SOBREPIN COUGH SED 15 MG/ML ORAL DROPS SOLUTION 1 GLASS BOTTLE OF 19 ML WITH CHILD-RESISTANT CLOSURE

Name
SOBREPIN COUGH SEDATIVE 15 mg/ml ORAL DROPS solution
Dextromethorphan hydrobromide


What is it and what is it for?
SOBREPIN COUGH SEDATIVO contains the active ingredient dextromethorphan, which belongs to the group of medicines used to treat dry coughs. Contact your doctor if you don't feel better or if you feel worse after 5 days.


What you need to know before taking the medicine
Do not take SOBREPIN 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 breathing problems (bronchial asthma, chronic obstructive pulmonary disease);
• if you have difficulty breathing (including respiratory depression);
• if you have pneumonia, a lung infection;
• if you suffer from blood circulation or heart diseases (cardiovascular diseases);
• if you have high blood pressure (hypertension);
• if you suffer from thyroid gland disorders (hyperthyroidism);
• if you have diabetes;
• if you have an eye disorder (glaucoma);
• if you suffer from prostate problems (prostatic hypertrophy);
• if you suffer from stomach, intestinal or urinary tract problems (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have serious liver disease;
• if the patient is a child under 12 years of age;
• if you are taking medicines used to treat depression (MAO inhibitor antidepressants); before taking SOBREPIN COUGH SEDATIVO you must wait two weeks after taking antidepressant medicines (see the section "Other medicines and SOBREPIN COUGH SEDATIVO");
• if you are in the first trimester of pregnancy and if you are breastfeeding.


Warnings and precautions
Talk to your doctor or pharmacist before taking SOBREPIN COUGH SEDATIVE.
The duration of treatment with this medicine should not exceed 5-7 days.
The use of SOBREPIN COUGH SEDATIVO, especially for prolonged treatments, may cause a decrease in effectiveness and the need to continue using the medicine (habituation, tolerance, and mental and physical dependence). Therefore, short-term treatment is recommended and under close medical supervision, especially if you have a predisposition to this condition. This medicine is not indicated for the treatment of persistent cough (chronic cough), which may be due to smoking or lung (emphysema) or breathing problems (asthma). If you have a persistent cough, stop treatment and contact your doctor, as it may be a symptom of certain breathing disorders (asthma). If you have a cough accompanied by copious amounts of mucus, do not take this medicine. If your cough causes you pain and discomfort (irritating cough) and is accompanied by mucus, contact your doctor who will carefully evaluate the need for treatment with this medicine. If your doctor deems treatment essential, he or she will monitor you during therapy. Take this medicine with caution if you experience fever, skin irritation (rash), headache, nausea, and vomiting.
You can start treatment with SOBREPIN COUGH SEDATIVE only after careful evaluation by your doctor and under close supervision if:
• suffers from circulatory and heart diseases (cardiovascular diseases);
• if you have high blood pressure (hypertension);
• if you suffer from thyroid gland disorders (hyperthyroidism);
• if you have diabetes;
• if you have an eye disorder (glaucoma);
• if you suffer from prostate problems (prostatic hypertrophy);
• if you suffer from stomach, intestinal or urinary tract problems (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have serious liver disease;
• if you are taking medicines used to treat depression (MAO inhibitor antidepressants); before taking SOBREPIN COUGH SEDATIVO, two weeks must have passed since taking antidepressant medicines. In all the situations mentioned above, taking this medicine is not recommended, and should only be used in cases of absolute necessity (see section 2. "Do not take SOBREPIN COUGH SEDATIVO").

CHILDREN AND ADOLESCENTS
The use of this medicine in children under 12 years of age is not recommended.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not known (the frequency of which cannot be established from the available data)
• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• difficulty moving (dystonia);
• dizziness;
• mental confusion and behavioral changes (bad language);
• serotonin syndrome (see section "Warnings and precautions"), characterised by nausea, low blood pressure, tremors and muscle disorders (clonic spasm, myoclonus, increased reflex response and pyramidal rigidity), nervous system disorders (autonomic nervous system hyperactivity), fever, rapid heartbeat (tachycardia), shortness of breath (tachypnoea), dilation of the black part of the eye (mydriasis), profuse sweating (diaphoresis), mental disorders (agitation, excitement, confusion), heart block (cardiac arrest) and death;
• mental disorders (psychosis), hallucinations;
• need to continue taking the medicine (psychological dependence);
• diabetes mellitus;
• nausea and vomiting;
• stomach and intestinal disorders, reduced appetite;
• allergic skin reactions (rashes).

Following the instructions in the package leaflet reduces the risk of side effects.

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.