Furosemide FisioPharma

Package leaflet: Information for the user

FUROSEMIDE FISIOPHARMA 20 mg/2 ml injection solution

Furosemide
Please read all of this leaflet carefully before you start using 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FUROSEMIDE FISIOPHARMA is and what it is used for

FUROSEMIDE FISIOPHARMA contains the active substance furosemide, which belongs to a group of medicines called diuretics used to promote the elimination of excess fluids.
FUROSEMIDE FISIOPHARMA 20 mg/2 ml injectable solution is indicated for the treatment of:

• all forms of edema (swelling due to fluid accumulation) caused by heart problems (e.g. due to heart failure), and ascites resulting from liver problems (hepatic cirrhosis);
• edema caused by kidney problems (such as nephrotic syndrome, in which it may be used together with other medicines such as ACTH or corticosteroids) or by obstruction of an organ or blood vessels;
• peripheral edema (swelling due to fluid accumulation in the extremities);
• mild to moderate high blood pressure.

2. What you should know before using FUROSEMIDE FISIOPHARMA

Do not use FUROSEMIDE FISIOPHARMA:

• if you are allergic (hypersensitive) to furosemide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines called sulfonamides used for infections;
• if you have a severely reduced blood volume (hypovolemia) or are dehydrated;
• if you are not producing urine (anuria) due to severe kidney problems (renal failure);
• if you have low levels of potassium (hypokalaemia) or sodium (hyponatraemia) in the blood;
• if you are in a pre-coma or coma state with brain disorders caused by liver damage (hepatic encephalopathy);
• if you have taken high doses of heart medications called digitalis;
• if you are in the first three months of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using FUROSEMIDE FISIOPHARMA.
Use this medicine under direct medical supervision.
FUROSEMIDE FISIOPHARMA should be administered with caution in the following cases:

• if you have problems emptying your bladder or suffer from conditions causing difficulty in eliminating urine (prostatic hyperplasia or urethral stenosis). In individuals where urinary flow is obstructed, careful monitoring is required, especially at the beginning of treatment;
• if you have low blood pressure or are at risk of excessive drop in arterial blood pressure due to circulatory problems (significant narrowing of coronary arteries or blood vessels supplying the brain);
• if you suffer from diabetes (latent or overt diabetes mellitus). During treatment, your doctor will need to monitor sugar levels in blood and urine;
• if you suffer from a condition called gout, caused by accumulation of uric acid. During treatment, your doctor will need to monitor uric acid levels in the blood;
• if you have severe liver or kidney problems (hepatorenal syndrome, functional renal failure associated with severe hepatopathy);
• if you have low levels of protein in the blood (hypoproteinaemia);
• if you are at risk of electrolyte imbalances in the blood 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 discontinue furosemide treatment and follow appropriate therapy to restore normal electrolyte levels;
• if you are elderly, if you are taking other medicines that may lower blood pressure, or if you suffer from other conditions that increase the risk of low blood pressure;
• if you are taking a medicine called risperidone, used for mental disorders. Cases of death have been reported in elderly patients with dementia taking risperidone together with furosemide (see section “Other medicines and FUROSEMIDE FISIOPHARMA”).

To reduce the risk of low potassium levels in the blood, during treatment with
FUROSEMIDE FISIOPHARMA follow a diet rich in potassium (potatoes, bananas, oranges,
tomatoes, spinach, dried fruit). Your doctor will advise you, if necessary, to take medicines to
restore normal potassium levels in the blood.
In case of ascites due to liver problems (hepatic cirrhosis with ascites),
FUROSEMIDE FISIOPHARMA should only be administered in hospital.
FUROSEMIDE FISIOPHARMA does not alter blood pressure values in normotensive individuals,
but has a hypotensive effect in hypertensive patients; in severe forms of hypertension, combination
therapy with other agents is recommended.
For individuals engaged in sports, using this medicine without therapeutic need constitutes doping and
may lead to a positive anti-doping test.

Children
This medicine may cause kidney problems (nephrocalcinosis/nephrolithiasis) in premature infants.
Therefore, during treatment with FUROSEMIDE FISIOPHARMA, your doctor should closely monitor
your child’s kidney function.

Other medicines and FUROSEMIDE FISIOPHARMA
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

• FUROSEMIDE FISIOPHARMA is not recommended if you are taking any of the following medicines:
• chloral hydrate, a sedative medicine. If furosemide is injected intravenously within 24 hours of taking chloral hydrate, it may cause skin flushing, sudden sweating, agitation, nausea, increased blood pressure, and tachycardia disturbances;
• aminoglycosides, medicines used against bacterial infections and other medicines that may cause ear damage. FUROSEMIDE FISIOPHARMA may increase the ototoxic effects in this case.

