FROBEN CHEESY COUGH "4 MG/5 ML SYRUP" 250 ML BOTTLE

Name
Froben Chesty Cough 4 mg/5 ml syrup
Bromhexine hydrochloride
Equivalent medicine


What is it and what is it for?
Froben Chesty Cough contains the active ingredient bromhexine. Bromhexine is a substance that thins mucus that accumulates in the airways. This promotes the expulsion of mucus from the airways and consequently makes breathing easier.

Froben Cough is therefore indicated for the symptomatic treatment of chesty cough and secretion disorders during acute and chronic respiratory diseases (such as bronchitis).


What you need to know before taking the medicine
Do not take/administer Froben Chesty Cough
- if you are allergic to bromhexine or any of the other ingredients of this medicine (listed in section 6)
- if you are breastfeeding (see section 2 "Pregnancy, breastfeeding and fertility")
- if the person who is to take the medicine is a child under 2 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking Froben Chesty Cough:
- if you suffer from a respiratory disease that develops and worsens over a relatively short period of time (acute respiratory conditions). Consult your doctor if your symptoms do not improve or worsen during treatment;
- if you are pregnant (see section 2 "Pregnancy, breastfeeding and fertility");
- if you suffer from lesions of the stomach or intestine (ulcer).

Cases of serious skin reactions associated with bromhexine administration have been reported. If you develop a skin rash (including lesions of the mucous membranes such as the mouth, throat, nose, eyes, and genitals), stop taking Froben Chesty Cough and contact your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized by peeling skin and severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).
Most of these could be due to serious pre-existing diseases or the concomitant use of other medications.
Additionally, 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 treated symptomatically with cough and cold medication.

Treatment with Froben Chesty Cough causes an increase in bronchial secretion (this promotes expectoration).

Take/administer this medicine for short periods.

Children
Do not give this medicine to children under 2 years of age. Mucolytics, such as Froben Chesty Cough, can cause bronchial obstruction due to the physiological characteristics of children in this age group.


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

The following side effects may occur with the use of Froben Chesty Cough:
Uncommon (may affect up to 1 in 100 people)
- diarrhea, nausea, vomiting and upper abdominal pain

Rare (may affect up to 1 in 1,000 people)
Froben Chesty Cough 4 mg/5 ml syrup
- hypersensitivity reactions
- skin rash, hives (appearance of red spots on the skin)

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)
- narrowing of the bronchi which makes breathing difficult (obstruction)

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.