ACTIFED COMPOSTO*SYR 100ML

ACTIFED COMPOSTO syrup
Triprolidine hydrochloride; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide

What it is and what it is used for
ACTIFED COMPOSTO contains pseudoephedrine hydrochloride, a decongestant that relieves nasal and upper airway congestion, triprolidine hydrochloride, an antihistamine that reduces sneezing and nasal secretions, and dextromethorphan hydrobromide, a cough suppressant.
ACTIFED COMPOSTO is a medicine used to relieve symptoms of nasal and upper airway congestion, particularly those due to allergy.

This medicine should only be used by adults and children over 12 years of age.

Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

What you need to know before taking the medicine
Do not take ACTIFED COMPOSTO:
• if you are allergic to triprolidine hydrochloride, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, other antihistamines or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• if you are taking or have taken in the last 2 weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs) (see Other medicines and ACTIFED COMPOSTO);
• if you are taking medicines for breathing problems, including medicines to treat asthma (see Warnings and precautions);
• if you have or are at risk of severe breathing problems (respiratory failure);
• if you have pre-existing cardiovascular diseases, coronary artery disease;
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by medication;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you are pregnant or breastfeeding;
• if you suffer from glaucoma (increased eye pressure with possible worsening of vision);
• if you have narrowing (stenosis) of the stomach or intestine, bladder (bladder neck obstruction), urethra or ureters;
• if you have thyroid problems;
• if you have an enlarged prostate (prostatic hypertrophy, which causes problems such as difficulty urinating or frequent urination);
• if you suffer from epilepsy;
• if you have diabetes.

Warnings and precautions
Talk to your doctor or pharmacist before taking ACTIFED COMPOSTO if:
• you have breathing problems that are not treated with medicines such as: emphysema or chronic bronchitis or asthma (see Do not use ACTIFED COMPOSTO);
• you have a persistent or long-lasting (chronic) cough or a cough with a lot of mucus secretion;
• you have severe liver problems;
• you are elderly, due to increased sensitivity to antihistamines and pseudoephedrine;
• you have an intolerance to some sugars (see ACTIFED COMPOSTO contains);
• you are taking medicines such as some antidepressants or antipsychotics: ACTIFED COMPOSTO may interact with these medicines and mental status changes (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38℃, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) may occur.

This medicine can lead to dependence. Therefore, treatment should be of short duration.

Stop treatment and contact your doctor or seek immediate medical attention if, with the use of ACTIFED COMPOSTO:
- your symptoms do not improve, if symptoms persist or worsen or if new symptoms appear, high fever or you notice other undesirable effects,
- you develop a generalized febrile rash associated with pustules (see section 4. Possible undesirable effects). Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with products containing pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small pustules, mostly non-follicular, arising from a widespread edematous erythema and mainly localized on skin folds, trunk and upper limbs.

Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of pseudoephedrine-containing medicines. PRES and RCVS are rare conditions that can result in reduced blood supply to the brain. Stop using Actifed Composto immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 Possible undesirable effects for symptoms).

With ACTIFED COMPOSTO, sudden onset may occur:
- abdominal pain or rectal bleeding due to an inflammation of the colon (ischemic colitis). If you experience these gastrointestinal symptoms, stop using ACTIFED COMPOSTO and contact your doctor or seek immediate medical attention (see section 4. Possible undesirable effects);
- a reduction in blood flow to the optic nerve. If sudden vision loss occurs, stop taking ACTIFED COMPOSTO and contact your doctor immediately or seek immediate medical attention. See section 4.

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

Stop treatment with Actifed Composto immediately and seek urgent medical attention if:
- you develop symptoms that could be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision
- Allergic reactions (hypersensitivity), manifesting with a more or less sudden appearance of skin lesions, including severe ones, such as patchy or widespread colour changes, appearance of blisters or skin peeling, itching, swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, increased heart rate and sudden drop in blood pressure.
- Inflammation of the colon due to insufficient blood flow (ischemic colitis) (See section 2 Warnings and precautions).
- The sudden onset of fever, skin redness or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first two days of treatment with ACTIFED COMPOSTO (See section 2 Warnings and precautions).

Not known (frequency cannot be estimated from the available data)
• serious conditions affecting brain blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• anxiety, hallucinations including visual hallucinations, restlessness, irritability, agitation;
• altered sensation (paresthesia), hyperactivity;
• stroke (cerebrovascular accidents);
• feeling of heart racing (palpitations);
• heart attack (myocardial infarction);
• nosebleeds (epistaxis);
• abdominal discomfort or pain, ischemic colitis (See section 2);
• reduced blood flow to the optic nerve (ischemic optic neuropathy);
• itching, hives, erythema;
• severe skin rash characterized by the formation of pustules (acute generalized exanthematous pustulosis) (See section 2);
• difficulty urinating (dysuria);
• increased blood pressure;
• decreased appetite.

Tell your doctor if you experience any other undesirable effects during treatment with ACTIFED COMPOSTO:
• dry mouth, nausea, vomiting, diarrhoea;
• dizziness, difficulty falling asleep (insomnia) and nervousness;
• euphoric mood;
• headache, drowsiness, muscle tremors, dizziness;
• changes in heart rhythm (arrhythmia), increased heart rate (tachycardia);
• feeling unwell (fatigue);
• skin rashes;
• difficulty urinating (urinary retention);
• altered blood parameters;
• low blood pressure;
• skin reactions after exposure to light (photosensitization);
• increased bronchial secretions.

Reporting of undesirable effects
If you get 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.