Leaflet: information for the user

Mucibrón 3 mg/ml

oral solution

Ambroxol hydrochloride

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

If your symptoms worsen or persist after 5 days of treatment, or if you experience: fever, skin eruptions, persistent headache or sore throat, you should consult a doctor.

1.What Mucibrón is and for what it is used

2.What you need to knowbeforestarting totake Mucibrón

3.How to take Mucibrón

4.Possible side effects

5Storage of Mucibrón

6.Contents of the pack and additional information

:

Mucibrón belongs to a group of medications called mucolitics.

The ambroxol, active ingredient of this medication, acts by reducing the viscosity of mucus, fluidifying it and facilitating its elimination.

Reduces the viscosity of mucus and phlegm, facilitating its expulsion, in colds and flu for adults and children aged 2 years and above.

Consult a doctor if it worsens or does not improve after 5 days of treatment.

Do not take mucibrón

If you are allergic to ambroxol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mucibrón.

Severe skin reactions have been reported associated with the administration of ambroxol. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using mucibrón and consult your doctor immediately. If you have problems with bronchial function, avoid taking mucolytics.

If you have liver or kidney problems, or a history of stomach or duodenal ulcers, consult your doctor before using this medication, as you may need to reduce the dosage.

Patients with known histamine intolerance should avoid long-term treatment with this medication. Symptoms of intolerance include headache, rhinitis, and itching.

Mucibrón interactions with other medications:

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

The concurrent use of this medication with cough suppressants (antitussives) may cause the accumulation of pulmonary secretions due to the reduction of the cough reflex.

The administration of this medication with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) may increase the concentration of antibiotics in pulmonary tissue.

Mucibrón interactions with food and beverages

Do not take with meals and take with a glass of water. Taking more liquids may increase the activity of this medication.

Pregnancy, breastfeeding, and fertility

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

Ambroxol should only be used during pregnancy, especially during the first trimester, if your doctor recommends it.

Mothers breastfeeding should only take ambroxol if their doctor recommends it.

Driving and operating machinery

No adverse effects on the ability to drive and operate machinery have been observed.

Mucibrón contains sorbitol

This medication contains 350 mg of sorbitol (E-420) per milliliter of oral solution.

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Mucibrón contains methyl and propyl parahydroxybenzoates

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Mucibrón contains benzyl alcohol

This medication contains 0.00012 mg of benzyl alcohol per milliliter of oral solution.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This medication should not be used for more than a week in children under 3 years old unless your doctor or pharmacist recommends it.

Mucibrón contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per milliliter of oral solution; it is essentially "sodium-free."

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

The recommended dose is:

Adults and adolescents 12 years and older:

The usual dose is 10 ml (30mg), 3 times a day (every 8 hours).

Use in children

Children under 2 years

It is contraindicated.

Children from 2 to 5 years

The usual dose is 2.5 ml up to 3 times a day.

Children from 6 to 12 years

The usual dose is 5 ml up to 3 times a day.

Patients with kidney and/or liver diseases:If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual.

How to take:

This medication is takenby mouth.

Measure the amount of medication to take with the dosifier included inthe box. Drinkdirectly from the dosifier and take a glass of liquid (preferably water). After each dose, wash the dosifier

Do not take with meals.

If symptoms worsen or persist after 5 days of treatment, or if you experience: fever, skin eruptions, persistent headache or sore throat, consult a doctor

If you take more mucibrón than you should

If you take more medication than you should, you may noticeshort-term agitation and diarrhea.

Accidental or intentional overdose may cause an increase in saliva production, nausea, vomiting, and low blood pressure.

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 ingested.

If you forget to take mucibrón:

Do not take a double dose to compensate for the missed dose.

If symptoms continue, take the medication in the same way as indicated in section 3. How to take mucibrón.

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

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

Infrequent may affect up to 1 in 100 patients: nausea, vomiting, stomach pain, fever.

Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria.

Unknown frequency (cannot be estimated from available data): anaphylactic reactions, such as anaphylactic shock, angioedema (rapid progression of skin, subcutaneous tissues, mucous membranes, or submucosal tissues swelling) and pruritus. Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute exanthematous pustulosis).

At the first sign of an allergy, stop taking the medication and consult your doctor or pharmacist.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible 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 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.

This medication does not require special storage conditions.

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

Composition of mucibrón

The active principle is ambroxol hydrochloride. Each ml of solution contains 3 mg of ambroxol hydrochloride.

The other components (excipients) are: Tartaric acid, citric acid monohydrate, disodium edetate, hydroxyethylcellulose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate, sorbitol (E-420), strawberry flavor (contains glucose in maltodextrin from corn and benzyl alcohol) and purified water.

Appearance of the product and contents of the packaging

Mucibrón 3 mg/ml oral solution is presented in the form of a solution. Its appearance is slightly viscous, transparent or slightly opaque, practically colorless or slightly colored and with a strawberry odor. Each package contains 200 ml in a polyethylene terephthalate bottle of topaz color. A dosifier with measurements for: 2.5, 5, 7.5, 10, and 15 ml is included.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet: October 2021

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