Name
BRONCHENOL SEDATIVE AND FLUIDIFYING, 1.5 mg/ml + 10 mg/ml, syrup
Dextromethorphan hydrobromide, Guaifenesin


What is it and what is it for?
This medicine contains 2 active substances:
• dextromethorphan hydrobromide, which is used to calm coughs;
• guaifenesin, which works by thinning phlegm.
which belong to the class of cough sedative and expectorant medicines.
BRONCHENOL SEDATIVE AND FLUIDIFYING is used for the symptomatic treatment of coughs, it serves to calm the cough and make the phlegm more fluid, therefore more easily eliminated.
Talk to 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 SEDATIVE AND FLUIDIFIER if:
• are allergic to dextromethorphan hydrobromide, guaifenesin or any of the other ingredients of this medicine (listed in section 6);
• are taking or have taken in the last two weeks medicines used against depression called monoamine oxidase inhibitors (MAOIs);
• have or are at risk of having breathing problems (respiratory failure), for example you have chronic obstructive airway disease, pneumonia, an ongoing asthma attack or worsening of your asthma.
Do not use BRONCHENOLO SEDATIVE AND FLUIDIFIER in children under 6 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCHENOLO SEDATIVE AND FLUIDIFIER if:
• have a long-standing (chronic or persistent) cough, such as occurs with asthma (a disease that causes narrowing and inflammation of the bronchi) or emphysema (a lung disease that causes difficulty breathing);
• the cough does not decrease or gets worse despite treatment or if it is accompanied by high fever, skin rash or headache;
• have serious liver or kidney problems;
• are taking medicines such as some antidepressants or antipsychotics. BRONCHENOL SEDATIVE AND FLUIDIFIER may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38℃, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) may occur;
• are taking any other cough or cold medicines.
Concomitant use of BRONCHENOLO SEDATIVE AND FLUIDIFIER with sedative medicines such as benzodiazepines, hypnotics (drugs that induce sleep), sedatives (calming agents), and anxiolytics (drugs that reduce anxiety) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma (deep unconsciousness) and may be life-threatening. Tell your doctor about all sedative medicines you are taking and carefully follow their dosage recommendations. It may be helpful to inform friends or family so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.
Cases of abuse and addiction have been reported.
Dextromethorphan can be habit-forming: with prolonged use (e.g., exceeding the recommended treatment period), tolerance to the drug may develop, as well as mental and physical dependence (resulting in the use of higher than recommended doses or repeated doses over time). If you have a tendency to abuse or depend on medications, narcotics, or alcohol, you should take BRONCHENOLO SEDATIVE AND FLUIDIFIER for short periods and under strict medical supervision.
During treatment with BRONCHENOLO SEDATIVE AND FLUIDIFYING it is not recommended to consume alcoholic beverages.

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


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

Tell your doctor if you notice any of the following during treatment with BRONCHENOLO SEDATIVE AND FLUIDIFIER:
Uncommon side effects (may affect up to 1 in 100 people):
• drowsiness and dizziness;
• abdominal, stomach or intestinal discomfort, nausea, vomiting.

Unknown side effects (frequency cannot be estimated from the available data):
• serotonin syndrome which manifests itself with changes in mental status, increased blood pressure, agitation, brief and involuntary muscle contractions, increased reflexes, excessive sweating, chills and tremors;
• agitation;
• heachache;
• hypersensitivity (allergy);
• rash (skin eruption);
• hives, (skin irritation);
• angioedema (swelling of the face, eyes, lips, throat which may cause difficulty breathing and swallowing);
• confusion;
• insomnia (difficulty sleeping);
• diarrhea.

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.