BRONCHENOLO SED FLUI*SYR150ML

BRONCHENOLO SEDATIVO E FLUIDIFICANTE, 1.5 mg/ml + 10 mg/ml, syrup
Dextromethorphan hydrobromide, Guaifenesin

What it is and what it is used for
This medicine contains 2 active ingredients:
• dextromethorphan hydrobromide, which helps to calm coughs;
• guaifenesin, which acts as a mucolytic.
These belong to the class of cough suppressants and expectorants.
BRONCHENOLO SEDATIVO E FLUIDIFICANTE is used for the symptomatic treatment of coughs, it helps to calm coughs and to make phlegm more fluid, and therefore easier to eliminate.

Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment.

What you need to know before taking the medicine
Do not take BRONCHENOLO SEDATIVO E FLUIDIFICANTE if:
• you are allergic to dextromethorphan hydrobromide, guaifenesin or any of the other ingredients of this medicine (listed in section 6);
• you are taking or have taken medicines used to treat depression called monoamine oxidase inhibitors (MAOIs) in the last two weeks;
• you have or are at risk of respiratory problems (respiratory insufficiency), for example, chronic obstructive pulmonary disease, pneumonia, an ongoing asthma attack or worsening asthma.

Do not use BRONCHENOLO SEDATIVO E FLUIDIFICANTE in children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking BRONCHENOLO SEDATIVO E FLUIDIFICANTE if:
• you have a long-standing (chronic or persistent) cough, such as that which occurs in cases of asthma (a disease that causes narrowing and inflammation of the bronchi) or emphysema (a lung disease that causes breathing difficulties);
• the cough does not decrease or worsens despite treatment, or if it is accompanied by high fever, skin rash or headache;
• you have severe liver or kidney problems;
• you are taking medicines such as certain antidepressants or antipsychotics. BRONCHENOLO SEDATIVO E FLUIDIFICANTE may interact with these medicines and mental status changes (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38℃, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) may occur;
• you are taking other cough or cold medicines.

The concomitant use of BRONCHENOLO SEDATIVO E FLUIDIFICANTE with sedative medicines such as benzodiazepines, hypnotics (medicines that induce sleep), sedatives (calming agents), anxiolytics (which reduce anxiety) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma (a state of deep unconsciousness) and can be life-threatening. Inform your doctor about all sedative medicines you are taking and carefully follow their recommendations on the dose. It may be useful to inform friends or family so that they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.
Cases of abuse and dependence have been reported.
Dextromethorphan can be addictive: following prolonged use (e.g., exceeding the recommended treatment period), tolerance to the medicine, as well as mental and physical dependence (which cause the use of higher or repeated doses over time) can develop. If you have a tendency to abuse or depend on medicines, narcotics or alcohol, you should take BRONCHENOLO SEDATIVO E FLUIDIFICANTE for short periods and under strict medical supervision.
During treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE, alcohol consumption is not recommended.

Children and adolescents
Serious side effects such as breathing difficulties and sedation may occur in children. If these signs appear, contact your doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Inform your doctor if, during treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE, you notice:

Uncommon side effects (may affect up to 1 in 100 people)
• drowsiness and dizziness;
• abdominal, stomach or intestinal disorders, nausea, vomiting;

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• serotonin syndrome, which manifests with changes in mental status, increased blood pressure, agitation, short and involuntary muscle contractions, increased reflexes, excessive sweating, chills and tremors;
• agitation;
• headache;
• hypersensitivity (allergy);
• rash (skin eruption);
• urticaria (skin irritation);
• angioedema (swelling of the face, eyes, lips, throat that can cause difficulty in breathing and swallowing);
• confusion;
• insomnia (difficulty sleeping);
• diarrhea.

Reporting of side effects
If you get any side effects, including those 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.