BRONCHENOLO COUGH*SYRUP 150ML

BRONCHENOLO COUGH 1.54 mg/ml syrup
Dextromethorphan hydrobromide

What it is and what it is used for
This medicine contains dextromethorphan hydrobromide, an active ingredient belonging to the class of cough suppressant medicines.
BRONCHENOLO COUGH is used to soothe coughs.
Contact your doctor if you do not feel better or if you feel worse after 5-7 days of treatment.

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

Do not use BRONCHENOLO COUGH in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCHENOLO COUGH if:
• you have had a long-term cough (chronic or persistent), 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 is accompanied by phlegm;
• the cough does not subside 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 COUGH can 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 stiffness, 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 COUGH with sedative medicines such as benzodiazepines, hypnotics (medicines that induce sleep), sedatives (calming agents), anxiolytics (which reduce anxiety) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma (deep unconscious state) and can be life-threatening. Inform your doctor about all sedative medicines you are taking and follow his/her dose recommendations carefully. It may be helpful 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 doses greater than those recommended or repeated over time) may develop. If you have a tendency to abuse or depend on medicines, narcotics, or alcohol, you should take BRONCHENOLO COUGH for short periods and under strict medical supervision.
During treatment with BRONCHENOLO COUGH, it is not recommended to consume alcoholic beverages.

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

Side effects of unknown frequency (frequency cannot be estimated from the available data)
• Serotonin syndrome manifesting as mental status changes, increased blood pressure, agitation, short and involuntary muscle contractions, increased reflexes, excessive sweating, chills, and tremors
• Agitation
• Headache
• Hypersensitivity (allergy)
• Rash (skin rash)
• Urticaria (skin irritation)
• Angioedema (swelling of the face, eyes, lips, throat which can cause difficulty 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.