FUROSEMIDE FISIOPHARMA should be administered with caution if you are taking any of
the following medicines:

• cisplatin, a medicine used for certain tumours. Taken together with furosemide, it may cause damage to the ears and kidneys;
• sucralfate, a medicine for ulcers. Take sucralfate at least two hours apart from furosemide, as simultaneous intake may reduce its effect;
• lithium salts, medicines used for depression. Furosemide may increase the toxic effects of lithium; therefore, if both medicines are taken together, your doctor must closely monitor blood lithium levels;
• ACE inhibitors or angiotensin II receptor antagonists, medicines used to lower blood pressure. In this case, your doctor will determine the appropriate furosemide dose and may advise you to temporarily stop its administration;
• risperidone, a medicine used for mental disorders (see section “Warnings and precautions”).

The concomitant use of the following medicines with furosemide should be carefully evaluated by your
doctor, as they may reduce the effect of furosemide:

• non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, medicines used for inflammation that may also increase toxic effects. If you are dehydrated or have low blood volume, you may also develop kidney problems;
• phenytoin, a medicine for epilepsy;
• probenecid, a medicine used for gout, and methotrexate, a medicine used to treat certain tumours, as they may reduce the effect of furosemide.

The concomitant use of the following medicines with furosemide should be carefully evaluated by your
doctor, as they may increase the toxic effects of these medicines or alter their efficacy:

• nephrotoxic medicines (nephrotoxic agents) such as cephalosporins (antibiotics used against bacterial infections);
• corticosteroids, medicines for inflammation, carbenoxolone, a medicine for ulcers, and laxatives used long-term, 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, medicines for treating high blood pressure, and diuretics, medicines that promote urine elimination, as a marked drop in blood pressure may occur;
• antidiabetics, medicines used to treat diabetes;
• sympathomimetics such as adrenaline and noradrenaline;
• curare-like muscle relaxants, used in anaesthesia;
• theophylline;
• cephalosporins, medicines used against bacteria, as kidney damage may occur;
• cyclosporine A, a medicine used after transplantation, as it may increase the risk of uric acid accumulation;
• contrast media, medicines used for certain diagnostic tests, as kidney damage may occur.

In general, treatment with FUROSEMIDE FISIOPHARMA at high doses increases the risk of
adverse effects.

FUROSEMIDE FISIOPHARMA 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.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your
doctor or pharmacist before using this medicine.
FUROSEMIDE FISIOPHARMA 20 mg/2 ml solution for injection should not be administered
during the first three months of pregnancy. However, it may be administered during the second and
third trimesters only if clearly needed and under direct medical supervision.

Breastfeeding
During treatment with FUROSEMIDE FISIOPHARMA, discontinue breastfeeding, as furosemide
passes into breast milk.

Driving and using machines
This medicine may affect your ability to concentrate and your reactivity. If this occurs, avoid driving
vehicles or operating machinery.

FUROSEMIDE FISIOPHARMA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to use FUROSEMIDE FISIOPHARMA

This medicine must be administered by experienced personnel, strictly following the instructions given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose, duration of treatment, method, and rate of injection according to the condition being treated and your individual health status.
The medicine must be injected intravenously or administered slowly via an appropriate infusion device.
Infusion solutions should be used immediately after preparation.
In emergency situations when oral administration or intravenous injection is not possible, FUROSEMIDE FISIOPHARMA 20 mg/2 ml may be administered by intramuscular injection.

If you use more FUROSEMIDE FISIOPHARMA than you should
Overdose with this medicine may lead to reduced blood volume (hypovolemia), dehydration, alteration of the blood (haemoconcentration), heart problems (arrhythmias, including A-V block and ventricular fibrillation). Symptoms may include a severe drop in blood pressure (up to shock), serious kidney problems (acute renal failure), circulatory problems (thrombosis), muscle paralysis (flaccid paralysis), delirium, apathy, or confusion.
Depending on your condition, your doctor will decide on appropriate treatment.
If you have taken an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur:

Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):

• dehydration, decreased levels of sodium, chloride, potassium, calcium or magnesium in the blood (hyponatremia, hypochloremia, hypokalemia, hypocalcemia or hypomagnesemia), increased blood pH (metabolic alkalosis);
• low blood pressure.

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

• heart rhythm problems (arrhythmias);
• drowsiness, headache, dizziness, confusion, loss of sensation (paresthesia);
• visual disturbances;
• dry mouth, nausea, vomiting, diarrhea, intestinal problems (intestinal motility disorders);
• problems with urination (urinary retention in patients with prostatic hypertrophy, urethral stenosis or difficulty in bladder emptying);
• reduced glucose tolerance, hyperuricemia, gout, increased cholesterol, increased triglycerides, increased creatinine and urea;
• dizziness upon standing due to low blood pressure (orthostatic hypotension), reduced blood volume (hypovolemia), circulatory problems (thrombosis);
• muscle problems (cramps, tetany, myasthenia);
• fatigue;
• hearing loss (sometimes irreversible).

