Leaflet: information for the user

Furosemide Alter 40 mg tablets EFG

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Furosemida Alter is a diuretic belonging to the sulfonamide group. It acts by increasing urine elimination (diuretic) and reducing blood pressure (anti-hypertensive).

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

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

Please read the instructions provided in section 3, “How to take Furosemida Alter” carefully.

Do not take Furosemida Alter

• 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 decrease in your 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 your blood potassium levels (severe hypokalemia).
• If you have a severe deficiency of sodium salts in your 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 or pharmacist before starting to take Furosemida Alter. 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 (hepato-renal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to having, for example, nephrotic syndrome (see the section “Possible adverse effects”).
• In premature children (see the section “Possible adverse effects”).
• There is a possibility of exacerbating or activating systemic lupus erythematosus.
• 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 decreased 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 the age of advanced dementia who are taking risperidone should be especially careful when taking this medication. Risperidone is a medication used to treat certain mental illnesses, such as dementia (a disease characterized by several symptoms: memory loss, problems speaking, problems thinking).

Other medications and Furosemida Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some substances may increase your toxicity in the ear and kidneys if administered together with this medication. 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).

Inform your doctor if you are being treated with medications for:

• High blood pressure (aliskiren).

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

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

• Diabetes medications (antidiabetics).
• Medications used to raise blood pressure (sympathomimetics with a 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 (may increase toxicity).
• Medications that 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 Alter.

Additionally, they may reduce the effect of Furosemida Alter 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 Alter:

• Corticosteroids (anti-inflammatory medications).
• Carbenoxolone (medication for the treatment of oral mucosa lesions).
• Significant amounts of licorice root.
• 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 cephalosporin antibiotics may experience a decrease in kidney function.

The concomitant administration of Furosemida Alter and cyclosporine A may produce gouty arthritis.

Patients at high risk of nephropathy (kidney disease) who receive Furosemida Alter may experience a deterioration in kidney function.

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

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

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 Alter contains lactose

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

Use in athletes

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

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 Alter on an empty stomach, swallowing it without chewing and with sufficient liquid.

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

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

For adultsit 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 2 mg/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 your treatment before.

If you take more Furosemida Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital emergency department accompanied by this leaflet, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested or administered.

An accidental overdose could lead to a severe decrease in blood pressure (which may evolve into shock), kidney problems (acute renal insufficiency), coagulation problems (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion. There is no known specific antidote. In cases of overdose, treatment will be based on symptoms.

If you forgot to take Furosemida Alter

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

The side effects have been grouped according to their frequency in accordance with the following classification:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

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

Frequency not known (cannot be estimated from available data).

Metabolic and nutritional disorders

Very common: electrolyte imbalances (including symptomatic), dehydration and decreased total blood volume (hypovolemia), particularly in elderly patients, elevated levels of creatinine and triglycerides in the blood.

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

Uncommon:alteration of glucose tolerance. May manifest latent diabetes mellitus.

Frequency not known:decreased levels of calcium (hypocalcemia), magnesium (hypomagnesemia), increased level of urea in the blood, metabolic alkalosis, pseudo-Bartter syndrome in case of misuse and/or prolonged use of furosemide.

Vascular disorders

Rare: allergic inflammation of blood vessels (vasculitis). Frequency not known: alteration of blood coagulation (thrombosis).

Renal and urinary disorders

Common: increased urine volume. Rare: allergic renal reaction (tubulointerstitial nephritis).

Frequency not known: increased sodium and chloride levels in the urine, urinary retention (in patients with partial obstruction of urine flow), kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure.

Gastrointestinal disorders

Uncommon: nausea.

Rare: vomiting, diarrhea.

Very rare: acute pancreatitis.

Hepatobiliary disorders

Very rare: liver problem (cholestasis), increased liver enzymes (transaminases).

Vestibular and labyrinthine disorders

Uncommon: auditory disturbances, although transient, especially in patients with renal insufficiency, decreased levels of proteins in the blood (hypoproteinemia) and/or after rapid intravenous administration of furosemide, deafness (sometimes irreversible).

Very rare: subjective sensation of ringing (tinnitus).

Dermatological and subcutaneous tissue disorders

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

Frequency not known: severe vesicular skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), and generalized acute pustular exanthema (PEGA) and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS).

Immune system disorders

Rare: severe allergic reactions (anaphylactic or anaphylactoid) (e.g. with shock).

Nervous system disorders

Common: mental alterations in patients with liver problems (hepatic encephalopathy)

Rare: sensation of tingling in the extremities (paresthesias).

Frequency not known: dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).

Haematological and lymphatic system disorders

Common: increased blood viscosity (hemoconcentration).

Uncommon: decreased platelet levels (thrombocytopenia).

Rare: decreased white blood cell levels (leucopenia), increased levels of a type of white blood cell, eosinophils (eosinophilia).

Very rare: decreased levels of a type of white blood cell, granulocytes (agranulocytosis), decreased red blood cell count (aplastic anemia, hemolytic anemia).

Genetic, familial and congenital disorders

Frequency not known: increased risk of persistence of the patent ductus arteriosus when furosemide is administered to premature infants during the first weeks of life.

General disorders and administration site conditions

Rare: fever.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the 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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Furosemida Alter

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: lactose monohydrate, pregelatinized cornstarch, anhydrous colloidal silica (E551), cornstarch, povidone K 30, sodium lauryl sulfate, poloxamer 407, talc (E553b), and magnesium stearate (E470b).

Appearance of the product and content of the packaging

White or off-white, round, 7 mm in diameter, flat, beveled edge tablets, engraved with "40" on one face and scored on the other. The tablet can be divided into equal doses.

PVC green-aluminum blisters (standard and single-dose). Containers containing 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for Manufacturing

Zydus France ZAC

Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

O

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

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 .