BISOLVON COUGH SED "10.5 MG GUMMY LOZENGES"20 GUMMY LOZENGES"

Name
BISOLVON COUGH SEDATIVE 10.5 mg gummy tablets
dextromethorphan hydrobromide


What it is and what it is used for
Bisolvon Cough Sedative contains dextromethorphan and is indicated for the treatment of dry cough in adults and adolescents aged 12 years and over.


What you need to know before taking the medicine
This medicine can lead to addiction. Therefore, treatment should be short-term.
Do not use Bisolvon Cough Sedative
- if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from asthma, a disease that makes breathing difficult;
- if you have COPD (chronic obstructive pulmonary disease), a disease that makes it difficult to empty air from your lungs;
- if you suffer from inflammation of the lungs (pneumonia) or have difficulty breathing (respiratory distress, respiratory depression);
- if you suffer from heart disease (cardiovascular disease) and high blood pressure (hypertension);
- if you suffer from an eye disease (glaucoma);
- if you suffer from a thyroid disease caused by increased thyroid activity (hyperthyroidism);
- if you suffer from an enlarged prostate (prostatic hypertrophy);
- if the subject to be treated is under 12 years of age (see "how to take Bisolvon cough sedative");
- if you suffer from narrowing (stenosis) of the stomach or intestines or urinary tract;
- if you suffer from a disease characterized by uncontrolled body movements and loss of consciousness (epilepsy);
- if you suffer from severe liver disease;
- if you are in the first 3 months of pregnancy or are breast-feeding (see section 2. "Pregnancy, breast-feeding and fertility");
- if you are taking or have taken in the last 2 weeks medicines to treat depression called monoamine oxidase inhibitors (MAOIs) (see section "Other medicines and Bisolvon Cough Sedative").


Warnings and precautions
Talk to your doctor or pharmacist before taking Bisolvon Cough Sedative:
• if you are taking medicines such as some antidepressants or antipsychotics:
Bisolvon Cough Sedative 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.
Talk to your doctor or pharmacist before taking Bisolvon Cough Sedative.
Talk to your doctor if:
- have liver or kidney problems, especially if you have severe kidney problems;
- if you suffer from a blood disease (mastocytosis);
- if you have/have had a cough that produces a lot of phlegm (mucus), for example if you suffer from bronchiectasis (a condition in which the airways are at times dilated because they are blocked by an excessive quantity of mucus) or cystic fibrosis (a disease characterised by obstruction of the bronchi due to the secretion of a very thick and viscous mucus);
- if you suffer from neurological diseases associated with a reduction in the cough reflex (such as stroke, Parkinson's disease and dementia).
Dextromethorphan can be habit-forming: following prolonged use (e.g. exceeding the recommended treatment period), tolerance to the drug may develop, as well as mental and physical dependence. If you have a tendency to abuse or dependence, you should take Bisolvon Cough Sedative for short periods and under strict medical supervision.
Cases of abuse of dextromethorphan have been reported.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur following the use of Bisolvon Cough Sedative:
very common (may affect more than 1 in 10 people)
- drowsiness;
- dizziness.
common (may affect up to 1 in 10 people)
- state of confusion;
- dizziness;
- fatigue;
- nausea;
- vomiting; stomach and intestinal disorders;
- reduction of appetite.
very rare (may affect up to 1 in 10,000 people)
- abuse (frequent or prolonged use or with excessive doses);
- dependence (need to continue taking the medicine);
- perception of things that do not exist in reality (hallucinations).
not known (frequency cannot be estimated from the available data)
- severe allergic reaction (anaphylactic reaction;
- swelling of the face, lips, mouth, tongue and throat which may cause problems with breathing and swallowing (angioedema);
- skin irritation (hives);
- constriction of the bronchi (bronchospasm);
- itching;
- skin rash;
- redness of the skin (erythema);
- drug rash;
- difficulty speaking (dysarthria);
- oscillatory, rhythmic, involuntary movements of the eyes (nystagmus);
- alteration of muscle tone (dystonia) especially in children.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.