FUROSEMIDE 10 mg /Ml Injectable Solution

Зміст інструкції

1. Furosemide Noridem 10 mg/mL injectable solution or infusion
   1. What is Furosemide Noridem and what is it used for
   2. What you need to know before taking Furosemide Noridem
   3. How to take Furosemide Noridem
   4. Possible side effects
   5. How to store Furosemide Noridem
   6. Package contents and other information

Furosemide Noridem 10 mg/mL injectable solution or infusion

Generic Equivalent Medicine

Read this leaflet carefully before you are given 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.
• Tell your doctor, pharmacist or nurse if you experience any side effects, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is Furosemide Noridem and what is it used for

Furosemide belongs to a group of medicines known as loop diuretics (they help to produce
more urine).
Furosemide Noridem is indicated for the treatment of congestive heart failure, hepatic cirrhosis (liver
irreversible fibrosis) or kidney disease accompanied by fluid retention.
It is indicated for hypertension (high blood pressure) as mono-therapy or in combination with
other antihypertensive medicines in patients with heart failure or chronic kidney disease, or
sustained hypertension or when first-line medicines are not sufficient or tolerated.
Intravenous administration is recommended when immediate diuresis is necessary (rapid
removal of excess fluids), such as in the case of pulmonary edema (excess fluid in the lungs).

2. What you need to know before taking Furosemide Noridem

Furosemide Noridem should not be administered
if you are allergic to furosemide or to any of the other ingredients of this medicine
(listed in section 6). Patients allergic to sulfonamides (e.g. antibiotics of the
sulfonamide group or sulfonylureas) and thiazide diuretics in general may experience cross-sensitivity
to Furosemide Noridem,
if you suffer from hypovolemia (low blood volume) or are dehydrated,
if you suffer from anuria due to renal failure, as these patients do not respond to
Furosemide Noridem,
if you have severe hypokalemia (low potassium (K) levels in the blood) (see section 4),
if you have severe hyponatremia (low sodium levels in the blood),
if you are in a comatose or precomatose state associated with hepatic encephalopathy (a decline in brain
function that occurs following severe liver failure),
if you suffer from renal failure due to poisoning from medicines that can damage
your kidneys or liver,
if you are breastfeeding. Regarding pregnancy see section “Warnings and
precautions”.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Furosemide Noridem .
Ensuring free urinary flow is necessary. In patients with partial obstruction of the urinary tract
(e.g. in patients with problems emptying the bladder, enlarged prostate or
urethral stricture) an increase in urine production may cause or worsen
disorders. Therefore, particularly careful monitoring of patients is required, especially
during the initial phases of treatment.
Treatment with furosemide requires regular medical check-ups. Particularly careful monitoring is necessary if the patient:

• has hypotension (low blood pressure),
• is at greater risk of a significant drop in blood pressure (blood vessels in your heart or brain are too constricted),
• if you suffer (or may suffer) from diabetes,
• if you have gout (inflamed and painful joints due to high uric acid levels),
• if you have any problems with your liver or kidneys,
• if you have low levels of proteins in your blood (hypoproteinemia), associated for example with nephrotic syndrome (a condition in which too much protein is found in the urine), as this may reduce the effects of the medicine and increase the risk of hearing damage. Dose adjustment is necessary.
• if a premature newborn needs to receive furosemide, renal function should be monitored and a renal ultrasound should be performed, as they may develop kidney stones. It also increases the risk of persistence of the patent ductus arteriosus (PDA) (a condition in which blood flows into the lungs) and involves respiratory distress syndrome of the newborn (causes breathing difficulties in newborns whose lungs are not yet fully developed).
• if you are elderly, if you are taking other medicines that may cause a drop in blood pressure or if you have other conditions that may affect your blood pressure. During treatment with Furosemide Noridem, careful monitoring of electrolyte concentrations, especially potassium, calcium, chlorides, bicarbonate and fluid balance is recommended. Frequent monitoring of creatinine and uric acid in the blood is also necessary. Carbohydrate metabolism should also be monitored.

