FUROSEMIDE UXA 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Furosemida Uxa 40 mg is a diuretic belonging to the group of sulfonamides. It acts by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive).

Always under the prescription of your doctor, this medicine 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 is given to the treatment of the underlying disease).
• Edema following burns.
• Mild to moderate arterial hypertension.

2. What you need to know before you take Furosemida Uxa

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

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

Warnings and precautions

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

Be especially careful with this medicine:

• If you have problems with urine elimination, especially at the start of treatment.
• If your blood pressure is low (hypotension).
• If you are at high risk of suffering a pronounced drop in blood pressure (for example, in patients with significant coronary or cerebral stenosis).
• If you have latent or manifest diabetes mellitus.
• If you suffer from gout.
• If you have severe kidney problems associated with severe liver disease (hepato-renal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to suffering from, for example, nephrotic syndrome (see "Possible side effects" section).
• In premature infants (see "Possible side effects" section).
• If you are an elderly person, if you are being treated with medicines that can cause a decrease in blood pressure or if you have other medical conditions that have associated risk of decreased blood pressure.

During treatment with this medicine, periodic control of your blood levels of sodium, potassium, and creatinine will generally be required, especially if you suffer from severe fluid loss due to vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may require the interruption of treatment.

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

Use in athletes

Patients should be warned that this medicine contains furosemide, which can produce a positive result in doping tests.

Use of Furosemida Uxa with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medicine.

Some substances can increase their toxicity in the ear and kidney if administered with this medicine. Therefore, if they are administered together, it should be under strict medical control. These substances include:

• Aminoglycoside antibiotics (infection medicines) such as gentamicin, kanamycin, and tobramycin.
• Cancer medicines (cisplatin).

This medicine 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 medicine can weaken the effect of other medicines such as:

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

It can also increase the action of other medicines such as:

• Asthma medicines (theophylline).
• Muscle relaxants such as curare.
• Medicines for depression (lithium), which can potentiate the harmful effects of lithium on the heart or brain.
• Salicylates.
• Blood pressure-lowering medicines (such as diuretics, ACE inhibitors, or angiotensin II receptor antagonists).
• Medicines toxic to the kidneys.

Some medicines for inflammation and pain, for example, indomethacin (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) and medicines for epilepsy (phenytoin) can reduce the effect of Furosemida Uxa.

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

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

• Medicines for inflammation (corticosteroids).
• Carbenoxolone (medicine for the treatment of oral mucosa lesions).
• Large amounts of licorice.
• Prolonged use of laxatives for constipation.

Some electrolyte disturbances (for example, decreased potassium levels in the blood (hypokalemia) or magnesium (hypomagnesemia)) can increase the toxicity of some heart medicines (for example, digitalis and medicines that induce the QT interval prolongation syndrome).

Some patients who receive high doses of antibiotics of the cephalosporin type may suffer from decreased kidney function.

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

Those patients at high risk of nephropathy (kidney disease) due to contrast who receive Furosemida Uxa may suffer from deterioration of kidney function.

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

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

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.

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

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

Driving and using machines

This medicine can cause dizziness or drowsiness. This can occur more frequently at the start of treatment, when your doctor increases the dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or drowsy.

Furosemida Uxa 40 mg tablets contain lactose

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

3. How to take Furosemida Uxa

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

Remember to take your medicine.

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

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Your doctor will prescribe the lowest sufficient dose to produce the desired effect.

• In adults, it is recommended to start treatment with half, one, or two tablets (20 to 80 mg of furosemide) daily. 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 2 mg/kg of body weight daily, up to a maximum of 40 mg per day.

Your doctor will indicate the duration of your treatment with this medicine. Do not suspend your 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 emergency department of the nearest hospital, accompanied by this leaflet, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount ingested or administered.

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

No specific antidote is known.

If you forget to take Furosemida Uxa

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As with other diuretics, after prolonged administration of this medicine, there may be an increase in sodium elimination (hyponatremia), chloride (hypochloremic alkalosis), and consequently water. There may also be an increase in potassium loss (hypokalemia), calcium, and magnesium. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contraction (tetany), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

In particular, in elderly patients, Furosemida Uxa can cause or contribute to the appearance of a decrease in total blood volume, dehydration, and coagulation alterations (thrombosis).

Furosemida can cause or worsen the discomfort of patients with difficulty urinating, thus producing acute urine retention with possible secondary complications.

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

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

Occasionally, there can be an excessive reduction in the number of platelets (thrombocytopenia). In rare cases, leucopenia (decrease in white blood cells), eosinophilia (increase in a type of white blood cells, eosinophils), or fever can occur; in isolated cases, agranulocytosis (decrease in a type of white blood cells, granulocytes) and a decrease in the number of red blood cells (aplastic anemia or hemolytic anemia) can appear.

Furosemida Uxa can decrease glucose tolerance. In patients with diabetes mellitus, a deterioration of metabolic control can be observed, and latent diabetes mellitus may manifest.

A decrease in blood pressure can occur. When this is pronounced, it can cause a worsening of concentration and reaction capacity, mental confusion (obnubilation) mild, sensation of pressure in the head, headache, dizziness, drowsiness, weakness, vision disorders, dry mouth, and 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 can occur, such as itching, rash, blisters, and more severe reactions like erythema multiforme, bullous pemphigoid (an autoimmune disease of the skin), Stevens-Johnson syndrome (severe vesicular reactions of the skin and mucous membranes), toxic epidermal necrolysis (severe skin alteration characterized by blister formation and exfoliative lesions), exfoliative dermatitis, purpura, and allergic reaction to the sun (photosensitivity). In rare cases, severe allergic reactions (anaphylactic or anaphylactoid) can occur.

Rarely, a tingling sensation in the limbs (paresthesia) and hepatic encephalopathy (mental alterations in patients with liver problems) can occur.

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

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

In isolated cases, liver problems (liver problems) can develop, such as intrahepatic cholestasis, increased liver enzymes, or pancreatitis (acute pancreatitis).

Frequency not known: acute generalized exanthematous pustulosis (AGEP), dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension)

Uncommon side effects: deafness (sometimes irreversible)

Other side effects in children

In premature infants, furosemide can cause the formation of kidney stones (nephrocalcinosis/nephrolithiasis) and can increase the risk of persistence of a severe congenital clinical picture (patent ductus arteriosus).

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Furosemida Uxa

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

No special storage conditions are required.

Do not use this medicine 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 via wastewater or household waste. 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. Contents of the pack and other information

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, corn starch, pregelatinized corn starch, sodium carboxymethyl starch (type A), and magnesium stearate.

Appearance of the product and contents of the pack

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

They are round, almost white tablets, scored on one face and marked with "F&40".

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

Marketing authorization holder and manufacturerHolder:

UXAFARMA, S.A.

Avda. J.V. Foix 62

08034 Barcelona

Manufacturer

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

Date of the last revision of this leaflet: April 2024

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