FUROSEMIDE ALTER 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Furosemide Alter 40 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Furosemide Alter and what is it used for

Furosemide Alter is a diuretic belonging to the group of sulfonamides. It works by increasing urine production (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 accumulation) 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 Furosemide Alter

Read carefully the instructions provided in section 3. "How to take Furosemide Alter".

Do not take Furosemide Alter

• 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 if you are dehydrated.
• If you have severe kidney problems, accompanied by a decrease in urine production (renal insufficiency with anuria), that do not respond to this medicine.
• If you have a severely decreased potassium level in your blood (severe hypokalemia).
• If you have a severely decreased sodium level in your 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 Furosemide Alter. Be especially careful with this medicine:

• If you have problems with urine production, especially at the start of treatment.
• If your blood pressure is low (hypotension).
• If you are at high risk of experiencing 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 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 suffering from, for example, nephrotic syndrome (see "Possible side effects" section).
• In premature infants (see "Possible side effects" section).
• There is a possibility of exacerbation or activation of systemic lupus erythematosus.
• 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 your treatment with this medicine, periodic monitoring of your blood levels of sodium, potassium, and creatinine will generally be required, and 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.

Elderly patients 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).

Other medicines and Furosemide Alter

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

Tell your doctor if you are being treated with medicines for:

• high blood pressure (aliskiren).

This medicine and sucralfate should not be administered together, with an interval of less than 2 hours, as the effect of Furosemide Alter 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 (can increase their toxicity).
• 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 Furosemide Alter.

Additionally, they can reduce the effect of Furosemide Alter 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 Furosemide Alter:

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

Some patients who receive high doses of cephalosporin-type antibiotics may experience a decrease in kidney function.

The combined administration of Furosemide Alter and cyclosporin A can produce gouty arthritis.

Those patients at high risk of nephropathy (kidney disease) due to contrast who receive Furosemide Alter may experience deterioration of kidney function.

The administration of Furosemide Alter together with risperidone in elderly patients with dementia could increase mortality.

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 Furosemide Alter under strict medical indication.

During breastfeeding, Furosemide Alter should not be administered. If its administration is essential, your doctor may require you to interrupt breastfeeding, as Furosemide Alter 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.

Furosemide Alter contains lactose

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

Use in athletes

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

3. How to take Furosemide Alter

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 Furosemide Alter on an empty stomach, swallowing it whole and with sufficient 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 adultsit 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 stop your treatment before.

If you take more Furosemide Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the emergency department of the nearest hospital with this package leaflet, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 failure), coagulation problems (thrombosis), delirium, flaccid paralysis of soft muscles (flaccid paralysis), apathy, and confusion. There is no specific antidote known. In cases of overdose, treatment will be based on symptoms.

If you forget to take Furosemide Alter

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

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

4. Possible side effects

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

Side effects have been grouped by frequency according to the following classification:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

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

Metabolic and nutritional disorders

Very common: electrolyte disturbances (including symptomatic ones), dehydration, and decreased total blood volume (hypovolemia), especially in elderly patients, elevated creatinine and triglyceride levels in the blood.

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

Uncommon: altered glucose tolerance. Latent diabetes mellitus may manifest.

Frequency not known: decreased calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increased urea level 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: renal allergic reaction (interstitial nephritis).

Frequency not known: 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, renal failure.

Gastrointestinal disorders

Uncommon: nausea.

Rare: vomiting, diarrhea.

Very rare: acute pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders

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

Ear and labyrinth disorders

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

Very rare: subjective sensation of ringing (tinnitus).

Skin and subcutaneous tissue disorders

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

Frequency not known: severe skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin disorder characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), and acute generalized exanthematous pustulosis (AGEP) 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 limbs (paresthesias).

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

Blood and lymphatic system disorders

Common: increased blood viscosity (hemoconcentration).

Uncommon: decreased platelet count (thrombocytopenia).

Rare: decreased white blood cell count (leukopenia), increased eosinophil count.

Very rare: decreased granulocyte count (agranulocytosis), decreased red blood cell count (aplastic anemia, hemolytic anemia).

Congenital, familial, and genetic disorders

Frequency not known: increased risk of persistent 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, after prolonged administration of this medicine, there may be an increase in the elimination of sodium, chloride, water, potassium, calcium, and magnesium. These disturbances manifest with intense thirst, headache, confusion, muscle cramps, painful contraction of the muscles, especially of the limbs (tetany), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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 Furosemide Alter

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Furosemida Alter Composition

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

Product Appearance and Package Contents

White or almost white, round tablets, approximately 7 mm in diameter, flat, with beveled edges, engraved with "40" on one side and scored on the other. The tablet can be divided into equal doses.

Green-Aluminum (standard and unit-dose) PVC blisters. Containers holding 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Zydus France ZAC

Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of Last Revision of this Leaflet: April 2024

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