FUROSEMIDE Fresenius Kabi 20 mg/2 ml Injectable Solution and Perfusion Solution

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

Do not use Furosemide Fresenius Kabi:

• If you are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6)

or 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 cannot urinate, despite treatment with furosemide
• If you have kidney failure as a result of poisoning with toxic substances for the kidneys or liver
• 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 not sure if you can or cannot use this medicine, consult your doctor or pharmacist.

Warnings and precautions

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

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

or if you have diabetes

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

or if you have liver disease (such as cirrhosis)

• If you have kidney problems (such as nephrotic syndrome)
• If you are dehydrated (have lost a lot of fluid due to vomiting or diarrhea), which can lead to circulatory collapse and clot formation.

or if you have gout (inflamed or painful joints) due to high levels of uric acid in the blood

• If you have an inflammatory disease called "lupus erythematosus" (SLE)
• If you have ear problems
• If you are taking sorbitol (a sugar substitute for diabetics)
• If you are taking medications that can cause an irregular heartbeat that can be life-threatening (prolongation of the QT interval)

or if you are taking lithium

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

or if your skin has high sensitivity to sunlight (photosensitivity)

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

If administered to premature babies, it can cause kidney stones or calcification

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

While using Furosemide Fresenius Kabi, your doctors may recommend that you have regular blood tests to check your sugar and uric acid levels. They may also want to check the levels of important salts like potassium and sodium in your blood. This monitoring is particularly important if you are ill or have diarrhea.

Other medicines and Furosemide Fresenius Kabi

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines. This is important because some medicines should not be used with Furosemide Fresenius Kabi.

In particular, tell your doctor or pharmacist if you are taking:

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

or risperidone – used for the treatment of certain psychoses

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

or medications to lower cholesterol or lipids, such as fibrates (clofibrate, fenofibrate, or bezafibrate), as they can increase the effect of furosemide

• Medications for diabetes, such as metformin and insulin, as they can increase blood sugar levels.

or anti-inflammatory medications, including non-steroidal ones (such as aspirin or celecoxib), as they can reduce the effect of furosemide; high doses of pain relievers (salicylates) can increase the adverse effects of furosemide.

• Anti-inflammatory or anti-allergic medications like corticosteroids, medications for stomach ulcers such as carbenoxolone, or laxatives, as they can affect potassium and sodium levels when combined with furosemide. Licorice has the same effect as carbenoxolone. Your doctor will check potassium levels in your blood.

or injections given during operations, including tubocurarine, succinylcholine, and curare derivatives.

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

or phenytoin or phenobarbital – for epilepsy, as the effect of furosemide may be reduced.

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

or amphotericin B – used for fungal infections (if used for a prolonged period)

• Probenecid – used with some other medications to protect the kidneys, can reduce the effect of furosemide.

or organoplatins – used in some types of cancer, as furosemide can increase their adverse effects.

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

or medications to increase blood pressure (vasopressor amines), as they may not have an effect when taken with furosemide.

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

or carbamazepine – used for the treatment of epilepsy or schizophrenia, can increase the adverse effects of furosemide.

• Cyclosporine – used to prevent rejection in transplants, there is a risk of gouty arthritis (joint pain)

or medications that can alter heart rhythm, such as amiodarone, sotalol, dofetilide, ibutilide, as they can increase the effect of furosemide.

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

Using Furosemide Fresenius Kabi with food, drinks, and alcohol

It is not expected that food will affect this medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Furosemide can pass from mother to child
• Therefore, this medicine is only administered to pregnant women if it is absolutely necessary.

Do not use Furosemide Fresenius Kabi if you are breastfeeding

• This medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Furosemide Fresenius Kabi can reduce your ability to concentrate and react. If you experience these symptoms, do not drive or use machines (see section 4, "Possible side effects")

Furosemide Fresenius Kabi contains sodium

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

3. How to use Furosemide Fresenius Kabi

Follow exactly the administration instructions of this medicine given by your doctor or nurse. If you are unsure, consult your doctor or nurse again

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

• a slow injection into a vein (intravenous) or
• exceptionally, into a muscle (intramuscular)

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 initial dose for adults (including adolescents from 15 years) is 20 to 40 mg.
• If your doctor believes a higher dose is necessary, you may be given additional injections of 20 mg. These are usually 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 medicine through continuous infusion into a vein (drip).

