SOBREPIN COUGH SEDATIVE*DROPS 19ML

SOBREPIN TOSSE SEDATIVO 15 mg/ml ORAL DROPS solution
Dextromethorphan hydrobromide

What it is and what it is used for
SOBREPIN TOSSE SEDATIVO contains the active ingredient Dextromethorphan, which belongs to the group of medicines used for the treatment of dry cough. Consult your doctor if you do not feel better or if you feel worse after 5 days.

What you need to know before taking the medicine
Do not take SOBREPIN TOSSE SEDATIVO
• if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in paragraph 6);
• if you suffer from breathing disorders (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 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 disorders (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have severe liver diseases;
• if the patient is a child under 12 years of age;
• if you are taking medicines used for the treatment of depression (MAO inhibitor antidepressants); before taking SOBREPIN TOSSE SEDATIVO, two weeks must have passed since taking antidepressant medicines (see the paragraph Other medicines and SOBREPIN TOSSE SEDATIVO);
• if you are in the first trimester of pregnancy and if you are breastfeeding.

Warnings and precautions
Consult your doctor or pharmacist before taking SOBREPIN TOSSE SEDATIVO.
The duration of treatment with this medicine should not exceed 5-7 days.
The use of SOBREPIN TOSSE SEDATIVO, especially for prolonged treatments, can cause a decrease in efficacy and the need to continue using the medicine (habituation, tolerance, and mental and physical dependence). Therefore, a short-term treatment under strict medical supervision is recommended, especially if you have a predisposition to manifest such a condition. This medicine is not indicated for the treatment of persistent cough (chronic cough), which may be due to smoking or lung disorders (emphysema) or breathing (asthma). If you have a persistent cough, stop treatment and consult your doctor, as it may be a symptom of certain breathing disorders (asthma). If you have a cough accompanied by abundant mucus, do not take this medicine. If the cough causes you pain and discomfort (irritating cough) and is accompanied by mucus, consult your doctor who will carefully evaluate the need for treatment with this medicine. If the doctor deems the treatment indispensable, you will need to be monitored during therapy. Take this medicine with caution if you experience fever, skin irritation (rash), headache, nausea, and vomiting.
You can start treatment with SOBREPIN TOSSE SEDATIVO only after careful evaluation by your doctor and under strict supervision if:
• you suffer from blood circulation 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 disorders (stenosis of the gastrointestinal and urogenital tract);
• if you suffer from epilepsy;
• if you have severe liver diseases;
• if you are taking medicines used for the treatment of depression (MAO inhibitor antidepressants); before taking SOBREPIN TOSSE SEDATIVO, two weeks must have passed since taking antidepressant medicines. In all the situations indicated above, the intake of this medicine is not recommended, and is reserved only for cases of absolute necessity (see paragraph 2. Do not take SOBREPIN TOSSE SEDATIVO).

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

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

Adherence to the instructions in the package leaflet reduces the risk of side effects.

Reporting 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.