Fluimucil Pediatrico 20 mg/ml oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluimucil Pediatric 20 mg/ml oral solution

Acetylcysteine

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

• Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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.

Contents of the leaflet

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

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

Acetylcysteine, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu in adolescents and children from 2 years of age.

You should consult a doctor if symptoms worsen or do not improve after 5 days.

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

Do not take Fluimucil pediatric:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (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 suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor. Caution is advised 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 gradually decrease during the course of treatment.

Children

It is contraindicated in children under 2 years of age.

In children aged 2 to 6 years, consult your doctor.

Taking Fluimucil pediatric with other medicines

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

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

Concomitant administration with the antiepileptic carbamazepine may lead to a reduction in carbamazepine efficacy.

Do not administer simultaneously with antitussive medicines (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines containing antibiotics such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines, separate their administration from that of Fluimucil pediatric by at least 2 hours.

Dissolving Fluimucil pediatric with other medicines is not recommended.

Taking Fluimucil pediatric with food and drinks

Taking food and drinks does not affect the efficacy of this medicine.

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 medicine.

As a precautionary measure, it is preferable to avoid use during pregnancy.

Use during breastfeeding should be avoided.

Driving and using machines

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

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

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

If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if other medicines containing propylene glycol or alcohol have been administered.

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

3. How to take Fluimucil pediatric

Follow exactly the administration instructions for this medicine as described in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

In children aged 2 to 7 years: 5 ml of oral solution (100 mg of acetylcysteine) every 8 hours. Do not exceed a daily dose of 15 ml (300 mg of acetylcysteine).

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

How to take:

Fluimucil pediatric is taken orally.

Measure the amount of medicine to be taken using the dosing cup provided in the package, and take it directly. It is recommended to drink a glass of water after each dose and plenty of fluids 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 aged 2 to 6 years, consult your doctor.

If you take more Fluimucil pediatric than you should

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

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

4. Possible adverse effects

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

The following adverse effects may 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's syndrome, sometimes identified in association with the concomitant use of another medicinal product.

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

If any skin or mucous membrane changes occur, acetylcysteine administration 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 an adverse effect not listed in this leaflet. You can 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 paediatric

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.

Discard the container 15 days after opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and other information

Composition of Fluimucil paediatric

The active substance 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 flavour (propylene glycol, ethanol), sodium hydroxide and purified water.

Appearance of the product and contents of the pack

Fluimucil paediatric is available in amber glass bottles containing 100 or 200 ml of oral solution. It is a clear, colourless solution with a fruity raspberry odour. A plastic graduated dosing cup is included for accurate dosing of the medicine.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: September 2020

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/.