of chronic renal failure, your doctor will carefully adjust the dose to reduce fluid retention (edema).

Use in children and adolescents
Furosemide Aurobindo Italia is not recommended for children and adolescents under 18 years of age due to insufficient data on safety and efficacy. Other pharmaceutical forms or dosage strengths may be more suitable 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 an adequate amount of liquid (for example, a glass of water).
Your doctor will determine how long you should continue taking Furosemide Aurobindo Italia, depending on the nature and severity of your condition.

If you take more Furosemide Aurobindo Italia than you should
If you take more than the prescribed dose, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may result from excessive fluid loss through urine, such as dehydration, excessive concentration of the blood, disturbances in heart rhythm (AV block and ventricular fibrillation), reduction in blood pressure, even severe (severe hypotension up to shock), kidney problems (acute renal failure), formation of blood clots in blood vessels (thrombosis), delirium, muscle paralysis, apathy, and confusion.

If you forget to take Furosemide Aurobindo Italia
Do not take a double dose to make up for the forgotten dose.

If you stop taking Furosemide Aurobindo Italia
Consult your doctor if you intend to discontinue treatment.

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 this medicine and contact your doctor or nurse immediately if you experience any of the following:
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 (alteration in the balance of salts in the blood);
dehydration;
reduction in blood volume (hypovolemia), especially in elderly patients;
increased levels in certain blood tests (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;
feeling unwell;
intestinal motility disorders;
itching, hives, 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 purple spots on the skin, with or without joint pain, muscle pain, weakness and fever (may indicate inflammation of blood vessel walls, known as purpura);
allergic reaction to sunlight, presenting as skin irritation with 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);
fever;
inflammation of blood vessels (vasculitis);
a kidney disease called interstitial nephritis;
altered sensation in limbs or other body parts (paraesthesia);
vomiting and diarrhoea.

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 in blood acidity (metabolic alkalosis);
increased blood urea levels;
Bartter syndrome (a rare kidney disease) in cases of furosemide abuse or prolonged use;
formation of blood clots within blood vessels (thrombosis);
skin disorders such as hives, 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), or Dress syndrome;
lichenoid reactions, characterised by small, itchy, reddish-purple, polygonal-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);
pain at the injection site if the medicine is administered intravenously;
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 cells with release of muscle contents into the blood (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 neonates;
increased risk of heart abnormalities (patent ductus arteriosus) in premature neonates 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 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging following
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Aurobindo Italia contains

The active substance is furosemide. Each tablet contains 500 mg of furosemide.
The other components are: microcrystalline cellulose, monohydrate lactose, magnesium stearate, maize starch, quinoline yellow, sodium starch glycolate (type A).

Description of the appearance of Furosemide Aurobindo Italia and package contents
Tablets.
Uncoated, yellow, round, biconvex tablets of approximately 13 mm, marked with "F" and "500" on one side and a quadrisect on the other side. The tablet can be divided into equal doses or into quarters.
Furosemide Aurobindo Italia tablets are available in blister packs.
Pack sizes: 20 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

Generis Farmacêutica S.A.
Rua João de Deus, 19, Venda Nova,
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Furosemide Aurobindo Italia
Netherlands: Furosemide Aurobindo 500 mg, tabletten
Portugal: Furosemida Generis Phar