Furosemide accord

Package leaflet: Information for the patient

Furosemid Accord, 10 mg/ml, solution for injection or infusion
Furosemidum
The name of the medicine is Furosemid Accord, 10 mg/ml, solution for injection or infusion, but in the remainder of this leaflet the name Furosemid Accord will be used.
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, please consult your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Furosemid Accord is and what it is used for

The active substance in Furosemid Accord is furosemid.
Furosemid belongs to a group of medicines called diuretics. Furosemid increases the amount of urine produced by the body, which helps relieve symptoms caused by excess fluid in the body.
Your doctor prescribes Furosemid Accord for one of the following reasons:

• when rapid and effective removal of excess fluid is required;
• when the patient cannot take this type of medicine orally or in emergency situations;
• if the patient has excess fluid around the heart, lungs, liver, or kidneys;
• in cases of very high blood pressure which may lead to life-threatening conditions (hypertensive crisis). Furosemid Accord may only be administered under medical supervision.

2. Important information before using Furosemid Accord

When not to take Furosemid Accord:

• if the patient is allergic (hypersensitive) to furosemide or to 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 large amounts of fluid, e.g. due to severe diarrhoea or vomiting);
• in case of kidney failure and absence of urine production despite administration of furosemide;
• in case of kidney failure caused by toxic substances affecting the kidneys or liver;
• if the patient has significantly low levels of potassium or sodium in the blood;
• if the patient is in a coma caused by liver failure;
• during breastfeeding. In case of any further doubts regarding the use of the medicine, consult a doctor or pharmacist.

When to exercise special caution with Furosemid Accord:

• if the patient has urinary disorders caused by urinary tract obstruction (e.g. related to enlarged prostate);
• if the patient has diabetes;
• if the patient has low blood pressure or episodes of sudden drop in blood pressure (e.g. coronary or cerebral vasospasm);
• if the patient has liver disease (e.g. cirrhosis);
• if the patient has kidney function disorders (e.g. nephrotic syndrome);
• if the patient is dehydrated (fluid loss due to severe diarrhoea or vomiting), which may lead to collapse or thrombosis;
• if the patient has gout (joint pain or inflammation) caused by high levels of uric acid (a metabolic product) in the blood;
• if the patient has an inflammatory disease called systemic lupus erythematosus (SLE);
• if the patient has hearing disorders;
• if the patient is using sorbitol (a sugar substitute for diabetic patients);
• if the patient has porphyria (a disorder characterized by impaired production of oxygen-binding substances in red blood cells and presence of purplish discoloration of urine);
• if the patient has increased skin sensitivity to sunlight (photosensitivity);
• if the patient is elderly, takes other medications that may lower blood pressure, or has other conditions increasing the risk of low blood pressure.

Administration of furosemide to premature infants may lead to formation of urinary stones, renal calcification, or a heart defect in which the blood vessel connecting the pulmonary artery with the aorta, normally open during fetal life, fails to close (patent ductus arteriosus).

If any of the above conditions apply to the patient, the doctor may wish to change the treatment or provide special advice. The doctor may recommend regular monitoring of blood glucose or uric acid levels. The doctor may also recommend monitoring levels of important electrolytes such as sodium and potassium, particularly if vomiting or diarrhoea occurs.

Furosemid Accord and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription. This is important because some medicines should not be used together with furosemide injection solution or infusion. In particular, inform your doctor or pharmacist if the patient is taking:

• lithium, used in mood disorders, because concomitant use with furosemide may enhance its effects and adverse reactions. The doctor will recommend concurrent use only if absolutely necessary and will monitor blood lithium levels and may adjust the dose;
• heart medications such as digoxin. The doctor may adjust the dose;
• medications used to treat high blood pressure, including thiazide diuretics (e.g. bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (e.g. lisinopril), angiotensin II receptor antagonists (e.g. losartan), because furosemide may cause excessive lowering of blood pressure. The doctor may adjust the dose of furosemide;
• cholesterol- and lipid-lowering drugs such as cholestyramine, colestipol, and fibrates (e.g. clofibrate), because the effect of furosemide may be reduced;

