Furosemide Kern Pharma 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Furosemide Kern Pharma 40 mg tablets EFG

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

Furosemide Kern Pharma works by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive). It is a diuretic belonging to the sulfonamide group.

Under medical prescription, 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), hepatic cirrhosis (ascites), or kidney disease, including nephrotic syndrome (a type of kidney disorder).
• Edema caused by burns.
• Mild to moderate arterial hypertension (high blood pressure).

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

Do not take Furosemide Kern Pharma

• If you are allergic to furosemide or to any of the other components of Furosemide Kern Pharma.
• If you are allergic to sulfonamides.
• If your total blood volume is reduced (hypovolemia), or if you are dehydrated.
• If you have severe kidney problems accompanied by reduced urine output (renal failure or anuria) that does not respond to this medicine.
• If you have severely low blood potassium levels (severe hypokalemia).
• If you have severe deficiency of sodium salts in the blood (severe hyponatremia).
• If you are in a pre-coma or coma state (associated with hepatic encephalopathy).
• If you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Furosemide Kern Pharma.

• If you have problems with urine output, especially at the beginning of treatment.
• If you have low blood pressure (hypotension).
• If you are at high risk of experiencing a marked drop in blood pressure (e.g., patients with narrowing of the arteries of the heart or brain).
• If you have diabetes mellitus (high blood glucose levels).
• If you suffer from gout.
• If you have severe kidney problems associated with serious liver disease (hepatorenal syndrome).
• If your blood protein levels are low (hypoproteinemia), especially if you also have, for example, nephrotic syndrome (a type of kidney disorder). In this case, the effect of furosemide may be weakened and its ototoxicity (ear toxicity) may be enhanced, requiring careful dose adjustment by your doctor.
• In premature infants.
• If you are an athlete, as this medicine contains a component that may lead to a positive analytical doping test result.
• If you are elderly, if you are being treated with medicines that may cause low blood pressure, or if you have other medical conditions associated with a risk of low blood pressure.

During treatment with Furosemide Kern Pharma, regular monitoring of blood levels of sodium, potassium, and creatinine is generally required, especially if you experience significant fluid loss due to vomiting, diarrhea, or excessive sweating (dehydration or hypovolemia), as your doctor may consider it necessary to discontinue treatment.

Use of Furosemide Kern Pharma with other medicines

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

Some substances may have increased toxicity to the ear and kidneys when administered together with this medicine. Therefore, if they are used concurrently, it must be under strict medical supervision. These substances include:

• Aminoglycoside antibiotics (medicines for infections) such as gentamicin, kanamycin, and tobramycin
• Medicines for cancer (cisplatin)

This medicine may reduce the effect of other medicines:

• Medicines used for diabetes (antidiabetics)
• Medicines used to raise blood pressure (sympathomimetic hypertensive agents such as epinephrine and norepinephrine)

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

• Medicines for asthma (theophylline)
• Muscle relaxants of the curare type
• Medicines for depression (lithium)
• Salicylates (a type of non-steroidal anti-inflammatory drug)
• Antihypertensive medicines (to lower blood pressure)
• Nephrotoxic medicines (toxic to the kidneys, such as certain antibiotics)

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

• Aliskiren – used to treat high blood pressure

Some medicines for inflammation and pain, such as 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 taken together within less than 2 hours of each other, as the effect of Furosemide Kern Pharma may be reduced.

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

• Medicines for inflammation (corticosteroids)
• Carbenoxolone
• Large amounts of licorice
• Abuse of medicines for constipation (laxatives)

Some electrolyte imbalances (e.g., low levels of potassium and magnesium in the blood) could increase the toxicity of certain heart medicines (e.g., digitalis and medicines that induce QT interval prolongation syndrome, such as some antiarrhythmics).

Some patients receiving high doses of cephalosporin-type antibiotics may experience reduced kidney function.

Concomitant administration of Furosemide Kern Pharma and cyclosporine A (used to prevent transplant rejection) may cause gouty arthritis (joint inflammation). Patients at high risk of contrast-induced nephropathy (a kidney disorder occurring during certain medical procedures) who receive Furosemide Kern Pharma may experience worsening kidney function.

