Leaflet:informationfortheuser

Furosemida Combix40mgtablets EFG

Readalltheleafletcarefullybeforeyoustarttakingthismedicine,becauseitcontainsimportantinformationforyou.

• Keepthisleaflet,andyoumayneedtoreaditagain.
• Ifyouhaveanydoubts,consultyourdoctororpharmacist.
• Thismedicinehasbeenprescribedforyoualone,andyoumustnotgiveittoothers,eveniftheyhavethesamesymptomsasyou,becauseitmayharmthem.
• Ifyouexperienceanyadverseeffects,consultyourdoctororpharmacist,eveniftheyarenotlistedinthisleaflet.Seesection4.

Contentsoftheleaflet

1. WhatisFurosemida Combixandwhatisitusedfor
2. WhatyouneedtoknowbeforestartingtotakeFurosemida Combix
3. HowtotakeFurosemida Combix
4. Adverseeffects
5. StorageofFurosemida Combix
6. Contentsofthepackagingandadditionalinformation

Furosemida Combix,isaloopdiureticbelongingtothesulfonamidegroup.Itactsbyincreasingtheexcretionofurine(diuretic)andreducingarterialpressure(antihypertensive).

Followtheprescriptiongivenbyyourdoctor,asitisrecommendedforthetreatmentof:

• Edema(swellingduetofluidretention)associatedwithcongestiveheartfailure,livercirrhosis(ascites),andrenaldisease,includinglupusnephritis(priorityshouldbegiventothetreatmentoftheunderlyingdisease).
• Edemaduetoothercausesthatpersistdespiteadequatediuretictherapy.
• Mildtomoderatearterialhypertension.

Please read carefully the instructions provided in section 3. “How to take Furosemida Combix”.

Do not take Furosemida Combix

• If you are allergic to furosemide, to furosemide-type medications (sulfonamides), or to any of the other components of this medication (listed in section 6).
• If you have decreased your total blood volume (hypovolemia), or are dehydrated.
• If you have severe kidney problems, accompanied by a decrease in urine elimination.

• (Renal insufficiency with anuria), which does not respond to this medication.
• If you have severe hypokalemia (low potassium levels in the blood).
• If you have severe hyponatremia (low sodium levels in the blood).
• If you are in a pre-comatose and comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.

If you are pregnant, see the section “Pregnancy, lactation, and fertility”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Furosemida Combix.

Be especially careful with this medication:

• If you have problems with urine elimination, especially at the beginning of treatment.
• If you have low blood pressure (hypotension).
• If you have a high risk of experiencing a significant drop in blood pressure (for example, in patients with significant coronary or cerebral stenosis).
• If you have latent or manifest diabetes mellitus.
• If you have gout.
• If you have severe kidney problems, associated with severe liver disease (hepato-renal syndrome).
• If you have low blood protein levels (hypoproteinemia), in addition to having, for example, nephrotic syndrome (see the section “Possible adverse effects”).
• In premature children (see the section “Possible adverse effects”).
• 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 the risk of a decrease in blood pressure.

During your treatment with this medication, you will generally require regular monitoring of your blood levels of sodium, potassium, and creatinine, and especially if you experience severe fluid loss, by vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may require the interruption of treatment.

Patients over the age of 65 with dementia who are taking risperidone should be especially careful when taking this medication. Risperidone is a medication used to treat certain mental illnesses, such as dementia (a disease characterized by several symptoms: memory loss, problems speaking, problems thinking).

Use of Furosemida Combix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• High blood pressure (aliskiren).

Some substances may increase their toxicity in the ear and kidneys if administered together with this medication. Therefore, if administered together, it should be under strict medical control. Among these substances are:

• Aminoglycoside antibiotics (infection medications) such as gentamicin, kanamicin, and tobramicin.
• Cancer medications (cisplatin).

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

This medication may weaken the effect of other medications such as:

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

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

• Asthma medications (theophylline).
• Muscle relaxants such as curare.
• Depression medications (lithium), which may potentiate the harmful effects of lithium on the heart or brain.
• Salicylates (may increase toxicity).
• Blood pressure-lowering medications, such as diuretics, ACE inhibitors, or angiotensin II receptor antagonists.
• Toxic medications for the kidneys.

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

Additionally, they may reduce the effect of Furosemida Combix or increase its adverse effects (by reducing renal elimination of these medications), medications such as probenecid and methotrexate, or other medications that have significant renal secretion.

The following substances may reduce potassium levels in the blood (hypokalemia) if administered with Furosemida Combix:

• Corticosteroids (anti-inflammatory medications).
• Carbenoxolone (medication for the treatment of oral mucosa lesions).
• Significant amounts of licorice root.
• 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 heart medications (for example, digitals and medications that induce the QT interval prolongation syndrome).

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

The concomitant administration of Furosemida Combix and cyclosporine A may produce gouty arthritis.

Patients at high risk of nephropathy (kidney disease) due to contrast who receive Furosemida Combix may experience a deterioration in kidney function.

The administration of Furosemida Combix together with risperidone in elderly patients with dementia may increase mortality.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you are pregnant, you will only use Furosemida Combix under strict medical indication.

During lactation, Furosemida Combix should not be administered, and if its administration is necessary, your doctor may require you to stop breastfeeding, as Furosemida Combix passes into breast milk.

Driving and operating machinery

This medication may cause dizziness or somnolence. This may occur more frequently at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or somnolent.

Furosemida Combix contains lactose

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

Use in athletes

Warn patients that this medication contains furosemide, which may produce a positive result in doping control tests.

