Furosemide Aurovitas 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Furosemide Aurovitas 40 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

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

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

2. What you need to know before taking Furosemida Aurovitas

Do not take Furosemida Aurovitas:

• If you are allergic to furosemide or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, swelling, or breathing difficulties, 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 you have low blood fluid volume or are dehydrated (with or without low blood pressure).
• If your doctor has told you that you have kidney failure. In some types of kidney failure, it may still be appropriate 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 levels of potassium and sodium in the blood, as shown in a blood test).
• If you are not passing urine (anuria).
• If you have a condition called “Addison’s disease.” This may make you feel tired or weak.
• If you are taking other medicines that alter the amount of potassium in your blood (see “Taking Furosemida Aurovitas with other medicines”).
• If you are breastfeeding (see below “Pregnancy, breastfeeding, and fertility”).

Warnings and precautions

Talk to your doctor or pharmacist before taking furosemide if:

• You have low blood pressure, your electrolyte balance needs to be monitored regularly, and your dose may need to be adjusted accordingly, or if you feel dizzy when standing up.
• You have diabetes (high blood sugar).
• You are 65 years of age or older.
• You have difficulty urinating.
• You have gout and liver or kidney problems.
• You have low levels of protein in your blood (hypoproteinemia).
• You experience symptoms of acute porphyria, which may include severe stomach, back, or thigh pain. Weakness in arms and legs, nausea, vomiting, or constipation may also occur.
• You are an elderly patient with dementia and are also being treated with risperidone.
• You have prostate problems.
• You feel dizzy or dehydrated. This may happen if you have lost a lot of fluid due to vomiting, diarrhea, or frequent urination. It may also occur if you have difficulty drinking or eating.
• You are scheduled for a glucose test.
• You have systemic lupus erythematosus (an immune system disease affecting the skin, bones, joints, and internal organs).
• You are taking any other diuretics.
• You intend to give this medicine to a premature infant.
• You are elderly, are taking other medicines that may lower blood pressure, or have any other condition that increases the risk of low blood pressure.

If any of the above situations apply to you, consult your doctor or pharmacist before taking furosemide tablets.

Use in athletes

This medicine contains furosemide, which may result in a positive finding in doping control tests.

Other medicines and Furosemida Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines without a prescription, including herbal medicines. This is because furosemide tablets may affect how other medicines work. Some medicines may also affect how furosemide works.

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

• Aliskiren – used to treat high blood pressure.

The following medicines may affect how Furosemida Aurovitas works and increase the risk 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 adjust your dose or ask you to stop taking them.
• Medicines for high blood pressure or heart problems. Your doctor may need to adjust your dose.
• Medicines used to treat high blood pressure or prostate problems, known as alpha-blockers, such as prazosin.
• Other medicines used to treat high blood pressure and other medicines used to remove 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 certain diuretics such as 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 to receive an anesthetic, make sure your doctor or nurse knows you are taking furosemide.
• Medicines for diabetes. These may not work as well when you are taking furosemide.
• Theophylline – used for wheezing or breathing difficulties.
• Phenytoin – used for epilepsy. It may reduce the effect of furosemide.
• Medicines used for mental disorders called “psychotic disorders,” such as risperidone, amisulpride, sertindole, pimozide, and chlorpromazine. Avoid using pimozide at the same time as furosemide.

The following medicines may 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 adjust your lithium dose and monitor blood levels.
• Platinum compounds.
• Cisplatin – used for certain types of cancer.
• Digoxin – used for heart problems. Your doctor may need to adjust your dose.
• 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.
• Cyclosporine, tacrolimus, aldesleukin – used to prevent organ rejection after transplantation.
• Moxisylyte – used in the treatment of Raynaud's syndrome.
• Medicines used to treat angina that you may spray or dissolve under your tongue, such as glyceryl trinitrate or isosorbide dinitrate.
• Methotrexate – used for skin cancer, joint diseases, or intestinal disorders.
• Carbenoxolone and sucralfate – used for ulcers in the digestive tract (throat).
• Reboxetine, amitriptyline, and phenelzine – used for depression.
• Amphotericin – used for fungal infections, especially 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, especially if taken in large amounts.
• 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 (radiographic contrast agents).
• Laxatives – used for constipation, especially if used long-term, such as bisacodyl or senna.
• Asthma medicines when given at 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 diuretics (water tablets), such as bendroflumethiazide. Your doctor may need to adjust your dose.

