FUROSEMIDE KERN PHARMA 40 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Furosemide Kern Pharma 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.

Contents of the pack:

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

1. What is Furosemide Kern Pharma and what is it used for

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

Always under the prescription of your doctor, this medicine 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).
• Edema caused by burns.
• Mild or moderate arterial hypertension (high blood pressure).

2. What you need to know before you take Furosemide Kern Pharma

Do not take Furosemide Kern Pharma

• If you are allergic to furosemide or any of the other components of Furosemide Kern Pharma.
• If you are allergic to sulfonamides.
• 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 production (renal insufficiency or anuria), that do not respond to this medicine.
• 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 or pharmacist or nurse before starting to take Furosemide Kern Pharma.

• 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 suffering a pronounced drop in blood pressure (for example, patients with narrowing of the heart or brain arteries).
• If you have diabetes mellitus (high blood sugar levels).
• 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 (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 a careful adjustment of the dose by your doctor may be required.
• In premature infants.
• If you are an athlete, since this medicine contains a component that can establish a positive doping control result.
• 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 Furosemide Kern Pharma, periodic monitoring of your blood levels of sodium, potassium, creatinine, and especially if you suffer from severe fluid loss, due to vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), may be required, as your doctor may consider it necessary to interrupt treatment.

Use of Furosemide Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Some substances may 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, among these substances are:

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

This medicine may weaken the effect of other medicines:

• Diabetes medicines (antidiabetics)
• Medicines used to increase blood pressure (sympathomimetics with hypertensive effect, such as epinephrine and norepinephrine)

It can also increase the action of other medicines such as:

• Asthma medicines (theophylline)
• Muscle relaxants such as curare
• Antidepressant medicines (lithium)
• Salicylates (a type of non-steroidal anti-inflammatory)
• Blood pressure lowering medicines (hypotensives)
• Kidney toxic medicines (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 medicines:

• Aliskiren - used to treat high blood pressure

Some medicines for inflammation and pain, for example, indomethacin (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) and medicines for epilepsy (phenytoin) may reduce the effect of Furosemide Kern Pharma.

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

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

• Inflammation medicines (corticosteroids)
• Carbenoxolone
• Large amounts of licorice
• Abuse of constipation medicines (laxatives)

Some electrolyte disturbances (for example, decreased potassium and magnesium levels in the blood) may increase the toxicity of some heart medicines (for example, digitalis and medicines that induce QT interval prolongation syndrome, such as some antiarrhythmics).

Some patients who receive high doses of cephalosporin-type antibiotics may suffer from decreased kidney function.

The concomitant administration of Furosemide Kern Pharma and cyclosporin A (used to prevent transplant rejection) may produce gouty arthritis (joint inflammation). Those patients at high risk of contrast nephropathy (a kidney disorder that occurs during some medical tests) who receive Furosemide Kern Pharma may suffer from deterioration of kidney function.

Use of Furosemide Kern Pharma with food and drink

Furosemide Kern Pharma should be taken on an empty stomach, swallowed without chewing and with sufficient liquid.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

During breastfeeding, Furosemide Kern Pharma should not be administered. In case its administration is essential, your doctor may require you to interrupt breastfeeding, as furosemide passes into breast milk.

Driving and using machines

Furosemide Kern Pharma may affect your alertness and ability to drive vehicles.

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

It is advisable not to drive or operate machinery until you know the particular sensitivity of the patient to the product.

Furosemide Kern Pharma contains lactose

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

Information for athletes

Athletes are informed that this medicine contains a component that can establish a positive doping control result.

3. How to take Furosemide Kern Pharma

Follow the administration instructions of Furosemide Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medicine.

Take Furosemide Kern Pharma on an empty stomach, swallowed without chewing and with sufficient liquid.

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

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

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) 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.

Infants and children

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

If you think the action of Furosemide Kern Pharma is too strong or too weak, tell your doctor or pharmacist.

If you take more Furosemide Kern Pharma than you should

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

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

No specific antidote is known.

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.

If you forget to take Furosemide Kern Pharma

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

Take the forgotten dose as soon as possible and then follow the usual schedule. However, if there are only a few hours left until the next dose, do not take the forgotten dose and wait until it is time to take the next tablet.

If you stop treatment with Furosemide Kern Pharma

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

4. Possible side effects

Like all medicines, Furosemide Kern Pharma can cause side effects, although not everybody gets them.

Renal and urinary disorders

As with other diuretics, after prolonged administration of this medicine, there may be an increase in sodium elimination (hyponatremia), chloride (hypochloremic alkalosis), and consequently water. There may also be an increase in potassium loss (hypokalemia), calcium, and magnesium. These disturbances manifest with intense thirst, headache, confusion, muscle cramps, painful contraction of the muscles, especially in the extremities (tetany), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

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

Furosemide may cause or worsen discomfort in patients with difficulty urinating. Thus, acute urine retention can occur with possible secondary complications.

In rare cases, cases of kidney problems have been reported, which may be a consequence of an allergic reaction (interstitial nephritis).

In premature infants, furosemide can lead to the formation of kidney stones (nephrocalcinosis/nephrolithiasis) that can evolve into a severe clinical picture (patent ductus arteriosus).

Blood and lymphatic system disorders

Treatment with furosemide may lead to temporary elevations in blood urea and creatinine levels, and an increase in serum cholesterol, triglycerides, and uric acid levels, which may lead to gout attacks.

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

Metabolism and nutrition disorders

Furosemide may decrease glucose tolerance. In patients with diabetes mellitus, a deterioration of metabolic control may be observed, and latent diabetes mellitus may manifest.

Vascular disorders

Furosemide may cause a decrease in blood pressure. When this is pronounced, it can lead to a worsening of concentration and reaction capacity, mild confusion, feeling of pressure in the head, headache, dizziness, drowsiness, weakness, vision disorders, dry mouth, and inability to maintain an upright position (orthostatic intolerance). In rare cases, cases of allergic inflammation of blood vessels (vasculitis) have been described.

Skin and subcutaneous tissue disorders

Occasionally, skin and mucous membrane reactions such as itching, rash, blisters, and more severe reactions such as erythema multiforme (circular lesions on the skin), 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: acute generalized exanthematous pustulosis (AGEP).

Nervous system disorders

Rarely, a sensation of tingling in the extremities (paresthesia) 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).

Ear and labyrinth disorders

With little frequency, deafness (sometimes irreversible) may appear.

In rare cases, reversible hearing problems and a sensation of ringing (tinnitus) may appear in patients with severe kidney problems and/or decreased blood protein levels (hypoproteinemia).

Gastrointestinal disorders

Rarely, gastrointestinal disorders such as nausea, vomiting, or diarrhea may appear.

Hepatobiliary disorders

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Furosemide Kern Pharma

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

No special storage conditions are required.

Do not use Furosemide Kern Pharma after the expiration date that appears 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 medicines you no longer need in the SIGRE collection point at the 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. Contents of the pack and further information

Composition of Furosemide Kern Pharma

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: lactose monohydrate, corn starch, pregelatinized corn starch, anhydrous colloidal silica, talc, and magnesium stearate (E-470b).

Appearance of the product and packaging contents

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

The tablets can be divided into two equal halves.

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

Packaging containing 10 or 30 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this leaflet: January 2024

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/