ACTIFED COMPOUND SYRUP 100 ML BOTTLE

Name
ACTIFED COMPOUND syrup
Triprolidine hydrochloride; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide


What is it and what is it used for?
ACTIFED COMPOSTO contains pseudoephedrine hydrochloride, a decongestant that provides relief from 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 due to allergies.

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

Talk to 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 used for breathing problems, including medicines to treat asthma (see "Warnings and precautions");
• if you have or are at risk of having severe breathing problems (respiratory failure);
• if you have pre-existing cardiovascular diseases, coronary heart diseases;
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs;
• 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 pressure in the eye with possible worsening of vision);
• if you have a 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 the need to urinate frequently);
• if you suffer from epilepsy;
• if you have diabetes.


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

This medicine can lead to addiction. Therefore, treatment should be short-term.

Stop treatment and contact your doctor or seek medical help immediately if you experience any of the following while using ACTIFED COMPOSTO:
- your symptoms do not improve, if your symptoms persist or worsen or if you develop new symptoms, high fever or notice other side effects,
- develops a generalized febrile erythema associated with pustules (see section "4. Possible side effects"). Severe 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, mostly non-follicular pustules arising from a widespread edematous erythema and located primarily in the skin folds, trunk, and upper limbs.

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

With ACTIFED COMPOSTO the following may occur suddenly:
- abdominal pain or rectal bleeding due to inflammation of the colon (ischemic colitis).
If you experience these gastrointestinal symptoms, stop using ACTIFED COMPOSTO and contact your doctor or seek medical help immediately (see section "4. Possible side 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment with Actifed Compound immediately and contact your doctor urgently if:
- develops symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset
• nausea
• vomit
• confusion
• convulsions
• changes in vision
- Allergic reactions (hypersensitivity), which manifest themselves with the more or less sudden appearance of skin lesions, even serious ones, such as blotchy or widespread changes in color, the appearance of blisters or peeling of the skin, 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 supply (ischemic colitis) (See section "2 Warnings and precautions").
- The sudden onset of fever, redness of the skin 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 paragraph "2 Warnings and precautions").

Not known (frequency cannot be estimated from the available data)
• serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• anxiety, hallucinations including visual ones, restlessness, irritability, agitation;
• alterations in sensitivity (paraesthesia), hyperactivity;
• stroke (cerebrovascular accident);
• feeling of heart in throat (palpitations);
• heart attack (myocardial infarction);
• nosebleeds (epistaxis);
• abdominal discomfort or pain, ischemic colitis (See section 2);
• reduction of blood flow to the optic nerve (ischemic optic neuropathy);
• itching, urticaria, erythema;
• severe skin rash characterised by the formation of pustules (acute generalised exanthematous pustulosis) (See section 2);
• difficulty in passing urine (dysuria);
• increased blood pressure;
• decreased appetite.

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

Reporting of side effects
If you experience 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.