Leaflet: information for the user

Mucibrón forte 6 mg/ml oral solution

Ambroxol hydrochloride

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any 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 you get worse or do not improve after 5 days (3 days in children under 6 years).

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

2. What you need to know before you start taking Mucibrón forte

3. How to take Mucibrón forte

4. Possible side effects

5. Storage of Mucibrón forte

6. Contents of the pack and additional information

Ambroxol hydrochloride, 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 children aged 2 years and above.

Consult a doctor if it worsens or does not improve after 5 days (3 days in children under 6 years).

Do not take Mucibrón forte

- If you are allergic to ambroxol hydrochloride or any of the other components of this medication (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 function problems, or a history of stomach or duodenal ulcers, consult your doctor before using this medication as you may need to reduce the dose.

- Severe skin reactions have been reported associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using Mucibrón forte and consult your doctor immediately.

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

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

Children

- Mucibrón forte is contraindicated in children under 2 years of age.

- In children aged 2 to 6 years, consult a doctor.

Taking Mucibrón forte with other medications

- Inform your doctor or pharmacist if 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) increases the concentration of antibiotics in lung tissue.

Taking Mucibrón forte with food and drinks

- Mucibrón forte can be taken with or without meals.

Pregnancy, breastfeeding, and fertility

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

- No adverse effects have been observed during pregnancy. However, the usual precautions regarding the use of medications during pregnancy should be followed. Mucibrón forte is not recommended, especially in the first trimester of pregnancy.

- The active ingredient of this medication, ambroxol, may pass into breast milk, and although adverse effects are not expected in the infant, its use should be avoided during breastfeeding. Mothers breastfeeding should only take Mucibrón forte if their doctor advises it.

- Animal studies do not indicate direct or indirect adverse effects on fertility.

Driving and operating machinery

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

Mucibrón forte contains sorbitol

This medication contains 183 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) suffer from 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 before taking this medication.

Mucibrón forte contains aspartame

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

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

Mucibrón forte 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 forte 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 you may accumulate large amounts of benzyl alcohol in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because you may accumulate large amounts of benzyl alcohol 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 difficulties") in children.

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

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

Mucibrón forte 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".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 improving, the dose can be reduced to half.

Use in children and adolescents

Older adolescents over 12 years: 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: 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 dosing regimen can be reduced to 2 times a day every 12 hours.

Children from 2 to 5 years: 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 dosing regimen can be reduced to 2 times a day every 12 hours.

Children under 2 years:

It is contraindicated.

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:

Mucibrón forte is taken orally.

Measure the amount of medication to take with the measuring device included in the box (taking into account the situations in which it may be necessary to make two measurements to obtain the necessary 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 you 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 in the pharynx, sensation of numbness in the mouth, or any other adverse effect described in section 4 Possible adverse effects.

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

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

If you forgot to take Mucibrón forte

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

If symptoms continue, take the medication in the same way as indicated in the section

If you interrupt the treatment with Mucibrón forte

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

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

The following adverse effects may occur:

- Frequent (may affect up to 1 in 10 people): nausea, alteration of taste, sensation of numbness in the throat, sensation of numbness in the mouth.

- Infrequent (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, rash, urticaria, dry throat.

- Frequency unknown (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 pustular exanthema).

Stop taking the medication at the first sign of an allergic reaction and consult your doctor or pharmacist.

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: http;//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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. 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 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, sodium 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 contents of the packaging

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 aroma.

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: October 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/