Furosemide Norameda

Package Leaflet: Information for the Patient

Furosemide Norameda, 10 mg/mL, Solution for Injection/Infusion

Furosemide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 1. What Furosemide Norameda is and what it is used for
• 2. Important information before using Furosemide Norameda
• 3. How to use Furosemide Norameda
• 4. Possible side effects
• 5. How to store Furosemide Norameda
• 6. Contents of the pack and other information

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

The active substance of Furosemide Norameda, 10 mg/mL, solution for injection/infusion is furosemide, which belongs to a group of medicines called diuretics. Furosemide increases the amount of urine produced by the body, which helps to relieve symptoms caused by excess fluid in the body.
Your doctor may prescribe Furosemide Norameda if:

• rapid and effective removal of excess fluid is necessary,
• the patient cannot take this medicine orally or in emergency situations,
• the patient has excess fluid around the heart, lungs, liver, or kidneys. Furosemide in the form of a solution for injection/infusion can only be administered under medical supervision.

2. Important information before using Furosemide Norameda

When not to use Furosemide Norameda:

• if the patient is allergic to furosemide or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to sulfonamide antibiotics,
• in case of significant dehydration (loss of a significant amount of fluid, e.g., due to severe diarrhea or vomiting),
• in case of renal failure and lack of urine production, despite the administration of furosemide,
• in case of renal failure caused by toxic substances to the kidneys or liver,
• if the patient has very low levels of potassium or sodium in the blood,
• if the patient has renal failure.,
• during breastfeeding,
• if the patient is in a coma caused by liver failure.

Warnings and precautions

Before starting treatment with Furosemide Norameda, discuss it with your doctor, pharmacist, or nurse.
Particular caution should be exercised when using Furosemide Norameda if:

• the patient has urinary disorders caused by narrowing of the urinary tract (e.g., due to prostate enlargement),
• the patient has diabetes,
• the patient has low blood pressure or experiences sudden drops in blood pressure,
• the patient has liver disease (e.g., cirrhosis),
• the patient has kidney function disorders (e.g., nephrotic syndrome),
• the patient is dehydrated (loss of fluid due to severe diarrhea or vomiting), which can cause collapse or thrombosis,
• the patient has gout (joint pain or inflammation) caused by high levels of uric acid (a metabolic product) in the blood,
• the patient has an inflammatory disease called systemic lupus erythematosus (SLE),
• the patient has hearing disorders,
• the patient uses sorbitol (a sugar substitute for diabetic patients),
• the patient has porphyria (a disease in which the production of a substance that binds oxygen in red blood cells is disrupted and the urine turns purple),
• the patient has increased skin sensitivity to sunlight (photosensitivity). If any of the above points apply to the patient, the doctor may recommend changing the treatment or providing special advice. The doctor may recommend regular monitoring of blood sugar or uric acid levels. The doctor may also recommend monitoring the levels of important electrolytes, such as sodium and potassium, which is particularly important in case of vomiting or diarrhea.

Children

Administration of furosemide to premature infants may cause kidney stones or kidney calcification. In premature infants, the duct between the pulmonary artery and the aorta, which is open in the fetus, may remain open after birth.

Furosemide Norameda and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. This is important because some medicines should not be used with Furosemide Norameda.
In particular, tell your doctor or pharmacist if you are taking:

• Lithium, used in mood disorders, as concurrent use with furosemide may increase the effect and side effects. The doctor will monitor lithium levels in the blood and may recommend a dose change.
• Cardiac glycosides, such as digoxin - the doctor may recommend a dose change.
• Medicines used to treat high blood pressure, including thiazide diuretics (such as bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (e.g., lisinopril), and angiotensin II receptor antagonists (e.g., losartan), as furosemide may cause excessive lowering of blood pressure. The doctor may recommend a dose change of furosemide.
• Cholesterol and lipid-lowering medicines, such as colestyramine, colestipol, and fibrates (e.g., clofibrate), as the effect of furosemide may be reduced.
• Medicines used to treat diabetes, such as metformin and insulin, as blood sugar levels may increase.
• Anti-inflammatory medicines, including non-steroidal anti-inflammatory drugs (NSAIDs, such as diclofenac, ibuprofen, celecoxib), as they may reduce the effect of furosemide. High doses of painkillers, such as acetylsalicylic acid (aspirin), may increase the side effects of furosemide.
• Anti-inflammatory and anti-allergic medicines, including corticosteroids (such as prednisolone, dexamethasone), carbenoxolone (used to treat stomach ulcers), or laxatives, as they may affect potassium levels in the blood when used with furosemide. The doctor will recommend monitoring potassium levels in the blood.

Medicines given by injection during surgical procedures, including tubocurarine, curare derivatives, and succinylcholine.

