FUROSEMIDE AUROVITAS 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Furosemide Aurovitas 40 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Furosemide Aurovitas and what is it used for
2. What you need to know before you take Furosemide Aurovitas
3. How to take Furosemide Aurovitas
4. Possible side effects
5. Storage of Furosemide Aurovitas
6. Contents of the pack and other information

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

Furosemide belongs to a group of medicines called diuretics, which increase the amount of urine that passes through the kidneys, helping to eliminate excess fluids from the body. Diuretic tablets are also known as "water tablets".

Furosemide tablets are used to treat edema (fluid retention) caused by heart, kidney, or liver disorders, alone or in combination with other antihypertensive agents. The tablets can also be used to treat pulmonary edema (fluid accumulation in the lungs) and mild to moderate hypertension (high blood pressure).

2. What you need to know before you take Furosemide Aurovitas

Do not take Furosemide Aurovitas:

• If you are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include: rash, inflammation or breathing problems, swelling of the lips, face, throat or tongue.
• If you are allergic to amiloride, sulfonamides or sulfonamide derivatives, such as sulfadiazine or cotrimoxazole.
• If you have been told that you have a low blood volume or are dehydrated (with or without low blood pressure).
• If a doctor has told you that you have kidney failure. In some types of kidney failure, it is still suitable to take this medicine. Your doctor will decide.
• If you have severe liver problems (cirrhosis).
• If you have severe liver disease along with brain disorders (hepatic encephalopathy).
• If you have an electrolyte deficiency (e.g., low potassium and sodium levels in the blood, as shown in a blood test).
• If you do not urinate.
• If you have a disease called "Addison's disease". It can make you feel tired or weak.
• If you are taking other medicines that alter the amount of potassium in your blood (see "Taking Furosemide Aurovitas with other medicines").
• If you are breastfeeding (see "Pregnancy, breastfeeding and fertility" below).

Warnings and precautions

Consult your doctor or pharmacist before starting to take furosemide if:

• You have low blood pressure, your electrolyte balance must be regularly monitored and the dose adjusted accordingly, or if you feel dizzy when standing up.
• You have diabetes (high blood sugar).
• You are 65 years or older.
• You have difficulty urinating.
• You have gout and liver or kidney problems.
• You have low protein levels in the blood (hypoalbuminemia).
• You experience symptoms of acute porphyria that may include severe abdominal, back or thigh pain. You may also experience weakness in your arms and legs, nausea, vomiting or constipation.
• You are an elderly patient with dementia and are also being treated with risperidone.
• You have prostate problems.
• You feel dizzy or dehydrated. This occurs if you have lost a lot of water by vomiting, have had diarrhea or are urinating frequently. It also occurs if you have problems drinking or eating.
• You are going to have a glucose test.
• You have systemic lupus erythematosus (a disease of the immune system that affects the skin, bones, joints, and internal organs).
• You are taking any other diuretic.
• You are going to give this medicine to a premature baby.
• You are an elderly patient, if you are being treated with other medicines that can cause a drop in blood pressure and if you have any other disease that is a risk for decreased blood pressure.

In case any of the above situations occur, consult your doctor or pharmacist before taking the furosemide tablets.

Use in athletes

This medicine contains furosemide, which can produce a positive result in doping tests.

Other medicines and Furosemide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines without a prescription, including herbal medicines. This is because furosemide tablets can affect the way other medicines work. Some medicines can also affect the functioning of furosemide.

Your doctor may need to change your dose and/or take other precautions if you are taking one of the following medicines:

• Aliskiren - used to treat high blood pressure.

The following medicines can affect the way Furosemide Aurovitas works and increase the possibility of side effects:

• Medicines such as ramipril, enalapril, perindopril (called "ACE inhibitors") or losartan, candesartan, irbesartan (called "angiotensin II receptor antagonists"). Your doctor may need to change the dose of your tablets or ask you to stop taking them.
• Medicines for high blood pressure or heart problems. Your doctor may need to change the dose of your medicine.
• Medicines used to treat high blood pressure or prostate problems, known as alpha-blockers, such as prazosin.
• Other medicines for high blood pressure and other medicines used to eliminate water from the body called diuretics, such as amiloride, spironolactone, acetazolamide, and metolazone.
• Medicines that alter the amount of potassium in your blood. These include potassium supplements such as potassium chloride or some diuretic medicines like triamterene.
• Medicines used to treat irregular heartbeats, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol, and mexiletine.
• Medicines that help you sleep or relax, such as chloral hydrate.
• Medicines used as general anesthetics to relax your muscles during surgery. If you are going to be given an anesthetic, make sure your doctor or nurse knows that you are taking furosemide.
• Medicines for diabetes. They may not work well when you are taking furosemide.
• Theophylline - used for wheezing or breathing difficulties.
• Phenytoin - used for epilepsy. It can decrease the effect of furosemide.
• Medicines used for mental problems called "psychotics", such as risperidone, amisulpride, sertindole, pimozide, and chlorpromazine. Avoid using pimozide at the same time as furosemide.

