Package Insert:Information for the User

Furosemide Uxa 40 mg Tablets EFG

Read this package insert carefully before starting to take the 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 should not be given 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 Uxa 40 mg, is a diuretic belonging to the sulfonamide group. It acts by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive).

Under the prescription of your doctor, this medication is indicated for the treatment of:

• Edema (swelling due to fluid retention) associated with congestive heart failure, liver cirrhosis (ascites) and kidney disease, including nephrotic syndrome (priority treatment of the underlying disease).
• Edemas following burns.
• Mild to moderate arterial hypertension.

Read carefully the instructions provided in section 3. "How to take Furosemida Uxa".

Do not take Furosemida Uxa

• If you are allergic to furosemide, to furosemide-type medications (sulfonamides), or to any of the other components of this medication (listed in section 6).
• If you have a decreased total blood volume (hypovolemia), or if you are dehydrated.
• If you have severe kidney problems, accompanied by a decrease in urine elimination (renal insufficiency with anuria), that do not respond to this medication.
• If you have a severe decrease in blood potassium levels (severe hypokalemia).
• If you have a severe deficiency of sodium salts in the blood (severe hyponatremia).
• If you are in a pre-comatose and comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.

If you are pregnant, see the section "Pregnancy, lactation, and fertility".

Warnings and precautions

Consult your doctor, pharmacist before starting to take Furosemida Uxa.

Be especially careful with this medication:

• If you have problems with urine elimination, especially at the beginning of treatment.
• If your blood pressure is low (hypotension).
• If you have a high risk of experiencing a significant drop in blood pressure (for example, in patients with significant coronary or cerebral stenosis).
• If you have latent or manifest diabetes mellitus.
• If you have gout.
• If you have severe kidney problems, associated with severe liver disease (hepatorenal syndrome).
• If you have low blood protein levels (hypoproteinemia), in addition to having, for example, nephrotic syndrome (see "Possible adverse effects").
• In premature children (see "Possible adverse effects").
• If you are an elderly person, if you are being treated with medications that may cause a decrease in blood pressure, or if you have other medical conditions that are associated with the risk of a decrease in blood pressure.

During your treatment with this medication, you will generally require regular monitoring of your blood levels of sodium, potassium, and creatinine, and especially if you experience a severe loss of fluids, by vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may require the interruption of treatment.

Patients over 65 years old with dementia who are taking risperidone should be especially careful when taking this medication. Risperidone is a medication used to treat certain mental disorders, such as dementia (a disease characterized by several symptoms: memory loss, problems speaking, problems thinking).

Use in athletes

Inform patients that this medication contains furosemide, which can produce a positive result in doping tests.

Use of Furosemida Uxa with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Some substances may increase the toxicity of this medication in the ear and kidneys, if administered together. Therefore, if administered together, it should be under strict medical control. Among these substances are:

• Aminoglycoside antibiotics (infection medications) such as gentamicin, kanamicin, and tobramicin.
• Cancer medications (cisplatin).

This medication and sucralfate should not be administered together, with an interval of less than 2 hours, as the effect of Furosemida Uxa may be reduced.

This medication may weaken the effect of other medications such as:

• Medications used for diabetes (antidiabetics).
• Medications used to increase blood pressure (sympathomimetics with hypertensive effect, for example, epinephrine and norepinephrine).

It may also increase the action of other medications such as:

• Asthma medications (theophylline).
• Muscle relaxants such as curare.
• Depression medications (lithium), which may potentiate the harmful effects of lithium on the heart or brain.
• Salicylates.
• Medications used to lower blood pressure, such as diuretics, ACE inhibitors, or angiotensin II receptor antagonists.
• Toxic medications for the kidneys.

Some anti-inflammatory and pain medications, such as indomethacin (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) and epilepsy medications (phenytoin), may reduce the effect of Furosemida Uxa.

Additionally, they may reduce the effect of Furosemida Uxa or increase its adverse effects (by reducing renal elimination of these medications), medications such as probenecid and methotrexate, or other medications that have significant renal secretion.

The following substances may reduce blood potassium levels (hypokalemia) if administered with Furosemida Uxa.

• Corticosteroids (anti-inflammatory medications).
• Carbenoxolone (medication for the treatment of oral mucosa lesions).
• Significant amounts of licorice.
• Prolonged use of laxatives for constipation.

Some electrolyte alterations (for example, a decrease in blood potassium levels (hypokalemia), or magnesium (hypomagnesemia)) may increase the toxicity of some heart medications (for example, digitalis and medications that induce the QT interval prolongation syndrome).

Some patients who receive high doses of cefalosporin-type antibiotics may experience a decrease in kidney function.

The concomitant administration of Furosemida Uxa and cyclosporin A may produce gouty arthritis.

Patients with a high risk of nephropathy (kidney disease) due to contrast who receive Furosemida Uxa may experience a deterioration in kidney function.

The administration of Furosemida Uxa together with risperidone in patients over 65 years old with dementia may increase mortality.

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, if you think you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, you will only use Furosemida Uxa under strict medical indication.

During breastfeeding, Furosemida Uxa should not be administered, as it passes into breast milk. If its administration is necessary, your doctor may require you to interrupt breastfeeding.