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

• blood disorders (leukopenia, aplastic anemia, agranulocytosis, thrombocytopenia, hemolytic anemia, eosinophilia);
• liver problems (intrahepatic cholestasis, increased liver transaminases);
• ringing in the ears (tinnitus), reversible or irreversible hearing loss, especially in case of too rapid intravenous administration of furosemide;
• inflammation of the pancreas (acute pancreatitis);
• severe kidney problems (nephrocalcinosis/nephrolithiasis in preterm neonates treated with furosemide, interstitial nephritis);
• skin reactions (urticaria, pruritus, purpura, bullous dermatitis, erythema multiforme, exfoliative dermatitis, photosensitivity reactions);
• inflammation of blood vessels (vasculitis);
• fever, allergic reactions including severe reactions, and irritation at the injection site.

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

• severe liver problems (hepatic encephalopathy in patients with hepatocellular insufficiency);
• severe skin damage (bullous pemphigoid, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• acute generalized exanthematous pustulosis (AGEP) (acute febrile drug eruption);
• dizziness, fainting and loss of consciousness (due to symptomatic hypotension).

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

5. How to store FUROSEMIDE FISIOPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging, tightly closed, to protect the medicine from light. No special
storage conditions regarding temperature are required.
Do not dispose of any 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 FISIOPHARMA 20 mg/2 ml injectable solution contains

• The active substance is furosemide. Each vial contains 20 mg of furosemide.
• The other components are: sodium hydroxide, sodium chloride and water for injections q.s. 2 ml.

Description of the appearance of FUROSEMIDE FISIOPHARMA and contents of the pack
Pack containing 5, 10, 50 or 100 vials of 2 ml.
Marketing Authorisation Holder and Manufacturer
FISIOPHARMA Srl – Industrial Area 84020 Palomonte (SA) – Italy

The following information is intended exclusively for healthcare professionals:

FUROSEMIDE FISIOPHARMA 20 mg/2 ml injectable solution
Furosemide
The following information is intended exclusively for physicians or healthcare professionals
Dosage and method of administration
FUROSEMIDE FISIOPHARMA 20 mg/2 ml injectable solution:
In the presence of intestinal malabsorption disorders or when rapid removal of edematous fluid is required, parenteral administration of FUROSEMIDE FISIOPHARMA is indicated at a dose of 20 mg (1 vial) 1–2 times daily, depending on need.
Administration
Intravenous injection/infusion: intravenous furosemide must be injected or infused slowly, without exceeding a rate of 4 mg/minute. In patients with severely impaired renal function (serum creatinine > 5 mg/dL), a maximum infusion rate of 2.5 mg per minute is recommended.
Intramuscular injection: intramuscular administration should be limited to exceptional circumstances when neither intravenous nor oral administration of the drug is possible. It should be emphasized that intramuscular injection is not suitable for the treatment of acute conditions, such as pulmonary edema.
Dosage in renal impairment: dose adjustment is necessary when glomerular filtration rate falls below 10 ml/min.
Dosage in hepatic impairment: dose adjustment may be necessary in patients with hepatic cirrhosis and in those with concomitant renal and hepatic insufficiency. Response to furosemide is reduced in patients with hepatic cirrhosis.
Overdose
No specific antidote for furosemide is known. If drug intake has just occurred, attempts may be made to limit systemic absorption of the active substance by measures such as gastric lavage or those reducing absorption (e.g., activated charcoal). Clinically significant disturbances in fluid and electrolyte balance must be corrected.
In addition to preventing and treating serious complications arising from such imbalances and other effects on the body, corrective action may require intensive monitoring of clinical status and appropriate therapeutic measures.
In patients with urinary disorders, such as prostatic hypertrophy or unconsciousness, it is necessary to ensure restoration of free urinary flow.
Incompatibilities
Furosemide, as a derivative of anthranilic acid, dissolves in alkaline medium forming a salt. The solution has a pH of approximately 9 and has no buffering effect; the active ingredient precipitates below pH 7. Therefore, it should be noted that FUROSEMIDE FISIOPHARMA may be mixed with alkaline, neutral, or weakly acidic solutions having modest buffering capacity. Salts of organic bases in solution (e.g., local anesthetics, alkaloids, sedatives, and antihistamines) may precipitate when combined with furosemide solutions.
FUROSEMIDE FISIOPHARMA injectable or infusion solution must not be mixed with other drugs in the same syringe.
Once diluted, the solution should be used immediately after preparation.
For further information, consult the Summary of Product Characteristics.