MUCIBRÓN 3 mg/ml ORAL SOLUTION

Introduction

Leaflet: information for the user

Mucibrón 3 mg/ml

oral solution

Ambroxol hydrochloride

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 pharmacist exactly.

• 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 side effects not listed in this leaflet.

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

Contents of the leaflet

1. What Mucibrón is and what it is used for
2. What you need to know before taking Mucibrón
3. How to take Mucibrón
4. Possible side effects

5 Conservation of Mucibrón

1. Package contents and additional information

:

1. What is Mucibrón and what is it used for

Mucibrón belongs to the group of medications called mucolytics.

Ambroxol, the active ingredient of this medication, acts by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

It reduces the viscosity of mucus and phlegm, making it easier to expel, in colds and flu for adults and children over 2 years old.

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

2. What you need to know before taking Mucibrón

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.

There have been reports of severe skin reactions associated with the administration of ambroxol. If a skin rash appears (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, you should 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 dose.

Patient with known histamine intolerance should avoid treatment with this medication for long periods. The symptoms of intolerance are: headache, rhinitis, and itching.

Mucibrón interaction with other medications:

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

Taking this medication with cough suppressants (antitussives) may cause accumulation of pulmonary secretions due to decreased cough reflex.

Administration of this medication with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of the antibiotic in lung tissue.

Mucibrón interaction with food and beverages

It should not be taken with meals and should be taken with a glass of water. Drinking more liquids can increase the activity of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan 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 who are breastfeeding should only take it if their doctor recommends it.

Driving and using machines

No effects on the ability to drive and use 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 told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol can cause gastrointestinal upset and a mild laxative effect.

Mucibrón contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

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 can cause allergic reactions.

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

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") 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 one 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; that is, it is essentially "sodium-free".

3. How to take Mucibrón

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

The recommended dose is:

Adults and adolescents from 12 years old:

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

Use in children

Children under 2 years old

It is contraindicated.

Children from 2 to 5 years old

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

Children from 6 to 12 years old

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

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

How to take:

This medication is taken orally.

Measure the amount of medication to be taken with the dosing device included in the box. Drink directly from the dosing device and take a glass of liquid (preferably water). After each dose, wash the dosing device.

It should not be taken with meals.

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

If you take more Mucibrón than you should

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

Accidental or intentional overdose may cause increased saliva production, nausea, vomiting, and decreased blood pressure.

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 ingested.

If you forget to take Mucibrón:

Do not take a double dose to make up for the forgotten dose.

If symptoms continue, take the medication again as indicated in section 3. How to take Mucibrón.

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

4. Possible side effects

Like all medications, Mucibrón can cause side effects, although not everyone will experience them.

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

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

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

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

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

Reporting side effects

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

Keep this medication out of the sight and reach of children.

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.

This medication does not require special storage conditions.

Medications should not be thrown away through the sewers or in 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 way, you will help protect the environment.

6. Package contents and additional information

Mucibrón composition

The active ingredient is ambroxol hydrochloride. Each milliliter 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 package contents

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 flavor. Each package contains 200 ml in a topaz-colored polyethylene terephthalate bottle. A dosing device with measures for 2.5, 5, 7.5, 10, and 15 ml is included.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet: October 2021

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/