• antidiabetic drugs such as metformin and insulin, because blood glucose levels may increase;
• anti-inflammatory drugs, including NSAIDs (e.g. aspirin and celecoxib), because they may reduce the effectiveness of furosemide. High doses of painkillers (salicylates) may increase furosemide's adverse effects;
• anti-inflammatory and antiallergic drugs such as corticosteroids, carbenoxolone (used to treat gastric ulcers), or laxatives. When used together with furosemide, they affect blood levels of sodium and potassium. The doctor will recommend monitoring blood potassium levels;
• drugs administered by injection during surgical procedures, including tubocurarine, curare derivatives, and succinylcholine;
• chloral hydrate, used for sleep disorders (in isolated cases, intravenous administration of furosemide within 24 hours before chloral hydrate may cause sudden facial flushing, excessive sweating, restlessness, nausea, increased blood pressure, and rapid heartbeat). For this reason, concomitant use of furosemide and chloral hydrate is not recommended;
• phenytoin or phenobarbital, used to treat epilepsy, because the effect of furosemide may be reduced;
• theophylline, used to treat asthma, because furosemide may enhance its effect;
• antibiotics such as cephalosporins, polymyxins, aminoglycosides or quinolones, and other drugs affecting kidney function such as immunosuppressants, iodinated contrast agents, foscarnet or pentamidine, because furosemide may enhance their adverse effects;
• probenecid, used with certain other drugs to protect the kidneys, because it may reduce the effect of furosemide;
• organic platinum compounds, used in the treatment of certain cancers, because furosemide may enhance their adverse effects;
• methotrexate, used to treat certain cancers and severe arthritis, because it may reduce the effect of furosemide;
• drugs that increase blood pressure (pressor amines), because concomitant use of furosemide may reduce their effectiveness;
• aminoglutethimide, used to suppress corticosteroid production (Cushing's syndrome), because it may enhance adverse effects of furosemide;
• carbamazepine, used to treat epilepsy or schizophrenia, because it may enhance adverse effects of furosemide;
• sucralfate, used to treat gastric ulcers. Furosemide should not be taken within two hours after sucralfate, as its effect may be reduced;
• cyclosporine, used to prevent transplant rejection, because there is a risk of developing gout (joint pain);
• drugs affecting heart function such as amiodarone, sotalol, dofetilide, ibutilide, because furosemide may enhance their effect;
• risperidone, used to treat psychiatric disorders;
• other diuretics such as bendroflumethiazide and metolazone;
• thyroid medications such as levothyroxine.

Furosemid Accord with food, drink and alcohol

Food is not expected to affect the action of this medicine when administered intravenously. Prolonged moderate or excessive alcohol consumption increases blood pressure and reduces the effectiveness of antihypertensive drugs. Patients may experience dizziness and fainting shortly after drinking alcohol during treatment.

Pregnancy and breastfeeding

Furosemide should not be used during pregnancy unless there are clear medical indications for such treatment. Furosemide passes into human milk; therefore, breastfeeding should not be undertaken during treatment with this medicine.

If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using furosemide or any other medicine.

Driving and operating machinery

Do not drive or operate machinery, as furosemide may impair concentration.

Important information about certain ingredients of Furosemid Accord

Furosemid Accord, 10 mg/ml, solution for injection or infusion (2 ml, 4 ml and 5 ml)
The medicine contains less than 1 mmol of sodium (23 mg) per ampoule, meaning the medicine is considered "sodium-free". This should be taken into account in patients controlling sodium intake in their diet.

Furosemid Accord, 10 mg/ml, solution for injection or infusion (25 ml)
The medicine contains approximately 93 mg of sodium per vial. This should be taken into account in patients controlling sodium intake in their diet.

3. How to use Furosemid Accord

Furosemid Accord is administered:

• by slow intravenous injection (intravenously), or
• in exceptional cases, into the muscle (intramuscularly). The required dose, timing of administration, and duration of treatment will be determined by the physician. This will depend on the patient's age, body weight, medical history, other medications being taken, and the type and severity of the condition being treated. General
• Parenteral administration of furosemide is indicated when oral administration is not possible or ineffective (e.g. in cases of reduced intestinal absorption), or when a rapid effect is required.
• When parenteral administration is necessary, a transition to oral administration should be made as soon as possible.
• To achieve optimal efficacy and prevent compensatory reactions, continuous infusion of furosemide is generally preferred over repeated bolus (rapid) injections.
• If continuous infusion of furosemide is not feasible during continuation of treatment after one or more bolus doses, a regimen using low doses administered at short intervals (approximately every 4 hours) is preferred over regimens involving large bolus doses given at longer intervals.
• Furosemide should be administered intravenously by slow injection or infusion. The infusion rate must not exceed 4 mg per minute, and the drug must not be mixed with other medications in the same syringe. Dosage Adults
• In the absence of a need to reduce the dose (see below), the recommended initial dose for adults and adolescents over 15 years of age is 20 mg to 40 mg of furosemide administered intravenously (or, in exceptional cases, intramuscularly); the maximum dose will vary depending on the individual patient's response.
• If higher doses are required, they should be increased by 20 mg increments and administered no more frequently than every two hours.
• The recommended maximum daily dose of furosemide in adults is 1500 mg.
• In certain circumstances, higher initial or maintenance doses may be required, depending on the patient's clinical condition. This will be determined by the physician. If such doses are needed, they may be administered via continuous infusion. Children and adolescents (up to 18 years)
• Experience with the use of furosemide in children and adolescents is limited. Intravenous administration of furosemide in children and adolescents under 15 years of age is recommended only in exceptional cases.
• Dosage should be adjusted according to body weight, with a recommended dose of 0.5 to 1 mg/kg body weight per day, up to a maximum total daily dose of 20 mg. Transition to oral treatment should be made as soon as possible. Renal impairment
• In patients with severe renal impairment (serum creatinine concentration > 5 mg/dl), the infusion rate should not exceed 2.5 mg of furosemide per minute. Elderly patients
• The recommended initial dose is 20 mg per day. The dose should be gradually increased until the desired response is achieved. Administration of a higher than recommended dose of Furosemid Accord If a patient suspects having received too high a dose of furosemide, they should immediately contact a doctor or other medical personnel. Symptoms that may occur after an overdose include: dry mouth, increased thirst, irregular heartbeat, mood changes, muscle cramps or pain, nausea or vomiting, feeling tired or weak, weak pulse, or loss of appetite. Missed dose of Furosemid Accord If a patient suspects they may have missed a dose of furosemide, they should immediately contact a doctor or other medical personnel.

