Furosemide Uxa 40 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Furosemide Uxa 40 mg tablets EFG

Read this 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; do not pass it on to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Always under a doctor's prescription, this medicine is indicated for the treatment of:

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

2. What you need to know before taking Furosemida Uxa

Carefully read the instructions provided in section 3, "How to take Furosemida Uxa".

Do not take Furosemida Uxa

• If you are allergic to furosemide, to furosemide-like drugs (sulfonamides), or to any of the other components of this medicine (listed in section 6).
• If your total blood volume is decreased (hypovolemia), or if you are dehydrated.
• If you have severe kidney problems accompanied by reduced urine output (renal failure with anuria) that do not respond to this medicine.
• If you have severely low levels of potassium in your blood (severe hypokalemia).
• If you have severe deficiency of sodium salts in your blood (severe hyponatremia).
• If you are in a pre-comatose or comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.

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

Warnings and precautions

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

Take special care with this medicine:

• If you have problems with urine elimination, especially at the beginning of treatment.
• If your blood pressure is low (hypotension).
• If you are at high risk of experiencing a marked drop in blood pressure (e.g., in patients with significant coronary or cerebral stenosis).
• If you have latent or overt diabetes mellitus.
• If you suffer from gout.
• If you have severe kidney problems associated with severe liver disease (hepatorenal syndrome).
• If your blood protein levels are low (hypoproteinemia), especially if you also have nephrotic syndrome (see section "Possible side effects").
• In premature infants (see section "Possible side effects").
• If you are elderly, if you are being treated with medicines that may cause low blood pressure, or if you have other medical conditions associated with risk of low blood pressure.

During treatment with this medicine, periodic monitoring of blood levels of sodium, potassium, and creatinine is generally required, especially if you experience significant fluid loss due to vomiting, diarrhea, or excessive sweating (dehydration or hypovolemia), as your doctor may need to discontinue treatment.

Elderly patients with dementia who are taking risperidone should exercise particular caution 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, difficulty speaking, difficulty thinking).

Use in athletes

Patients should be advised that this medicine contains furosemide, which may result in a positive doping test.

Taking Furosemida Uxa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The toxicity of certain substances to the ear and kidneys may increase when administered together with this medicine. Therefore, if they are used together, close medical supervision is required. These substances include:

• Aminoglycoside antibiotics (medicines for infections) such as gentamicin, kanamycin, and tobramycin.
• Medicines for cancer (cisplatin).

This medicine and sucralfate should not be administered together within less than 2 hours, as the effect of Furosemida Uxa may be reduced.

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

• Medicines used for diabetes (antidiabetics).
• Medicines used to raise blood pressure (sympathomimetics with hypertensive effect, e.g., epinephrine and norepinephrine).

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

• Medicines for asthma (theophylline).
• Curare-type muscle relaxants.
• Medicines for depression (lithium), potentially enhancing lithium's harmful effects on the heart or brain.
• Salicylates.
• Antihypertensive medicines (to lower blood pressure), 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), may reduce the effect of Furosemida Uxa.

Additionally, medicines such as probenecid and methotrexate, or other medicines that are significantly excreted by the kidneys, may reduce the effect of Furosemida Uxa or increase its adverse effects (by reducing the renal elimination of these medicines).

The following substances may reduce potassium levels in blood (hypokalemia) when administered with Furosemida Uxa:

• Medicines for inflammation (corticosteroids).
• Carbenoxolone (a medicine used to treat oral mucosal lesions).
• Large amounts of licorice.
• Prolonged use of laxatives for constipation.

Some electrolyte imbalances (e.g., decreased blood levels of potassium (hypokalemia) or magnesium (hypomagnesemia)) may increase the toxicity of certain heart medicines (e.g., digitalis and medicines that induce QT interval prolongation syndrome).

Some patients receiving high doses of cephalosporin-type antibiotics may experience reduced kidney function.

Concomitant administration of Furosemida Uxa and cyclosporine A may cause gouty arthritis.

Patients at high risk of contrast-induced nephropathy (kidney disease) who receive Furosemida Uxa may experience worsening of kidney function.

Administration of Furosemida Uxa together with risperidone in patients over 65 years of age with dementia may increase mortality.

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

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 should only use Furosemida Uxa under strict medical indication.

Furosemida Uxa must not be administered during breastfeeding. If administration is essential, your doctor may require you to discontinue breastfeeding, as Furosemida Uxa passes into breast milk.

Driving and use of machines

This medicine may cause dizziness or drowsiness. This is more likely at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machinery if you feel dizzy or drowsy.

Furosemida Uxa 40 mg tablets contain lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Furosemida Uxa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Take Furosemida Uxa on an empty stomach, swallowing it whole with sufficient liquid.

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

Your doctor will prescribe the lowest effective dose required to achieve the desired effect.

• In adults, treatment should be started 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 determined by your doctor depending on your response to treatment.

Use in children

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

Your doctor will advise you on the duration of your treatment with this medicine. Do not stop treatment prematurely.

If you take more Furosemida Uxa 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, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested or administered.

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

There is no known specific antidote.

If you forget to take Furosemida Uxa

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

4. Possible adverse effects

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

As with 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 disturbances may manifest as intense thirst, headache, confusion, muscle cramps, painful muscle contractions especially in the limbs (tetany), muscle weakness, disturbances in heart rhythm, and gastrointestinal symptoms.

In particular in elderly patients, Furosemida Uxa may cause or contribute to a reduction in total blood volume, dehydration, and disturbances in blood coagulation (thrombosis).

Furosemide may cause or worsen symptoms in patients with difficulty urinating; thus, acute urinary retention with possible secondary complications may occur.

Rarely, cases of kidney problems have been reported, which may result from an allergic-type reaction in the kidneys (interstitial nephritis).

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

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

Furosemida Uxa may reduce glucose tolerance. In patients with diabetes mellitus, a worsening of metabolic control may occur, and latent diabetes mellitus may become apparent.

A drop in blood pressure may occur. When pronounced, this may lead to impaired concentration and reaction ability, mild mental confusion (obnubilation), sensation of pressure in the head, headache, dizziness, somnolence, weakness, visual disturbances, dry mouth, and inability to maintain an upright position (orthostatic intolerance). Rarely, 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 such as erythema multiforme, bullous pemphigoid (an autoimmune skin disease), Stevens-Johnson syndrome (severe blistering reactions of the skin and mucous membranes), toxic epidermal necrolysis (a serious skin condition characterized by blistering and exfoliative lesions), exfoliative dermatitis, purpura, and allergic skin reactions to sunlight (photosensitivity). Rarely, severe allergic-type reactions (anaphylactic or anaphylactoid) may occur.

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

Rarely, hearing problems and subjective sensation of ringing in the ears (tinnitus) may occur, although usually reversible, especially in patients with severe kidney problems and/or low blood protein levels (hypoproteinemia).

Rarely, gastrointestinal disturbances such as nausea, vomiting, or diarrhea may occur.

In isolated cases, liver problems (hepatic disorders) may develop, such as intrahepatic cholestasis, increased liver enzymes, or inflammation of the pancreas (acute pancreatitis).

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

Uncommon adverse effects: deafness (sometimes irreversible)

Other adverse effects in children

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of 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 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furosemide Uxa 40 mg tablets

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

Appearance of the medicinal product and contents of the pack

Furosemide Uxa 40 mg tablets are supplied in packs containing 10 or 30 tablets.

The tablets are round, almost white, with a score on one side and marked with “F&40”.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
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 most recent review of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/