Package Insert: Information for the User

Fluimucil Pediatric 20 mg/ml Oral Solution

Acetylcysteine

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

• Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist. Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Acetylecysteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it 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 old.

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

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 in children under 2 years.

Warnings and precautions

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

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

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

If you experience stomach discomfort while taking the medication, you should discontinue treatment and consult your doctor. Caution is recommended in patients with peptic ulcers or a history of peptic ulcers.

During the first few days of treatment, you may observe an increase in mucus and phlegm, which will decrease over time.

Children

It is contraindicated in children under 2 years.

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

Taking Fluimucil pediatric with other medications

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

The concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

The concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

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

When taking medications containing minerals such as iron or calcium, or medications with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate the intake of Fluimucil pediatric from the intake of these medications by at least 2 hours.

Do not dissolve Fluimucil pediatric with other medications.

Taking Fluimucil pediatric with food and beverages

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

Pregnancy and lactation

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

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

It is recommended to avoid its intake during lactation.

Driving and operating machinery

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

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

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

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 old).

This medication contains 38.21 mg of sodium (main component of table salt) in each 10 ml, which is equivalent to 1.9% of the recommended daily maximum sodium intake 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 recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

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

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

This medication contains 3.85 mg of alcohol (ethanol) in each 100 ml, which is equivalent to 0.04% v/v. The amount of alcohol in 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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Follow exactly the administration instructions of the medication 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:

For children between 2 and 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).

For adolescents and children over 7 years: 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 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 abundant amounts of liquid throughout the day.

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

Use in children

It is contraindicated in children under 2 years.

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

If you take more Fluimucil pediatric than you should

If you take more Fluimucil pediatric than you should, you may experience: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other adverse effect described in section 4. Possible adverse effects. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects may occur:

Infrequent (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 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.

In the event of any skin or mucous membrane alteration, discontinue acetilcisteína 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 an 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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of the packaging within 15 days of opening.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and unused medications at theSIGREcollection point at 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 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 saccharin, sodium cyclamate, sucralose, raspberry flavor (propylene glycol, ethanol), sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging

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

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:

Zambon, S.p.A.

Via della Chimica, 9

36100-Vicenza (Italy)

Last review date of this leaflet: September 2020

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/.