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

• Lithium - used for mental illnesses. To help prevent side effects, your doctor may need to change your lithium dose and check your blood levels.
• Platinum compounds.
• Cisplatin - used for some types of cancer.
• Digoxin - used for heart problems. Your doctor may need to change the dose of your medicine.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as aspirin, ibuprofen, ketoprofen, or indomethacin.
• Carbamazepine - used for epilepsy.
• Aminoglutethimide - used for breast cancer.
• Cyclosporin, tacrolimus, aldesleukin - used to prevent organ rejection after a transplant.
• Moxisilyte - used to treat Raynaud's syndrome.
• Medicines used to treat angina that can be placed under your tongue, such as glyceryl trinitrate or isosorbide dinitrate.
• Methotrexate - used for skin or joint cancer, or intestinal diseases.
• Carbenoxolone and sucralfate - used for stomach ulcers (esophagus).
• Reboxetine, amitriptyline, and phenelzine - used for depression.
• Amphotericin - used for fungal infections if used for a long time.
• Corticosteroids - used for inflammation, such as prednisolone.
• Atomoxetine - used to treat Attention Deficit Hyperactivity Disorder (ADHD).
• Medicines that relax muscles, such as baclofen and tizanidine.
• Antihistamines - used to treat allergies, such as cetirizine.
• Alprostadil - used to treat male impotence.
• Estrogens and drospirenone, used as contraceptives or in Hormone Replacement Therapy (HRT).
• Licorice - often used in cough medicines, if taken in large quantities.
• Probenecid - used with another medicine for HIV.
• Medicines for infections, such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin, or high doses of cephalosporins.
• Injectable medicines before an X-ray examination (radiological contrast).
• Medicines used for constipation (laxatives), if used for a long time, such as bisacodyl or senna.
• Medicines for asthma when given in high doses, such as salbutamol, terbutaline sulfate, salmeterol, formoterol, or bambuterol.
• Medicines used for nasal congestion, such as ephedrine and oxymetazoline.
• Potassium salts used to treat low potassium levels in the blood.
• Medicines used to treat Parkinson's disease, such as levodopa.
• Other diuretic medicines, such as bendroflumethiazide. Your doctor may need to change the dose of your medicine.

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

Taking Furosemide Aurovitas with food, drinks, and alcohol

You should avoid drinking alcohol while taking Furosemide Aurovitas, as it can further lower your blood pressure.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.

• Do nottake Furosemide Aurovitas if you are pregnant. Consult your doctor before taking this medicine if you are pregnant, think you may be pregnant, or are planning to have a baby.
• Do not breastfeed if you are taking Furosemide Aurovitas, as a small amount of the medicine may pass into breast milk. Consult your doctor before taking this medicine if you are breastfeeding or planning to breastfeed.

If you are pregnant or breastfeeding, consult your doctor or pharmacist for further advice before taking this medicine.

Driving and using machines

This medicine can make you feel dizzy or unwell. This may happen more often at the start of treatment, when your doctor increases your dose, or if you drink alcohol. Do not drive or operate machinery if this happens to you.

Furosemide Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Furosemide Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Furosemide Aurovitas

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

• The number of tablets you need will depend on your illness. The tablets should be swallowed whole with a glass of water.
• You should take the tablets at about the same time each day before meals or as your doctor has told you.

Adults and elderly patients

The recommended dose is 1 or 2 tablets in the morning. Your doctor will tell you how many tablets to take.

Children and adolescents (under 18 years)

• Initial dose:calculated by the doctor based on the child's body weight.
• Maximum dose:1 tablet per day.

If you are taking sucralfate(a medicine for stomach ulcers). Do not take sucralfate at the same time as the furosemide tablets. Take your dose at least 2 hours before or after furosemide, as it can affect the way your medicine works.

If you take more Furosemide Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor immediately or go to the emergency department of the nearest hospital with this leaflet, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Take the medicine with you in its original packaging to help the doctor identify it. Taking too many furosemide tablets can make you feel confused, unable to focus, or lacking emotion or interest.

You may also experience dizziness, drowsiness, fainting (due to low blood pressure), irregular heartbeat, muscle weakness, or blood clots (signs include pain and swelling in the affected part of the body). You may also have kidney or blood problems.

If you forget to take Furosemide Aurovitas

Take the missed dose as soon as you remember, unless it is at night. In that case, if you take the missed dose, you may wake up to urinate during the night. Take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Furosemide Aurovitas

Continue taking the furosemide tablets unless your doctor tells you to stop.

Blood tests

Your doctor may perform blood tests to check that the levels of certain salts in your blood are correct.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

STOP TAKINGthis medicine and inform your doctor immediately if you experience any of the following symptoms:

• Allergic reactions such as itching, skin rash with intense itching and hives, fever, sun allergy, severe allergic reaction with fever (high), red spots on the skin, joint pain and/or eye inflammation, severe and acute allergic reaction accompanied by fever and blisters on the skin/desquamation of the skin and cutaneous hemorrhage present as tiny spots.

