PATIENT INFORMATION LEAFLET

Furosemide Kern Pharma 40 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine, 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 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.

Furosemida Kern Pharma acts by increasing the elimination of urine (diuretic) and reducing blood pressure (antihypertensive). It is a diuretic belonging to the group of sulfonamides.

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 (difficulty of the heart to pump blood), liver cirrhosis (ascites) or kidney disease, including nephrotic syndrome (a type of kidney disorder).
• Edemas caused by burns.
• Mild to moderate high blood pressure.

Do not take Furosemida Kern Pharma

• if you are allergic to furosemide or any of the other components of Furosemida Kern Pharma.
• if you are allergic to sulfonamides.
• if you have a decrease in your total blood volume (hypovolemia), or are dehydrated.
• if you have severe kidney problems, accompanied by a decrease in urine elimination (renal insufficiency or anuria), that does 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).
• in case you are in a state of precoma or coma (associated with hepatic encephalopathy).
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Furosemida Kern Pharma.

• 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, patients with coronary artery or cerebral artery stenosis).
• if you have diabetes mellitus (high blood glucose levels).
• 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), and you also have, for example, nephrotic syndrome (a type of kidney disorder). In this case, the effect of furosemide may be weakened and its toxicity in the ear may be increased, so your doctor may need to carefully adjust the dose.
• in premature children.
• if you are an athlete, as this medication contains a component that may establish a positive analytical result for doping control.
• 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 a risk of decreased blood pressure.

During treatment with Furosemida Kern Pharma, regular monitoring of your blood levels of sodium, potassium, creatinine, and especially if you experience severe fluid loss, by vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), may be required, as your doctor may need to consider interrupting treatment.

Use of Furosemida Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Some substances may increase the toxicity of furosemide in the ear and kidneys if administered together with this medication. Therefore, if administered together, they should be under strict medical control. These substances include:

• aminoglycoside antibiotics (infection medications) such as gentamicin, kanamicin, and tobramicin
• chemotherapy medications (cisplatin)

This medication may weaken the effect of other medications:

• diabetes medications (antidiabetics)
• blood pressure medications (sympathomimetics with a hypertensive effect, such as epinephrine and norepinephrine)

It may also increase the action of other medications:

• asthma medications (theophylline)
• muscle relaxants (curare)
• depression medications (lithium)
• salicylates (a type of non-steroidal anti-inflammatory medication)
• blood pressure medications (hypotensives)
• kidney-toxic medications (such as some antibiotics)

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

• aliskiren - used to treat high blood pressure

Some anti-inflammatory and pain medications, such as indomethacin (non-steroidal anti-inflammatory medications, including acetylsalicylic acid) and epilepsy medications (phenytoin), may reduce the effect of Furosemida Kern Pharma.

Additionally, medications such as probenecid (used to treat gout) and methotrexate (used to treat cancer and rheumatic diseases) may reduce the effect of Furosemida Kern Pharma or increase its adverse effects. Sucralfate (a medication for ulcers) and furosemide should not be administered together, with an interval of less than 2 hours, as the effect of Furosemida Kern Pharma may be reduced.

The following substances may reduce blood potassium levels (hypokalemia) if administered with Furosemida Kern Pharma:

• corticosteroids (inflammation medications)
• carbenoxolone
• large amounts of licorice
• abuse of laxatives (laxatives)

Some electrolyte alterations (such as a decrease in potassium and magnesium levels in the blood) may increase the toxicity of some heart medications (such as digitalis and medications that induce the prolongation of the QT interval, such as some antiarrhythmics).

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

The concomitant administration of Furosemida Kern Pharma and cyclosporine A (used to prevent transplant rejection) may cause gouty arthritis (inflammation of the joints). Patients with a high risk of nephropathy due to contrast (a kidney disorder that occurs during some medical tests) who receive Furosemida Kern Pharma may experience a deterioration in kidney function.

Use of Furosemida Kern Pharma with food and drink

Furosemida Kern Pharma should be taken on an empty stomach, swallowing it without chewing and with sufficient liquid.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant or believe you may be pregnant, you will only use furosemide under strict medical indication.

During breastfeeding, Furosemida Kern Pharma should not be administered. If its administration is necessary, your doctor may require you to interrupt breastfeeding, as furosemide passes into breast milk.

Driving and operating machinery

Furosemida Kern Pharma may affect your alertness as well as your ability to drive vehicles.

Certain effects, such as drowsiness and a significant drop in blood pressure, may decrease your ability to concentrate and react.

It is recommended not to drive or operate machinery until you know your individual sensitivity to the product.

Furosemida Kern Pharma contains lactose

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

Information for athletes

It is informed to athletes that this medication contains a component that may establish a positive analytical result for doping control.

Follow exactly the administration instructions for Furosemida Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Take Furosemida Kern Pharma on an empty stomach, swallowing it without chewing and with sufficient liquid.