• In children (only children under 15 years will be treated in exceptional cases), the dose depends on body weight. The initial dose is 0.5 to 1 mg/kg per day.

In elderly patients, the initial dose is usually 20 mg/day. This can be gradually increased until the desired fluid loss is achieved.

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

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

If you use more Furosemide Fresenius Kabi than you should:

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

The symptoms that could indicate you have received a too high dose are: dry mouth, increased thirst, irregular heartbeat, mood changes, muscle pain or cramps, discomfort, weakness, or unusual fatigue, weak pulse, or loss of appetite.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to use Furosemide Fresenius Kabi

If you think you have missed an injection, consult your doctor or nurse. Do not use a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, consult your doctor or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. During treatment with furosemide, the following adverse effects may appear:

Frequent

Hepatic encephalopathy in patients with hepatocellular insufficiency (symptoms include memory loss, seizures, mood changes, and coma

Uncommon (affects 1 to 10 out of every 1,000 patients):

• Skin rashes (including redness, itching, scaling), tendency to produce bruises or sensitivity to sunlight

Rare (affects 1 to 10 out of every 10,000 patients):

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

• Deafness (sometimes irreversible)

Very Rare (affects less than 1 in 10,000 patients):

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

• Anaphylaxis, a severe allergic reaction that can cause skin rash, swelling, difficulty breathing, and loss of consciousness. Seek medical help immediately.

• Kidney damage (interstitial nephritis)
• Very low levels of white blood cells in the blood (which can lead to life-threatening infections). Seek medical help immediately.

• Muscle problems, including muscle weakness and leg cramps
• Pain or discomfort when the injection is administered (especially after intramuscular administration)

• Systemic lupus erythematosus or worsening of it
• Changes in blood tests (blood lipids)
• Dizziness, tingling, or numbness
• High fever
• Blurred vision, confusion, drowsiness
• Dry mouth

Frequency Not Known (cannot be estimated from available data):

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

• Pancreatitis (abdominal pain) due to pancreas inflammation.

Also, the following may occur:

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

• Low potassium levels in the blood. It can cause muscle weakness, tingling, and numbness, slight inability to move a part of the body, feeling of dizziness, constipation, increased gas in the intestines, increased urine production, increased need to drink, irregular or slower heart rate. 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"). Extreme potassium losses can temporarily reduce intestinal movement or attention capacity, 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 through urine. Low sodium levels typically cause lack of interest, calf cramps, loss of appetite, weakness, drowsiness, confusion, and dizziness. Low calcium levels cause muscle cramps. Low magnesium levels can also cause muscle cramps or an irregular heart rate.

• 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 blood changes can cause jaundice (yellow skin, dark urine, fatigue).

• A decrease in body fluid volume, especially in the elderly. Severe fluid losses can increase the concentration of blood cells and the tendency to form blood clots.

• Premature babies may develop calcifications or kidney stones.
• In premature babies, the channel between the aorta and the hepatic artery, which is open in fetuses, may remain open.

Reporting of Adverse Effects

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

5. Conservation of Furosemide Fresenius Kabi

• Keep this medicine out of sight and reach of children.
• Do not use this medicine 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 away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Furosemide Fresenius Kabi

• The active ingredient is furosemide.

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

Appearance of the Product and Package Contents

Furosemide Fresenius Kabi is a clear 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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.

C/ Marina 16-18, 17th floor

Torre Mapfre

E-08005 Barcelona

Tel: +34 932256580

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) under the following names:

Date of Last Revision of this Prospectus: 05/2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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; the speed should not exceed 4 mg per minute and should never be given in association with other medications in the same syringe.

Intramuscular administration should be restricted to exceptional cases where oral 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 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 in 20 mg increments and not more frequently than every 2 hours.

In adults, the recommended maximum dose of furosemide is 1,500 mg.

Incompatibilities

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

Furosemide should not be mixed with strong acid solutions (pH below 5.5), such as solutions with 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. Discard any remaining content after use.

Product validity period: 3 years.

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

After dilution:

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 not used immediately, the use time, storage, and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at a temperature between 2°C and 8°C, unless the solution has been prepared in controlled and validated aseptic conditions.