Leaflet: information for the user

Fluimucil complex 500 mg / 200 mg effervescent tablets

Paracetamol / Acetilcisteína

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

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

2.What you need to know before starting to take Fluimucil complex

3. How to take Fluimucil complex

4. Possible side effects

5. Storage of Fluimucil complex

6. Contents of the pack and additional information

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 reducing the viscosity of mucous secretions, liquefying them 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 old.

Consult a doctor if it worsens or does not improve after 5 days or if the fever, if it exists, persists after 3 days.

• The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient acetilcisteína, 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 over the course of treatment.

Do not take Fluimucil complex:

• if you are allergic to the active ingredients or 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 be careful not to take more than 2 g/day of paracetamol.
• In cases of liver insufficiency, do not exceed 2 g/day of paracetamol and the minimum interval between doses will be 8 hours.
• Concomitant use of this medication with other medications containing paracetamol should be avoided, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as concomitant use may reduce efficacy and increase hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Patients with asthma or a history of asthma, and sensitive to acetylsalicylic acid, should consult their doctor before taking this medication.
• Patients with diseases that predispose them to gastrointestinal bleeding, such as stomach or duodenal ulcers, should consult their doctor before taking this medication.
• Patients with a hereditary deficiency of glutathione (a substance involved in metabolism) may experience a reduction in red blood cells, and should consult their doctor before taking this medication.

Inform your doctor immediately if you have severe diseases, such as severe kidney insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

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

Interference with analytical tests

Inform your doctor if you are undergoing any analytical tests (including blood, urine, skin tests using allergens, etc.) as this medication may alter the results.

Use of Fluimucil complex with other medications

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

Particularly, 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). Concomitant 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 reduce blood cholesterol levels: (colestiramine).
• Medications used to increase urine elimination (diuretics such as furosemide).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Antitussives (cough medications) or those that reduce bronchial secretions, such as anticholinergics, antihistamines (for allergies, dizziness, etc.), as it may cause a buildup of fluidified mucus.
• Nitroglycerin (used for heart diseases). Concomitant therapy with nitroglycerin may cause headaches and hypotension, which may be severe.
• Separate the intake of acetilcysteine and the following medications by at least 2 hours:
• • Antibiotics (amphotericin B, ampicillin sodium, cephalosporins, lactobionate of erythromycin, or some tetracyclines).
  • Salts of some minerals (such as gold, calcium, iron).
• Do not dissolve Fluimucil complex with other medications.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (denominated 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

In case of need, Fluimucil Complex may be used during pregnancy. 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 do not decrease or if you need to take the medication more frequently.

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

Driving and operating machinery

There is no evidence of effects on the ability to drive and operate machinery.

Fluimucil complex contains sorbitol, sodium, and aspartame

• This medication contains 510 mg of sorbitol in each tablet.
• Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a fructose intolerance or 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 (main component of table salt) in each tablet, which is equivalent to 13.65% of the maximum daily sodium intake recommended for an adult.

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

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

The recommended dose is:

Individuals over 12 years old: 1 effervescent tablet every 8-12 hours (2-3 times a day). Do not exceed a 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 of 8 hours between each dose. They should not take more than 3 tablets in 24 hours, divided into 3 doses.

Oral administration.

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

It is recommended to drink an abundant amount of liquid during the day.

Always use the lowest effective dose.

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

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

Use in children

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

If you take more Fluimucil complex than you should

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

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

The treatment of an overdose is more effective if initiated within 4 hours of taking the overdose.

Patients undergoing treatment 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 acetaminophen, if you have taken more Fluimucil complex than recommended, you may experience an intensification of adverse effects, especially of a digestive nature. You will need to apply symptomatic treatment.

In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological 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.

Like all medications, Fluimucil complex may produce adverse effects, although not all people may experience them.

Rare adverse 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 adverse effects that may affect up to 1 in 10,000 people: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Severe skin reactions have been reported very rarely.

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

The following adverse effects may 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 difficulty, digestive discomfort.

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

Unknown frequency (cannot be estimated from available data): facial swelling, a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

In case of any skin or mucous membrane alteration, discontinue acetaminophen administration immediately and seek medical assistance.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

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

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

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fluimucil complex

The active principles 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), apple flavor, leucine, dimethicone, sodium docusate.

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Zambon S.A.U.

Maresme 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda (Barcelona)

Spain

Responsible for manufacturing

E-Pharma Trento S.p.A.

Via Provina 2

38040 Ravina di Trento (Italy)

Last review date of this leaflet: January 2025

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