Product Information for the User

Furosemide Fresenius Kabi 20 mg/2 ml Injectable Solution and for Infusion EFG

furosemide

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

-Keep this product information, as you may need to read it again.

-If you have any questions, consult your doctor or nurse.

-This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this product information.

1.What is Furosemide Fresenius Kabi and how is it used

2.What you need to know before starting to use Furosemide Fresenius Kabi

3.How to use Furosemide Fresenius Kabi

4.Possible adverse effects

5.Storage of Furosemide Fresenius Kabi

6.Contents of the package and additional information

Furosemida Fresenius Kabi belongs to a group of medicines called diuretics.

Furosemida increases the amount of urine produced by your body.

Furosemida is used to remove excess fluid (also known as edema) from your body.

The excess fluid may be caused by:

• heart problems
• liver problems
• kidney problems

Furosemida is also used in periods where blood pressure is extremely high, which can be dangerous to your health (hypertensive crises).

No use Furosemida Fresenius Kabi:

• If you are allergic to furosemide or any of the other components of this

medication (listed in section 6)

• If you are allergic to sulfonamides
• If you are severely dehydrated (have lost a large amount of body fluid, for example due to severe vomiting or diarrhea)
• If you have kidney failure and are unable to urinate, despite treatment with furosemide
• If you have kidney failure as a result of a toxic substance poisoning or liver failure
• If you have very low levels of potassium or sodium in your blood
• If the patient is in a coma due to liver failure
• If you are breastfeeding

If you are unsure whether you can or cannot use this medication, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or nurse before starting to use Furosemida Fresenius Kabi:

• If you normally have problems eliminating fluid due to an obstruction (such as

prostate hypertrophy)

• If you have diabetes

• If you have low blood pressure or occasionally experience significant drops in blood pressure (your heart or brain blood vessels are very narrow)

arterial (arterial)

• If you have liver disease (such as cirrhosis)
• If you have kidney problems (such as nephrotic syndrome)
• If you are dehydrated (have lost a large amount of fluid due to severe vomiting or diarrhea),

which may lead to circulatory collapse and clot formation.

• If you have gout (inflamed or painful joints) due to high levels of uric acid (produced by metabolism) in your blood

(produced by metabolism) in your blood

• If you have a condition called systemic lupus erythematosus (SLE)
• If you have hearing problems
• If you are taking sorbitol (a sugar substitute for diabetics)
• If you are taking medications that can cause irregular heart rhythms that threaten

life (prolongation of the QT interval)

• If you are taking lithium
• If you have porphyria (a disease in which oxygen cannot bind to the proteins of red blood cells and urine becomes purple)

cells and urine becomes purple)

• If your skin is highly sensitive to sunlight (photosensitivity)
• If you are an athlete; this medication may give a positive result in doping tests
• If you have systemic lupus erythematosus (LES), a disease of the immune system that affects the skin, bones, joints, and internal organs
• If you are an elderly person, if you are being treated with medications that may cause a decrease in blood pressure, or if you have other medical conditions that are associated with a risk of decreased blood pressure

If administered to premature babies, it may cause kidney stones or calcification in the kidneys

If any of these circumstances occur, your doctor may want to change your treatment or give you special warnings.

While using Furosemida Fresenius Kabi, your doctors may recommend regular blood tests to check your sugar and uric acid levels. You may also want to check your blood levels of important salts such as potassium and sodium. This monitoring is particularly important if you are ill or have diarrhea.

Other medications and Furosemida Fresenius Kabi

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication. This is important because some medications should not be taken with Furosemida Fresenius Kabi.

Specifically, inform your doctor or pharmacist if you are taking:

• Lithium – for behavioral disorders, as its adverse effects may be increased by furosemide. Your doctor should only prescribe this medication if it is absolutely necessary and should check your lithium levels in the blood and possibly adjust the prescribed dose.

Your doctor may need to adjust the dose.

• Risperidone – used for the treatment of certain psychoses
• Heart medications, such as digoxin. Your doctor may need to adjust the dose.
• Any blood pressure medication, including thiazide diuretics (such as bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (such as lisinopril), angiotensin II antagonists (such as losartan), as furosemide may lower blood pressure significantly. Your doctor may need to adjust the dose of furosemide.

blood pressure. Your doctor may need to adjust the dose of furosemide.