• Chloral hydrate (used in sleep disorders) - it is not recommended to use furosemide injections and chloral hydrate at the same time, as side effects such as sudden facial flushing, excessive sweating, anxiety, nausea, increased blood pressure, and rapid heart rate may occur.
• Phenytoin or phenobarbital, used to treat epilepsy, as the effect of furosemide may be reduced.
• Carbamazepine, used to treat epilepsy or schizophrenia, as it may increase the side effects of furosemide.
• Theophylline, used to treat asthma, as furosemide may increase its effect.
• Medicines that may affect kidney function, such as antibiotics (cephalosporins, aminoglycosides, polymyxins, quinolones), immunosuppressants, foscarnet (used to treat viral infections), or iodine-based contrast agents, as furosemide may increase their harmful effect on the kidneys.
• Probenecid, used with other medicines to protect the kidneys, as it may reduce the effect of furosemide.
• Methotrexate, used to treat certain cancers and severe arthritis, as it may reduce the effect of furosemide.
• Medicines that increase blood pressure (vasopressors, such as adrenaline, noradrenaline), as concurrent use with furosemide may reduce their effect.
• Aminoglutethimide, used to treat Cushing's syndrome, as it may increase the side effects of furosemide.
• Sucralfate, used to treat stomach ulcers - do not take furosemide within 2 hours of taking sucralfate, as the effect of furosemide may be reduced.
• Cyclosporine, used to prevent organ rejection, as the risk of gouty arthritis (joint pain) may increase.
• Cisplatin, used to treat cancer, or aminoglycoside antibiotics, such as kanamycin, gentamicin, and tobramycin, as furosemide may increase their side effects on hearing (ototoxicity), especially in patients with kidney function disorders.
• Medicines that affect heart rhythm, such as amiodarone, sotalol, dofetilide, ibutilide, as furosemide may increase their effect.
• Risperidone, used to treat mental disorders.

Furosemide Norameda with food, drink, and alcohol

Food does not affect the action of this medicine when given intravenously. Chronic moderate or excessive alcohol consumption increases blood pressure and reduces the effectiveness of antihypertensive medicines. Patients may experience dizziness or fainting soon after drinking alcohol during treatment.

Pregnancy and breastfeeding

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 should not be used during pregnancy unless it is absolutely necessary. Furosemide passes into breast milk, so breastfeeding should be avoided during treatment with this medicine.

Driving and using machines

The ability to drive and use machines may be reduced during treatment with furosemide, especially at the beginning of treatment, when changing the medicine, or in combination with alcohol. If you experience disturbances in attention during treatment with furosemide, do not drive or operate machinery.

Furosemide Norameda contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per dose (40 mg), which means that the medicine is considered "sodium-free".

3. How to use Furosemide Norameda

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.
The medicine is administered by a doctor or nurse:

• by slow injection into a vein (intravenously) or
• in exceptional cases, into a muscle (intramuscularly).

The doctor will determine the dose suitable for you, the time of administration, and the duration of treatment. This will depend on your age, weight, medical history, other medicines you are taking, and the type and severity of the disease.

Adults

The recommended dose is 20 mg to 40 mg of furosemide. If a higher dose is required, the doctor may administer an additional 20 mg by injection. Injections are usually repeated every 2 hours until the desired fluid loss is achieved. In some cases, instead of injection, the doctor may recommend continuous intravenous infusion (drip). The recommended maximum daily dose of furosemide is 1500 mg.

Use in children and adolescents over 15 years

In children (children under 15 years are treated with furosemide only in special cases), the dose is determined based on body weight. The initial dose is 0.5-1 mg/kg body weight per day, up to a maximum total daily dose of 20 mg. The usual initial dose in adolescents over 15 years is 20 to 40 mg.
Kidney function disorders
In patients with severe kidney function disorders (serum creatinine > 5 mg/dl), it is recommended not to exceed an infusion rate of 2.5 mg of furosemide per minute.
Elderly patients
The recommended initial dose is 20 mg per day. The dose is increased gradually to achieve the desired fluid loss.
Weight loss due to fluid loss should not exceed 1 kg of body weight per day.

Using a higher dose of Furosemide Norameda than recommended

If you think you have received too much of this medicine, contact your doctor immediately. Symptoms that may occur after taking too much of this medicine include: dryness of the mucous membranes, increased thirst, irregular heartbeat, mood changes, muscle cramps or pain, nausea or vomiting, feeling of fatigue or weakness, barely perceptible pulse or loss of appetite.

Missing a dose of Furosemide Norameda

If you think you have missed a dose, contact your doctor or nurse.

Stopping treatment with Furosemide Norameda

If you stop treatment before your doctor recommends, excess fluid may have a serious impact on your heart, lungs, or kidneys.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must immediatelyinform your doctor or nurse if you notice any of the following symptoms:
Anaphylaxis, a severe allergic reaction, which can cause a rash, swelling of the face, lips, tongue, or throat, difficulty breathing, and loss of consciousness.

