NIROLEX COUGH AND CATARRH*SYR

NIROLEX COUGH AND PHLEGM 4 mg/5 ml syrup
Bromhexine hydrochloride

What it is and what it is used for
NIROLEX COUGH AND PHLEGM contains the active ingredient bromhexine.

Bromhexine is a substance that can thin the mucus present in the respiratory tract. This facilitates the elimination of mucus from the respiratory tract and consequently makes breathing easier.

NIROLEX COUGH AND PHLEGM is therefore indicated for secretion disorders during acute and chronic respiratory diseases, with cough and phlegm production.

Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period.

What you need to know before taking the medicine
Do not take NIROLEX COUGH AND PHLEGM:
- 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 Pregnancy and breastfeeding).

Do not give this medicine to children under 2 years of age (see paragraph below Children).

Warnings and precautions
Consult your doctor or pharmacist before taking NIROLEX COUGH AND PHLEGM.
If you suffer or have suffered from stomach or intestinal ulcers, its use is recommended only after consulting your doctor.
Avoid taking this medicine for prolonged periods. After a short period of treatment without appreciable results, consult your doctor.

Cases of severe skin reactions associated with bromhexine 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 NIROLEX COUGH AND PHLEGM and contact your doctor immediately.

For those involved in sports: this medicine contains ethyl alcohol and may lead to positive results in doping tests.

Children
Mucolytics can induce a reduction in breathing capacity (bronchial obstruction) in children under 2 years of age. In fact, the ability to eliminate mucus from the bronchi is limited in this age group. These medicines should not be used in children under 2 years of age (see paragraph "Do not take NIROLEX COUGH AND PHLEGM").

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

Side effects such as diarrhea, nausea, vomiting, stomach and intestinal problems may occur.

In addition, the following side effects may occur:
Rare: may affect up to 1 in 1,000 people:
- hypersensitivity reactions;
- rash, urticaria.

Not known: frequency cannot be estimated from the available data:
- bronchial obstruction;
- 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, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).

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.