AMBROXOL MY "15 MG/5 ML SYRUP" 200 ML BOTTLE"

Name
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 substance ambroxol, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the airways.

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

Talk to 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
Talk to your doctor or pharmacist before taking Ambroxol Mylan Generics if:
- have a stomach or intestinal problem called peptic ulcer;
- has mild or moderate impairment of kidney function;
- suffers from serious liver problems;
- during the first three months of pregnancy or if you are breastfeeding.

Cases of serious skin reactions associated with the administration of ambroxol have been reported.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Ambroxolo Mylan Generics and contact your doctor immediately.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes 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 contact your doctor if you experience any of the following conditions: itching, skin spots (urticaria, rash), swelling (angioedema) of the face, eyes, lips and/or throat with difficulty breathing, due to allergy (hypersensitivity).

The following side effects may occur:

Common (may affect up to 1 in 10 people):
- alteration or decrease in taste;
- loss of sensation in the mouth and throat;
- nausea.

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

Rare (may affect up to 1 in 1,000 people):
- heachache;
- 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, mucosa and submucosal tissues) and pruritus;
- serious cutaneous adverse reactions (including erythema multiforme, Stevens Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
- obstruction of the airways (bronchi);
- dry throat.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.