Furosemidum Aurovitas

Leaflet accompanying the packaging: patient information

Furosemidum Aurovitas, 40 mg, tablets

Furosemidum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Furosemidum Aurovitas and what is it used for
• 2. Important information before taking Furosemidum Aurovitas
• 3. How to take Furosemidum Aurovitas
• 4. Possible side effects
• 5. How to store Furosemidum Aurovitas
• 6. Contents of the packaging and other information

1. What is Furosemidum Aurovitas and what is it used for

Furosemide belongs to a group of medicines called diuretics, which increase the amount of urine excreted by the kidneys, helping to remove excess fluids from the body. Diuretics are also known as water pills.
Furosemide is used to treat edema (fluid retention) caused by heart, kidney, or liver disorders, either alone or in combination with other antihypertensive medicines. It can also be used to treat pulmonary edema (fluid accumulation in the lungs) and mild to moderate hypertension (high blood pressure).

2. Important information before taking Furosemidum Aurovitas

When not to take Furosemidum Aurovitas

• if the patient is allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, swelling or difficulty breathing, swelling of the lips, face, throat, or tongue;
• if the patient is allergic to amiloride, sulfonamides, or sulfonamide derivatives, such as sulfadiazine or cotrimoxazole;
• if the patient has reduced intravascular volume or is dehydrated (with accompanying low blood pressure or without);
• if the patient has kidney failure - in some types of kidney failure, this medicine can still be taken - the doctor will decide;
• if the patient has severe liver disease (cirrhosis);
• if the patient has severe liver disease with brain disorders (hepatic encephalopathy);
• if the patient has an electrolyte imbalance (e.g., low potassium or sodium levels in the blood, as shown in a blood test);
• if the patient is unable to urinate;
• if the patient has a disease called Addison's disease, which can cause fatigue and weakness;
• if the patient is taking other medicines that affect potassium levels in the blood (see "Furosemidum Aurovitas and other medicines");
• if the patient is breastfeeding (see "Pregnancy, breastfeeding, and fertility", below).

Warnings and precautions

Before starting treatment with Furosemidum Aurovitas, the patient should discuss with their doctor or pharmacist if they:

• have low blood pressure, it is necessary to regularly check electrolyte levels and adjust the dose accordingly, as well as if the patient experiences dizziness when standing up;
• have diabetes (high blood sugar levels);
• are 65 years of age or older;
• have difficulty urinating;
• have gout, liver, or kidney disorders;
• have low protein levels in the blood (hypoproteinemia);
• have symptoms of acute porphyria, such as severe abdominal, back, or leg pain, as well as nausea, vomiting, or constipation with accompanying weakness of the arms and legs;
• are elderly and have dementia and are taking risperidone;
• have prostate disorders;
• experience dizziness or are dehydrated - such symptoms may occur if the patient has lost a lot of fluids due to vomiting, diarrhea, or very frequent urination, as well as if the patient has difficulty drinking or eating;
• will undergo a glucose tolerance test;
• have systemic lupus erythematosus (an autoimmune disease that affects the skin, bones, joints, and internal organs);
• are taking other diuretic medicines;
• plan to give this medicine to a child born prematurely;
• are elderly, taking other medicines that may cause low blood pressure, or have other conditions that may increase the risk of low blood pressure.

In case of doubt about any of the above conditions, the patient should consult their doctor or pharmacist before taking Furosemidum Aurovitas.

Athletes

It should be noted that this medicine contains furosemide, which may give positive results in doping tests.

Furosemidum Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines bought without a prescription, including herbal medicines. Furosemidum Aurovitas may affect the action of other medicines, and other medicines may affect the action of Furosemidum Aurovitas.
The doctor may recommend changing the dose and/or other precautions if the patient is taking any of the following medicines:

• Aliskiren - used to treat high blood pressure.

