ACUIX 40 mg TABLETS

Introduction

Leaflet: information for the user

Acuix 40 mg tablets EFG

furosemide

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Acuix and what is it used for
2. What you need to know before taking Acuix
3. How to take Acuix
4. Possible side effects
5. Storage of Acuix
6. Package contents and additional information

1. What is Acuix and what is it used for

Acuix 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 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 is given to treating the underlying disease).
• Edema following burns.
• Mild to moderate arterial hypertension.

2. What you need to know before taking Acuix

Read carefully the instructions provided in section 3, "How to take Acuix".

Do not take Acuix

• If you are allergic to furosemide, to furosemide-like medications (sulfonamides), or to any of the other components of this medication (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 medication.
• If you have a severely decreased potassium level in the blood (severe hypokalemia). See section 4, "Possible side effects".
• 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 Acuix.

Be particularly careful with this medication:

• If you have urine elimination problems, especially at the start of treatment.
• If your blood pressure is low (hypotension).
• If you are at special risk of suffering a pronounced drop in blood pressure (e.g., 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 a severe liver disease (hepato-renal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to suffering from, for example, nephrotic syndrome (see section 4, "Possible side effects").
• In premature children (see section 4, "Possible side effects").
• There is a possibility of exacerbation or activation of systemic lupus erythematosus.
• If you are an elderly person, if you are being treated with medications that can cause a decrease in blood pressure, or if you have other medical conditions that have associated risks of decreased blood pressure.

During treatment with this medication, periodic monitoring 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 well as any significant electrolyte and acid-base balance alterations, should be corrected. Treatment interruption may be required.

Elderly patients with dementia who are taking risperidone should be particularly careful when taking risperidone and furosemide at the same time. Risperidone is a medication used to treat certain mental illnesses, such as dementia (a disease characterized by several symptoms: memory loss, speech problems, thinking problems).

Use in athletes

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

Use of Acuix with other medications

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

The effect of treatment with this medication may be affected if used at the same time as other medications.

Certain substances can increase their toxicity in the ear and kidneys if administered together with this medication. Therefore, they should only be administered together if there are medical reasons that require it. These substances include:

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

Concomitant use of Acuix with other medications can weaken the effect of these medications, such as:

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

In other cases, concomitant use can increase the effects of these medications, such as:

• Asthma medications (theophylline).
• Muscle relaxants such as curare.
• Depression medications (lithium salts): may increase the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.
• Patients undergoing treatment with diuretics may suffer from severe hypotension and deterioration of kidney function, especially when an ACE inhibitor (Angiotensin-Converting Enzyme) or an angiotensin II receptor antagonist is administered for the first time or at a high dose.
• If medications for high blood pressure, diuretics, or other medications that can decrease blood pressure are administered together with furosemide, a more pronounced decrease in blood pressure should be expected. Nephrotoxic medications: concomitant administration can potentiate the harmful effect of these medications on the kidneys.

Certain anti-inflammatory and pain medications (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) and epilepsy medications (phenytoin) can reduce the effect of Acuix. Furosemide can increase the toxicity of salicylates.

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

Medications such as probenecid and methotrexate, or other medications that have significant renal elimination, can reduce the effect of Acuix. In high-dose treatment, they can increase serum levels and increase the risk of side effects due to furosemide or concomitant administration.

The following substances can increase the risk of reducing potassium levels in the blood (hypokalemia) if administered with Acuix:

• Anti-inflammatory medications (corticosteroids).
• Carbenoxolone (medication for the treatment of oral mucosa lesions).
• Large amounts of licorice.
• Prolonged use of laxatives for constipation.

Certain electrolyte alterations (e.g., decreased potassium levels in the blood, hypokalemia, or decreased magnesium levels, hypomagnesemia) can increase the toxicity of certain medications (e.g., digitalis medications and medications that induce QT interval prolongation syndrome).

Patients undergoing treatment with Acuix and receiving high doses of certain cephalosporins (antibiotics) may suffer from decreased kidney function.

Concomitant administration of Acuix and cyclosporin A (a medication used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to increased blood urea levels and kidney urea elimination problems.

Patients at high risk of suffering from nephropathy (kidney disease) due to contrast media who receive Acuix have a higher risk of kidney function deterioration.

Administration of Acuix together with risperidone in elderly patients with dementia could increase mortality.

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

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 medication.