Particularly careful monitoring is necessary for patients at higher risk of developing
electrolyte imbalances or in case of significant additional fluid loss (e.g. due to
vomiting, diarrhea or excessive sweating). Any hypovolemia (low blood volume) or
dehydration, as well as any significant changes in acid-base and electrolyte balance,
must be corrected. This may require temporary suspension of Furosemide
Noridem.
There is a possibility of worsening or triggering systemic lupus erythematosus (SLE).
Furosemide Noridem in combination with risperidone
Caution should be exercised, and the risk/benefit ratio of this combination or concomitant treatment with other potent diuretics should be assessed before starting therapy. No increase in mortality was recorded among patients taking other diuretics in
concomitance with risperidone treatment. Regardless of treatment, dehydration was
a general risk factor for mortality, and therefore should be avoided in elderly patients with dementia.

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

Combinations not recommended
In isolated cases, the intravenous administration of furosemide within 24 hours of taking chloral hydrate (used as a sedative) may cause flushing, excessive sweating, restlessness,
nausea, increased blood pressure and tachycardia. The use of Furosemide Noridem together with
chloral hydrate is therefore not recommended.
You should take furosemide together with aminoglycosides (a category of antibiotics) and other
medicines that can damage hearing only for compelling medical reasons, as this
combination may cause irreversible damage.

Tell your doctor if you are taking:

• cisplatin (used as a chemotherapeutic agent). When taken in combination with furosemide, it increases the risk of hearing damage. It can also cause kidney damage if furosemide is not administered at a low dose (e.g. 40 mg in patients with normal renal function) and with a positive fluid balance.
• lithium salts (used for the treatment of mental health problems). Furosemide may cause an increase in serum lithium levels. Your doctor may request blood tests to check your lithium levels.
• an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (used to lower blood pressure). When administered for the first time or when the dose is increased in patients taking diuretics, significant drops in blood pressure and deterioration of renal function, including cases of renal failure, may occur. Temporary interruption or at least reduction of the furosemide dose for 3 days should be considered before starting or increasing the dose of an ACE inhibitor or an angiotensin II receptor blocker.
• risperidone (used to treat certain mental/mood disorders) - caution should be exercised and the risk/benefit ratio of this combination or concomitant treatment with furosemide or other potent diuretics should be assessed before starting therapy.
• levothyroxine (medicine for the thyroid) - high doses of furosemide may inhibit the binding of thyroid hormones to transport proteins when administered with levothyroxine, and therefore lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in thyroid hormone levels. Your doctor may request blood tests to check your thyroid hormone levels. Some medicines can interact with Furosemide Noridem, and may alter their effects. These include:
• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (used as a pain reliever), may reduce the effects of furosemide. In dehydrated patients, or with hypovolemia, non-steroidal anti-inflammatory drugs may cause acute renal failure. Salicylate toxicity may be increased by furosemide.
• Phenytoin, for treating epilepsy - may reduce the effect of Furosemide Noridem.
• corticosteroids (anti-inflammatory drugs), carbenoxolone, large amounts of licorice, and prolonged use of laxatives may increase the risk of hypokalemia (low potassium levels in the blood).
• digitalis preparations (used to treat certain heart conditions) and medicines that induce QT prolongation - their toxicity may be potentiated by changes in electrolyte concentration (e.g. hypokalemia, hypomagnesemia).
• antihypertensive agents, diuretics or other medicines with the potential to lower blood pressure, if administered in combination with furosemide, a greater drop in blood pressure can be expected.
• probenecid (used to treat gout), methotrexate (used in oncological therapies), and other medicines eliminated from the body through the kidneys may reduce the effects of furosemide. Conversely, furosemide may reduce the renal elimination of these drugs. In case of high-dose treatment (especially when furosemide is administered in combination with other medicines), an increase in serum levels and an increased risk of adverse effects of furosemide or the drug combination may occur.
• medicines for treating diabetes and medicines that increase blood pressure (such as adrenaline, noradrenaline), as their effects may be attenuated.
• Furosemide Noridem counteracts the action of curare-like muscle relaxants and potentiates the action of succinylcholine (used during general anesthesia).
• theophylline (used to treat asthma).
• medicines that have a harmful effect on the kidneys - their harmful effect on the kidneys may be potentiated.
• cephalosporins (a category of antibiotics) - in patients receiving concomitant therapies with furosemide and high doses of certain cephalosporins, renal failure may develop.
• taking cyclosporine A (used for rheumatoid arthritis, psoriasis, Crohn's disease, nephrotic syndrome, and in organ transplants to prevent rejection) together with furosemide - has been associated with an increased risk of developing gouty arthritis, secondary to hyperuricemia induced by furosemide and impaired renal excretion of urates induced by cyclosporine.
• contrast agents - patients at high risk for contrast-induced nephropathy (temporary worsening of kidney function) treated with furosemide had a higher incidence of deterioration of renal function after receiving the contrast agent compared to high-risk patients who had received only intravenous hydration before the contrast agent.
• metolazone when taken with furosemide, may cause intense diuresis (increased urine production) in patients who do not respond to furosemide alone.
• alcohol, narcotics (used as pain relievers) and barbiturates - these may increase the risk of developing a drastic drop in blood pressure when standing up.