Followexactlytheinstructionsfortheadministrationofthismedicationasindicatedbyyourdoctororpharmacist.Incaseofdoubt,consultyourdoctororpharmacistagain.

Remembertotakeyourmedication.

TakeFurosemida Combixwithanemptystomach,swallowingitwholewithsufficientamountofliquid.

Ifyoufeelthattheactionofthismedicationistoostrongortooweak,consultyourdoctororpharmacist.

Yourdoctorwillprescribetheminimumdosenecessarytoproducethedesiredeffect.

Inadults,itisrecommendedtostarttreatmentwithhalftooneortwotablets(20to80mgoffurosemida)perday.Themaintenancedoseishalftoonetabletperdayandthemaximumdosewillbeindicatedbyyourdoctorandwilldependonyourresponsetotreatment.

Useinchildren

Ininfantsandchildren,thedailydoseof2mg/kgofbodyweightisrecommended,uptoamaximumof40mgperday.

Yourdoctorwillindicatethedurationoftreatmentwiththismedication.Donotsuspendtreatmentbeforehand.

IfyoutakemoreFurosemida Combixthanyoushould

Incaseofoverdoseoraccidentalingestion,consultyourdoctororpharmacistimmediately,ordirectyourselftotheemergencydepartmentofthenearesthospital,orcalltheInformationServiceon915620420indicatingthemedicationandtheamountingestedoradministered.

Apossibleoverdosemaycauseaseriousdecreaseinbloodpressure(whichmayevolveintoshock),kidneyproblems(acuterenalinsufficiency),bloodclottingproblems(thrombosis),delirium,flaccidparalysisofmusclesandapathy,andconfusion.

Nospecificantidoteisknown.

Incasesofoverdose,treatmentwillbebasedonsymptoms.

IfyouforgettotakeFurosemida Combix

Donottakeadoubledosetomakeupforthemisseddose.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects have been grouped by frequency according to the following classification:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare:may affect up to 1 in 10,000 patients

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

Metabolic and nutritional disorders

Very common: electrolyte imbalances (including symptomatic), dehydration, and decreased total blood volume (hypovolemia), particularly in elderly patients, elevated levels of creatinine and triglycerides in the blood.

Common:decreased levels of sodium (hyponatremia), chloride (hypochloremia), potassium

(hypokalemia), increased levels of cholesterol and uric acid in the blood, gout attacks.

Uncommon:alteration of glucose tolerance. Latent diabetes mellitus may manifest.

Frequency not known:decreased levels of calcium (hypocalcemia), magnesium (hypomagnesemia), increased levels of urea in the blood, metabolic alkalosis, pseudo-Bartter syndrome in case of misuse and/or prolonged use of furosemide.

Vascular disorders

Rare:allergic inflammation of blood vessels (vasculitis).

Frequency not known:alteration of blood coagulation (thrombosis).

Renal and urinary disorders

Common:increased urine volume.

Rare:allergic renal reaction (tubulointerstitial nephritis).

Frequency not known:increased levels of sodium and chloride in the urine, urinary retention (in patients with partial obstruction of urine flow), kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure.

Gastrointestinal disorders

Uncommon: nausea.

Rare:vomiting, diarrhea.

Very rare:inflammation of the pancreas (acute pancreatitis).

Hepatobiliary disorders

Very rare: liver problem (cholestasis), increased levels of liver enzymes (transaminases).

Vestibular disorders

Uncommon:auditory disturbances, although transient, especially in patients with renal insufficiency, decreased levels of proteins in the blood (hypoproteinemia) and/or after a too rapid intravenous administration of furosemide, hearing loss (sometimes irreversible)

Very rare:subjective sensation of ringing in the ears (tinnitus).

Skin and subcutaneous tissue disorders

Uncommon: itching, rash, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.

Frequency not known:severe vesicular skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), and generalized acute pustular exanthema (PEGA) and drug reaction with eosinophilia and systemic symptoms (DRESS).

Immune system disorders

Rare:severe allergic reactions (anaphylactic or anaphylactoid) (e.g., with shock).

Nervous system disorders

Common:mental alterations in patients with liver problems (hepatic encephalopathy)

Rare:tingling sensation in the extremities (paresthesias).

Frequency not known:dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension).

Blood and lymphatic system disorders

Common:increased blood viscosity (hemoconcentration).

Uncommon:decreased levels of platelets(thrombocytopenia).

Rare:decreased levels of white blood cells (leucopenia), increased levels of a type of white blood cell, eosinophils (eosinophilia).

Very rare: decreased levels of a type of white blood cell, granulocytes (agranulocytosis), decreased levels of red blood cells (aplastic anemia, hemolytic anemia).

Congenital, familial, and genetic disorders

Frequency not known:increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

General disorders and administration site conditions

Rare: fever.

Like other diuretics, prolonged administration of this medicine may increase the elimination of sodium, chloride, water, potassium, calcium, and magnesium. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contractions, especially in the extremities (tetany), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication away from children.

Store below 25°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD has been used. The expiration date is the last day of the month indicated.

Medicines are not effective beyond their expiration date. Dispose of expired medicines and those that have not been used in the SI GRE of the pharmacy. In case of doubt, consult your pharmacist on how to dispose of the expired medicines and those that have not been used.

Composition of Furosemida Combix

Appearance of the product and content of the packaging

White or off-white, round, flat, beveled-edge tablets, engraved with "40" on one face and scored on the other.

The tablet can be divided into equal doses.

PVC-Aluminum blisters (standard and perforated). Containers containing 10 and 30 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: April 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .