MUCICLAR "30 MG GRANULES FOR ORAL SOLUTION" 30 SACHETS"

Name
MUCICLAR 15mg/5ml syrup
MUCICLAR 75 mg prolonged-release capsules
MUCICLAR 30 mg granules for oral solution
Ambroxol hydrochloride
Equivalent medicine


What is it and what is it for?
This medicine contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the airways.

MUCICLAR is indicated for the treatment of secretion in acute and chronic bronchial and lung diseases (in the presence of cough and phlegm).

Talk to your doctor if you do not feel better or if you feel worse.


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

MUCICLAR should not be taken by children under 2 years of age.


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

Take this medicine with caution and tell your doctor:
- if you suffer from a stomach or intestinal problem called peptic ulcer;
- if you suffer from kidney problems (renal failure).

Cases of serious skin reactions associated with ambroxol administration have been reported. If a skin rash occurs (including lesions of the mucous membranes such as the mouth, throat, nose, eyes, and genitals), stop taking MUCICLAR and contact your doctor immediately.
Especially in the initial phase of these diseases, you may experience flu-like symptoms, such as fever, pain, runny nose (rhinitis), cough, and sore throat.

Children
MUCICLAR 15 mg/5 ml syrup, MUCICLAR 75 mg prolonged-release capsules and MUCICLAR 30 mg granules for oral solution should not be administered to children under 2 years of age, as they may induce bronchial obstruction and prevent normal breathing due to children's limited ability to eliminate secretions.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):
- alterations in the sense of taste (dysgeusia);
- loss of sensation (hypoesthesia) of the oral cavity and pharynx;
- nausea.

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

Rare (may affect up to 1 in 1,000 people):
- headache (cephalalgia);
- increased mucus production, runny nose (rhinorrhea);
- heartburn and esophageal pain (pyrosis);
- constipation (constipation);
- skin irritation (rash, hives, contact dermatitis);
- difficulty passing urine (dysuria);
- tiredness;
- hypersensitivity reactions.

Not known (the frequency of which cannot be established based on the available data):
- anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), pruritus and other hypersensitivity reactions;
- serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
- bronchial obstruction (bronchial obstruction);
- dry throat.

Reporting of side effects
If you experience 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.