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

Pregnancy
Furosemide crosses the placental barrier. You should not take this medicine during
pregnancy unless there are compelling medical reasons and for a short period of time. The
treatment during pregnancy requires monitoring of fetal growth.

Breastfeeding
Furosemide passes into breast milk and inhibits lactation. You should not breastfeed while you are
taking Furosemide Noridem.

Driving and operating machinery
Some side effects (such as a sudden and pronounced drop in blood pressure) may
affect your ability to concentrate and react. Therefore, you should not drive vehicles or
operate machinery if you experience these effects after taking Furosemide Noridem.
This is especially important at the beginning of treatment, or when changing medicine, or
if combined with alcohol.

Furosemide Noridem contains sodium
2 ml, 4 ml, 5 ml vials:
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning it is
essentially "sodium-free".

25 ml bottle
This medicine contains up to 93.25 mg of sodium (mainly from table salt) per bottle. This is equivalent to 4.67% of the recommended daily intake of
sodium in the diet.

3. How to take Furosemide Noridem

This medicine will be administered to you by a doctor or nurse.
To obtain the best possible response and suppress the counter-regulation, continuous infusion of furosemide is generally preferred over repeated bolus injections.
Use the minimum effective dose to achieve the desired results.

Adults and adolescents over 15 years of age:
In the absence of conditions requiring a specific dosage, the recommended initial dosage is between
20 mg and 40 mg of Furosemide Noridem. If necessary, a 20 mg dose may be repeated every 2
hours until the desired effect is achieved. This individually calculated dose may be
administered once or twice daily.
Acute pulmonary edema (fluid in the lungs): the initial dose to be administered is 40 mg of
Furosemide Noridem slowly intravenously. If a satisfactory result is not obtained
within one hour, the dose should be increased to 80 mg of Furosemide Noridem intravenously.
Treatment of congestive heart failure, hepatic cirrhosis or renal insufficiency,
accompanied by fluid retention when oral administration is not possible: 20 - 40 mg
of Furosemide Noridem intramuscularly or intravenously. The dose should be increased by 20 mg
at two-hour intervals, until the desired effect is achieved. Subsequently, this dose will be
administered as a single dose or divided into two daily administrations.
Higher dosages should be administered with an infusion rate not exceeding 4 mg/min.
Continuation of treatment depends on the elimination and replacement of fluids as well as
the loss of electrolytes.
In case of acute acid or base poisoning, alkalinization or acidification of the urine may
increase urination.

Newborns, children and adolescents under 15 years of age:
Generally, furosemide should be administered orally.
Parenteral administration (drip infusion) is only permitted in cases of life-threatening danger.
For the drip infusion of Furosemide Noridem, the dosage is 1 mg/kg of body weight up to
a maximum of 20 mg. The switch to oral therapy should be made as soon as possible.
The duration of therapy is determined by the doctor based on the type and severity of the condition.

