AZIMIL*OS NEBUL 15FL 15MG 2ML

Azimil 15 mg/2 ml nebuliser solution and oral solution
Azimil 15 mg/5 ml syrup in single-dose container
Azimil 15 mg/5 ml syrup in multi-dose bottle
Ambroxol hydrochloride

What it is and what it is used for
Azimil contains ambroxol, an active ingredient belonging to a group of medicines called mucolytics, which works by making mucus more fluid and therefore easier to eliminate from the respiratory tract (bronchi and lungs).

Azimil is used in patients with acute and chronic respiratory tract diseases characterised by thick and viscous mucus.

What you need to know before taking the medicine
Do not take Azimil if:
• you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
• you have severe liver and/or kidney disease.

Do not use Azimil in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Azimil if:
- you have stomach lesions (peptic ulcer);
- you have a mild to moderate alteration of kidney function;
- you are in the first three months of pregnancy or are breastfeeding.

PAY ATTENTION:
Cases of severe skin reactions associated with ambroxol administration have been reported.
- If you develop a rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking Azimil and contact your doctor immediately.
- If you experience coughing during inhalation, try to breathe in and out normally. If you are particularly sensitive, you can preheat the solution to body temperature.
- If you suffer from asthma, it is recommended to take your usual asthma medications (bronchial antispasmodics) before inhaling Azimil with an aerosol device. This will help prevent possible breathing difficulties.

Children
Do not use Azimil in children under 2 years of age, as mucolytics can cause airway obstruction (bronchi).

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

Tell your doctor if you notice:
Common side effects (may affect up to 1 in 10 people):
• altered or decreased sense of taste (dysgeusia);
• decreased sensitivity (hypoesthesia) of the mouth and pharynx (oral cavity);
• nausea.

Uncommon side effects (may affect up to 1 in 100 people):
• vomiting;
• diarrhoea;
• indigestion (dyspepsia);
• abdominal pain;
• dry mouth.

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

Side effects with unknown frequency: (frequency cannot be estimated from the available data):
• airway obstruction (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
• severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to 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.