The following medicines may affect the action of Furosemidum Aurovitas and increase the risk of side effects:

• Medicines such as ramipril, enalapril, perindopril (called ACE inhibitors) or losartan, candesartan, irbesartan (so-called angiotensin II receptor antagonists). The doctor may change the dose or recommend stopping them.
• Medicines used to treat high blood pressure or heart disorders. The doctor may change the dose of the medicine.
• Medicines used to treat high blood pressure or prostate disorders, called alpha-adrenergic blockers, such as prazosin.
• Other medicines used to treat high blood pressure and other medicines used to remove excess fluid from the body, called diuretics, such as amiloride, spironolactone, acetazolamide, and metolazone.
• Medicines that affect potassium levels in the blood. These include potassium supplements, such as potassium chloride, or certain diuretics (e.g., triamterene).
• Medicines used to treat heart rhythm disorders, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol, and mexiletine.
• Sedatives and tranquilizers, e.g., chloral hydrate.
• Anesthetics used for general anesthesia to relax muscles during surgery. In case of anesthesia, the doctor or nurse should be informed that the patient is taking furosemide.
• Antidiabetic medicines - their action may be weakened when taking furosemide.
• Theophylline - used for wheezing or breathing difficulties.
• Phenytoin - used to treat epilepsy - may weaken the action of furosemide.
• Medicines used to treat mental disorders called psychoses, such as risperidone, amisulpride, sertindole, pimozide, and chlorpromazine. Pimozide should be avoided when taking furosemide.

The following medicines may increase the risk of side effects when taken with furosemide:

• Lithium - used to treat mental illnesses. To prevent side effects, the doctor may change the lithium dose and recommend checking lithium levels in the blood.
• Platinum compounds.
• Cisplatin - used to treat certain cancers.
• Digoxin - used to treat heart conditions. The doctor may change the dose of the medicine.
• Non-steroidal anti-inflammatory medicines (NSAIDs) - used as painkillers and to treat inflammatory conditions, such as aspirin, ibuprofen, ketoprofen, or indomethacin.
• Carbamazepine - used to treat epilepsy.
• Aminoglutethimide - used to treat breast cancer.
• Cyclosporine, tacrolimus, aldesleukin - used to prevent rejection of a transplanted organ.
• Moxisylyte used to treat Raynaud's syndrome.
• Medicines used to treat angina pectoris in inhalation or tablet form, which dissolve under the tongue, such as glyceryl trinitrate or isosorbide dinitrate.
• Methotrexate - used to treat skin, joint, or bowel diseases.
• Carbenoxolone and sucralfate - used to treat esophagitis and stomach ulcers.
• Reboxetine, amitriptyline, and phenelzine - used to treat depression.
• Amphotericin - used to treat fungal infections, in case of prolonged administration.
• Corticosteroids - used to treat inflammatory conditions, such as prednisolone.
• Atomoxetine used to treat attention deficit hyperactivity disorder (ADHD).
• Muscle relaxants, such as baclofen and tizanidine.
• Antihistamines used to treat allergies, such as cetirizine.
• Alprostadil, used to treat impotence in men.
• Estrogens and drospirenone, used as contraceptives or in hormone replacement therapy (HRT).
• Licorice - often found in cough medicines, in case of high doses.
• Probenecid (used with other medicines for HIV infection).
• Medicines used to treat infections, such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin, or cephalosporins in high doses.
• Substances used in injections before X-ray examinations (contrast agents used in radiology).
• Laxatives (used for constipation), used for a long time, such as bisacodyl or senna.
• Asthma medicines used in high doses, such as salbutamol, terbutaline sulfate, salmeterol, formoterol, or bambuterol.
• Medicines used to treat nasal congestion, such as ephedrine and xylometazoline.
• Potassium salts used in case of low potassium levels in the blood.
• Medicines used to treat Parkinson's disease, such as levodopa.
• Other diuretic medicines, such as bendroflumethiazide. The doctor may change the dose of the medicine.

High doses of furosemide given with levothyroxine may initially lead to a transient increase in free thyroid hormones, followed by a general decrease in total thyroid hormone levels.

