Acuix 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acuix 40 mg tablets EFG

furosemide

Read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Acuix is and what it is used for

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

Under your 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 to moderate arterial hypertension.

2. What you need to know before starting to take Acuix

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

Do not take Acuix

• If you are allergic to furosemide, to drugs of the furosemide type (sulfonamides), or to any of the other components of this medicine (listed in section 6).
• If you have a decreased total blood volume (hypovolemia) or 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). See section 4, "Possible side effects".
• If you have a 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.
• If you are pregnant, see section "Pregnancy, lactation and fertility".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acuix.

Take special care with this medicine:

• If you have problems with urine elimination, especially at the beginning of treatment.
• If you have low blood pressure (hypotension).
• If you are at special risk of experiencing a pronounced drop in blood pressure (e.g., 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 4, "Possible side effects").
• In premature infants (see section 4, "Possible side effects").
• There is a possibility of exacerbation or activation of systemic lupus erythematosus.
• 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 a 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 and any significant electrolyte or acid-base imbalances should be corrected. Treatment interruption may be necessary.

Elderly patients with dementia who are taking risperidone should exercise particular caution when taking risperidone and furosemide together. 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

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

Taking Acuix with other medicines

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

The effect of treatment with this medicine may be altered if used at the same time as other medicines.

Some substances may have increased toxicity in the ear and kidneys when administered together with this medicine. Therefore, they should only be used together if there is a medical need. These substances include:

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

The concomitant use of Acuix with other medicines may weaken the effect of these medicines, such as:

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

In other cases, concomitant use may increase the effects of these medicines, such as:

• Medicines for asthma (theophylline).
• Muscle relaxants of the curare type.
• Medicines for depression (lithium salts): may increase the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.
• Patients receiving treatment with diuretics may experience severe hypotension and worsening of kidney function, especially when initiating treatment or increasing the dose of an ACE inhibitor (Angiotensin-Converting Enzyme) or an angiotensin II receptor antagonist for the first time.
• If medicines for high blood pressure, diuretics, or other medicines that may lower blood pressure are administered together with furosemide, a more pronounced drop in blood pressure should be anticipated.
• Medicines toxic to the kidneys: concomitant administration may enhance the harmful effects of these medicines on the kidneys.

Some medicines for inflammation and pain (non-steroidal anti-inflammatory drugs including acetylsalicylic acid) and medicines for epilepsy (phenytoin) may reduce the effect of Acuix. Furosemide may increase the toxicity of salicylates.

This medicine and sucralfate should not be administered together within less than a 2-hour interval, as the effect of Acuix may be reduced.

Medicines such as probenecid and methotrexate, or other medicines that are significantly eliminated by the kidneys, may reduce the effect of Acuix. When used at high doses, they may increase serum levels and increase the risk of adverse effects due to furosemide or concomitant administration.

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

• 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., low blood potassium levels (hypokalemia) or low magnesium levels (hypomagnesemia)) could increase the toxicity of certain medicines (e.g., digitalis medicines and medicines that induce QT interval prolongation syndrome).

Patients receiving Acuix and high doses of certain cephalosporins (antibiotics) may experience reduced kidney function.

Concomitant administration of Acuix and cyclosporine A (a medicine used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to elevated blood urea levels (hyperuricemia) and impaired urea excretion by the kidneys.

Patients at high risk of contrast medium-induced nephropathy (kidney disease) who receive Acuix have a higher likelihood of experiencing worsening kidney function.

The administration of Acuix together with risperidone in elderly patients with dementia may increase mortality.

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.

Pregnancy, lactation 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 Acuix if there is a medical need.

Breastfeeding is not recommended during treatment with Acuix. If administration is essential, your doctor may advise you to discontinue breastfeeding, as furosemide 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.

Some adverse effects (e.g., a pronounced, undesirable drop in blood pressure) may impair your ability to concentrate and react, and therefore pose 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 diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Acuix

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

Remember to take your medicine.

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

If you think 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 initiated 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 and depends 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 indicate the duration of your treatment with this medicine. Do not stop treatment prematurely.

If you take more Acuix than you should

In case of overdose or accidental ingestion, consult your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you, or call the Toxicology Information Service at 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.

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

If you forget to take Acuix

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

4. Possible adverse effects

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

Adverse effects have been grouped according to their frequency:

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

• Electrolyte disturbances (including symptomatic ones), dehydration, and decreased total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in blood.

Common (may affect up to 1 in 10 patients)

• Decreased levels of sodium (hyponatremia), chloride (hypochloremia), and potassium (hypokalemia); increased cholesterol and uric acid levels in blood; and gout attacks.

• Increased urine volume.

• Mental disturbances (hepatic encephalopathy) in patients with liver problems (hepatocellular insufficiency).

• Increased blood viscosity (hemoconcentration).

Uncommon (may affect up to 1 in 100 patients)

• Impaired glucose tolerance. Latent diabetes mellitus may become apparent.

• Nausea.

• Hearing disorders, although usually temporary, especially in patients with renal insufficiency, low blood protein levels (hypoproteinemia), and/or after too rapid intravenous administration of furosemide. Deafness (sometimes irreversible).

• Itching, rash, eruptions, blisters, and other more serious reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reactions.

• Decreased platelet levels (thrombocytopenia).

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

• Allergic inflammation of blood vessels (vasculitis).

• Allergic-type kidney reaction (tubulointerstitial nephritis).

• Vomiting, diarrhea.

• Subjective sensation of ringing in the ears (tinnitus).

• Severe allergic reactions (anaphylactic or anaphylactoid reactions) (e.g. with shock).

• Tingling sensation in the limbs (paresthesias).

• Decreased white blood cell count (leukopenia), increased levels of a type of white blood cells, eosinophils (eosinophilia).

• Fever.

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

• Inflammation of the pancreas (acute pancreatitis).

• Liver problems (cholestasis), increased liver enzymes (transaminases).

• Decreased levels of a type of white blood cells, granulocytes (agranulocytosis), decreased number of red blood cells (aplastic anemia or hemolytic anemia).

Frequency not known (cannot be estimated from available data)

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

• Impaired blood clotting (thrombosis).

• Increased levels of sodium and chloride in urine, urinary retention (in patients with partial obstruction of urinary flow), formation of kidney stones (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure.

• Severe blistering skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin disorder characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), lichenoid reactions, characterized by small, itchy, reddish-purple, polygonal lesions appearing 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, frequently in patients with severe hypokalemia (low blood potassium levels) (see section “Do not take Acuix”).

• Increased risk of persistence of the ductus arteriosus when furosemide is administered to premature infants during the first weeks of life.

As with other diuretics, prolonged administration of this medicine may increase the excretion of sodium, chloride, water, potassium, calcium, and magnesium. These disturbances may manifest as intense thirst, headache, confusion, muscle cramps, painful muscle contractions, especially in the limbs (tetany), muscle weakness, cardiac arrhythmias, and gastrointestinal symptoms.

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 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 Acuix

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 refers to 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 collection point at the pharmacy. If you are in doubt, 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 Acuix 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 carboxymethylstarch (type A) (from potato), and magnesium stearate.

Appearance of the product and contents of the pack

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

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

They are packaged in PVDC/PVC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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 most recent review of this package leaflet: November 2019

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/