Mucibron forte 6 mg/ml oral solution 250 ml

Mucibron forte 6 mg/ml oral solution 250 ml

1. What Mucibron 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 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 flus, for adults and children from 2 years of age.

You should consult a doctor if it gets worse or if it does not improve after 5 days (3 days in children under 6 years of age).

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

Do not take Mucibron forte

- If you are allergic to ambroxol hydrochloride or 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 you start taking Mucibron forte.

- If you have problems with your 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 need to be reduced.

- There have been reports of serious skin reactions associated with 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 function of your bronchial tubes, you should avoid taking mucolytics.

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

Children

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

- In children between 2 and 6 years of age, a doctor should be consulted.

Taking Mucibron forte with other medicines

- Tell your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicines.

- Taking this medicine together with cough suppressants (antitussives) may cause a build-up of secretions in the lungs due to a decreased cough reflex.

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

Taking Mucibron forte with food and drink

- Mucibron forte can be taken with or without food.

Pregnancy, breast-feeding and fertility

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

- No harmful effects have been observed during pregnancy. However, the usual precautions regarding the use of medicines during pregnancy should be observed. The use of Mucibron forte is not recommended especially in the first trimester of pregnancy.

- The active substance of this medicine, ambroxol, can pass into breast milk and although no harmful effects on the nursing infant are expected, its use should be avoided during breast-feeding. Breast-feeding mothers should only take it if directed to do so by their doctor.

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

Driving and use of machines

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

Important information about some of the ingredients of Mucibron forte

Mucibron forte contains

- Sorbitol (E-420) If you have been told by your doctor that you have an intolerance to certain sugars, ask your doctor before taking this medicine.

- Methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216) May cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

- Aspartame (E951) may be harmful to people with phenylketonuria because it contains aspartame which is a source of phenylalanine.

3. How to take Mucibron forte

Follow the instructions for taking this medicine exactly as directed by your doctor or pharmacist. If you are in any doubt, ask your doctor or pharmacist again.

The recommended dose is:

Adults: 10 ml, twice a day (every 12 hours), which means a maximum daily dose 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 ambroxol hydrochloride), twice a day (every 12 hours), which means a maximum daily dose of 60 to 90 mg ambroxol hydrochloride.

Children aged 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 ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.

Children aged 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 ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosing schedule can be reduced to 2 times a day every 12 hours.

Children under 2 years of age:

Contraindicated.

Patients 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:

Mucibron forte is taken by mouth.

Measure the amount of medicine to be taken with the measuring device provided in the box (taking into account situations where 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 fluids during the day. After each dose, wash out 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).

If you take more Mucibron forte than you should

If you have taken more Mucibron forte than you should, you may experience nausea, altered sense of taste, numbness of the pharynx, numbness of the mouth or any of the other side effects described in section 4 Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Poisons Information Service, telephone 915 620 420, indicating the medicinal product and the quantity taken.

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

If you forget to take Mucibron forte

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

If the symptoms continue, take the medicine again in the same way as indicated in the section on "If you stop taking Mucibron forte".

If you stop taking Mucibron forte

If you have any other questions 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 everybody gets them.

The following side effects may occur:

- Frequent (may affect up to 1 in 10 people): nausea, altered sense of taste, numbness of the pharynx, numbness of the mouth.

- Rare (may affect up to 1 in 100 people): vomiting, diarrhoea, indigestion, pain in the abdomen, dry mouth.

- Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, rash, urticaria, dry throat.

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

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

Reporting side effects

If you experience any side effects, please tell your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse effects you can help to provide more information on the safety of this medicine.

5. Storage of Mucibron forte

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require special storage conditions.

Medicines should not be flushed down the drain or thrown away. Please dispose of unneeded medicines and containers at the SIGRE Point at the pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help to protect the environment.

6. Package contents and additional information

Composition of Mucibron forte

- The active substance is ambroxol hydrochloride.

- The other ingredients (excipients) are: tartaric acid, citric acid monohydrate, strawberry flavouring, raspberry flavouring, disodium edetate, sorbitol (E-420), hydroxyethylcellulose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate dihydrate, aspartame (E-951), glycerol and purified water.

Product appearance and package contents

Mucibron forte 6 mg/ml oral solution is presented as a solution.

The solution should be slightly viscous, clear or almost clear, colourless or slightly coloured and with a strawberry and raspberry flavour.

It is presented as an oral solution. Each pack contains 250 ml of oral solution and a 5 ml graduated dosing syringe marked at 1.25 ml, 2.50 ml and 5 ml.