Name
AZIMIL 15 mg/2 ml solution for nebulization and oral administration
AZIMIL 15 mg/5 ml syrup in single-dose container
AZIMIL 15 mg/5 ml syrup in multidose bottle
Ambroxol


What it is and what it is used for
AZIMIL contains the active substance ambroxol which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the airways.
AZIMIL is indicated for the treatment of bronchial and lung diseases (acute and chronic) accompanied by excessive mucus.


What you need to know before taking the medicine
Do not take AZIMIL
• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have serious liver or kidney problems;
• if you suffer from rare hereditary diseases which may be incompatible with one of the other ingredients of this medicine (See the sections “Warnings and precautions” and “Contents of the pack and other information”);
• if it is for a child under 2 years of age (for children of this age, oral forms are contraindicated).


Warnings and precautions
Talk to your doctor or pharmacist before taking AZIMIL.

Take this medicine with caution and tell your doctor:
- if you suffer from a stomach or intestinal problem called peptic ulcer.

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 AZIMIL and contact your doctor immediately.

If you experience an irritating cough while taking the nebulizer, try to inhale and exhale normally while inhaling. If you are particularly sensitive, you can pre-warm the inhaler to body temperature.

If you suffer from bronchial asthma, it is advisable to use a medicine (bronchial antispasmodic) before inhalation.

Children
Do not give the medicine in oral forms to a child under 2 years of age.


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

Diarrhea episodes have been observed commonly.
Nausea, vomiting, other mild gastrointestinal disturbances, allergic reactions have been reported uncommonly.
In rare cases, heartburn and digestive difficulties have been reported.

Rare (may affect up to 1 in 1000 people):
• hypersensitivity reactions;
• rash, urticaria.

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.
• Severe cutaneous adverse reactions (including erythema multiforme, Stevens–Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
• bronchial obstruction.

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.