BISOLVON COUGH SED*20PAST 10.5

BISOLVON COUGH SEDATIVE 10.5 mg chewable lozenges
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 and over.

What you need to know before taking this medicine
This medicine can cause dependence. 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 suffer from COPD (chronic obstructive pulmonary disease), a disease that makes it difficult to empty air from the 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 its increased activity (hyperthyroidism);
- if you suffer from an enlarged prostate (prostatic hypertrophy);
- if the person to be treated is under 12 years of age (see how to take Bisolvon cough sedative);
- if you suffer from a 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 breastfeeding (see section 2. Pregnancy, breastfeeding and fertility);
- if you are taking or have taken medicines for depression called monoamine oxidase inhibitors (MAOIs) in the last 2 weeks (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 can interact with these medicines, and changes in mental state (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.
Consult your doctor or pharmacist before taking Bisolvon Cough Sedative.
Consult your doctor if:
- you 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 with a lot of phlegm (mucus) production, for example if you suffer from bronchiectasis (a condition in which the airways are sometimes dilated because they are obstructed by an excessive amount of mucus) or cystic fibrosis (a disease characterized by obstruction of the bronchi due to the secretion of 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 addictive: following prolonged use (e.g. exceeding the recommended treatment period), tolerance to the medicine, as well as mental and physical dependence, may develop. 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 dextromethorphan abuse 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 after using Bisolvon Cough Sedative:
very common (may affect more than 1 in 10 people)
- drowsiness;
- dizziness.
common (may affect up to 1 in 10 people)
- confusion;
- vertigo;
- fatigue;
- nausea;
- vomiting; stomach and intestinal disorders;
- reduced 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 unreal things (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 that can cause breathing and swallowing problems (angioedema);
- skin irritation (hives);
- narrowing of the bronchi (bronchospasm);
- itching;
- skin rash;
- skin redness (erythema);
- drug eruption;
- speech difficulties (dysarthria);
- oscillating, rhythmic and involuntary eye movements (nystagmus);
- alteration of muscle tone (dystonia) especially in children.

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