Name
ACTIFED 2.5 mg + 60 mg tablets
ACTIFED 2.5 mg/10 ml + 60 mg/10 ml syrup
Triprolidine hydrochloride, pseudoephedrine hydrochloride


What is it and what is it for?
ACTIFED contains pseudoephedrine hydrochloride, a nasal decongestant, and triprolidine hydrochloride, an antihistamine that reduces nasal secretions.
ACTIFED is a medicine used to relieve the symptoms of nasal congestion due to the common cold.

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 use ACTIFED:
• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to other antihistamines;
• 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 taking or have taken in the last 2 weeks monoamine oxidase inhibitors (MAOIs) medicines for depression, because the use of these medicines with ACTIFED may cause an increase in blood pressure;
• if you are taking medicines used for breathing problems, for example medicines to treat asthma, because using these medicines with ACTIFED may cause an increase in blood pressure;
• if you have heart problems and suffer from high blood pressure (hypertension);
• if you suffer from glaucoma (increased pressure in the eye with possible worsening of vision);
• if you have a narrowing (stenosis) of your stomach or intestines, bladder, urethra or ureters;
• if your thyroid works too much (hyperthyroidism);
• 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;
• if you are under 12 years of age;
• if you are pregnant or breastfeeding.


Warnings and precautions
Talk to your doctor or pharmacist before taking ACTIFED if:
• has breathing problems such as emphysema or chronic bronchitis or acute or chronic bronchial asthma;
• has serious liver problems;
• has reduced kidney function;
• is elderly, as he or she is more likely to develop adverse events from this medicine;
• have an intolerance to some sugars (see "Excipients with known side effects").

Contact your doctor if using ACTIFED does not improve your symptoms, if your symptoms worsen or if new symptoms appear, if you develop a high fever or notice other side effects.

Stop using ACTIFED and contact your doctor if you experience:
- sudden abdominal pain, blood in the stool: with ACTIFED you may experience sudden abdominal pain or rectal bleeding due to inflammation of the colon ( ischemic colitis );
- a generalized febrile erythema associated with pustules : Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported 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 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, a reduction in blood flow to the optic nerve may occur.
If you experience sudden vision loss, stop taking ACTIFED and contact your doctor or healthcare provider immediately. See section 4.

If you experience any of these symptoms, stop using ACTIFED and contact your doctor or seek medical help immediately. (See section "4. Possible side effects").


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

Stop treatment with Actifed immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset;
• nausea;
• vomit;
• confusion;
• convulsions;
• changes in vision.

Common side effects (may affect up to 1 in 10 people):
• dry mouth, nausea;
• dizziness, difficulty falling asleep (insomnia) and nervousness.

Very rare side effects (may affect up to 1 in 10,000 people):
• anxiety, euphoric mood, hallucination, even visual, restlessness;
• headache, changes in sensation (paraesthesia), psychomotor hyperactivity, drowsiness, muscle tremors;
• alterations in heart rhythm (arrhythmia, extrasystoles), perception of the heartbeat (palpitations), increased heartbeat (tachycardia);
• weakness (asthenia);
• nosebleeds (epistaxis);
• vomiting, stomach and intestinal disorders;
• itching, rash, hives;
• severe skin rash characterised by the formation of pustules (acute generalised exanthematous pustulosis AGEP) (See section 2 "Warnings and precautions")*;
• swelling of the face, eyes, lips and throat with possible difficulty breathing (angioedema);
• difficulty passing urine (dysuria), urine retention;
• increased blood pressure;
• allergic reactions (hypersensitivity).

Side effects with unknown frequency (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);
• skin reactions after exposure to light (photosensitivity);
• thickening of bronchial secretions;
• diarrhea;
• alteration of some blood values;
• lowering of blood pressure (especially in the elderly);
• stroke (cerebrovascular accident);
• heart attack, reduced blood supply to the heart which may cause discomfort or pain in the chest, neck, back, jaw, shoulders or arms (known as angina);
• severe headache, confusion, convulsions, visual disturbances (See section 2 "Warnings and precautions");
• inflammation of the colon due to insufficient blood supply (ischemic colitis) (See section 2 "Warnings and precautions");
• Reduction of blood flow to the optic nerve (ischemic optic neuropathy).

*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.

Stop using ACTIFED if you develop these symptoms and contact your doctor and/or seek medical attention immediately.

Side effects in children and adolescents
• psychomotor hyperactivity manifested by excessive motor activity such as pacing, inability to sit still, restlessness, wringing one's hands, or incessantly manipulating clothing or other objects. This side effect occurs very rarely.

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.