Use of Furosemide Kern Pharma with food and drink

Furosemide Kern Pharma should be taken on an empty stomach, swallowed whole with sufficient liquid.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Breastfeeding is not recommended during treatment with Furosemide Kern Pharma. If administration is essential, your doctor may require you to discontinue breastfeeding, as furosemide passes into breast milk.

Driving and use of machines

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

Certain side effects, such as drowsiness and a marked drop in blood pressure, could reduce your concentration and reaction ability.

It is advisable not to drive or operate machinery until you know how you personally react to this medicine.

Furosemide Kern Pharma contains lactose

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

Information for athletes

Athletes should be aware that this medicine contains a component that may result in a positive analytical finding in doping controls.

3. How to take Furosemida Kern Pharma

Follow exactly the administration instructions for Furosemida Kern Pharma given 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 an adequate amount of liquid.

Your doctor will determine the duration of your treatment with Furosemida Kern Pharma. Do not stop your treatment prematurely.

Your doctor will prescribe the lowest effective dose necessary to achieve the desired effect.

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

Adults

Treatment is recommended to begin 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 determined by your doctor and depend on your response to treatment.

Infants and children

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

If you feel that the effect 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

Contact your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you.

Symptoms of overdose include: severe drop in blood pressure (which may progress to shock), kidney problems (acute renal failure), coagulation disorders (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

There is no known specific antidote.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medication and the amount ingested.

If you forget to take Furosemida Kern Pharma

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

Take the missed dose as soon as possible, then continue with your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and wait until your next scheduled dose.

If you stop taking Furosemida Kern Pharma

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

4. Possible adverse effects

Like all medicines, Furosemida Kern Pharma can produce adverse effects, although not everyone will experience them.

Renal and urinary disorders

As with other diuretics, prolonged administration of this medicine may increase the excretion of sodium (hyponatremia), chloride (hypochloremic alkalosis), and consequently water. It may also increase the loss of potassium (hypokalemia), calcium, and magnesium. These imbalances may manifest as intense thirst, headache, confusion, muscle cramps, painful muscle contractions especially in the extremities (tetany), muscle weakness, disturbances in heart rhythm, and gastrointestinal symptoms.

In particular, in elderly patients, this medicine may cause or contribute to a reduction in total blood volume (hypovolemia), dehydration, and coagulation disorders (thrombosis).

Furosemide may provoke or worsen symptoms in patients with difficulty urinating. Thus, acute urinary retention with possible secondary complications may occur.

Rarely, cases of kidney problems have been reported, which may result from allergic-type renal ureteral obstruction (interstitial nephritis).

In premature infants, furosemide may lead to the formation of kidney stones (nephrocalcinosis/nephrolithiasis), which may progress to a serious clinical condition (patent ductus arteriosus).

Blood and lymphatic system disorders

Treatment with furosemide may cause temporary increases in blood levels of urea and creatinine, and elevated serum levels of cholesterol, triglycerides, and uric acid, potentially leading to gout attacks.

Occasionally, platelet count may be excessively reduced (thrombocytopenia); rarely, leukopenia (decrease in white blood cells), eosinophilia (increase in a type of white blood cells called eosinophils), or fever may occur; in isolated cases, agranulocytosis (decrease in a type of white blood cells called granulocytes) and reduction in red blood cells (aplastic anemia or hemolytic anemia) may appear.

Metabolism and nutrition disorders

Furosemide may reduce glucose tolerance. In patients with diabetes mellitus, worsening of metabolic control may occur, and latent diabetes mellitus may become apparent.

Vascular disorders

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

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 allergic reaction to sunlight (photosensitivity) may occur. Rarely, severe allergic-type reactions (anaphylactic or anaphylactoid) have been observed.

The following adverse effect has been reported with unknown frequency: acute generalized exanthematous pustulosis (AGEP).

Nervous system disorders

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

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

Ear disorders

Hearing loss (sometimes irreversible) may occur infrequently.

Rarely, hearing problems and reversible ringing in the ears (tinnitus) may occur in patients with severe kidney problems and/or reduced levels of proteins in the blood (hypoproteinemia).

Gastrointestinal disorders

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

Hepatobiliary disorders

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform 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 expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Furosemide Kern Pharma

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

Appearance of the product and contents of the pack

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

The tablets may be divided into equal halves.

Furosemide Kern Pharma tablets are packaged in PVC/aluminum blisters.

Packs 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 most recent review of this leaflet: January 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/