Package Insert: Information for the User

Furosemide Aurovitas 40 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Furosemida belongs to a group of medications 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 “diuretics”.

Furosemida tablets are used in the treatment of edema (fluid retention) caused by heart, kidney, or liver abnormalities, 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).

Do not take Furosemida Aurovitas:

• If you are allergic to furosemide or any of the other components of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, inflammation, or respiratory 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 in your body 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 medication. Your doctor will decide.
• If you have severe liver problems (cirrhosis).
• If you have severe liver disease combined with brain disorders (hepatic encephalopathy).
• If you have electrolyte deficiencies (e.g., low levels of potassium and sodium in the blood, as shown in a blood test).
• If you are unable to urinate.
• If you have a condition called "Addison's disease". It may make you feel tired or weak.
• If you are taking other medications that alter the amount of potassium in your blood (see "Taking Furosemida Aurovitas with other medications").
• If you are breastfeeding (see below "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

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

• You have low blood pressure, your electrolyte balance should be monitored regularly, and the dose should be 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 levels of protein in the blood (hypoproteinemia).
• You have symptoms of acute porphyria, which may include severe stomach, 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 urinated frequently. It also occurs if you have difficulty drinking or eating.
• You are about 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 about to give this medication to a premature baby.
• You are an elderly patient, if you are being treated with other medications that can cause a drop in blood pressure and if you have any other condition that is a risk for a drop in blood pressure.

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

Use in athletes

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

Other medications and Furosemida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications, including herbal medications. This is because furosemide tablets can affect how other medications work. Some medications may 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 medications:

• Aliskiren - used to treat high blood pressure.

The following medications may affect how Furosemida Aurovitas works and increase the risk of adverse effects:

• Medications 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.
• Medications used to treat high blood pressure or heart problems. Your doctor may need to change the dose of your medication.
• Medications used to treat high blood pressure or prostate problems, known as alpha-blockers, such as prazosin.
• Other medications used to treat high blood pressure and other medications used to eliminate water from the body called diuretics, such as amiloride, spironolactone, acetazolamide, and metolazone.
• Medications that alter the amount of potassium in your blood. These include potassium supplements such as potassium chloride or some medications used to urinate (diuretics) such as triamterene.
• Medications used to treat irregular heartbeats, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol, and mexiletine.
• Medications used to help you sleep or relax, such as chloral hydrate.
• Medications used as general anesthetics to relax your muscles during surgery. If you are to be given an anesthetic, make sure your doctor or nurse knows that you are being treated with furosemide.
• Medications used to treat diabetes. They may not work well when you are taking furosemide.
• Theophylline - used to treat wheezing or breathing difficulty.
• Phenytoin - used to treat epilepsy. It may reduce the effect of furosemide.
• Medications used to treat mental problems called "psychotics", such as risperidone, amisulpride, sertindol, pimozide, and chlorpromazine. Avoid using pimozide at the same time as furosemide.

The following medications may increase the risk of adverse effects when taken with furosemide:

• Lithium - used to treat mental illnesses. To help you stop the adverse effects, your doctor may need to change your dose of lithium and check your blood levels.
• Platinum compounds.
• Cisplatin - used to treat some types of cancer.
• Digoxin - used to treat heart problems. Your doctor may need to change the dose of your medication.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used to treat pain and inflammation, such as aspirin, ibuprofen, ketoprofen, or indomethacin.
• Carbamazepine - used to treat epilepsy.
• Aminoglutethimide - used to treat breast cancer.
• Ciclosporin, tacrolimus, aldesleukin - used to prevent organ rejection after a transplant.
• Moxisiltin - used to treat Raynaud's syndrome.
• Medications used to treat angina that can dissolve or break down under your tongue, such as glyceryl trinitrate or isosorbide dinitrate.
• Methotrexate - used to treat skin and joint cancer or intestinal diseases.
• Carbenoxolone and sucralfate - used to treat stomach ulcers.
• Reboxetine, amitriptyline, and phenelzine - used to treat depression.
• Ampicillin - used to treat fungal infections if used for a long period.
• Corticosteroids - used to treat inflammation, such as prednisolone.
• Atomoxetine - used to treat Attention Deficit Hyperactivity Disorder (ADHD).
• Medications 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).
• Regaliz - used frequently in medications for coughs, if taken in large quantities.
• Probenecid - used with another medication for HIV.
• Medications used to treat infections, such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin, or high doses of cephalosporins.
• Medications injected before an X-ray examination (contrast medium).
• Medications used to treat constipation (laxatives), if used for a prolonged period, such as bisacodyl or senna.
• Medications used to treat asthma when administered in high doses, such as salbutamol, terbutaline sulfate, salmeterol, formoterol, or bambuterol.
• Medications used to treat nasal congestion, such as ephedrine and oxymetazoline.
• Potassium salts used to treat low potassium levels in the blood.
• Medications used to treat Parkinson's disease, such as levodopa.
• Other medications used to urinate (diuretics), such as bendroflumethiazide. Your doctor may need to change the dose of your medication.