• Cholesterol-lowering medications, such as fibrates (clofibrate, fenofibrate, or bezafibrate), as it may increase the effect of furosemide

may increase the effect of furosemide

• Diabetes medications, such as metformin and insulin, as it may increase blood sugar levels

may increase blood sugar levels

• Non-steroidal anti-inflammatory medications, including non-steroidal anti-inflammatory drugs (such as aspirin or celecoxib), as they may reduce the effect of furosemide; high doses of salicylates may increase the adverse effects of furosemide.

may increase the adverse effects of furosemide.

• Anti-inflammatory or antiallergic medications such as corticosteroids, medications for stomach ulcers such as carbenoxolone, or laxatives, as they may affect potassium and sodium levels. Licorice root has the same effect as carbenoxolone. Your doctor will check your potassium levels in the blood.

blood.

• Injections administered during surgery, including tubocurarine, succinylcholine, and curaric derivatives

derivatives

• Chloral hydrate – for sleep problems. In isolated cases, the intravenous administration of furosemide for a period of 24 hours prior to the administration of chloral hydrate may cause flushing, increased sweating, anxiety, nausea, increased blood pressure, and heart rate. Consequently, the concurrent administration of furosemide and chloral hydrate is not recommended.

is not recommended.

• Phenytoin or phenobarbital – for epilepsy, as it may reduce the effect of furosemide.

may reduce the effect of furosemide.

• Theophylline – for asthma, may increase the effect of furosemide.
• Some antibiotics, including certain cephalosporins, polymyxins, aminoglycosides, or quinolones, or other medications that may affect your kidneys, such as immunosuppressants, iodinated contrast media, foscarnet, or pentamidine, as furosemide may worsen their function.

may worsen their function.

• Ambotericin B – used for fungal infections (if used for a prolonged period)
• Probenecid – used with some other medications to protect the kidneys, may reduce the effect of furosemide.

may reduce the effect of furosemide.

• Organoplatins – used in some types of cancer, as furosemide may increase their adverse effects.

may increase their adverse effects.

• Methotrexate – used in some types of cancer and for severe arthritis, may reduce the effect of furosemide

may reduce the effect of furosemide

• Medications to increase blood pressure (vasopressors), as they may not be effective when taken with furosemide.

may not be effective when taken with furosemide.

• Aminoglutethimide – used to suppress the production of corticosteroids (Cushing's syndrome), may increase the effect of furosemide

may increase the effect of furosemide

• Carbamazepine – used to treat epilepsy or schizophrenia, may increase the adverse effects of furosemide

may increase the adverse effects of furosemide

• Ciclosporin – used to prevent rejection in transplants, there is a risk of gouty arthritis (painful joints)

gouty arthritis (painful joints)

• Medications that may alter heart rhythm, such as amiodarone, sotalol, dofetilide, ibutilide,

may increase the effect of furosemide

• Injectable medications used before X-ray examinations
• Levothyroxine – used for thyroid problems

Use of Furosemida Fresenius Kabi with food, drinks, and alcohol

No food is expected to affect this medication when administered intravenously.You can eat and drink normally while taking furosemide. You do not need to change your diet unless your doctor advises you to.

Pregnancy, breastfeeding, and fertility

Furosemide should not be used during pregnancy unless there are very good medical reasons to use it.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Furosemide may pass from the mother to the baby
• Therefore, this medication is only administered to pregnant women if it is absolutely necessary.

is only administered to pregnant women if it is absolutely necessary.

Do not use Furosemida Fresenius Kabi if you are breastfeeding

• This medication passes through breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Furosemida Fresenius Kabi may decrease your ability to concentrate and react. If you experience these symptoms, do not drive or operate machines (see section 4, "Possible side effects")

Furosemida Fresenius Kabi contains sodium

This medication contains 3.7 mg of sodium (the main component of table salt) in each ml. This is equivalent to 0.2% of the maximum recommended daily dietary intake for an adult.

