Package Insert: Information for the User

Fluimucil 200 mg Oral Granule

Acetylecysteine

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 additional 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 you do not improve after 5 days.

Acetilcisteine, 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, for adults and adolescents aged 12 years and above.

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

Do not take Fluimucil:

• If you are allergic to acetylcysteine and its derivatives, or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluimucil.

If you are asthmatic or have a severe respiratory disease, you should consult with 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 spoiled.

If you experience stomach discomfort after taking the medication, you should discontinue treatment and consult your doctor. Caution is recommended for 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 the course of treatment.

Children

Children between 2 and 12 years old should not take this medication.

There are other presentations more suitable for this population.

Taking Fluimucil 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 your intake of Fluimucil by at least 2 hours.

Do not dissolve Fluimucil with other medications.

Taking Fluimucil 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 should be avoided during lactation.

Driving and operating machinery

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

Fluimucil contains Aspartame, Sorbitol, Glucose, and Lactose

This medication contains 25 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the inability of the body to eliminate it correctly.

This medication contains 675 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

This medication contains glucose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

The recommended dose is:

For adults and adolescents 12 years of age and older: 1 sachet every 8 hours. Do not exceed 3 sachets per day.

How to take:

Fluimucil is taken orally.

Dissolve the contents of the sachet in a glass of water. It is recommended to drink plenty 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

Children under 12 years of age cannot take this medication.

There are other presentations more suitable for this population.

If you take more Fluimucil than you should

If you take more Fluimucil 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.

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

Like all medications, Fluimucil may produce adverse effects, although not everyone 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, occasionally 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 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 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.

Do not store at a temperature above 30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluimucil

The active ingredient is acetylcysteine. Each sachet contains 200 mg of acetylcysteine.

The other components are: aspartame (E951), sorbitol (E420) and orange aroma.

Appearance of the product and contents of the packaging

Fluimucil is presented in the form of sachets with a white granulated powder.

Each package contains 30 sachets of granulated powder.

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

Responsible for manufacturing:

Zambon, S.p.A.

Via della Chimica, 9,

36100Vicenza (Italy)

Zambon S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona

Last review date of this leaflet: November 2021

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