Driving and operating machines

This medication may cause dizziness or somnolence. This may occur more frequently at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or somnolent.

Furosemida Uxa 40 mg tablets contain lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Take Furosemida Uxa on an empty stomach, swallowing it without chewing and with sufficient liquid.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Your doctor will prescribe the minimum effective dose.

• For adults, it is recommended to start treatment with half, one, or two tablets (20 to 80 mg of furosemide) per day. The maintenance dose is half to one tablet per day, and the maximum dose will be indicated by your doctor and will depend on your response to treatment.

Use in children

In infants and children, it is recommended to administer 2mg/kg of body weight per day, up to a maximum of 40 mg per day.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment before.

If you take more Furosemida Uxa 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 915620420 indicating the medication and the amount ingested or administered.

An accidental overdose could lead to a severe decrease in blood pressure (which may progress to shock), kidney problems (acute renal insufficiency), coagulation problems (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

No specific antidote is known.

If you forgot to take Furosemida Uxa

Do not take a double dose to compensate for the missed doses.

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

Like other diuretics, prolonged administration of this medicine may increase the elimination of sodium (hyponatremia), chloride (hypochloremic alkalosis), and consequently water. It may also increase the loss of potassium (hypokalemia), calcium, and magnesium. These changes manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contractions, especially in the extremities (tetany), muscle weakness, cardiac rhythm alterations, and gastrointestinal symptoms.

Particularly in elderly patients, Furosemida Uxa may lead to or contribute to a decrease in total blood volume, dehydration, and coagulation disorders (thrombosis).

This medicine may cause or worsen the discomfort of patients with difficulty urinating, thus leading to acute urinary retention with possible secondary complications.

In rare cases, there have been reported cases of kidney problems that may be a consequence of an allergic reaction in the kidneys (interstitial nephritis).

Treatment with Furosemida Uxa may lead to temporary elevations in blood levels of urea, creatinine, and increases in blood levels of cholesterol, triglycerides, and uric acid, which may lead to gout attacks.

Occasionally, the number of platelets may be excessively reduced (thrombocytopenia). In rare cases, leucopenia (decrease in white blood cells), eosinophilia (increase in a type of white blood cell, eosinophils), or fever may occur; in isolated cases, agranulocytosis (decrease in a type of white blood cell, granulocytes) and anemia aplastic or hemolytic anemia may occur.

Furosemida Uxa may decrease glucose tolerance. In patients with diabetes mellitus, a deterioration in metabolic control may be observed, which may manifest as latent diabetes mellitus.

A decrease in blood pressure may occur. When this is pronounced, it may lead to a worsening of concentration and reaction capacity, mild mental confusion (obnubilation), headache, dizziness, somnolence, weakness, visual disturbances, dry mouth, inability to maintain an upright position (orthostatic intolerance). In rare cases, allergic inflammation of blood vessels (vasculitis) has been described.

Occasionally, skin and mucous membrane reactions may occur, such as itching, rash, blisters, and more severe reactions like erythema multiforme, bullous pemphigoid (autoimmune skin disease), Stevens-Johnson syndrome (severe vesicular skin and mucous membrane reactions), toxic epidermal necrolysis (severe skin alteration characterized by blister formation and exfoliative lesions), exfoliative dermatitis, purpura, and sun allergy (photosensitivity). In rare cases, severe allergic reactions (anaphylactic or anaphylactoid) may occur.

Rarely, a sensation of tingling in the extremities (paresthesias) and hepatic encephalopathy (mental alterations in patients with liver problems) may occur.

In rare cases, hearing problems and a subjective sensation of ringing in the ears (tinnitus) may occur, although usually of reversible character, especially in patients with severe kidney problems and/or decreased blood protein levels (hypoproteinemia).

Rarely, digestive disorders such as nausea, vomiting, or diarrhea may occur.

In isolated cases, liver problems (hepatic problems) such as intrahepatic cholestasis, increased liver enzymes, or acute pancreatitis may occur.

Unknown frequency: generalized acute pustular exanthema (PEGA), dizziness, and loss of consciousness (caused by symptomatic hypotension)

Rare side effects: deafness (sometimes irreversible)

Other side effects in children

In premature children, furosemide may lead to the formation of kidney stones (nephrocalcinosis/nephrolithiasis) and may increase the risk of a severe congenital clinical condition (patent ductus arteriosus).

Reporting side effects

If you experience any of these side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for 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.

No special storage conditions are required.

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

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Furosemida Uxa 40 mg tablets

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

Appearance of the product and contents of the packaging

Furosemida Uxa 40 mg tablets are presented in packaging of 10 or 30 tablets.

They are round, almost white, scored on one side, and marked with “F&40”.

They are packaged in white opaque PVC/PVDC/Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturingHolder:

UXAFARMA, S.A.

Avda. J.V. Foix 62

08034 Barcelona

Responsible for Manufacturing

Industria Química y Farmacéutica VIR

c/ Laguna 66-70. P.I. URTINSA II

28923 Alcorcón (Madrid)

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas 28108, Madrid

or

Laboratorio DAU

Calle de la Lletra C, 12-14

Polígono Industrial Zona Franca

08040 Barcelona

Last review date of this leaflet: April 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/