Actifed Decongestant 12 tablets 2.5mg + 60mg

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Decongestant of the nasal mucosa, especially in case of colds.

CONTRAINDICATIONS

• hypersensitivity to the active substances, to other antihistamines or to any of the excipients listed in paragraph 6.1; • children under the age of 12; • Pregnancy and breastfeeding; • in patients being treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment, and in the treatment of lower respiratory tract diseases, including bronchial asthma. In such cases the concomitant use of ACTIFED may cause an increase in blood pressure or hypertensive crisis; • glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric and duodenal stenosis or other tracts of the gastrointestinal and urogenital system (due to its anticholinergic effects); • cardiovascular diseases, arterial hypertension, hyperthyroidism, epilepsy and diabetes.

WARNINGS AND PRECAUTIONS FOR USE

If symptoms persist or worsen, or if new symptoms appear, patients should stop using the medicine and consult a doctor. If symptoms do not improve within 7 days or if high fever or other side effects appear, patients should be advised to stop treatment and consult their doctor. Before taking triprolidine, patients with the following respiratory conditions such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma, should be advised to consult a doctor. Triprolidine may cause drowsiness and may increase the sedative effects of substances that depress the central nervous system such as alcohol, sedatives, tranquilizers. It is necessary to inform patients that the use of alcoholic beverages should be avoided during treatment with ACTIFED and that it is advisable to consult the doctor before taking ACTIFED concomitantly with medicines that depress the central nervous system. At common therapeutic doses, antihistamines present secondary reactions that vary greatly from subject to subject and from compound to compound. For the dosage in the elderly it is necessary to consider their greater sensitivity towards antihistamines and pseudoephedrine. Although pseudoephedrine did not produce important effects on the blood pressure of normotensive subjects, ACTIFED should not be taken by patients treated with antihypertensives, tricyclic antidepressants, sympathomimetic agents, such as decongestants, anorectics, amphetamine-like agents. Rare cases of posterior reversible encephalopathy have been reported with sympathomimetic drugs, including pseudoephedrine (posterior reversible encephalopathy, PRES)/reversible cerebral vasoconstriction syndrome (reversible cerebral vasoconstriction syndrome, RCVS). Reported symptoms include sudden onset of severe headache, nausea, vomiting, and visual disturbances. If signs or symptoms of PRES/RCVS develop, treatment with pseudoephedrine should be discontinued and a doctor should be consulted immediately. Ischemic colitis Some cases of ischemic colitis have been reported with medicinal products containing pseudoephedrine. If sudden abdominal pain, rectal tenesmus, rectal bleeding or other symptoms of ischemic colitis develop (see section 4.8), the use of pseudoephedrine should be discontinued and medical advice should be sought. Ischemic optic neuropathy Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of a scotoma. Skin Safety 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, mostly non-follicular pustules resulting from a widespread edematous erythema and localized mainly on the skin folds, trunk and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or numerous small pustules are observed, the administration of ACTIFED should be stopped and appropriate measures taken if necessary (see section 4.8). ACTIFED should not be used by patients with severe liver disease or reduced kidney function unless the doctor deems it necessary. Important information about some excipients: ACTIFED syrup contains: • sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. This medicine contains 7 g of sucrose per dose. To be taken into consideration in people suffering from diabetes mellitus; • methyl parahydroxybenzoate. May cause allergic reactions (even delayed); • sunset yellow (E110). May cause allergic reactions; • 10 mg of sodium benzoate per dose (10 ml of syrup) • less than 1 mmol (23 mg) of sodium per dose (10 ml of syrup), i.e. essentially “sodium-free”. ACTIFED tablets contains lactose: • Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

INTERACTIONS

During concomitant use of monoamine oxidase inhibitors (MAOIs) and sympathomimetic amines, acute hypertensive crises have been reported in the medical literature. Pseudoephedrine exerts a vasoconstrictor action by stimulating adrenergic receptors and releasing norepinephrine from neuronal sites. Monoamine oxidase inhibitors (MAOIs) may enhance the pressor effect of pseudoephedrine, as they prevent the metabolism of sympathomimetic amines and increase the releasable amount of norepinephrine in adrenergic nervous tissue. The effects of antihistamines are made more evident by alcohol, hypnotics, sedatives, tranquilizers, and other substances with an anticholinergic action or depressant effect on the central nervous system, which therefore should not be taken during therapy. Antihistamines can shorten the duration of action of oral anticoagulants. The use of antihistamines can mask the early signs of ototoxicity of certain antibiotics. Furazolidone causes a progressive inhibition of monoamine oxidase, so it should not be taken at the same time as ACTIFED. The effect of antihypertensives that interfere with sympathetic activity (e.g. methyldopa, alpha and beta blockers, debrisoquine, guanethidine, betanidine and bretylium) can be partially canceled out by ACTIFED, which therefore, also in this case, should not be taken at the same time.

SIDE EFFECTS

The following are adverse reactions reported with a frequency ≥1%, identified in randomized placebo-controlled studies, with formulations containing pseudophedrine as the single active ingredient: dry mouth, nausea, dizziness, insomnia and nervousness. There are no placebo-controlled clinical studies with sufficient data regarding adverse reactions for the combination of the active ingredients pseuoephedrine and triprolidine. Adverse reactions identified during post-marketing experience with pseudoephedrine, triprolidine or the combination are reported in Table 1 according to frequency categories using the following convention: § very common (≥ 1/10); • common (≥ 1/100 and <1/10); • uncommon (≥ 1/1,000 and < 1/100); • rare (≥ 1/10,000 and <1/1,000); • very rare (<1/10,000); • not known (frequency cannot be estimated from the available data).

Psychiatric disorders

Very rare | Anxiety, euphoric mood, hallucination, restlessness, visual hallucination.

Nervous system disorders

Very Rare | Headache, paraesthesia, psychomotor hyperactivity (in the pediatric population), drowsiness, tremor.

Not known | Cerebrovascular accident*, posterior reversible encephalopathy (PRES), reversible cerebral vasoconstriction syndrome (RCVS) (see section 4.4)

Cardiac diseases

Very Rare | Arrhythmia, extrasystoles, palpitations, tachycardia

Not known | Myocardial infarction/Myocardial ischemia*

Systemic pathologies and conditions relating to the administration site

Very Rare | Asthenia.

Immune system disorders

Very rare | Hypersensitivity

Respiratory, thoracic and mediastinal disorders

Very rare | Epistaxis

Gastrointestinal disorders

Very rare | Vomiting, abdominal discomfort.

Not known | Ischemic colitis (see section 4.4)*

Pathologies of the skin and subcutaneous tissue

Very rare | Itching, rash, urticaria, angioedema. acute generalized exanthematous pustulosis (AGEP) (see section 4.4), angioedema.

Renal and urinary disorders

Very rare | Dysuria, urinary retention.

Diagnostic tests

Very rare | Increased blood pressure.

Eye pathologies

Not known | Ischemic optic neuropathy

*adverse reactions collected during post-marketing experience with pseudoephedrine ACTIFED can also cause dizziness, photosensitivity reaction, diarrhea, hyperviscosity of bronchial secretions, very rarely blood changes and especially in the elderly, hypotension. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.