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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Do not take Furosemida Aurovitas if you are pregnant. Consult your doctor before taking this medicine if you are pregnant, may be pregnant, or think you could be pregnant.
• Do not breastfeed while taking Furosemida 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 plan to breastfeed.

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

Driving and using machines

This medicine may make you feel dizzy or unwell. This is more likely at the beginning of treatment, when your doctor increases your dose, or if you drink alcohol. Do not drive or operate machinery if this occurs.

Furosemida Aurovitas contains lactose

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

Furosemida Aurovitas contains sodium

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

3. How to take Furosemide Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

• The number of tablets you need will depend on your condition. The tablets should be swallowed whole with a glass of water.
• You should take the tablets at approximately the same time each day, before a meal, or as directed by your doctor.

Adults and elderly patients

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

Children and adolescents (under 18 years of age)

• Starting dose: determined by the doctor according to 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 furosemide tablets. Take your dose at least 2 hours before or after furosemide, as it may affect how your medicine works.

If you take more Furosemide Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you. Alternatively, call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested.

Bring the medicine in its original packaging to assist the doctor in identifying it. Taking too many furosemide tablets may make you feel confused, unable to concentrate, or emotionally flat or uninterested.

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

If you forget to take Furosemide Aurovitas

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

If you stop taking Furosemide Aurovitas

Continue taking furosemide tablets unless your doctor tells you otherwise.

Blood tests

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

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

4. Possible adverse effects

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

STOP TAKING this 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/skin peeling and skin hemorrhage present as tiny spots.

• Sudden inflammation of the pancreas accompanied by acute pain in the upper abdomen, radiating to the back.

The remaining possible adverse effects are classified according to their frequency, according to the following categories:

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

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

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

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

Frequency not known (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 occur include: thirst, headache, confusion, muscle cramps and increased muscle sensitivity, muscle weakness, changes in heart rhythm, and gastrointestinal problems such as feeling unwell and stomach discomfort with nausea or diarrhea.

Slight increase in uric acid (hyperuricaemia), possibly triggering a gout attack.

Increased creatinine in the blood.

If you have low sodium (sodium deficiency):

• Calf muscle cramps.
• Loss of appetite.
• Lethargy.
• Weakness.
• Dizziness.
• Drowsiness.
• Confusion.

If you have low potassium (potassium deficiency):

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

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

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

Uncommon

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

Rare

• Altered blood count (deficiency of white blood cells) accompanied by increased susceptibility to infection.
• Increase in certain substances (eosinophils) in the blood.
• Tingling sensation in the skin, itching or tingling without apparent reason.
• Unconsciousness that may be life-threatening.
• Hearing disorders and ringing in the ears. These disorders are usually temporary in nature.
• Inflammation of a blood vessel.
• Lichenoid reactions, characterized by small, itchy, reddish-purple, polygon-shaped lesions on the skin, genitals, or in the mouth.
• Acute renal failure.
• Inflammation of the kidneys associated with presence of blood in urine, fever, and flank pain. If you have a urinary tract obstruction, urine production may increase or worsen.
• If you have a bladder disorder, enlarged prostate, or ureteral narrowing, urine production may stop suddenly.
• Shock (severe drop in blood pressure, extreme paleness, restlessness, weak and rapid pulse, moist skin, consciousness disturbances) as a result of sudden and severe dilation of blood vessels due to allergy to certain substances.
• Fever.
• Mild mental disorders.

Very rare

• Anaemia (a condition characterized by a deficiency of red blood cells).
• Severe blood disorder (deficiency of white blood cells) accompanied by sudden high fever, severe sore throat, and mouth ulcers.
• Agranulocytosis.
• Certain disorders of liver function.
• Brain disorders (hepatic encephalopathy) may develop in patients with severe liver disease (hepatic failure).
• Increase in certain liver enzymes.

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

Frequency not known

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Furosemide Aurovitas

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

Do not use this medicine after the expiry date stated on the outer packaging or blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Furosemida Aurovitas

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

Appearance of the product and contents of the pack

White to off-white, uncoated, round tablets (8 mm in diameter), with bevelled edges and flat surfaces, marked on one side with "F" and "40" separated by a score line, and plain on the other side. The tablet can be divided into equal doses.

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

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer Responsible:

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 medicinal product 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, tabletten

Poland: Furosemidum Aurovitas

Portugal: Furosemida Generis Phar

Date of the most recent revision of this leaflet: February 2024

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