ACTIFED*12TAB 2.5MG+60MG

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

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

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 use ACTIFED:
• if you are allergic to the active ingredients or 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 medication;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you are taking or have taken monoamine oxidase inhibitors (MAOIs) for depression in the last 2 weeks, because the use of these medicines with ACTIFED can cause an increase in blood pressure;
• if you are taking medicines used for respiratory problems, such as medicines to treat asthma, because the use of these medicines with ACTIFED can cause an increase in blood pressure;
• if you have heart problems and suffer from high blood pressure (hypertension);
• if you suffer from glaucoma (increased eye pressure with possible worsening of vision);
• if you have a narrowing (stenosis) of the stomach or intestine, bladder, urethra, or ureters;
• if your thyroid is overactive (hyperthyroidism);
• if you have an enlarged prostate (prostatic hypertrophy, which causes problems such as difficulty urinating or needing to urinate often);
• 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
Consult your doctor or pharmacist before taking ACTIFED if:
• you have respiratory problems, emphysema or chronic bronchitis, or acute or chronic bronchial asthma;
• you have severe liver problems;
• you have reduced kidney function;
• you are elderly, as you are more likely to experience adverse events with this medicine;
• you have an intolerance to certain sugars (see Excipients with known undesirable effects).

Contact your doctor if the use of ACTIFED does not improve your symptoms, if your symptoms worsen or if new symptoms appear, if you develop a high fever or notice other undesirable effects.

Stop using ACTIFED and consult your doctor if you experience:
- sudden abdominal pain, blood in stools: sudden abdominal pain or rectal bleeding due to inflammation of the colon (ischemic colitis) may occur with ACTIFED;
- a generalized febrile rash associated with pustules: severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products. This acute pustular eruption can occur within the first 2 days of treatment, with fever and numerous small, mostly non-follicular pustules, arising from a very 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 lead to reduced blood supply to the brain. Stop using Actifed immediately and seek immediate medical assistance if you develop symptoms that could be signs of PRES or RCVS (see section 4 Possible side effects for symptoms).

A reduction in blood flow to the optic nerve may occur with ACTIFED.
If you experience sudden vision loss, stop taking ACTIFED and contact your doctor or a healthcare facility immediately. See section 4.

If you experience any of these symptoms, stop using ACTIFED and contact your doctor or seek immediate medical assistance (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 urgently consult your doctor 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.

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, visual hallucinations, restlessness;
• headache, changes in sensation (paresthesia), psychomotor hyperactivity, drowsiness, muscle tremors;
• heart rhythm changes (arrhythmia, extrasystoles), sensation of heartbeat (palpitations), increased heart rate (tachycardia);
• weakness (asthenia);
• nosebleed (epistaxis);
• vomiting, stomach and intestinal disorders;
• itching, skin rash, hives;
• severe skin rash characterized by the formation of pustules (acute generalized exanthematous pustulosis AGEP) (See section 2 Warnings and precautions)*;
• swelling of the face, eyes, lips and throat with possible breathing difficulties (angioedema);
• difficulty urinating (dysuria), urinary retention;
• increased blood pressure;
• allergic reactions (hypersensitivity).

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• serious conditions affecting cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• skin reactions after light exposure (photosensitivity);
• thickening of bronchial secretions;
• diarrhea;
• alteration of some blood values;
• low blood pressure (especially in the elderly);
• stroke (cerebrovascular accidents);
• heart attack, reduced blood flow to the heart that can cause discomfort or pain in the chest, neck, back, jaw, shoulders or arms (known as angina);
• severe headache, confusion, seizures, 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, 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.

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

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.