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

• skin rashes (including itching, redness, peeling), easy bruising, or increased sensitivity of the skin to sunlight,
• blood disorders that can cause bleeding (with increased risk of bleeding).

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

• nausea or vomiting, diarrhea, constipation, loss of appetite, feeling of discomfort in the mouth and stomach,
• hearing disorders and tinnitus (ringing in the ears), especially in patients with kidney function disorders,
• kidney damage (interstitial nephritis),
• very low white blood cell count (which can cause life-threatening infections) - you should immediately contact your doctor if you have an increased risk of infection or are unable to fight them in the usual way,
• muscle disorders, including muscle cramps or weakness,
• pain or discomfort at the injection site (especially after intramuscular injection),
• possibility of developing or worsening a condition called systemic lupus erythematosus,
• changes in blood test results, including cholesterol and triglyceride levels,
• feeling of numbness or tingling of the skin,
• dizziness,
• high fever,
• blurred vision, disorientation, drowsiness,
• dryness of the mucous membranes.

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

• severe muscle disorders, including tremors, cramps, or tetany (also known as tetanus),
• blood disorders that can cause anemia and inability to fight infections,
• pancreatitis, causing severe abdominal pain,
• liver function disorders or changes in liver enzyme activity in the blood, which can cause jaundice (yellowing of the skin, dark urine, fatigue).

Other side effects may also occur:

• at the beginning of treatment, low blood pressure, which can cause fainting or dizziness; it can also cause a feeling of pressure in the head, joint pain, blood clots, or circulatory collapse (shock),
• low potassium levels in the blood, which can cause muscle weakness, tingling, or numbness, slight difficulty moving parts of the body, vomiting, constipation, bloating, increased urine production, increased thirst, slow or irregular heartbeat,
• low sodium, calcium, and magnesium levels in the blood, which can occur due to increased excretion of sodium, calcium, and magnesium in the urine; low sodium levels can cause indifference, muscle cramps (which can also be related to low calcium or low magnesium levels in the blood), decreased appetite, weakness, drowsiness, vomiting, and disorientation,
• gout may occur or worsen,
• urination difficulties may occur or worsen,
• diabetes may occur or worsen,
• reduced fluid volume in the body, especially in elderly patients - significant fluid loss can cause blood thickening, leading to the formation of blood clots.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, email: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Furosemide Norameda

There are no special storage instructions for this medicine.
Store the ampoules in the outer packaging to protect them from light. Do not freeze.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule after "EXP". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
For single use only. Use immediately after opening. Discard any remaining contents.
Information on the storage of the diluted medicinal product is provided in section 6 "Information intended for healthcare professionals only".

6. Contents of the pack and other information

What Furosemide Norameda contains

The active substance is furosemide.
The other ingredients are sodium hydroxide, sodium chloride, concentrated hydrochloric acid, and water for injections.

What Furosemide Norameda looks like and contents of the pack

Furosemide, 10 mg/mL, solution for injection/infusion is a clear, colorless or almost colorless solution, essentially free from visible particles.
It is available in orange glass ampoules (type I) containing 2 mL or 5 mL of solution.
Each carton contains 10 or 25 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
UAB Norameda
Meistrų 8a, Vilnius, LT-02189, Lithuania
Manufacturer / importer:
UAB Norameda
Meistrų 8a, Vilnius, LT-02189, Lithuania
Tramco Sp. z o.o.
ul. Wolska 14, Wolskie, Płochocin 05-860, Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia
Furosemide Norameda
Finland
Furosemide Norameda 10 mg/ml injektioneste, liuos
Hungary
Furosemide Norameda 10 mg/ml oldatos injekció
Latvia
Furosemide Norameda 10 mg/ml ml šķīdums injekcijām
Lithuania
Furosemide Norameda 10 mg/ml injekcinis tirpalas
Poland
Furosemide Norameda
Slovakia
Furosemide Norameda 10 mg/ml injekčný roztok

Date of last revision of the package leaflet: 03/2018

Information intended for healthcare professionals only:

The ampoule contains a single dose.
Use immediately after opening. Discard any remaining contents. Do not use the solution if it contains visible particles.
Due to the risk of precipitation, furosemide should not be mixed with strongly acidic solutions (pH less than 5.5), such as solutions containing ascorbic acid, noradrenaline, and adrenaline.
Furosemide Norameda, 10 mg/mL, solution for injection/infusion should not be mixed with any other medicines.
After dilution:
Furosemide Norameda, 10 mg/mL, solution for injection/infusion can be mixed with neutral or slightly alkaline solutions with a pH of 7-10, such as 0.9% sodium chloride solution and Ringer's solution with lactate in non-PVC bags.
Chemical and physical stability during use has been demonstrated for 48 hours after dilution at 25°C and at a temperature of 2-8°C, protected from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage time and conditions, usually no longer than 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.