FLUIMUCIL PEDIATRIC 20 mg/ml ORAL SOLUTION

Introduction

Leaflet: information for the user

Fluimucil pediatric 20 mg/ml oral solution

Acetylcysteine

Read the entire 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 leaflet or as 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 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 your condition worsens or does not improve after 5 days.

Contents of the leaflet

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

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

Acetylcysteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, in adolescents and children from 2 years of age.

You should consult a doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before taking Fluimucil pediatric

Do not take Fluimucil pediatric:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

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

If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medication.

The possible sulfurous odor (like rotten eggs) of the medication is characteristic of the active ingredient, but it does not indicate that the medication is in poor condition.

If you experience stomach discomfort when taking the medication, you should stop treatment and consult your doctor. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will decrease throughout the treatment.

Children

It is contraindicated in children under 2 years of age.

In children from 2 to 6 years of age, consult a doctor.

Taking Fluimucil pediatric with other medications

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

Concomitant therapy with nitroglycerin may cause headache and hypotension should be monitored, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medications (for cough) or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking any medication that contains minerals such as iron or calcium, or any medication with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of Fluimucil pediatric by at least 2 hours.

It is not recommended to dissolve Fluimucil pediatric with other medications.

Taking Fluimucil pediatric with food and drinks

The intake of food and drinks does not affect the efficacy of this medication.

Pregnancy and lactation

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.

As a precaution, it is preferable to avoid its use during pregnancy.

Its intake should be avoided during breastfeeding.

Driving and using machines

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

Fluimucil pediatric contains methyl p-hydroxybenzoate, sodium benzoate, sodium, propylene glycol, and ethanol.

It may cause allergic reactions (possibly delayed) because it contains methyl p-hydroxybenzoate.

This medication contains 15 mg of sodium benzoate in each 10 ml.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains 38.21 mg of sodium (main component of table salt) in each 10 ml. This is equivalent to 1.9% of the maximum daily sodium intake recommended for an adult.

This medication contains 23.4 mg of propylene glycol in each 10 ml. If you are pregnant or breastfeeding, do not take this medication unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney failure, do not take this medication unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if they have been given other medications that contain propylene glycol or alcohol.

This medication contains 3.85 mg of alcohol (ethanol) in each 100 ml, which is equivalent to 0.04% p/v. The amount per dose of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

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3. How to take Fluimucil pediatric

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

The recommended dose is:

In children between 2 and 7 years of age: 5 ml of oral solution (100 mg of acetylcysteine) every 8 hours. Do not exceed the dose of 15 ml (300 mg of acetylcysteine) per day.

Adolescents and children over 7 years of age: 10 ml of oral solution (200 mg of acetylcysteine) every 8 hours. Do not exceed the dose of 30 ml (600 mg of acetylcysteine) per day.

How to take:

Fluimucil pediatric is taken orally.

Measure the amount of medication to be taken with the dosing cup included in the box and ingest it directly. It is recommended to drink a glass of water after each dose and a large amount of liquid throughout the day.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Use in children

It is contraindicated in children under 2 years of age.

In children from 2 to 6 years of age, consult a doctor.

If you take more Fluimucil pediatric than you should

If you take more Fluimucil pediatric than you should, you may notice: nausea, vomiting, burning and stomach pain, diarrhea, or any other side effect described in section 4. Possible side effects. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount taken. In case of massive accidental administration, symptomatic treatment is recommended.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects may 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): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

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 concomitant use of another medication.

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

In case of any alteration in the skin or mucous membranes, the administration of acetylcysteine should be interrupted immediately and medical assistance sought.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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 pediatric

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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Discard the packaging 15 days after opening.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of 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 pediatric

The active ingredient is acetylcysteine. Each ml contains 20 mg of acetylcysteine.

The other components are: methyl p-hydroxybenzoate (E218), sodium benzoate (E211), disodium edetate, sodium carmellose, sodium saccharin, sodium cyclamate, sucralose, raspberry flavor (propylene glycol, ethanol), sodium hydroxide, and purified water.

Appearance of the product and package contents

Fluimucil pediatric is presented in amber glass bottles with 100 or 200 ml of oral solution. Its appearance is that of a clear and colorless solution. It has a fruity raspberry odor. A graduated plastic dosing cup is included for the correct dosing of the medication.

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:

Zambon, S.p.A.

Via della Chimica, 9

36100-Vicenza (Italy)

Date of the last revision of this leaflet: September 2020

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/.