AMBROXOL MY*SYR200ML15MG/5ML

Ambroxol Mylan Generics 15 mg/5 ml syrup
ambroxol hydrochloride
Equivalent medicine

What it is and what it is used for
This medicine contains the active ingredient ambroxol, belonging to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.

Ambroxol Mylan Generics is indicated for the treatment of acute and chronic diseases of the bronchi and lungs accompanied by excessive mucus.

Consult your doctor if you do not feel better or if you feel worse after a few days.

What you need to know before taking the medicine
Do not take Ambroxol Mylan Generics
- if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from severe liver or kidney problems.

Do not use this medicine in children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Ambroxol Mylan Generics if you:
- suffer from a stomach or intestinal problem called peptic ulcer;
- have a mild or moderate alteration of kidney function;
- suffer from severe liver problems;
- during the first three months of pregnancy or if you are breastfeeding.

Cases of severe skin reactions associated with ambroxol administration have been reported.
If you develop a skin rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking Ambroxol Mylan Generics and contact your doctor immediately.
Consult your doctor if the problem occurs repeatedly or if you have noticed any recent change in its characteristics.

Children
Ambroxol Mylan Generics should not be administered to children under 2 years of age, as it can obstruct the bronchi and prevent normal breathing.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ambroxol Mylan Generics immediately and consult your doctor if you experience any of the following: itching, skin spots (hives, 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 decreased taste;
- loss of sensation in the mouth and pharynx;
- nausea.

Uncommon (may affect up to 1 in 100 people):
- vomiting, diarrhoea, digestive difficulties, abdominal pain;
- dry mouth;
- heartburn.

Rare (may affect up to 1 in 1,000 people):
- headache;
- hypersensitivity reactions;
- rash, hives.

Not known (frequency cannot be estimated from the available data):
- anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucous membrane and submucosal tissues) and itching;
- severe cutaneous adverse reactions (including erythema multiforme, Steven Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
- obstruction of the respiratory tract (bronchi);
- dry throat.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.