• Sudden inflammation of the pancreas accompanied by acute pain in the upper part of the stomach, which moves towards the back.

The rest of the possible adverse effects are classified according to their frequency, in accordance with the following categories:

Frequent (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).

Frequent

Furosemide may cause excessive depletion of body fluids (e.g., urinating more frequently than normal) and minerals (sodium, potassium, magnesium, calcium). The symptoms that may appear are: thirst, headache, confusion, cramps, and increased muscle sensitivity, muscle weakness, alterations in heart rhythm, and gastrointestinal problems such as a feeling of discomfort and stomach upset with a desire to vomit or diarrhea.

Mild increase in uric acid (hyperuricemia), possibly causing a gout attack.

Increased creatinine in the blood.

If you have a lack of sodium (sodium deficiency):

• Cramp in the calf muscles.
• Lack of appetite.
• Lethargy.
• Weakness.
• Dizziness.
• Drowsiness.
• Confusion.

If you have a lack of potassium (potassium deficiency):

• Muscle weakness and inability to contract one or more muscles (paralysis), increased urinary excretion.
• Cardiac problems.
• In the case of a severe potassium deficiency: obstruction of intestinal function or confusion, which can result in coma.

If you have a lack of magnesium and calcium (magnesium and calcium deficiency):

• Increased muscle sensitivity.
• Alterations in heart rhythm.
• Decrease in blood pressure, resulting in deficient concentration and reactions, dizziness, feeling of pressure in the head, headache, drowsiness, feeling of weakness, visual disturbances, dry mouth, and inability to stand.

Uncommon

• Altered blood count accompanied by bruising and tendency to bleed.
• Decrease in platelet levels (thrombocytopenia).
• Sensitivity to light (photosensitivity).
• Involuntary loss of urine.
• In elderly patients, this can lead to a decrease in blood volume, fluid depletion, and thickening of the blood, which can cause clots.
• Deafness (sometimes irreversible).
• Blisters on the skin or mucous membranes (pemphigoid).
• Decrease in glucose tolerance. Latent diabetes mellitus may manifest.

Rare

• Altered blood count (deficiency of white blood cells) accompanied by increased susceptibility to infection.
• Increase in certain substances (eosinophils) in the blood.
• Feeling of tingling in the skin, itching, or tingling without any reason.
• Loss of consciousness that can be life-threatening.
• Hearing disorders and ringing in the ears. These disorders are generally temporary.
• Inflammation of a blood vessel.
• Lichenoid reactions, characterized as small, itchy, reddish-purple lesions, polygonal in shape, on the skin, genitals, or mouth.
• Acute kidney failure.
• Inflammation of the kidneys associated with the appearance of blood in the urine, fever, and pain in the sides. If you have a urinary tract obstruction, it can increase or worsen urine production.
• If you have a bladder disorder, enlarged prostate, or narrowing of the ureters, urine production may suddenly stop.
• Shock (sharp drop in blood pressure, extreme paleness, restlessness, weak and rapid pulse, moist skin, consciousness problems) as a result of a sudden and severe dilation of blood vessels due to an allergy to certain substances.
• Fever.
• Mild mental disorders.

Very Rare

• Anemia (a condition characterized by a deficit of red blood cells).
• Severe alteration of the blood (deficiency of white blood cells) accompanied by sudden high fever, intense throat pain, and ulcers in the mouth.
• Agranulocytosis.
• Certain disorders of liver function.
• Cerebral disorders (hepatic encephalopathy) can develop in patients with severe liver disease (liver failure).
• Increased levels of certain liver enzymes.

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

Frequency Not Known

• Acute generalized exanthematous pustulosis (AGEP) (acute and febrile drug rash).
• Dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension).
• Reduction of calcium or magnesium levels in the blood.
• Metabolic alkalosis.
• Pseudo-Bartter syndrome in case of misuse and/or prolonged use of furosemide.
• Exacerbation or activation of systemic lupus erythematosus.
• Cases of rhabdomyolysis have been reported, often in cases where there is a severe decrease in potassium levels in the blood (hypokalemia).
• Formation of kidney stones (nephrocalcinosis/nephrolithiasis) in premature babies.

Reporting of Adverse Effects

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

5. Conservation of Furosemide Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging or blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. 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 ofFurosemide Aurovitas

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A) (derived from potato starch), and magnesium stearate.

Appearance of the Product and Package Contents

White to off-white, uncoated, round (8 mm in diameter) tablets, with a beveled edge and flat, engraved on one side with "F" and "40" separated by a notch and flat on the other side. The tablet can be divided into equal doses.

Furosemide Aurovitas tablets are available in blister packs and HDPE bottles.

Package 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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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:

Spain: Furosemida Aurovitas 40 mg tablets EFG

Netherlands: Furosemide Aurobindo 40 mg, tablets

Poland: Furosemidum Aurovitas

Portugal: Furosemida Generis Phar

Date of the Last Revision of this Prospectus:February 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)