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

Taking Furosemida Aurovitas with food, drinks, and alcohol

You should avoid consuming alcohol while taking Furosemida Aurovitas as it may further lower your blood pressure.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

• Do nottake Furosemida Aurovitas if you are pregnant. Consult your doctor before taking this medication if you are pregnant, may be pregnant, or think you may be pregnant.
• Do not breastfeed if you are taking Furosemida Aurovitas as it may pass a small amount of the medication into breast milk. Consult your doctor before taking this medication if you are breastfeeding or plan to be.

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

Driving and operating machines

This medication may make you feel dizzy or unwell. This may occur more frequently at the start of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate machinery if this occurs.

Furosemida Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medication.

Furosemida Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The number of tablets you need will depend on your illness. The tablets must be swallowed whole with a glass of water.
• It should be taken approximately at the same time every day before meals or as your doctor has indicated.

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)

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

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

If you take more Furosemida Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor immediately or go to the nearest hospital emergency department accompanied by this leaflet, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Carry the medication with you in its original packaging to facilitate the doctor's identification. Taking too many furosemide tablets can make you feel confused, unable to focus, lacking emotion or interest.

You may also experience dizziness, vertigo, fainting (due to decreased blood pressure), irregular heartbeats, muscle weakness or cramps, and blood clots (the signs include pain and swelling in the affected part of the body). You may also experience problems with your kidneys or blood.

If you forgot to take Furosemida Aurovitas

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

If you interrupt treatment with Furosemida Aurovitas

Continue taking furosemide tablets unless your doctor tells you otherwise.

Blood tests

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Allergic reactions such as itching, intense skin rash, urticaria, fever, sun allergy, severe allergic reaction with high fever (fever), red skin patches, joint pain, and/or eye inflammation, severe and acute allergic reaction accompanied by fever and skin blisters/peeling skin and cutaneous hemorrhage present as small spots.

• Sudden pancreatitis accompanied by severe upper abdominal pain that shifts to the back.

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

Frequent (may affect up to 1 in 10 patients).

Rare (may affect up to 1 in 1,000 patients).

Very rare (may affect up to 1 in 10,000 patients).

Unknown frequency (cannot be estimated from available data).

Frequent

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

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

Increased creatinine in the blood.

If you have low sodium (sodium deficiency):

• Cramp in the calf muscles.
• Loss of appetite.
• Lethargy.
• Weakness.
• Dizziness.
• Somnolence.
• Confusion.

If you have low potassium (potassium deficiency):

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

If you have low magnesium and calcium (magnesium and calcium deficiency):

• Increased muscle sensitivity.
• Heart rhythm disturbances.
• Decreased blood pressure, resulting in concentration and reaction deficiencies, dizziness, sensation of pressure in the head, headache, somnolence, sensation of weakness, visual disturbances, dry mouth, and inability to stand upright.

Rare

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

Very rare

• Severe anemia (a condition characterized by a deficiency of red blood cells).
• Severe alteration of blood (leukopenia) accompanied by high fever, intense throat pain, and mouth ulcers.
• Agranulocytosis.
• Certain liver function disorders.
• Cerebral disorders (hepatic encephalopathy) may develop in patients with severe liver disease (hepatic insufficiency).
• Increased levels of certain liver enzymes.

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

Unknown frequency

• Generalized acute exanthematous pustulosis (PEGA) (acute and febrile drug eruption).
• 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, often in cases of severe hypokalemia.
• Formation of kidney stones (nephrocalcinosis/nephrolithiasis) in premature babies.

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication 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 medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition ofFurosemida Aurovitas

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

Appearance of the product and contents of the package

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

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

Packaging sizes:

Blister pack: 10, 20, 30, 50, 60, 90, and 100 tablets.

HDPE bottle: 30, 50, 60, 90, 100, and 500 (only for hospital use or dispensing of doses) tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

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 with the following names:

Spain:Furosemida Aurovitas 40 mg tablets EFG

Netherlands:Furosemide Aurobindo 40 mg, tablets

Poland:Furosemidum Aurovitas

Portugal:Furosemida Generis Phar

Last review date of this leaflet:February 2024

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