Your doctor will indicate the duration of your treatment with Furosemida Kern Pharma. Do not discontinue your treatment before.

Your doctor will prescribe the minimum effective dose.

Follow these instructions unless your doctor has given you different instructions.

Adults

It 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.

Infants and children

It is recommended to administer 2 mg per kg of body weight per day, up to a maximum of 40 mg per day.

If you estimate that the action of Furosemida Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you take more Furosemida Kern Pharma than you should

Consult your doctor immediately or go to the nearest hospital emergency service, accompanied by this leaflet.

The symptoms of overdose are: severe decrease in blood pressure (which may evolve into shock), kidney problems (acute renal failure), blood clotting problems (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

No specific antidote is known.

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

If you forget to take Furosemida Kern Pharma

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

Take the missed dose as soon as possible and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait until it is time to take the next tablet.

If you interrupt treatment with Furosemida Kern Pharma

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

Like all medications, Furosemida Kern Pharma may cause side effects, although not everyone will experience them.

Renal and urinary disorders

Similar to other diuretics, prolonged administration of this medication may increase the elimination of sodium (hyponatremia), chloride (hypochloremic alkalosis) and consequently water. It may also increase the loss of potassium (hypokalemia), calcium, and magnesium. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contractions, especially in the extremities (tetany), muscle weakness, cardiac rhythm alterations, and gastrointestinal symptoms.

In particular, in elderly patients, it may lead to or contribute to a decrease in total blood volume (hypovolemia), dehydration, coagulation disorders (thrombosis).

Furosemida may cause or worsen discomfort in patients with difficulty urinating. This may result in acute urinary retention with possible secondary complications.

In rare cases, cases of kidney problems that may be a consequence of a type of allergic renal urethral retention (interstitial nephritis) have been reported.

In premature children, furosemida may lead to the formation of kidney stones (nephrocalcinosis/nephrolithiasis) that may evolve into a severe clinical condition (patent ductus arteriosus).

Blood and lymphatic system disorders

Treatment with furosemida may lead to temporary elevations in blood levels of urea and creatinine, and increased serum levels of cholesterol, triglycerides, and uric acid, which may lead to gout attacks.

Occasionally, the number of platelets may be excessively reduced (thrombocytopenia), and in rare cases, it may produce leukopenia (decrease in white blood cells), eosinophilia (increase in a type of white blood cell, eosinophils), or fever; in isolated cases, agranulocytosis (decrease in a type of white blood cell, granulocytes) and anemia aplastic or hemolytic anemia may appear.

Metabolism and nutrition disorders

Furosemida may decrease glucose tolerance. In patients with diabetes mellitus, a deterioration in metabolic control may be observed, which may manifest as latent diabetes mellitus.

Vascular disorders

Furosemida may cause a decrease in blood pressure. When this is pronounced, it may lead to a worsening of concentration and reaction ability, mild confusion, sensation of pressure in the head, headache, dizziness, somnolence, weakness, visual disturbances, dry mouth, inability to maintain an upright position (orthostatic intolerance). In rare cases, allergic inflammation of blood vessels (vasculitis) has been described.

Skin disorders

Occasionally, skin and mucous membrane reactions such as itching, rash, blisters, and more severe reactions such as erythema multiforme (circular skin lesions), exfoliative dermatitis (skin inflammation), purpura (appearance of purple spots on the skin), and sun allergy (photosensitivity) may occur.

In rare cases, severe allergic reactions (anaphylactic or anaphylactoid) may occur.

The following adverse effect has been reported with an unknown frequency: generalized acute pustular exanthema (PEGA).

Nervous system disorders

Rarely, a sensation of tingling in the extremities (paresthesias) and encephalopathy (mental alterations in patients with liver problems) may occur.

The following adverse effects have been reported with an unknown frequency: dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension).

Auditory disorders

With low frequency, hearing loss (in some cases, irreversible) may occur.

In rare cases, reversible hearing problems and tinnitus (ringing in the ears) may occur in patients with severe kidney problems and/or decreased blood protein levels (hypoproteinemia).

Digestive disorders

Rarely, digestive disorders such as nausea, vomiting, or diarrhea may occur.

Liver and bile duct disorders

In isolated cases, liver problems such as intrahepatic cholestasis (obstruction of bile flow within the liver), increased liver enzymes (transaminases), or acute pancreatitis may develop.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

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

No special storage conditions are required.

Do not use Furosemida Kern Pharma 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 through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.By doing so, you will help protect the environment.

Composition of Furosemida Kern Pharma

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: lactose monohydrate, cornstarch without gluten, pregelatinized cornstarch, anhydrous colloidal silica, talc, and magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

Furosemida Kern Pharma 40 mg are flat, round, white, and scored tablets on both sides.

The tablets can be divided into equal halves.

The Furosemida Kern Pharma tablets are packaged in PVC/Aluminum blisters.

Packages containing 10 or 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet: January 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/