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 due to a 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 components of this medicine (listed in paragraph 6);
• if you have had an allergic reaction to other antihistamines;
• 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;
• if you suffer from high blood pressure (hypertension);
• if you are pregnant or breastfeeding;
• if you suffer from glaucoma (increased eye pressure with possible worsening of vision);
• if you have a narrowing (stenosis) of the stomach or intestines, 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 frequent urination);
• if you suffer from epilepsy;
• if you have diabetes;
• if you are under 12 years of age.

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;
• have severe liver problems;
• have reduced kidney function;
• are elderly, as you are more likely to develop adverse events to this medicine;
• have an intolerance to some 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 contact your doctor if you experience:
- sudden severe headaches, nausea, vomiting, confusion, seizures, visual disturbances: with ACTIFED, sudden severe headaches, nausea, vomiting, confusion, seizures, visual disturbances, symptoms of reversible posterior encephalopathy (PRES/RCVS) may occur;
- sudden abdominal pain, blood in the stool: with ACTIFED, sudden abdominal pain or rectal bleeding may occur due to colon inflammation (ischemic colitis);
- 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 rash may occur within the first 2 days of treatment, with fever and numerous small, mostly non-follicular pustules, arising from a very diffuse erythematous edema and localized mainly on the skin folds, trunk and upper limbs.

Reduced blood flow to the optic nerve may occur with ACTIFED.
If you experience sudden vision loss, stop taking ACTIFED and consult your doctor or a healthcare facility immediately. See paragraph 4.

If you experience any of these symptoms, stop using ACTIFED and contact your doctor or seek immediate medical attention. (see section 4. Possible side effects).

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

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, hallucinations including visual, restlessness;
• headache, altered sensation (paresthesia), psychomotor hyperactivity, somnolence, muscle tremors;
• heart rhythm changes (arrhythmia, extrasystoles), perception 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 paragraph 2 Warnings and precautions)*;
• swelling of the face, eyes, lips, and throat with possible difficulty breathing (angioedema);
• difficulty in urinating (dysuria), urinary retention;
• increased blood pressure;
• allergic reactions (hypersensitivity).

Side effects with unknown frequency (frequency cannot be estimated from the available data):
• 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 supply to the heart which can cause discomfort or pain in the chest, neck, back, jaw, shoulders or arms (known as angina);
• severe headache, confusion, seizures, visual disturbances (See paragraph 2 Warnings and precautions);
• inflammation of the colon due to insufficient blood supply (ischemic colitis) (See paragraph 2 Warnings and precautions);
• reduced 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 attention.

Side effects in children and adolescents
• psychomotor hyperactivity which manifests as excessive motor activity such as pacing back and forth, 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.