Furosemidum Aurovitas with food, drink, and alcohol

While taking furosemide, the patient should avoid consuming alcohol, as it may further lower blood pressure.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• Do not take Furosemidum Aurovitas during pregnancy. The patient should contact their doctor before taking this medicine if they are pregnant, plan to become pregnant, or suspect they are pregnant.
• Do not breastfeed while taking Furosemidum Aurovitas, as small amounts may pass into breast milk. The patient should contact their doctor before taking this medicine if they are breastfeeding or plan to breastfeed.

In case of pregnancy or breastfeeding, before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

This medicine may cause dizziness or fainting. This may happen more often at the beginning of treatment, when changing the dose, or in combination with alcohol. In such cases, the patient should not drive or operate machinery.

Furosemidum Aurovitas contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Furosemidum Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Furosemidum Aurovitas

This medicine should always be taken according to the doctor's instructions. In case of doubt, the patient should consult their doctor or pharmacist.

• The doctor will determine the number of tablets needed based on the patient's condition. The tablets should be swallowed whole with a glass of water.
• The tablets should be taken daily, approximately at the same time, before a meal or as directed by the doctor.

Adults and elderly:
The recommended dose is one or two tablets in the morning. The doctor will inform the patient how many tablets to take.
Children and adolescents (under 18 years of age):

• initial dose:the doctor will determine the dose based on the child's body weight
• maximum dose:1 tablet per day.

Patients taking sucralfate (a medicine used to treat stomach ulcers)

Sucralfate should not be taken at the same time as furosemide. The patient should take sucralfate at least 2 hours before or after taking furosemide, as sucralfate may affect the action of furosemide.

Taking a higher dose of Furosemidum Aurovitas than recommended

In case of accidental overdose or if a child has taken any dose, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital, even if no symptoms are present. The patient should take the medicine packaging with them, so the doctor knows what medicine was taken. Overdose of furosemide may cause disorientation, inability to focus, lack of emotions or interest in anything.
It may also cause dizziness, a feeling of "emptiness" in the head, fainting (due to low blood pressure), irregular heartbeat, weakness or muscle cramps, and blood clots (causing pain and swelling in the affected area). It may also cause kidney or blood disorders.

Missing a dose of Furosemidum Aurovitas

The patient should take the missed dose as soon as they remember, unless it is evening, in which case they should skip the missed dose to avoid having to urinate during the night. The next dose should be taken at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Furosemidum Aurovitas

The patient should continue taking furosemide until their doctor recommends stopping treatment.

Blood tests

The doctor may perform blood tests to check if the levels of certain electrolytes are within the normal range.

In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following symptoms occur, the patient should stop taking the medicineand immediately consult their doctor:

• allergic reactions, such as itching, skin rash with intense itching and hives, fever, sensitivity to light, severe allergic reaction with (high) fever, red spots on the skin, joint pain, and/or eye inflammation, severe, acute reaction (allergic) with fever and blisters or peeling of the skin, as well as petechiae (small spots due to bleeding into the skin).
• acute pancreatitis, which is accompanied by severe abdominal pain radiating to the back.

Other possible side effects are listed according to their frequency, as follows:
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1,000 patients
Very rare: may affect up to 1 in 10,000 patients
Frequency not known: cannot be estimated from the available data

Common

Furosemide may cause increased fluid and electrolyte loss (e.g., more frequent urination) and symptoms that may occur include: thirst, headache, confusion, muscle cramps, increased muscle irritability, muscle weakness, heart rhythm disorders, and gastrointestinal disorders, such as discomfort in the stomach with vomiting or diarrhea.
Mild increase in uric acid levels (hyperuricemia), potentially leading to a gout attack.
Slightly increased creatinine levels in the blood.