Follow exactly the administration instructions of this medication indicated by your doctor or nurse. In case of doubt, consult your doctor or nurse again.

Normally, a doctor or nurse will administer Furosemida Fresenius Kabi to you. You will be administered:

• through a slow injection into a vein (intravenously) or
• exceptionally into a muscle (intramuscularly)

Your doctor will decide the dose. The dose depends on your particular condition, the severity of the disease, and

the time you have been treated.

• The recommended first dose for adults (including adolescents from 15 years old) is 20 to 40mg.
• If your doctor believes a higher dose is needed, they may administer additional injections

of 20 mg. Normally, you will be administered every 2 hours until the desired fluid loss is achieved.

• In some cases, instead of injections, your doctor may recommend the administration of this medication through continuous intravenous infusion (drip).

This medication can be administered through continuous intravenous infusion (drip).

• In children, (only children under 15 years old will be treated in exceptional cases), the dose

depends on weight. The first dose is 0.5 to 1 mg/kg per day.

• In the elderly, the initial dose is usually 20 mg/day. This can be gradually increased

until the desired fluid loss is achieved.

The weight loss by fluid elimination should not exceed 1 kg of body weight per day.

If you continue to need Furosemida Fresenius Kabi, your doctor will probably recommend, as soon as possible, a change from injections to an oral form (tablets) of this

medication.

If you use more Furosemida Fresenius Kabi than you should:

If you think you have received too much medication, inform your doctor directly.

The symptoms that may indicate you have received too high a dose are: dry mouth,

increased thirst, irregular heart rate, changes in mood, muscle pain or cramps, discomfort, weakness or unusual fatigue, weak pulse, or loss of appetite.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone

91 562 04 20.

If you forgot to use Furosemida Fresenius Kabi

If you think you have forgotten an injection, consult with your doctor or nurse. Do not use a double dose to

compensate for missed doses.

If you have any other doubts about the use of this medication, consult with your doctor or nurse.

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

During treatment with furosemide, the following side effects may appear:

Frequent

Acute hepatocerebral syndrome in patients with hepatocellular insufficiency (symptoms include memory loss, seizures, mood changes, and coma

Less frequent (affects between 1 and 10 of every 1,000 patients):

• Skin eruptions (including redness, itching, peeling), tendency to produce cardinals or sensitivity to sunlight

Changes in blood cells that can cause bleeding disorders (increased risk of hemorrhages)

• Deafness (sometimes irreversible)

Rare (affects between 1 and 10 of every 10,000 patients):

• Discomfort, diarrhea, constipation, loss of appetite, mouth and stomach discomfort
• Hearing problems (more common in people with renal failure) and tinnitus (ringing in the ears)

Anaphylaxis, a severe allergic reaction that can cause skin eruptions, swelling, difficulty breathing, and loss of consciousness. Seek medical helpimmediately.

• Kidney damage (interstitial nephritis)
• Very low white blood cell counts in the blood (which can lead to life-threatening infections). Seek medical helpimmediately.
  • Muscle problems, including muscle weakness and leg cramps
  • Pain or discomfort when the injection is administered (especially after intramuscular administration)
  • Lupus erythematosus or exacerbation of this condition
  • Changes in blood tests (lipids in the blood)
  • Dizziness, tingling, or numbness
  • High fever
  • Blurred vision, confusion, drowsiness
  • Dry mouth

  Very rare (affects fewer than 1 of every 10,000 patients):

  • Severe muscle problems, including spasms, cramps, and muscle weakness.
  • Changes in blood cells that can cause anemia, inability to fight infections.

  Pancreatitis (abdominal pain) due to inflammation of the pancreas.

  Unknown frequency (cannot be estimated from available data):

  • Stevens-Johnson syndrome (formation of blisters or peeling of the skin, lips, eyes, nose, and genitals, flu-like symptoms, and fever).
  • Toxic epidermal necrolysis (the skin layers can peel off, leaving large areas of exposed skin).
  • Generalized acute pustular psoriasis (PEGA).
  • Drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS).
  • Dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension or other causes), headache.
  • Exacerbation or activation of systemic lupus erythematosus (symptoms may include rash, joint pain, fever).
  • Rhabdomyolysis, a condition in which muscle tissue breaks down, has been reported, often in association with severe hypokalemia.