While using Furosemid Accord
If serious allergic reactions occur, such as facial and (or) throat swelling or fever, the doctor or other medical personnel should be notified immediately.
Discontinuation of Furosemid Accord
If treatment is stopped earlier than prescribed by the doctor, excess fluid may significantly affect the heart, lungs, and kidneys.
If there are any further questions about the use of this medicine, consult a doctor or other medical personnel.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You should immediately contact your doctor or nurse if you notice any of the following serious side effects – urgent treatment may be required.
Very common (affects more than 1 in 10 people)

• Increased thirst, headache, dizziness or feeling lightheaded, fainting, disorientation, muscle or joint pain or weakness, cramps, stomach upset or irregular heartbeat. These may be symptoms of dehydration or disturbances in the levels of certain chemicals in the body. Severe dehydration may lead to thickening of the blood or blood clots.

Common (affects less than 1 in 10 people)

• In patients with existing liver disorders, a more severe condition called hepatic encephalopathy may occur. Symptoms include: memory disturbances, tremors, mood changes and coma.

Rare (affects less than 1 in 1,000 people)

• Allergic reaction. Symptoms include: difficulty breathing, swelling, dizziness, cold, clammy skin, paleness, rapid heartbeat and loss of consciousness.
• Easy bruising, more frequent infections, unusual weakness or fatigue. Furosemide may affect blood cell counts, leading to serious blood disorders.
• Inflammation of blood vessels (vasculitis). Symptoms may include: fever, loss of appetite, weight loss and pain.
• Kidney inflammation with blood in the urine, fever and lower back pain (interstitial nephritis). Rarely, this may lead to acute kidney failure.

Very rare (affects less than 1 in 10,000 people)

• Severe abdominal or back pain. These may be symptoms of pancreatitis.

Frequency not known

• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• Difficulty passing urine. This may be a sign of acute urinary retention.
• Kidney disease with increased calcium levels in the kidneys. This may be a sign of nephrocalcinosis.
• Blood in the urine or pain in the lower abdomen or groin. This may be a sign of kidney stones.
• Blisters or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This may be Stevens-Johnson syndrome. In the more severe form of this condition, known as toxic epidermal necrolysis, layers of the epidermis may peel off, leaving large areas of exposed skin all over the body.
• Blood clots; symptoms may include: sudden shortness of breath, chest pain, swelling of a leg or arm, pain or tenderness in a leg, redness or discoloration of a leg or arm, sudden vision disturbances.
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).
• Lichenoid reaction with small, itchy, reddish-purple, polygonal skin lesions appearing on the skin, genital organs or in the mouth.
• Muscle weakness, tenderness or pain. Malaise or high fever. Rhabdomyolysis, a rare but serious, potentially life-threatening condition.

If any of the following side effects occur, you should contact your doctor as soon as possible:
Very common (affects more than 1 in 10 people)

• Headache or dizziness upon standing quickly. Difficulty concentrating, slowed reactions, drowsiness or weakness, visual disturbances, dry mouth. These may be caused by low blood pressure.
• Changes in levels of certain minerals (such as calcium, potassium, magnesium, sodium and chlorides) essential for normal body function. Symptoms include: increased thirst,

headache, low blood pressure, disorientation, muscle cramps, muscle weakness, rapid or
irregular heartbeat and stomach upset.
Common (affects less than 1 in 10 people)

• Gout caused by high levels of uric acid in the blood, manifesting as painful joint inflammation.

