Package leaflet: Information for the patient

Ambroxol Mylan Generics 15 mg/5 ml syrup

ambroxol hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a few days.

Contents of this leaflet:

What Ambroxol Mylan Generics is and what it is used for
What you need to know before taking Ambroxol Mylan Generics
How to take Ambroxol Mylan Generics
Possible side effects
How to store Ambroxol Mylan Generics
Contents of the pack and other information

1. What Ambroxolo Mylan Generics is and what it is used for

This medicine contains the active substance ambroxol, which belongs to a group of medicines called mucolytics, used to help clear mucus from the airways.
Ambroxolo Mylan Generics is indicated for the treatment of acute and chronic diseases of the bronchi and lungs associated with excessive mucus production.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking Ambroxol Mylan Generics

Do not take Ambroxol Mylan Generics

if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver or kidney problems.
Do not use this medicine in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ambroxol Mylan Generics if:

you suffer from a stomach or intestinal condition called peptic ulcer;
you have mild or moderate impairment of kidney function;
you suffer from severe liver problems;
you are in the first three months of pregnancy or if you are breastfeeding.

Serious skin reactions have been reported with ambroxol administration.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Ambroxol Mylan Generics and contact your doctor immediately.
Consult your doctor if your symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.

Children
Ambroxol Mylan Generics must not be given to children under 2 years of age, as it may obstruct the bronchi and interfere with normal breathing.

Other medicines and Ambroxol Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking antibiotics for the treatment of bacterial infections, such as amoxicillin, cefuroxime, and erythromycin.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Ambroxol Mylan Generics during the first three months of pregnancy or while breastfeeding without first consulting your doctor.

Driving and using machines
Ambroxol Mylan Generics does not affect the ability to drive or operate machinery.

Ambroxol Mylan Generics contains sorbitol, parahydroxybenzoates, and ethanol
This medicine contains 3.5 g of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has diagnosed you (or the child) as having intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak to your doctor before taking this medicine. It may cause gastrointestinal disturbances and has a mild laxative effect.
Ambroxol Mylan Generics contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
This medicine contains 3.875 mg of alcohol (ethanol) in 5 ml. The amount in 5 ml of this medicine is equivalent to less than 0.1 ml of beer or 0.04 ml of wine.

3. How to take Ambroxol Mylan Generics

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents
The initial dose is 10 ml of syrup three times a day, unless otherwise directed by the doctor;
subsequently, 5 ml three times a day.
Use in children
Children from 2 to 5 years of age
The recommended dose is 2.5 ml three times a day, unless otherwise directed by the doctor.
Children over 5 years of age
The recommended dose is 5 ml three times a day, unless otherwise directed by the doctor.
Take Ambroxol Mylan Generics with meals.
At the beginning of treatment, the dose may be increased or even doubled at the doctor's discretion.
Do not exceed the recommended doses.
Use the dosing cup with graduated markings at 10 ml, 5 ml and 2.5 ml provided in the package to ensure the correct dose is taken.
5 ml of syrup corresponds to 15 mg of ambroxol hydrochloride.
If you take more Ambroxol Mylan Generics than you should
If an excessive dose of Ambroxol Mylan Generics is accidentally ingested or taken, the risk of experiencing adverse effects increases. Immediately contact your doctor or go to the nearest hospital emergency department.
Take this leaflet, the bottle and its packaging with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take Ambroxol Mylan Generics
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ambroxol Mylan Generics immediately and contact your doctor if you experience any of the following: itching, skin rash (urticaria, skin rash), swelling (angioedema) of the face, eyes, lips and/or throat with breathing difficulties due to allergy (hypersensitivity).

The following side effects may occur:

Common (may affect up to 1 in 10 people)

altered or reduced taste;
loss of sensation in the mouth and pharynx;
nausea.

Uncommon (may affect up to 1 in 100 people)

vomiting, diarrhoea, digestive disturbances, abdominal pain;
dry mouth;
heartburn.

Rare (may affect up to 1 in 1,000 people)

headache;
hypersensitivity reactions;
rash, urticaria.

Not known (frequency cannot be estimated from the available data)

anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
obstruction of the respiratory tract (bronchi);
dry throat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ambroxol Mylan Generics

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.".
The expiry date refers to the last day of that month.
After first opening the bottle, the medicine should be used within 30 days; after this period, any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ambroxol Mylan Generics contains

The active substance is ambroxol hydrochloride. 5 ml of syrup contain 15 mg of ambroxol hydrochloride.
The other components are: sorbitol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, glycerol, raspberry flavour, ammonium glycyrrhizinate, hydrochloric acid, sodium hydroxide (pH adjuster), purified water.

Description of the appearance of Ambroxol Mylan Generics and package contents
Pack containing 1 bottle of 200 ml and a graduated oral syringe.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan
Manufacturer
ABC Farmaceutici S.p.A., Via Canton Moretti 29 - 10090 S. Bernardo d’Ivrea (TO)