  It may also occur:

  • Low blood pressure, making you feel weak or dizzy. It can cause a sensation of pressure in the head, joint pain, formation of blood clots, or circulatory collapse (shock).

  Low potassium levels in the blood. It can cause muscle weakness, tingling, and numbness, mild inability to move some part of the body, dizziness, constipation, increased gas in the intestines, increased urine production, increased need to drink, irregular or slow heart rhythm. These complications are more likely if you have liver problems, a very low-potassium diet, or are taking other medications (see "Use of other medications"). Severe potassium losses can temporarily reduce bowel movement or ability to focus in some cases, with deep and prolonged loss of consciousness. Regular blood tests and potassium supplements may be necessary.

  • Low levels of magnesium, calcium, and sodium in the blood due to increased elimination by the kidneys. Low sodium levels typically cause lack of interest, leg cramps, lack of appetite, weakness, drowsiness, confusion, and dizziness. Low calcium levels cause muscle cramps. Low magnesium levels can also cause muscle cramps or irregular heart rhythm.
  • Gout, or it may worsen if you already have it.
  • Existing fluid elimination problems may worsen.
  • Diabetes, or it may worsen if you already have it.
  • Liver problems or changes in the blood can cause jaundice (yellow skin, dark urine, fatigue).
  • A reduced volume of body fluids, especially in the elderly. Severe fluid losses can increase the concentration of cells in the blood and thereby the tendency to form clots.
  • Calcifications or kidney stones may develop in premature babies.
  • In premature babies, the channel between the aorta and the hepatic artery, which is open in fetuses, may remain open.

  Reporting side effects

  If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date refers to the last day of the month.
• Keep the ampoules in their outer case to protect them from light.

• Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Furosemide Fresenius Kabi

• The active ingredient is furosemide.

• The other components are: sodium chloride, sodium hydroxide, and water for injection preparations.

Aspect of the product and contents of the packaging

Furosemide Fresenius Kabi is a transparent and colorless or almost colorless solution.

The packaging may contain 5, 50, or 100 amber-colored ampoules with 2 ml of Furosemide Fresenius Kabi 20 mg/2 ml.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the Marketing Authorization:

Fresenius Kabi España, S.A.

C/ Marina 16-18, 17th floor

Torre Mapfre

E-08005 Barcelona

Tel: +34 932256580

Responsible manufacturer:

LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group)

Lagedo, 3465-157 Santiago de Besteiros

Portugal

Tel: +351 232 831100

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: 05/2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended for healthcare professionals:

Administration

The intravenous administration of furosemide should be slow; it should not exceed a rate of 4 mg per minute and should never be given in association with other medications in the same syringe.

The intramuscular administration should be restricted to exceptional cases where oral administration or intravenous administration is not possible. It should be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary edema.

The recommended initial dose in adults and adolescents over 15 years old is 20 to 40 mg (1 or 2 ampoules) administered intravenously (or intramuscularly in exceptional cases); the maximum dose varies depending on individual response. If higher doses are needed, they should be administered by increasing the dose by 20 mg and not administered more frequently than every 2 hours.

The maximum recommended dose of furosemide in adults is 1,500 mg.

Incompatibilities

Furosemide can be mixed with neutral and weakly alkaline solutions with a pH between 7 and 10, such as sodium chloride 0.9% and Ringer's solution.

Furosemide should not be mixed with strong acids (pH below 5.5), such as solutions containing ascorbic acid, noradrenaline, and adrenaline, due to the risk of precipitation.

If the product contains visible particles, it should not be used.

Single-use product. Dispose of any remaining contents after use.

Product shelf life: 3 years.

After the first opening, the product should be used immediately.

After dilution:

The physical and chemical stability is guaranteed for 24 hours at 25°C and protected from light.

The product should be used immediately from a microbiological point of view. If it is not used immediately, the storage time, storage conditions, and previous use are the responsibility of the user and usually should not exceed 24 hours at a temperature between 2°C and 8°C, unless the solution was prepared in controlled and validated aseptic conditions.