Symptoms of sodium deficiency:

• muscle cramps in the legs
• loss of appetite
• apathy
• feeling of weakness
• dizziness
• drowsiness
• confusion

Symptoms of potassium deficiency:

• muscle weakness and loss of muscle tone (paralysis), increased urination
• heart rhythm disorders
• in case of significant potassium deficiency: effect on bowel function or disorientation, which may lead to coma

Symptoms of magnesium and calcium deficiency:

• increased muscle irritability
• heart rhythm disorders
• low blood pressure, causing concentration and reaction disorders, feeling of "emptiness" in the head, feeling of pressure in the head, headache, dizziness, drowsiness, feeling of weakness, vision disturbances, dryness of the mucous membranes, and inability to straighten up

Uncommon

• abnormal blood cell count, accompanied by bruising and a tendency to bleed
• reduced platelet count (thrombocytopenia)
• sensitivity to light
• involuntary urination
• in elderly patients - decreased intravascular volume, dehydration, and blood concentration, which may lead to the formation of blood clots
• hearing loss (sometimes irreversible)
• blistering of the skin or mucous membranes (pemphigoid)
• impaired glucose tolerance. This may manifest as latent diabetes.

Rare

• abnormal blood cell count (leukopenia), accompanied by increased susceptibility to infections
• increased levels of certain blood cells (eosinophils) in the blood
• feeling of crawling on the skin, itching, or tingling without cause
• life-threatening loss of consciousness
• hearing disorders and ringing in the ears, which are usually temporary
• vasculitis
• lichenoid reactions, characterized by small, itchy, red-purple, polygonal lesions on the skin, genitals, or mouth
• acute kidney failure
• kidney inflammation with blood in the urine, fever, and pain in the side or back - in case of urinary tract obstruction, urine retention may occur
• if the patient has a bladder disorder, prostate enlargement, or urethral stricture, sudden urinary retention may occur
• shock (significant low blood pressure, extreme pallor, anxiety, barely perceptible, rapid pulse, sweaty skin, impaired consciousness) due to sudden, significant vasodilation caused by an allergic reaction to certain substances
• fever
• mild mental disorders

Very rare

• anemia (a condition characterized by a lack of red blood cells)
• severe blood disorders (leukopenia) with accompanying high fever, severe sore throat, and mouth ulcers
• agranulocytosis
• certain liver function disorders
• brain function disorders (hepatic encephalopathy) may develop in patients with severe liver disease (liver failure)
• increased activity of certain liver enzymes

During treatment with furosemide, the levels of certain fats in the blood (cholesterol and triglycerides) may increase, but usually return to normal within 6 months.

Frequency not known

• acute generalized exanthematous pustulosis (acute drug rash with fever)
• dizziness, fainting, and loss of consciousness (due to symptomatic hypotension)
• decreased calcium or magnesium levels in the blood
• metabolic alkalosis
• Pseudo-Bartter syndrome in case of improper use and/or prolonged use of furosemide
• exacerbation or occurrence of systemic lupus erythematosus
• reports of rhabdomyolysis, often in cases with significant potassium deficiency (hypokalemia)
• formation of kidney stones (nephrocalcinosis/kidney stones) in premature infants.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Furosemidum Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" / "EXP:". The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Furosemidum Aurovitas contains

• The active substance of the medicine is furosemide. Each tablet contains 40 mg of furosemide.
• The other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethyl starch (type A), magnesium stearate.

What Furosemidum Aurovitas looks like and contents of the pack

Tablet.
White, uncoated, round (8 mm in diameter), flat, with beveled edges tablets with the inscription "F and 40" separated by a dividing line on one side and smooth on the other side.
The tablet can be divided into equal doses.
Furosemidum Aurovitas is packaged in blisters and HDPE bottles, in a cardboard box.
Pack sizes:
Blister: 10, 20, 30, 50, 60, 90, and 100 tablets.
HDPE bottle: 30, 50, 60, 90, 100, and 500 (only for hospital use or dose dispensing) tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

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

Netherlands:
Furosemide Auro 20 mg, tablets
Furosemide Aurobindo 40 mg, tablets
Poland:
Furosemidum Aurovitas
Portugal:
Furosemida Generis
Spain:
Furosemida Aurovitas 40 mg, comprimidos EFG

Date of last revision of the leaflet: 12/2024