If you are pregnant, you will only use Acuix if there are medical reasons that require it.

During breastfeeding, do not administer Acuix. If administration is essential, your doctor may require you to interrupt breastfeeding, as furosemide passes into breast milk.

Driving and using machines

This medication can cause dizziness or drowsiness. This may 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.

Certain side effects (e.g., a pronounced, undesirable drop in blood pressure) can impair your ability to concentrate and react, and therefore constitute a risk in situations where these skills are particularly important (e.g., operating vehicles or machinery).

Acuix 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 medication.

3. How to take Acuix

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

Remember to take your medication.

Take this medication on an empty stomach, swallowing it whole and with sufficient liquid.

If you think the action of this medication is too strong or too weak, inform 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 medication. Do not suspend treatment before.

If you take more Acuix than you should

In case of overdose or accidental ingestion, consult your doctor or go to the emergency department of the nearest hospital, accompanied by this leaflet, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested or administered.

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

No specific antidote is known. In case of overdose, treatment will be based on symptoms.

If you forget to take Acuix

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects have been grouped by frequency:

Very common(may affect more than 1 in 10 patients)

? electrolyte alterations (including symptomatic ones), dehydration, and decreased total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in the blood.

Common(may affect up to 1 in 10 patients)

? decreased sodium (hyponatremia), chloride (hypochloremia), potassium (hypokalemia) levels, increased cholesterol and uric acid levels in the blood, and gout attacks.

? increased urine volume.

? mental alterations (hepatic encephalopathy) in patients with liver problems (hepatocellular insufficiency).

? increased blood viscosity (hemoconcentration).

Uncommon(may affect up to 1 in 100 patients)

? altered glucose tolerance. Latent diabetes mellitus may manifest.

? nausea.

? hearing disorders, although usually transient, especially in patients with renal insufficiency, decreased protein levels in the blood (hypoproteinemia), and/or after rapid intravenous administration of furosemide. Deafness (sometimes irreversible).

? itching, rash, eruptions, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.

? decreased platelet levels (thrombocytopenia).

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

? allergic inflammation of blood vessels (vasculitis).

? allergic renal reaction (tubulointerstitial nephritis).

? vomiting, diarrhea.

? subjective sensation of ringing (tinnitus).

? severe allergic reactions (anaphylactic or anaphylactoid) (e.g., with shock).

? sensation of tingling in the limbs (paresthesias).

? decreased white blood cell levels (leukopenia), increased eosinophil levels (eosinophilia).

? fever.

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

? inflammation of the pancreas (acute pancreatitis).

? liver problem (cholestasis), increased liver enzymes (transaminases).

? decreased granulocyte levels (agranulocytosis), decreased red blood cell levels (aplastic or hemolytic anemia).

Frequency not known(cannot be estimated from available data)

? decreased calcium levels (hypocalcemia), decreased magnesium levels (hypomagnesemia), increased urea levels in the blood, metabolic alkalosis, pseudo-Bartter syndrome in cases of misuse and/or prolonged use of furosemide.

? alteration of blood coagulation (thrombosis).

? increased sodium and chloride levels in the urine, urine retention (in patients with partial obstruction of urine flow), kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature infants, kidney failure.

? severe vesicular skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), lichenoid reactions, characterized as small, itchy, red-purple lesions, with a polygonal shape, that appear on the skin, genitals, or mouth.

• exacerbation or activation of systemic lupus erythematosus.

? dizziness, fainting, and loss of consciousness, headache.

? cases of rhabdomyolysis have been reported, often in cases where there is a severe decrease in potassium levels in the blood (hypokalemia) (see section "Do not take Acuix").

? increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

As with other diuretics, prolonged administration of this medication can increase the elimination of sodium, chloride, water, potassium, calcium, and magnesium. These alterations manifest as intense thirst, headache, confusion, muscle cramps, painful muscle contractions (tetany), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

Reporting side effects

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

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acuix

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Acuix 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) (potato) and magnesium stearate.

Appearance of the Product and Packaging Contents

Acuix 40 mg tablets are available in packs of 10 and 30 tablets.

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

They are packaged in PVDC/PVC/Aluminum blisters.

Marketing Authorization Holder and ManufacturerHolder:

UXA FARMA, S.A.

Avda. San Francisco Javier 24

Sevilla 41018 Spain

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Date of the Last Revision of this Leaflet: November 2019

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