SOBREPIN COUGH INF RAF 650MG/20MG/4MG GRANULES FOR ORAL SOLUTION 10 SACHETS IN PAPER/LDPE/AL/HEAT-FUSE RESIN

Name
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 cough 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 (irritating cough, nervous cough), nasal congestion and sneezing, in adults and adolescents aged 14 years and over.

Contact 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:
- are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, listed in section 6;
- in case of severe liver disease;
- suffers from respiratory failure, asthmatic cough and productive cough (with phlegm);
- if you suffer from severe kidney disease or are undergoing haemodialysis;
- are taking a class 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 the treatment of cancer) (see the 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 more than the recommended dose in section 3 " How to take SOBREPIN COUGH FLU COLD ". A higher dose than recommended (overdose) could cause liver damage. In case of overdose, seek medical advice immediately. Immediate medical advice is essential for both adults and children, even if you do not notice any signs or symptoms.

Those who regularly consume large quantities of alcoholic beverages should ask their doctor if they can take paracetamol or other painkillers or antipyretics 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 damage your liver. Do not take more than one medicine containing paracetamol without consulting a doctor. Before you start taking SOBREPIN COUGH FLU COLD, talk to a doctor or pharmacist if:
- suffer from kidney, heart or lung disease;
- suffers from anemia;
- suffer from liver disease (with or without liver failure) or viral hepatitis, since the medicine increases the risk of hepatotoxicity;
- suffer from asthma or are sensitive to acetylsalicylic acid;
- is sensitive (allergic) to an antihistamine, as he/she may be sensitive to other antihistamines, such as chlorphenamine;
- 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 medicine;
- suffers from atopic dermatitis;
- is a slow metabolizer of CYP2D6 or takes CYP2D6 inhibitors;
- suffers 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.

While taking SOBREPIN COUGH FLU COLD, tell your doctor immediately if:
- if you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a long period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.

This medicine may increase the sedative effects of CNS depressants, including alcohol, sedatives and tranquilizers. It is therefore recommended that you avoid drinking alcohol or taking CNS depressants (barbiturates, tranquilizers, MAOIs) while taking this medicine. This medicine may cause drowsiness. Avoid drinking alcohol and taking certain medications while taking this medicine, as they may increase this effect.
See sections "Other medicines and SOBREPIN COUGH FLU COLD" and "SOBREPIN COUGH FLU COLD with food, drink and alcohol".

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

Very rarely, cases of serious 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 drugs containing dextromethorphan have been reported in adolescents, therefore this 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 be addictive, therefore 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 have been 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, hives, rash and skin lesions after taking the medicine (fixed drug exanthema), increased transaminases and a serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Consuming alcohol during treatment may increase adverse events. Do not drink alcohol during treatment.

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