Furosemide Combix 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Furosemide Combix 40 mg tablets EFG

Read the entire leaflet carefully before starting to take 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Under medical prescription, this medicine is indicated for the treatment of:

• Edema (swelling due to fluid accumulation) associated with congestive heart failure, hepatic cirrhosis (ascites), and kidney disease, including nephrotic syndrome (treatment of the underlying condition takes priority).
• Edema following burns.
• Mild to moderate arterial hypertension.

2. What you need to know before taking Furosemida Combix

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 medicines of the furosemide type (sulfonamides), or to any of the other components of this medicine (listed in section 6).
• 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 with anuria) that do not respond to this medicine.
• If your blood potassium levels are severely low (severe hypokalaemia).
• If you have severe deficiency of sodium salts in the blood (severe hyponatraemia).
• If you are in a pre-comatose or comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.

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

Warnings and precautions

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

Take special care with this medicine:

• 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., in patients with significant coronary or cerebral stenosis).
• If you have latent or overt diabetes mellitus.
• If you suffer from gout.
• If you have severe kidney problems associated with severe liver disease (hepatorenal syndrome).
• If your blood protein levels are low (hypoproteinaemia), especially if you also have, for example, nephrotic syndrome (see section “Possible side effects”).
• In premature infants (see section “Possible side effects”).
• 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 this medicine, regular monitoring of blood levels of sodium, potassium, and creatinine is generally required, especially if you experience significant fluid loss due to vomiting, diarrhoea, or excessive sweating (dehydration or hypovolemia), as your doctor may need to discontinue treatment.

Elderly patients with dementia who are taking risperidone should take special care when using this medicine. Risperidone is a medicine used to treat certain mental illnesses, such as dementia (a disease characterised by several symptoms: memory loss, difficulty speaking, difficulty thinking).

Use of Furosemida Combix with other medicines

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

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

• High blood pressure (aliskiren).

The toxicity of certain substances to the ear and kidneys may increase when administered together with this medicine. Therefore, if administered together, 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 and sucralfate should not be administered together within less than 2 hours, as the effect of Furosemida Combix could be reduced.

This medicine may weaken the effect of other medicines such as:

• Medicines used for diabetes (antidiabetics).
• Medicines used to raise blood pressure (sympathomimetics with hypertensive effect, e.g., epinephrine and norepinephrine).

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

• Medicines for asthma (theophylline).
• Muscle relaxants of curare type.
• Medicines for depression (lithium), potentially enhancing the harmful effects of lithium on the heart or brain.
• Salicylates (may increase their toxicity).
• Antihypertensive medicines (to lower blood pressure), such as diuretics, ACE inhibitors, or angiotensin II receptor antagonists.
• Medicines toxic to the kidneys.

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 Furosemida Combix.

Additionally, medicines such as probenecid and methotrexate, or other medicines significantly excreted by the kidneys, may either reduce the effect of Furosemida Combix or increase its adverse effects (by reducing the renal elimination of these medicines).

The following substances may reduce blood potassium levels (hypokalaemia) when administered with Furosemida Combix:

• Medicines for inflammation (corticosteroids).
• Carbenoxolone (a medicine used to treat lesions of the oral mucosa).
• Large amounts of liquorice.
• Prolonged use of laxatives for constipation.

Some electrolyte imbalances (e.g., low blood potassium levels (hypokalaemia) or low magnesium levels (hypomagnesaemia)) could increase the toxicity of certain heart medicines (e.g., digitalis and QT interval prolongation-inducing medicines).

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

Concomitant administration of Furosemida Combix and cyclosporine A may cause gouty arthritis.

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

During breastfeeding, Furosemida Combix must not be administered. If administration is essential, your doctor may require you to stop breastfeeding, as Furosemida Combix passes into breast milk.

Driving and use of machines

This medicine may cause dizziness or drowsiness. This is more likely at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machinery if you feel dizzy or drowsy.

Furosemida Combix contains lactose

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

Use in athletes

Patients should be advised that this medicine contains furosemide, which may lead to a positive result in doping control tests.

3. How to take Furosemida Combix

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

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

In adults, treatment should be initiated 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 depends on your response to treatment.

Use in children

In infants and children, a daily dose of 2 mg/kg body weight is recommended, up to a maximum of 40 mg per day.

Your doctor will indicate how long your treatment with this medicine should last. Do not stop treatment prematurely.

If you take more Furosemida Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department with this leaflet, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested or administered.

An accidental overdose could lead to a severe drop in blood pressure (which may progress to shock), kidney problems (acute renal failure), blood clotting disorders (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

No specific antidote is known.

In cases of overdose, treatment will depend on the symptoms.

If you forget to take Furosemida Combix

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

4. Possible adverse effects

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

Adverse effects have been grouped according to their frequency based on the following classification:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known (cannot be estimated from available data).

Disorders of metabolism and nutrition

Very common: electrolyte disturbances (including symptomatic ones), dehydration and reduction in total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in blood.

Common: decreased levels of sodium (hyponatremia), chloride (hypochloremia), potassium (hypokalemia), increased levels of cholesterol and uric acid in blood, gout attacks.

Uncommon: impaired glucose tolerance. Latent diabetes mellitus may become apparent.

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

Vascular disorders

Rare: allergic inflammation of blood vessels (vasculitis).

Frequency not known: blood coagulation disorders (thrombosis).

Renal and urinary disorders

Common: increased urine volume.

Rare: allergic-type kidney reaction (tubulointerstitial nephritis).

Frequency not known: increased levels of sodium and chloride in urine, urine 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 problems (cholestasis), increased liver enzymes (transaminases).

Ear and labyrinth disorders

Uncommon: hearing disturbances, although usually transient, especially in patients with renal impairment, low levels of protein in blood (hypoproteinemia), and/or following too rapid intravenous administration of furosemide, deafness (sometimes irreversible).

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

Skin and subcutaneous tissue disorders

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

Frequency not known: severe blistering reactions of the skin and mucous membranes (Stevens-Johnson syndrome), serious skin disorder characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Immune system disorders

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

Nervous system disorders

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

Rare: tingling sensation in the limbs (paresthesia).

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 platelet levels (thrombocytopenia).

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

Very rare: decreased levels of granulocytes (agranulocytosis), decreased number of red blood cells (aplastic anemia, hemolytic anemia).

Congenital, familial and genetic disorders

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

General disorders and administration site conditions

Rare: fever.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Furosemide Combix

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

Store below 25°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furosemida Combix

• The active substance is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: monohydrate lactose, 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 contents of the container

White or almost white, round, flat tablets with bevelled edges, marked with "40" on one side and scored on the other.

The tablet can be divided into equal doses.

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

Only certain pack sizes may be marketed.

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

Date of the most recent review of this leaflet: April 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/.