BRONCHENOLO SED FLUID*20PASTL

BRONCHENOLO SEDATIVO E FLUIDIFICANTE, 7.5 mg + 55 mg, mint-flavoured lozenges
Dextromethorphan hydrobromide, Guaifenesin

What it is and what it is used for
This medicinal product contains 2 active ingredients:
• dextromethorphan hydrobromide, which is used to calm coughs;
• guaifenesin, which acts by thinning mucus.
BRONCHENOLO SEDATIVO E FLUIDIFICANTE is used for the symptomatic treatment of coughs, to calm coughs and to make mucus thinner and thus easier to eliminate.
Consult 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 this medicinal product
Do not take BRONCHENOLO SEDATIVO E FLUIDIFICANTE if:
• you are allergic to dextromethorphan hydrobromide, guaifenesin or any of the other ingredients of this medicinal product (listed in section 6);
• you are taking or have taken antidepressants called monoamine oxidase inhibitors (MAOIs) in the last two weeks;
• you have or are at risk of respiratory problems (respiratory failure), for example, you have chronic obstructive airway diseases, 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 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 SEDATIVO E FLUIDIFICANTE may interact with these medicines, and changes in mental state (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) may occur;
• you are taking other cough or cold medicines.
The concomitant use of BRONCHENOLO SEDATIVO E FLUIDIFICANTE with sedatives such as benzodiazepines, hypnotics (medicines that induce sleep), sedatives, anxiolytics (which reduce anxiety) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma (a state of deep unconsciousness) and can be life-threatening. Tell your doctor about all sedatives you are taking and follow his/her dose recommendations carefully. It may be helpful to inform friends or family members 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 leads to the use of higher or repeated doses over time than recommended), may 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, it is not advisable 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.
Tell your doctor if you notice any of the following during treatment with BRONCHENOLO SEDATIVO E FLUIDIFICANTE:
Uncommon side effects (may affect up to 1 in 100 people)
• drowsiness and dizziness
• abdominal, stomach or intestinal disorders, nausea, vomiting
Unknown side effects (frequency cannot be estimated from the available data)
• serotonin syndrome, which manifests as changes in mental state, increased blood pressure, agitation, short and involuntary muscle contractions, increased reflexes, excessive sweating, chills and tremors.
• agitation
• headache
• hypersensitivity (allergy)
• rash
• urticaria (skin irritation)
• angioedema (swelling of the face, eyes, lips, throat that may cause difficulty in breathing and swallowing)
• confusion
• insomnia (difficulty sleeping)
• diarrhoea

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.