SOBREPIN COUGH INF*OS GRAT10BS

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 cough and chlorphenamine for nasal congestion.

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

Contact your doctor if symptoms worsen or if they 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 substances or to any of the other components of this medicine, listed in section 6;
- Suffers from respiratory failure, asthmatic cough and wet cough (with phlegm);
- You have serious kidney or liver problems;
- 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, linezolid-based therapies (an antibiotic) or procarbazine (for the treatment of cancer) (see the section "Other medicines and SOBREPIN COUGH, FLU, COLD");
- Children under the age of 14 cannot take this medicine, given the dosage of the active ingredients contained.

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

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

Those who constantly consume large quantities of alcoholic beverages should ask their doctor if they can take paracetamol or other painkillers 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 may cause an overdose of paracetamol, which may cause liver damage. Do not take more than one medicine containing paracetamol without consulting a doctor.

Before you start taking SOBREPIN COUGH FLU COLD, consult a doctor or pharmacist if:
- You suffer from kidney, heart or lung disease,
- You suffer from anemia,
- You suffer from liver disease (with or without liver failure) or viral hepatitis, since 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 may be sensitive to other antihistamines, such as chlorphenamine,
- You suffer from hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, bladder neck obstruction, prostatic hyperplasia with urine formation. Elderly patients may be more sensitive to the side effects of this drug,
- You suffer from atopic dermatitis,
- Is a poor metabolizer of CYP2D6 or takes 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 may cause drowsiness. Avoid drinking alcohol and taking certain medications while taking this medicine as they may make you drowsy.
Read the paragraphs " Other medicines and SOBREPIN COUGH FLU COLD " and " SOBREPIN COUGH FLU COLD with food, drinks and alcohol ".

People who are sedated, debilitated, or bedridden should not take this medication.

In rare cases, serious skin reactions with redness, rash or rashes may occur. If you notice any of these symptoms, stop taking the medicine and contact a doctor.
This medicine can cause addiction, therefore, it must be taken for short periods.

Children and adolescents
This medicine is contraindicated in children under 14 years of age, given the dosage of the active ingredients.

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

The following side effects were reported in 1 in 100 subjects during clinical trials of chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis and dyspepsia.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any 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.