MUCIBRON FORTE 6 mg/ml ORAL SOLUTION

Introduction

Leaflet: Information for the user

Mucibrón forte 6 mg/ml oral solution

Ambroxol hydrochloride

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days (3 days in children under 6 years).

Contents of the leaflet

1. What Mucibrón forte is and what it is used for
2. What you need to know before taking Mucibrón forte
3. How to take Mucibrón forte
4. Possible side effects
5. Storage of Mucibrón forte
6. Package contents and additional information

1. What Mucibrón forte is and what it is used for

Ambroxol hydrochloride, the active ingredient of this medicine, belongs to a group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and easier to eliminate.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults and children from 2 years old.

You should consult a doctor if your symptoms worsen or do not improve after 5 days (3 days in children under 6 years).

2. What you need to know before taking Mucibrón forte

Do not take Mucibrón forte

• If you are allergic to ambroxol hydrochloride or any of the other components of this medicine (listed in section 6).
• In children under 2 years of age.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Mucibrón forte.
• If you have liver or kidney problems, or a history of stomach or duodenal ulcers, consult your doctor before using this medicine, as you may need to reduce the dose.
• There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you experience a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Mucibrón forte and consult your doctor immediately.

- If you have bronchial problems, you should avoid taking mucolytics.

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

Children

• Mucibrón forte is contraindicated in children under 2 years of age.
• In children between 2 and 6 years old, consult a doctor.

Taking Mucibrón forte with other medicines

• Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.
• Taking this medicine with cough suppressants (antitussives) may cause accumulation of pulmonary secretions due to decreased cough reflex.

The administration of this medicine with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of antibiotic in lung tissue.

Taking Mucibrón forte with food and drinks

• Mucibrón forte can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• 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.
• No adverse effects have been observed during pregnancy. However, the usual precautions regarding the use of medicines during pregnancy should be followed. The use of Mucibrón forte is not recommended, especially during the first trimester of pregnancy.
• The active ingredient of this medicine, ambroxol, may pass into breast milk, and although no adverse effects are expected in the infant, its use should be avoided during breastfeeding. Breastfeeding mothers should only take it if their doctor recommends it.
• Studies in animals have not shown any direct or indirect adverse effects on fertility.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Mucibrón forte contains sorbitol

This medicine contains 183 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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Mucibrón forte contains aspartame

This medicine contains 5 mg of aspartame (E-951) per milliliter of oral solution.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Mucibrón forte 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 forte contains benzyl alcohol

This medicine 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 they may accumulate large amounts of benzyl alcohol in their 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 the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndromes") in children.

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

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

Mucibrón forte contains sodium

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

3. How to take Mucibrón forte

Follow the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: 10 ml, 2 times a day (every 12 hours), which means a maximum daily dose of 120 mg of ambroxol hydrochloride.

Once the patient starts to improve, the dose can be reduced by half.

Use in children and adolescents

Adolescents over 12 years old: 5 ml to 7.5 ml, as needed (30 mg to 45 mg of ambroxol hydrochloride), 2 times a day (every 12 hours), which means a maximum daily dose of 60 to 90 mg of ambroxol hydrochloride.

Children from 6 to 12 years old: 1 dose of 2.5 ml, 2-3 times a day (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.

Children from 2 to 5 years old: 1 dose of 1.25 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.

Children under 2 years old:

It is contraindicated.

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:

Mucibrón forte is taken orally.

Measure the amount of medicine to take with the measuring device included in the box (taking into account the situations in which two measurements are necessary to obtain the required dose).

After taking the dose, it is recommended to drink a glass of water and plenty of liquid throughout the day. After each dose, wash the dosifier.

You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment (3 days in children under 6 years).

If you take more Mucibrón forte than you should

If you have taken more Mucibrón forte than you should, you may experience nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth, or any other adverse effect described in section 4 Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

In case of massive accidental administration, symptomatic treatment is recommended.

If you forget to take Mucibrón forte

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

If your symptoms continue, take the medicine again as indicated in the section

If you stop taking Mucibrón forte

If you have any other doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects may occur:

• Frequent (may affect up to 1 in 10 people): nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth.
• Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, indigestion, abdominal pain, dry mouth.
• Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria, dry throat.
• Frequency not known (cannot be estimated from the available data): anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus. Serious skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute pustular exanthema).

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es/

5. Storage of Mucibrón forte

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Mucibrón forte

• The active ingredient is ambroxol hydrochloride
• The other components (excipients) are: tartaric acid, citric acid monohydrate, strawberry flavor (contains glucose in maltodextrin from corn and benzyl alcohol), raspberry flavor, disodium edetate, sorbitol (E-420), hydroxyethylcellulose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate dihydrate, aspartame (E-951), glycerol (E-422), and purified water.

Appearance of the product and package contents

Mucibrón forte 6 mg/ml oral solution is presented in the form of a solution.

The solution should be slightly viscous, transparent or almost transparent, colorless or slightly colored, and with a strawberry and raspberry flavor.

It is presented in an oral solution. Each package contains 250 ml of oral solution and a graduated dosing syringe of 5 ml with marks at 1.25 ml, 2.50 ml, and 5 ml.

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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/