FLUIMUCIL COMPLEX 500 mg/200 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Fluimucil complex 500 mg / 200 mg effervescent tablets

Paracetamol / Acetylcysteine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days or if the fever, if present, persists after 3 days.

Contents of the Package Leaflet

1. What Fluimucil complex is and what it is used for
2. What you need to know before taking Fluimucil complex
3. How to take Fluimucil complex
4. Possible side effects
5. Storage of Fluimucil complex
6. Package contents and additional information

1. What Fluimucil complex is and what it is used for

It is an association of paracetamol, an active ingredient that is effective in reducing pain and fever, and acetylcysteine, an active ingredient that belongs to the so-called mucolytics that act by decreasing the viscosity of mucous secretions, making them more fluid and facilitating their elimination.

It is indicated for symptomatic relief in colds and flu-like processes that occur with or without fever, mild or moderate pain, and thick mucous secretions, in adults and adolescents over 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 5 days or if the fever, if present, persists after 3 days.

2. What you need to know before taking Fluimucil complex

• The possible sulfurous odor (like rotten eggs) of the medication is characteristic of the active ingredient acetylcysteine, but it does not indicate that the medication is in poor condition.
• During the first days of treatment, you may notice an increase in mucus and phlegm, which will decrease throughout the treatment.

Do not take Fluimucil complex:

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluimucil complex.

• Do not exceed the recommended dose in section 3. How to take Fluimucil complex.
• Chronic alcoholics should not take more than 2 g/day of paracetamol.
• In case of liver failure, do not exceed 2 g/day of paracetamol, and the minimum interval between doses will be 8 hours.
• The simultaneous use of this medication with other medications that contain paracetamol should be avoided, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• In patients with kidney, liver, heart, or lung disease, and in patients with anemia, you should consult your doctor before taking this medication.
• When being treated with any medication for epilepsy, you should consult your doctor before taking this medication, as the combined use can decrease the efficacy and potentiate the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Asthmatic patients or those with a history of asthma, and sensitive to acetylsalicylic acid, should consult their doctor before taking this medication.
• If you have diseases that predispose you to suffer from digestive bleeding, such as stomach or duodenal ulcers, you should consult your doctor before taking this medication.
• If you have a hereditary deficiency of glutathione (a substance in metabolism), your red blood cell count may decrease, so you should consult your doctor before taking this medication.

During treatment with Fluimucil complex, inform your doctor immediately if you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Children under 12 years of age cannot take this medication due to the dose of paracetamol.

Interference with analytical tests

If you are going to undergo any analytical test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use of Fluimucil complex with other medications

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

In particular, if you are taking any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine). The combined administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.
• Medications to treat tuberculosis: (isoniazid, rifampicin).
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower cholesterol levels in the blood: (cholestyramine).
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Antitussives (cough medications) or those that decrease bronchial secretions such as anticholinergics, antihistamines (for allergies, dizziness...), as they can cause an accumulation of fluidified mucus.
• Nitroglycerin (used for heart diseases). The combined therapy with nitroglycerin can produce headaches and should control the appearance of hypotension, which can be severe.
• In addition, separate the intake of acetylcysteine and the following medications by at least 2 hours:
• • Antibiotics (amphotericin B, ampicillin sodium, cephalosporins, erythromycin lactobionate or some tetracyclines).
  • Salt of some minerals (such as gold, calcium, iron).
• It is not recommended to dissolve Fluimucil complex with other medications.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Fluimucil complex with food and drinks

Pregnancy and breastfeeding

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

If necessary, Fluimucil Complex can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, and it is not known if acetylcysteine passes into breast milk, so it is not recommended to use this medication during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive and use machines.

Fluimucil complex contains sorbitol, sodium, and aspartame

• This medication contains 510 mg of sorbitol in each effervescent tablet.
• Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.
• This medication contains 273 mg of sodium (the main component of table salt) in each effervescent tablet. This is equivalent to 13.65% of the maximum recommended daily sodium intake for an adult.

This medication contains 60 mg of aspartame in each effervescent tablet. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to take Fluimucil complex

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Over 12 years: 1 effervescent tablet every 8-12 hours (2-3 times a day). Do not exceed the dose of 3 effervescent tablets per day.

Do not take more than one tablet per dose.

Patients with liver or kidney disease: before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 3 tablets in 24 hours, divided into 3 doses.

Oral route.

Dissolve in a glass of water, do not drink until the effervescence has completely stopped.

It is recommended to drink plenty of liquid throughout the day.

Always use the lowest effective dose.

The administration of the preparation is subject to the appearance of symptoms. As they disappear, this medication should be suspended.

You should interrupt treatment and consult a doctor if your symptoms worsen or do not improve after 5 days or if the fever, if present, persists after 3 days.

Use in children

Children under 12 years of age cannot take this medication due to the dose of paracetamol.

If you take more Fluimucil complex than you should

As this medication contains paracetamol, if you have taken an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is more effective if started within 4 hours after taking the overdose.

Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of this medication because it contains paracetamol.

Due to the presence of acetylcysteine, if you have taken more Fluimucil complex than recommended, you may feel an intensification of side effects, especially of a digestive type. You should receive symptomatic treatment.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Fluimucil complex can cause side effects, although not everyone experiences them.

Rare side effects that may affect up to 1 in 1,000 people: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may affect up to 1 in 10,000 people: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or for prolonged treatments.

The following side effects can also occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients): drowsiness, bronchospasm, respiratory difficulties, digestive disorders.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, bleeding, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the simultaneous use of another medication.

Frequency not known (cannot be estimated from available data): facial swelling, a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

If you experience any skin or mucous membrane alterations, you should immediately interrupt the administration of acetylcysteine and seek medical attention.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fluimucil complex

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fluimucil complex

The active ingredients are paracetamol and acetylcysteine. Each effervescent tablet contains: 500 mg of paracetamol and 200 mg of acetylcysteine.

The other components (excipients) are: anhydrous citric acid (E-330), sorbitol (E-420), sodium hydrogen carbonate, anhydrous sodium carbonate, aspartame (E-951), citron flavor, leucine, dimethicone, sodium docusate.

Appearance of the product and package contents

Fluimucil complex are effervescent tablets. The tablets are round, flat, and white.

It is presented in a package containing 12 or 16 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zambon S.A.U.

Maresme 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Manufacturer

E-Pharma Trento S.p.A.

Via Provina 2

38040 Ravina di Trento (Italy)

Date of the last revision of this package leaflet: January 2025

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