Name
AMBROTUS 30 mg/10 ml syrup 200 ml bottle
AMBROTUS 30 mg/10 ml syrup single-dose containers 10 ml
Ambroxol hydrochloride


What it is and what it is used for
Ambrotus contains ambroxol, an active ingredient that works by dissolving phlegm and facilitating its elimination.

AMBROTUS is used in adults and children over 2 years of age for the treatment of secretions in acute and chronic bronchial and lung diseases (i.e. in the presence of cough and in case of difficulty expelling phlegm from the bronchi because it is increased or thickened).


What you need to know before taking the medicine
Do not take AMBROTUS
- 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;
- if the person who is to take this medicine is a child under 2 years of age (See section “Children”).


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

Take this medicine with caution and tell your doctor:
- if you have or have had lesions of the stomach and/or intestine (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 AMBROTUS and contact your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized by peeling of the skin and severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).
Also, in the early stages of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN), you may experience nonspecific flu-like symptoms, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Because of these misleading symptoms, you may be restarted on symptomatic treatment with cough and cold therapy.

Children
Do not give this medicine to children under 2 years of age. Mucolytics may cause bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways.


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

The following side effects may occur following the use of Ambrotus:
Common (may affect up to 1 in 10 people)
- nausea, altered taste (dysgeusia), numbness of the mouth and tongue (oral hypoaesthesia), numbness of the throat (pharyngeal hypoaesthesia).

Uncommon (may affect up to 1 in 100 people)
- vomiting, diarrhoea and abdominal pain, difficulty in digesting (dyspepsia), dry mouth.

Rare (may affect up to 1 in 1000 people)
- hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dry throat, difficulty passing urine (dysuria), tiredness.

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);
- bronchial obstruction (bronchial obstruction);
- heartburn (pyrosis);

These side effects are usually temporary. If they occur, consult your doctor or pharmacist.

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.