If you take more Furosemide Noridem than you should
The clinical picture in case of acute or chronic overdose depends primarily on the extent and
consequences of electrolyte and fluid loss, e.g. dehydration, cardiac arrhythmia. Symptoms of
overdose include a severe drop in blood pressure (leading to shock), acute renal failure, thrombosis (blood clot formation), delirium, weakness or paralysis with
loss of muscle tone, apathy (lack of emotions) and confusion.
There is no known specific antidote for furosemide.
The purpose of treatment is to replace fluids, correct the acid-base and
electrolyte imbalance, with regular and frequent monitoring of electrolytes and blood pressure. In
addition to the prevention and treatment of serious complications resulting from these imbalances and other effects on the body, this corrective action may require both intensive general and specific medical controls and therapeutic measures. Hemodialysis does not accelerate the removal of
furosemide.

If you forget to take Furosemide Noridem
The doctor or nurse will have instructions on when to administer this medicine to you. It is
unlikely that you will receive this medicine in a manner different from what is prescribed. But if you think you
have missed a dose, inform your doctor or nurse.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Common(may affect more than 1 in 10 people):

• electrolyte imbalance (also symptomatic), dehydration and hypovolemia, especially in elderly patients, increased creatinine in the blood and triglyceride levels.
• For intravenous infusions: low blood pressure, including orthostatic hypotension (see section 2 “Warnings and precautions”). Common(may affect up to 1 in 10 people):
• hyponatremia (low sodium concentration in the blood), hypochloremia (low chloride concentration in the blood), hypokalaemia (low potassium concentration), increased blood cholesterol, increased serum uric acid levels and gout attacks.
• increased urine production.
• hepatic encephalopathy (decline in brain function following severe liver damage) in patients with liver failure. (see section 2 “Warnings and precautions”). Therefore, regular monitoring of diuresis and electrolytes is necessary, as well as appropriate correction of any imbalance.
• hemoconcentration (Increase in red blood cells in the blood, due to a reduction in plasma volume)

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

• reduced glucose tolerance. Manifestation of latent diabetes mellitus. See section 2 “Warnings and precautions”.
• nausea (feeling unwell)
• hearing disorders, even if typically transient, especially in patients with renal failure, low blood protein levels (e.g. nephrotic syndrome) and/or when furosemide is administered intravenously very rapidly. Cases of deafness, sometimes irreversible, have been reported following oral or intravenous administration of furosemide.
• itching, urticaria, skin rashes, bullous dermatitis, erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, photosensitivity reactions.
• thrombocytopenia (low platelet count, which can cause bleeding).

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

• Inflammation of blood vessels
• tinnitus (ringing in the ears)
• inflammation of the renal tubules
• vomiting, diarrhea
• severe anaphylactic or anaphylactoid reactions (e.g. with shock)
• leukopenia (low white blood cell count), eosinophilia
• paresthesia (abnormal sensations, such as pins and needles)
• fever

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

• inflammation of the pancreas
• cholestasis, elevated levels of transaminases (enzymes)
• blood disorders (agranulocytosis, bone marrow aplasia, hemolytic anemia)

