Mucibron Forte 6mg/ml 250 ml

What Mucibron forte is and what it is used for
Ambroxol hydrochloride, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, thinning it and facilitating its elimination.
This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults and children from 2 years of age.
You should see a doctor if it worsens or does not improve after 5 days (3 days in children under 6 years of age).

What you need to know before you start taking Mucibron forte
Do not take Mucibron forte if:
- If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine.
- In children under 2 years of age.

Warnings and precautions
- Consult your doctor or pharmacist before taking Mucibron forte.
- If you have problems with liver or kidney function, or a history of stomach or duodenal ulcer, consult your doctor before using this medicine because the amount of medicine per dose may have to be reduced.
- There have been reports of serious skin reactions associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions of, for example, the mouth, throat, nose, eyes and genitals), stop using Mucibron forte and consult your doctor immediately.
-If you have problems with the functioning of the bronchi you should avoid taking mucolytics.
-Patients with known histamine intolerance should avoid treatment with this medication for long periods of treatment. The symptoms of intolerance are: headache, rhinitis and itching.
                         
Children
- Mucibron forte is contraindicated in children under 2 years of age.
- In children from 2 to 6 years old, the doctor should be consulted.

Taking Mucibron forte with other medicines
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Taking this medication together with medications to reduce cough (antitussives) may cause accumulation of lung secretions due to a decrease in the cough reflex.
Administration of this medication together with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of antibiotic in lung tissue.

Taking Mucibron forte with food and drinks
- Mucibron forte can be taken with or without food.

Pregnancy, lactation and fertility
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- No harmful effects have been observed during pregnancy. However, the usual precautions regarding the use of medications during pregnancy should be followed. The use of Mucibron forte is not recommended, especially in the first trimester of pregnancy.
- The active ingredient of this medication, ambroxol, can pass into breast milk and although no harmful effects are expected in the infant, its use should be avoided during breastfeeding. Breastfeeding mothers will only take it if their doctor tells them to.
- Animal studies do not indicate direct or indirect harmful effects on fertility.

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

Mucibron forte contains sorbitol
This medicine contains 183 mg of sorbitol (E-420) in each 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 (IHF), a rare genetic disease in which the patient cannot break down fructose, Consult you (or your child) with your doctor before taking this medicine.
Mucibron forte contains aspartame
This medicine contains 5 mg of aspartame (E-951) in each milliliter of oral solution.
Aspartame contains a source of phenylalanine which can be harmful if you have phenylketonuria (FCN), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it properly.
Mucibron 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).
Mucibron forte contains benzyl alcohol
This medicine contains 0.00012 mg of benzyl alcohol in each milliliter of oral solution.
Benzyl alcohol can cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breast-feeding. This is because they can accumulate large amounts of benzyl alcohol in their body and cause adverse effects (metabolic acids).

Consult your doctor or pharmacist if you have liver or kidney diseases. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).
Benzyl alcohol has been linked to the risk of serious adverse effects including breathing problems (“gasping syndromes”) in children.
Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor recommends it.
This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Mucibron forte contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per milliliter of oral solution; that is, essentially “sodium-free.”

How to take Mucibron forte
Exactly follow the instructions for administering this medication given 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 daily maximum of 120 mg of ambroxol hydrochloride.
Once the patient improves, the dose can be reduced by half.
Use in children and adolescents
Adolescents over 12 years of age: 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 daily maximum of 60 to 90 mg of ambroxol hydrochloride.
- Children from 6 to 12 years: 1 measure of 2.5 ml, 2-3 times a day (every 8-12 hours, as needed), which means a daily maximum of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage regimen can be reduced to 2 times a day every 12 hours.
- Children from 2 to 5 years: 1 measure of 1.25 ml, 3 times a day (every 8 hours), which means a daily maximum of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage regimen can be reduced to 2 times a day every 12 hours.
- Children under 2 years of age: It is contraindicated.

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

How to drink:
Mucibron forte is taken orally.
Measure the amount of medication to take with the measuring device included in the box (taking into account situations in which it is necessary to take two measurements to obtain the necessary dose).
After taking the dose, it is recommended to drink a glass of water and plenty of fluids during the day. After each dose, wash the dispenser.
You should consult a doctor if you get worse or if you do not improve after 5 days of treatment (3 days in children under 6 years of age).


LEAFLET