Fluimucil Complex 500 mg/200 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluimucil complex 500 mg / 200 mg effervescent tablets

Paracetamol / Acetylcysteine

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days, or if fever, if present, persists beyond 3 days.

Leaflet contents

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 adverse effects
5. How to store Fluimucil complex
6. Contents of the pack and other information

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

Fluimucil complex is a combination of paracetamol, an active ingredient effective in reducing pain and fever, and acetylcysteine, an active ingredient belonging to the group known as mucolytics, which work by reducing the viscosity of mucus secretions, making them more fluid and facilitating their elimination.

It is indicated for the symptomatic relief of colds and influenza-like conditions, with or without fever, mild to moderate pain, and thick mucus secretions, in adults and adolescents over 12 years of age.

You should consult a doctor if your condition worsens or does not improve after 5 days, or if fever, if present, persists beyond 3 days.

2. What you need to know before taking Fluimucil complex

• The possible sulfurous odor (like rotten eggs) of the medicine is due to the active substance acetylcysteine and does not indicate that the medicine is in poor condition.
• During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease over the course of treatment.

Do not take Fluimucil complex:

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

Warnings and precautions

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

• Do not exceed the recommended dose stated in section 3, How to take Fluimucil complex.
• Chronic alcoholics should take care not to take more than 2 g/day of paracetamol.
• In case of hepatic impairment, paracetamol dose should not exceed 2 g/day, and the minimum interval between doses should be 8 hours.
• Concomitant use of this medicine with other medicines containing paracetamol should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Patients with kidney, liver, heart, or lung diseases, or with anemia, should consult their doctor before taking this medicine.
• If you are being treated with any medicine for epilepsy, consult your doctor before taking this medicine, because when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is potentiated, especially with high-dose paracetamol treatment.
• Patients with asthma or a history of asthma, particularly those sensitive to acetylsalicylic acid, should consult their doctor before taking this medicine.
• If you have conditions that predispose you to gastrointestinal bleeding, such as stomach or duodenal ulcer, consult your doctor before taking this medicine.
• If you have a hereditary deficiency of glutathione (a metabolic substance), your red blood cell count may decrease; therefore, you should consult your doctor before taking this medicine.

During treatment with Fluimucil complex, inform your doctor immediately if you develop serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children

Children under 12 years of age must not take this medicine due to the paracetamol dose.

Interference with laboratory tests

If you are scheduled for any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Use of Fluimucil complex with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

In particular, if you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine). Concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.
• Medicines for tuberculosis: (isoniazid, rifampicin).
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol levels: (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used for gout treatment: (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used for treating high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Antitussives (cough medicines) or agents that reduce bronchial secretions such as anticholinergics, antihistamines (for allergies, dizziness, etc.), as they may cause accumulation of liquefied mucus.
• Nitroglycerin (used for heart conditions). Combined therapy with nitroglycerin may cause headache, and hypotension should be monitored as it may be severe.
• In addition, separate the administration of acetylcysteine and the following medicines by at least 2 hours:
  • Antibiotics (amphotericin B, sodium ampicillin, cephalosporins, erythromycin lactobionate, or certain tetracyclines).
  • Salts of certain minerals (such as gold, calcium, iron).
• Dissolving Fluimucil complex with other medicines is not recommended.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Taking Fluimucil complex with food and drinks

Pregnancy and breastfeeding

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

Fluimucil Complex may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not improve or if you need to take the medicine more frequently.

Paracetamol passes into breast milk and it is unknown whether acetylcysteine passes into breast milk; therefore, use of this medicine is not recommended 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 medicine contains 510 mg of sorbitol in each tablet.
• Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.
• This medicine contains 273 mg of sodium (main component of table salt) in each tablet. This corresponds to 13.65% of the maximum daily sodium intake recommended for an adult.

This medicine contains 60 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Fluimucil complex

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years of age: 1 effervescent tablet every 8–12 hours (2–3 times daily). Do not exceed a maximum of 3 effervescent tablets per day.

Do not take more than one tablet per dose.

Patients with liver or kidney disease: you must consult your doctor before taking this medicine. You should take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 3 tablets in 24 hours, divided into 3 doses.

For oral use.

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

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

Always use the lowest effective dose.

Treatment with this medicine should only be administered while symptoms are present. As symptoms improve, this medication should be discontinued.

Stop treatment and consult a doctor if your condition worsens or does not improve after 5 days, or if fever (if present) persists beyond 3 days.

Use in children

Fluimucil complex must not be given to children under 12 years of age due to the paracetamol dose.

If you take more Fluimucil complex than you should

Since this medicine contains paracetamol, if you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

Treatment for overdose is most effective if started within 4 hours of ingestion.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects of an overdose of this medicine because it contains paracetamol.

Due to the presence of acetylcysteine, if you have taken more Fluimucil complex than recommended, you may experience an intensification of adverse effects, especially gastrointestinal ones. Symptomatic treatment should be administered.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Fluimucil complex can cause adverse effects, although not everyone will experience them.

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

Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

The following adverse effects may also occur:

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

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.

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

Frequency not known (cannot be estimated from available data): facial swelling, a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

If any skin or mucous membrane changes occur, administration of acetylcysteine must be stopped immediately and medical advice sought.

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 Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluimucil complex

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Fluimucil complex

The active substances 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), lemon balm flavour, leucine, dimethicone, sodium docusate.

Appearance of the product and contents of the container

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

It is available in a pack 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 most recent revision of this leaflet: January 2025

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