Uncommon (affects less than 1 in 100 people)

• Rash, skin itching, skin discoloration, purple spots resembling bruises, numerous blisters on the skin, target-like lesions, skin peeling and increased sensitivity to sunlight
• Hearing disturbances
• Deafness (sometimes irreversible)

Rare (affects less than 1 in 1,000 people)

• Tingling or numbness of the skin

Very rare (affects less than 1 in 10,000 people)

• Ringing in the ears (tinnitus). This particularly affects people with existing kidney disorders.
• Decreased blood cell counts, which may lead to easy bruising, increased risk of infections, paleness, weakness or shortness of breath (anaemia)

Frequency not known

• Changes in the concentration of certain minerals (e.g. sodium or chloride) in the urine
• Dizziness, fainting or loss of consciousness (caused by symptomatic hypotension or other causes), headache
• Exacerbation of systemic lupus erythematosus (a disease in which the body's immune system attacks healthy tissue, causing symptoms such as joint swelling, fatigue and rash)

You should inform your doctor or pharmacist if any of the following side effects become severe or persist for more than a few days, or if you experience any side effects not listed in this leaflet.
Common (affects less than 1 in 10 people)

• Passing more urine than usual. This usually occurs 1 or 2 hours after taking the medicine.

Uncommon (affects less than 1 in 100 people)

• Nausea
• In patients with diabetes, control of blood glucose levels may become more difficult.

Rare (affects less than 1 in 1,000 people)

• Diarrhoea and vomiting
• Fever

Very rare (affects less than 1 in 10,000 people)

• A condition involving bile stasis in the liver (cholestasis). Symptoms include: jaundice, rash or fever, and darkening of the urine.
• Increased liver enzyme activity

Frequency not known

• Pain at the injection site. This occurs when the medicine is administered intramuscularly.

Blood tests
Furosemide may alter liver enzyme activity and levels of lipids such as cholesterol and triglycerides.
Blood tests may reveal changes in kidney function, indicating significant worsening of kidney performance.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Furosemid Accord

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Store ampoules/vials in the outer cardboard box to protect from light.
For single use only. Use immediately after first opening. Do not use this medicine after the expiry date stated on the ampoule and carton after "EXP". The expiry date refers to the last day of the stated month.
For storage conditions of the reconstituted/diluted medicine, see: Information below is intended solely for medical personnel or healthcare professionals.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Furosemid Accord contains
The active substance is furosemide.
1 ml of solution contains 10 mg of the active substance – furosemide.
2 ml of sterile injection solution contains 20 mg of furosemide.
4 ml of sterile injection solution contains 40 mg of furosemide.
5 ml of sterile injection solution contains 50 mg of furosemide.
25 ml of sterile injection solution contains 250 mg of furosemide.
The other ingredients are sodium chloride, sodium hydroxide, and water for injections.

What Furosemid Accord looks like and contents of the pack
Furosemid Accord is a colourless or almost colourless sterile solution for injection or infusion.
20 mg in 2 ml: an amber glass ampoule with two white rings and a white OPC dot, containing 2 ml of solution.
40 mg in 4 ml: a 5 ml amber glass type I ampoule with a white snap-off closure and a blue ring, containing 4 ml of solution.
50 mg in 5 ml: a 5 ml amber glass type I ampoule with a white snap-off closure and a white ring, containing 5 ml of solution.
250 mg in 25 ml: a vial made of amber glass type I, closed with a chlorobutyl rubber stopper and an aluminium flip-off cap with a red overseal, containing 25 ml of solution.

Pack sizes:
Ampoules: 5, 10 x 2 ml
Ampoules: 1, 5, 10 x 4 ml
Ampoules: 5, 10 x 5 ml
Vials: 1, 5, 10 x 25 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: + 48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice

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

The following information is intended for healthcare professionals only.
Any unused solution should be disposed of in accordance with local regulations.
Instructions for use
For single use only.
Do not use this medicinal product after the expiry date stated on the ampoule and outer carton after "EXP". The expiry date refers to the last day of the stated month.
Diluted Furosemid Accord solution at a concentration of 1 mg/ml is compatible with 0.9% NaCl solution and sodium lactate Ringer's solution for infusion for 24 hours.
Dilution of the injection/infusion solution must be carried out under aseptic conditions.
Examine visually for particulate matter and discoloration prior to use.
The solution should be used only if it is clear and free of particles.
Any unused product or waste material derived from it must be disposed of in accordance with local regulations. Do not use the product if visible particles are present.
For single use only.
After use, any remaining product should be discarded.
Furosemid Accord 10 mg/ml solution for injection or infusion must not be mixed with other medicinal products in the same infusion bottle.
Storage information
Do not store above 25°C.
Do not freeze.
Ampoules/vials should be stored in the outer cardboard container to protect from light.
After first opening: after opening, the product should be used immediately.
After dilution: chemical and physical stability of the medicinal product has been demonstrated for 24 hours at 25°C, when protected from light.