SOBREPIN COUGH AND THROAT IRRITATION*10 TABLETS

SOBREPIN COUGH FLU COLD 650 mg/20 mg/4 mg granules for oral solution
Paracetamol/Dextromethorphan hydrobromide/Chlorphenamine maleate

What it is and what it is used for
SOBREPIN COUGH FLU COLD is a medicine containing three active ingredients in combination: paracetamol, which reduces fever and relieves pain, dextromethorphan, which acts on coughs, and chlorphenamine for nasal congestion and sneezing.

The medicine is indicated for the treatment of cold and flu symptoms with mild to moderate pain, such as headache, fever, dry cough (irritant cough, nervous cough), nasal congestion, and sneezing, in adults and adolescents aged 14 and over.

Consult your doctor if symptoms worsen or persist for more than 5 days in adults or 3 days in adolescents, or if fever persists for more than 3 days.

What you need to know before taking the medicine
Do not take SOBREPIN COUGH FLU COLD if:
- You are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medicine, listed in section 6;
- In case of severe liver disease;
- You suffer from respiratory insufficiency, asthmatic cough and productive cough (with phlegm);
- You suffer from severe kidney disease or are undergoing hemodialysis
- You are taking a category of medicines called monoamine oxidase inhibitors (MAOIs) or have taken them in the last two weeks;
- You are taking or have recently taken other medicines such as, for example: antidepressants, medicines for Parkinson's disease, therapies based on linezolid (an antibiotic) or procarbazine (for cancer treatment) (see section Other medicines and SOBREPIN COUGH FLU COLD);
- Children under 6 years of age cannot take this medicine, given the dosage of the active ingredients it contains.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOBREPIN COUGH FLU COLD.

Do not take a dose higher than that recommended in section 3 How to take SOBREPIN COUGH FLU COLD. A dose higher than recommended (overdose) could cause liver damage. In case of overdose, consult a doctor immediately. Immediate medical consultation is essential for both adults and children, even if you do not notice any signs or symptoms.

Those who consistently consume large quantities of alcoholic beverages should ask their doctor if they can take paracetamol or other pain relievers or fever reducers and should also limit themselves to a maximum of 3 sachets per day (2 g of paracetamol).

Do not take other medicines containing paracetamol while taking this medicine, as this could cause an overdose of paracetamol, with possible liver damage. Do not take more than one medicine containing paracetamol without consulting a doctor.

Before starting to take SOBREPIN COUGH FLU COLD, consult a doctor or pharmacist if:
- You suffer from kidney, heart or lung diseases,
- You suffer from anemia,
- You suffer from liver diseases (with or without liver failure) or viral hepatitis, as the medicine increases the risk of hepatotoxicity,
- You suffer from asthma or are sensitive to acetylsalicylic acid,
- You are sensitive (allergic) to an antihistamine, as you might be sensitive to other antihistamines, such as chlorphenamine,
- You suffer from hypertension (high blood pressure), glaucoma (high ocular pressure), hyperthyroidism, bladder neck obstruction, prostate hyperplasia with urine retention. Elderly patients might be more sensitive to the side effects of this medicine,
- You suffer from atopic dermatitis,
- You are a slow metabolizer of CYP2D6 or take CYP2D6 inhibitors,
- You suffer from chronic respiratory problems, such as emphysema, chronic bronchitis, bronchial asthma or cough accompanied by excessive secretions, glaucoma or urinary difficulties caused by prostatic hyperplasia,
- This medicine can increase the sedative effects of CNS depressants, including alcohol, sedatives and tranquilizers. It is therefore recommended to avoid the consumption of alcohol or taking CNS depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine.

This medicine can cause drowsiness. Avoid drinking alcoholic beverages and taking certain medicines while taking this medicine, as they can increase this effect.
See sections Other medicines and SOBREPIN COUGH FLU COLD and SOBREPIN COUGH FLU COLD with food, drinks and alcohol.

Sedated, debilitated or bedridden people should not take this medicine.

Very rarely, cases of severe skin reactions called acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have occurred in association with the use of acetaminophen.
Discontinue treatment at the first sign of skin rash or hypersensitivity and consult your doctor.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents, therefore this data should be taken into consideration, as serious adverse effects may occur (see section If you take more SOBREPIN COUGH FLU COLD than you should).

This medicine can cause dependence, consequently, it should be taken for short periods.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects were reported in one out of 100 subjects during clinical trials conducted on chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis and dyspepsia.

The following adverse reactions occurred with unknown incidence: anaphylactic shock, hypersensitivity, insomnia, nervousness and restlessness (motor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of some areas of the skin), itching, urticaria, rash and skin lesions after taking the medicine (fixed drug eruption), and also increased transaminases.

Simultaneous consumption of alcohol during treatment can accentuate adverse events. Do not drink alcoholic beverages during treatment.

Reporting of 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.