FUROSEMIDE PHARMA COMBIX 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Furosemide Pharma Combix 40 mg tablets 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 to moderate arterial hypertension.

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

Read carefully the instructions provided in section 3. “How to take Furosemide Pharma Combix”.

Do not take Furosemide Pharma Combix

• If you are allergic to furosemide, to medicines of the furosemide type (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 Pharma Combix.

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 decrease 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, for example, from 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 balance alterations, must be corrected. Treatment interruption may be required.

Elderly patients with dementia who are taking risperidone must be especially careful with the concomitant use of risperidone and furosemide. 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.

Use of Furosemide Pharma Combix with other medicines

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

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

• High blood pressure (aliskiren).

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

Some substances may have their toxicity increased in the ear or kidneys if administered together with this medicine. Therefore, if they are administered concomitantly, it is because 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.

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

Furosemide may increase the toxicity of salicylates.

This medicine and sucralfate should not be administered concomitantly, 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 adverse 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.

Some electrolyte alterations (for example, a decrease in blood potassium levels (hypokalemia) or magnesium (hypomagnesemia)) may increase the toxicity of some medicines (for example, digitalis medicines and medicines that induce the 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 may increase the risk of secondary gouty arthritis due 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 an initial transient 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.

Some side effects (e.g., a pronounced undesirable decrease in blood pressure) may impair the 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 Pharma Combix 40 mg tablets contain lactose

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

Furosemide Pharma Combix 40 mg tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Furosemide Pharma Combix

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 Pharma Combix 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 treatment before.

If you take more Furosemide Pharma Combix than you should

In case of overdose or accidental ingestion, consult your doctor or go to the emergency department of the nearest hospital, accompanied by this leaflet, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

An accidental overdose could lead to a severe decrease in blood pressure (which may 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 Pharma Combix

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

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 people)

• electrolyte alterations (including symptomatic ones), 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 people)

• decrease in sodium (hyponatremia), chloride (hypochloremia), potassium (hypokalemia) levels, increase in cholesterol and uric acid levels in the blood, and gout attacks
• increase in urine volume
• mental alterations (hepatic encephalopathy) in patients with liver problems (hepatocellular insufficiency)
• increase in blood viscosity (hemoconcentration).

Uncommon(may affect up to 1 in 100 people)

• alteration of 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 other more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.
• decrease in platelet levels (thrombocytopenia).

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

• 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)
• sensation of tingling in the limbs (paresthesias)
• decrease in white blood cell levels (leukopenia), increase in a type of white blood cells, eosinophils (eosinophilia)
• fever.

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

• inflammation of the pancreas (acute pancreatitis)
• liver problem (cholestasis), increase in liver enzymes (transaminases)
• decrease in a type of white blood cells, granulocytes (agranulocytosis), decrease in red blood cell count (aplastic or hemolytic anemia).

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

• decrease in calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increase in blood urea levels, metabolic alkalosis, pseudo-Bartter syndrome in the case of misuse and/or prolonged use of furosemide
• alteration of blood coagulation (thrombosis)
• increase in sodium and chloride levels in the urine, urine retention (in patients with partial obstruction of urine flow), formation of kidney stones (nephrocalcinosis/nephrolithiasis) in premature children, kidney failure
• severe skin and mucous membrane vesicular reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blistering 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, reddish-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 (severe hypokalemia) (see section “Do not use Furosemide Pharma Combix”)
• increased risk of persistence of the “ductus arteriosus permeable” when furosemide is administered to premature children 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 alterations are manifested with intense thirst, headache, confusion, muscle cramps, painful contraction of the muscles, especially in 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, even if it is possible side effects that are 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 contribute to providing more information on the safety of this medicine.

5. Storage of Furosemida Pharma Combix

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

Do not store above 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry 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 any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Furosemida Pharma Combix

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The other ingredients 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).

Appearance of the Product and Package Contents

White or almost white, round, flat tablets with beveled edges, scored with "40" on one face and notched on the other.

The tablet can be divided into equal doses.

Green, transparent PVC-Aluminum blisters in packages containing 10 or 30 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (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

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

or

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of Last Revision of this Leaflet: April 2024

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