NEOBOROCIL FLUID COUGH*SYR200ML

Neo Borocillina Fluidificante Tosse 30 mg/10 ml syrup
Ambroxol hydrochloride

What it is and what it is used for
Neo Borocillina Fluidificante Tosse contains the active ingredient ambroxol hydrochloride; this medicine belongs to the class of mucolytics and acts as a fluidifier of respiratory secretions (phlegm).

Neo Borocillina Fluidificante Tosse is used for the treatment of cough accompanied by phlegm (for example, in the presence of acute and chronic respiratory diseases).

What you need to know before taking the medicine
Do not take Neo Borocillina Fluidificante Tosse
- if you are allergic to the active ingredient (ambroxol hydrochloride) or any of the other ingredients of this medicine (listed in paragraph 6);
- if you suffer from severe liver and/or kidney disorders;
- if you suffer from rare hereditary diseases that may be incompatible with one of the excipients (see paragraph Neo Borocillina Fluidificante Tosse contains Sorbitol).

Do not administer this medicine to children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Neo Borocillina Fluidificante Tosse.

- Take Neo Borocillina Fluidificante Tosse with caution if you have a lesion on the internal surface of your stomach (peptic ulcer).
- Consult your doctor before taking Neo Borocillina Fluidificante Tosse if you suffer from mild or moderate kidney problems.
- Cases of severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking Neo Borocillina Fluidificante Tosse and contact your doctor immediately. Particularly in the initial stages, you may also experience non-specific symptoms similar to those of the flu, such as fever, malaise, rhinitis, cough, and sore throat.
- Consult your doctor if the problem occurs repeatedly or if you have noticed any recent changes in its characteristics.

Children
Do not administer this medicine to children under 2 years of age.

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

Common side effects (may affect less than 1 in 10 people)
• Alterations in taste sensation (dysgeusia)
• Loss of sensation in the oral cavity and pharynx (hypoaesthesia)
• Nausea

Uncommon side effects (may affect less than 1 in 100 people)
• Vomiting, diarrhoea, gastric disorders (dyspepsia) and abdominal pain, dry mouth

Rare side effects (may affect less than 1 in 1,000 people)
• Headache (cephalgia)
• Increased nasal secretion (rhinorrhoea)
• Heartburn (pyrosis), constipation
• Hypersensitivity reactions
• Rash, urticaria, contact dermatitis
• Difficulty urinating (dysuria)
• Fatigue

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucosa, and submucous tissues) and itching
• Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)
• Bronchial obstruction
• Dry throat

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.