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

• hypocalcemia (low calcium levels in the blood), hypomagnesemia (low magnesium levels in the blood), increased blood urea, metabolic alkalosis (a condition that occurs when the blood becomes alkaline), pseudo-Bartter syndrome in circumstances of misuse and/or prolonged use of furosemide.
• Thrombosis (blood clots).
• increased sodium levels in the urine, increased chloride levels in the urine, urinary retention (in patients with partial obstruction of the urinary tract, see section 2 “Warnings and precautions”)
• kidney stones in premature infants (see section 2 “Warnings and precautions”)
• renal failure (see section 2 “Other medicines and Furosemide Noridem”)
• severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP) and drug rash with eosinophilia and systemic symptoms (DRESS)
• Dizziness, fainting or loss of consciousness, headache
• cases of rhabdomyolysis have been reported, often in clinical settings of severe hypokalaemia (see section 2).
• Increased risk of persistence of the patent ductus arteriosus, when furosemide was administered to a premature newborn in the first few weeks.
• following intramuscular injection, localized reactions such as pain.
• Xanthopsia (altered color perception), thrombophlebitis, (inflammation of a vein causing blood clot formation), abnormally elevated blood uric acid levels, azotemia (accumulation of creatinine and urea). Dehydration is common, especially in the elderly and during the summer months.
• worsening or activation of systemic lupus erythematosus (SLE)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 Noridem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, on the vial label
after “EXP”. The expiry date refers to the last day of that month.
Store the vials in the original packaging to protect them from light.
This medicine does not require any particular storage conditions.
After first opening, the product should be used immediately.
After dilution (only the PP infusion bags can be used for dilution):
Chemical and physical stability for use has been demonstrated for:

• 24 hours at 2 - 8°C and 23 - 27°C if protected from light.
• 24 hours at 23 - 27° under artificial light. From a microbiological point of view, the product must be used immediately If not used immediately, the storage times and conditions before use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2 ° C and 8 ° C, unless the opening/dilution has taken place under controlled and validated aseptic conditions. 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. Package contents and other information

What Furosemide Noridem contains

• The active ingredient is furosemide. Each 2 ml solution contains 20 mg of furosemide. Each 4 ml solution contains 40 mg of furosemide. Each 5 ml solution contains 50 mg of furosemide. Each 25 ml solution contains 250 mg of furosemide.
• The other excipients are sodium chloride, 5N sodium hydroxide, water for injections.

Description of the appearance of Furosemide Noridem and contents of the pack
Polypropylene vials containing 2 ml of solution in packs of 5 or 10 vials with an aluminum casing.
Polypropylene vials containing 4 ml of solution in packs of 5 or 10 vials with or without an aluminum casing.
Polypropylene vials containing 5 ml of solution in packs of 5 or 10 vials with or without an aluminum casing.
For heat-sealed vials: each casing contains 5 vials
Amber type I glass vials containing 25 ml of solution, in cartons of 5 or 10 vials,
closed with 20 mm bromobutyl rubber stopper and sealed with an aluminum cap, with a tear-off
plastic cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou, Mitsi Building 3, Office 115,
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY,
21st Km Athinon Lamias National Rd
14568 Krioneri, Attiki, Greece,

Τ:+30 210 8161802, F:+30 210 8161587.

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Italy Furosemide Noridem
Greece DEMEFUR 10 mg/ml Solution for injection/infusion
Poland Furosemid Noridem
Hungary Furosemid Noridem 10 mg/ml oldatos injekció/infúzió
<--------------------------------------------------------------------------------------------------------------------------
The following information is intended only for doctors or healthcare professionals:

Route of administration
Parenteral administration of Furosemide Noridem is indicated in cases of reduced intestinal absorption
or when rapid fluid excretion is necessary.-
Furosemide Noridem for intravenous use should be injected slowly, not exceeding a rate of
4 mg per minute. In patients with significant renal impairment (serum creatinine > 5
mg/dl) it is recommended that the infusion rate does not exceed 2.5 mg of furosemide per
minute.
Intramuscular administration should be reserved for exceptional cases where neither the oral nor the
intravenous route is possible. It should be emphasized that intramuscular injections are not suitable for the
treatment of acute conditions such as pulmonary edema.
The duration of therapy is determined by the doctor based on the type and severity of the disease.
This medicine should not be infused with other medicines or mixed in the same syringe with
other medicines.
Furosemide is a solution with a pH between 8.0 – 9.3 without regulatory properties. Therefore, the
active substance may precipitate at a pH below 7. Therefore, if this solution is diluted,
care must be taken to maintain the pH of the solution from slightly alkaline to neutral. Saline and Ringer's lactate are suitable solvents. It is recommended to administer the
diluted solution as soon as possible.