FUROSEMIDE TECNIGEN 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Furosemide Tecnigen 40 mg Tablets EFG

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

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

Contents of the Package Leaflet

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

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

Furosemide 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 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 the treatment of the underlying disease).
• Edema following burns.
• Mild and moderate arterial hypertension.

2. What you need to know before you take Furosemide Tecnigen

Do not take Furosemide Tecnigen

• If you are allergic to furosemide, to medicines belonging to the group of sulfonamides, or to any of the other components of this medicine (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 medicine.
• If you have a severe decrease in potassium levels 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 section "Pregnancy, breastfeeding, and fertility".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Furosemide Tecnigen.

Be especially careful with this medicine:

• If you have problems with urine elimination, 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 (for example, 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 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 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 control 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 imbalance, should be corrected. Treatment interruption may be required.

Elderly patients with dementia who are taking risperidone should be especially careful when using risperidone and furosemide concomitantly. 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).

Use in athletes

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

Other medicines and Furosemide Tecnigen

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

The effect of treatment may be affected if furosemide is used at the same time as other medicines.

Your doctor may need to change your dose and/or take other precautions if you are taking one of the following medicines:

Aliskiren - used to treat high blood pressure

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

Among these substances are:

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

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

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

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

• Asthma medicines (theophylline).
• Muscle relaxants such as curare.
• Depression medicines (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 a high dose is administered for the first time.
• If medicines to treat high blood pressure, diuretics, or other medicines that can decrease blood pressure are administered concomitantly with furosemide, a more pronounced decrease in blood pressure should be expected.
• Nephrotoxic medicines: concomitant administration may potentiate the harmful effect of these medicines on the kidneys.

Certain anti-inflammatory and pain medicines (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) and epilepsy medicines (phenytoin) may reduce the effect of furosemide.

Furosemide may increase the toxicity of salicylates.

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

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

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

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

Certain electrolyte disturbances (for example, decreased potassium levels in the blood (hypokalemia) or magnesium (hypomagnesemia)) may increase the toxicity of certain medicines (for example, digitalis medicines and medicines that induce QT interval prolongation syndrome).

Patients undergoing treatment with furosemide who receive high doses of certain cephalosporins (antibiotics) may suffer from a decrease in kidney function.

The concomitant administration of furosemide and cyclosporin A (a medicine used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to an increase in blood urea levels and kidney urea elimination problems.

Those patients at high risk of suffering from nephropathy (kidney disease) due to contrast media who receive furosemide are more likely to suffer from kidney function deterioration.

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

High doses of furosemide administered with levothyroxine may 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

During breastfeeding, do not administer furosemide. In the case that its administration is essential, your doctor may require you to interrupt breastfeeding, as furosemide passes into breast milk.

Driving and using machines

This medicine may cause dizziness or drowsiness. This can happen more often at the start of treatment, when your doctor increases the dose, or if you consume alcohol. Do not drive or use tools or machines if you feel dizzy or drowsy.

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

Furosemide Tecnigen contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Furosemide Tecnigen

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 on an empty stomach, swallowing it whole and with enough liquid. The tablet can be divided into equal doses.

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.

Use in adults

Treatment is recommended to 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 indicated by your doctor and will depend on your response to treatment.

Use in children

In infants and children, the recommended daily dose is 2 mg/kg of body weight, 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 before.

If you take more Furosemide Tecnigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

An accidental overdose could lead to a severe decrease in blood pressure (which can evolve into shock), kidney problems (acute renal failure), 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 Furosemide Tecnigen

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:

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

• electrolyte disturbances (including symptomatic), dehydration, and decreased total blood volume (hypovolemia), especially 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 disturbances (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 be revealed.
• nausea.
• hearing disorders, although usually 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).
• itching, rash, eruptions, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.
• decreased platelet count (thrombocytopenia)

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

• allergic inflammation of blood vessels (vasculitis).
• allergic kidney reaction (tubulointerstitial nephritis).
• vomiting, diarrhea.
• subjective sensation of ringing (tinnitus).
• severe allergic reactions (anaphylactic or anaphylactoid) (e.g., with shock).
• tingling sensation in the limbs (paresthesias).
• decreased white blood cell count (leukopenia), increased eosinophils (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 count (agranulocytosis), decreased red blood cell count (aplastic or hemolytic anemia).

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

• decreased calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increased urea levels in the blood, metabolic alkalosis, pseudo-Bartter syndrome in the case 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 skin and mucous membrane vesicular reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blister formation 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 Furosemide Tecnigen").
• 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, after prolonged administration of this medicine, there may be an increase in sodium, chloride, water, potassium, calcium, and magnesium elimination. These disturbances are manifested with intense thirst, headache, confusion, muscle cramps, painful muscle contraction, especially in the limbs (tetany), muscle weakness, cardiac rhythm disturbances, and gastrointestinal symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this 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 Furosemida Tecnigen

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

This medicine does not require any special storage temperature. Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

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

6. Packaging contents and additional information

Composition of Furosemida Tecnigen

• The active ingredient is furosemide.
• The other components are: lactose monohydrate, corn starch, pregelatinized corn starch, sodium potato carboxymethyl starch (type A), magnesium stearate.

Appearance of the product and packaging contents

White or off-white tablets, round (8 mm in diameter), marked with the inscription F40 on one side and flat on the other side. Furosemida Tecnigen is available in packs of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

Edificio America. Poligono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Manufacturer

Tecnimede - Sociedade Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the last revision of this prospectus:November 2021

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