FROBEN COUGH FAT*SYR 250ML

Froben Tosse Grassa 4 mg/5 ml syrup
Bromhexine hydrochloride
Equivalent medicine

What it is and what it is used for
Froben Tosse Grassa contains the active ingredient bromhexine. Bromhexine is a substance capable of fluidifying mucus that stagnates in the respiratory tract. This promotes the expulsion of mucus from the respiratory tract and consequently makes breathing easier.

Froben Tosse Grassa is therefore indicated for the symptomatic treatment of productive 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 Tosse Grassa
- if you are allergic to bromhexine or any of the other ingredients of this medicine (listed in paragraph 6)
- if you are breastfeeding (see paragraph 2 Pregnancy, breastfeeding and fertility)
- if the person who needs to take the medicine is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Froben Tosse Grassa:
- if you suffer from a respiratory tract disease that appears and worsens in a relatively short period of time (acute respiratory conditions). Consult your doctor if symptoms do not improve or worsen during therapy;
- if you are pregnant (see paragraph 2 Pregnancy, breastfeeding and fertility);
- if you suffer from stomach or intestinal lesions (ulcer).

Cases of severe skin reactions associated with bromhexine administration have been reported. If you experience a skin rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking Froben Tosse Grassa and contact your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized by skin peeling 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 simultaneous use of other medicines.
Furthermore, in the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), you may experience non-specific symptoms similar to those of the flu, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Due to these misleading symptoms, it is possible that you may undertake symptomatic treatment with cough and cold therapy.

Treatment with Froben Tosse Grassa leads to 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 Tosse Grassa, 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 everyone experiences them.

The following side effects may occur with the use of Froben Tosse Grassa:
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 Tosse Grassa 4 mg/5 ml syrup
- hypersensitivity reactions
- skin rash, urticaria (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 itching
- severe cutaneous adverse reactions (including erythema multiforme, Steven-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)
- narrowing of the bronchi that makes breathing difficult (obstruction)

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.