Mucibron Forte 6 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mucibrón forte 6 mg/ml oral solution
Ambroxol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for administration provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 5 days (3 days in children under 6 years of age).
Contents of the leaflet
- What Mucibrón forte is and what it is used for
- What you need to know before taking Mucibrón forte
- How to take Mucibrón forte
- Possible adverse effects
- How to store Mucibrón forte
- Contents of the pack and other information
1. What Mucibrón forte is and what it is used for
Ambroxol hydrochloride, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it less thick and helping its removal.
This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults and children from 2 years of age.
You should consult a doctor if you worsen or do not improve after 5 days (3 days in children under 6 years old).
2. What you need to know before taking Mucibrón forte
Do not take Mucibrón forte
- If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- In children under 2 years of age.
Warnings and precautions
- Consult your doctor or pharmacist before taking Mucibrón forte.
- If you have liver or kidney function problems, or a history of stomach or duodenal ulcer, consult your doctor before using this medicine, as your dose may need to be reduced.
- Serious skin reactions associated with ambroxol hydrochloride administration have been reported. 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.
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If you have bronchial function problems, you should avoid taking mucolytic agents.
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Patients with known histamine intolerance should avoid long-term treatment with this medicine. Symptoms of intolerance include: headache, rhinitis, and itching.
Children
- Mucibrón forte is contraindicated in children under 2 years of age.
- In children aged 2 to 6 years, consult your doctor.
Taking Mucibrón forte with other medicines
- Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.
- Taking this medicine together with cough suppressants (antitussives) may lead to accumulation of pulmonary secretions due to reduced cough reflex.
Administration of this medicine together with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases antibiotic concentration 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
- No harmful effects have been observed during pregnancy. However, usual precautions regarding medicine use during pregnancy should be followed. Use of Mucibrón forte is not recommended, especially during the first trimester of pregnancy.
- The active ingredient in this medicine, ambroxol, may pass into breast milk. Although harmful effects in the infant are not expected, use during breastfeeding should be avoided. Breastfeeding mothers should only take this medicine if specifically instructed by their doctor.
- Animal studies have not shown any direct or indirect harmful effects on fertility.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Mucibrón forte contains sorbitol
This medicine contains 183 mg of sorbitol (E-420) per millilitre of oral solution.
Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.
Mucibrón forte contains aspartame
This medicine contains 5 mg of aspartame (E-951) per millilitre of oral solution.
Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Mucibrón forte contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
May cause allergic reactions (possibly delayed) as 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 millilitre of oral solution.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because benzyl alcohol may accumulate in your body in large amounts and cause adverse effects (metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because benzyl alcohol may accumulate in the body in large amounts 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 of age) unless specifically recommended by your doctor.
This medicine should not be used for longer than one week in children under 3 years of age unless otherwise directed by your doctor or pharmacist.
Mucibrón forte contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per millilitre of oral solution; therefore, it is essentially "sodium-free".
3. How to take Mucibrón forte
Follow exactly 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, twice daily (every 12 hours), corresponding to a maximum daily dose of 120 mg of ambroxol hydrochloride.
Once the patient's condition improves, the dose may 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), twice daily (every 12 hours), corresponding to a maximum daily dose of 60 to 90 mg of ambroxol hydrochloride.
Children aged 6 to 12 years: 1 measure of 2.5 ml, 2–3 times daily (every 8–12 hours, as needed), corresponding to a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2–3 days, once the patient improves, the dosing regimen may be reduced to twice daily (every 12 hours).
Children aged 2 to 5 years: 1 measure of 1.25 ml, 3 times daily (every 8 hours), corresponding to a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2–3 days, once the patient improves, the dosing regimen may be reduced to twice daily (every 12 hours).
Children under 2 years of age:
Contraindicated.
Patients with kidney and/or liver disease:
If you suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose.
How to take:
Mucibrón forte is taken orally.
Measure the amount of medicine to be taken using the measuring device provided in the package (taking into account situations where two measurements may be necessary to obtain the required dose).
After taking the dose, it is recommended to drink a glass of water and plenty of fluids throughout the day. After each use, wash the dosing device.
You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment (3 days in children under 6 years of age).
If you take more Mucibrón forte than you should
If you have taken more Mucibrón forte than you should, you may experience nausea, altered taste sensation, numbness of the pharynx, numbness of the mouth, or any other adverse reaction described in section 4, Possible adverse effects.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.
In case of accidental massive administration, symptomatic treatment is recommended.
If you forget to take Mucibrón forte
Do not take a double dose to make up for missed doses.
If symptoms persist, resume taking the medicine in the same manner as indicated in the section
If you stop treatment with Mucibrón forte
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
The following adverse effects may occur:
- Common (may affect up to 1 in 10 people): nausea, altered taste sensation, numbness sensation in the pharynx, numbness sensation in the mouth.
- Uncommon (may affect up to 1 in 100 people): vomiting, diarrhoea, 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, mucosa or submucosal tissues), and pruritus. Serious skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
At the first sign of allergy, stop taking the medicine and consult your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mucibrón forte
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mucibrón forte
- The active substance is ambroxol hydrochloride.
- The other components (excipients) are: Tartaric acid, citric acid monohydrate, strawberry flavour (containing glucose in maltodextrin derived from maize and benzyl alcohol), raspberry flavour, 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 contents of the container
Mucibrón forte 6 mg/ml oral solution is presented as a solution.
The solution should be slightly viscous, transparent or almost transparent, colourless or slightly coloured, with a strawberry and raspberry odour.
It is presented as an oral solution. Each container contains 250 ml of oral solution and a graduated 5 ml dosing syringe with markings 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 most recent revision of this leaflet: October 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/