Actifed decongestant 1mg/ml nasal spray solution 10ml

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

INDICATIONS

Temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis.

CONTRAINDICATIONS

ACTIFED DECONGESTANT must not be used: - in patients with hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1; - in patients with high intraocular pressure, particularly in the presence of narrow-angle glaucoma; - in patients with "dry" inflammation of the nasal mucosa (Dry rhinitis); - in children under 12 years of age; - after transsphenoidal hypophysectomy or other transnasal/transoral surgery with exposure of the dura mater; - in patients being treated with monoamine oxidase inhibitors (MAOIs) or who have used these drugs in the previous 2 weeks, or in patients taking other medicinal products with potential hypertensive effect; - in patients with atrophic or vasomotor rhinitis.

WARNINGS AND PRECAUTIONS FOR USE

Xylometazoline, like other medicines belonging to the same pharmacological category, should be administered with caution in patients with a marked reaction to sympathomimetic substances. The use of substances of this type can cause a series of disorders in such patients, such as insomnia, dizziness, tremors, arrhythmia or increased blood pressure. Particular caution is necessary in the case of patients suffering from cardiovascular diseases, hypertension, hyperthyroidism or diabetes, as well as in the case of patients with prostatic hypertrophy and pheochromocytoma. Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias. In case of prolonged treatment with xylometazoline, the reappearance of the symptoms of rhinitis and edema of the mucous membrane is sometimes observed upon discontinuation of therapy. In these cases, it may also be the so-called "rebound" phenomenon caused by the medicine itself, which progresses to chronic edema and atrophy of the nasal mucosa (Rhinitis medicamentosa and Rhinitis sicca). To avoid this, the duration of treatment should be as short as possible (see section 4.2). Nasal and paranasal inflammations of bacterial origin must be treated appropriately. For the treatment of allergic rhinitis, this product can only be used temporarily as supportive therapy.

INTERACTIONS

The use of the product is not recommended in conjunction with tricyclic or tetracyclic antidepressant drugs or monoamine oxidase inhibitor drugs (MAOI), or within two weeks following the use of MAO inhibitors.

SIDE EFFECTS

The most frequently reported side effects of this medicine are tingling or burning of the nose and throat and dryness of the nasal mucosa. Based on their frequency, side effects have been divided into the following categories: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare <1/10,000 including isolated reports; Not known, frequency cannot be estimated from the available data.

Municipality | Uncommon | Rare | Not known

Immune system disorders | Rare: Systemic allergic reactions

Psychiatric disorders | Rare: Nervousness, insomnia

Pathology of the nervous system | Rare: Headache, dizziness

Eye pathologies | Rare: Transient visual disturbances

Cardiac diseases | Rare: Palpitation

Vascular pathologies | Rare: Rise in blood pressure

Respiratory, thoracic and mediastinal disorders | Municipality: Tingling and burning of the nose and throat and dryness of the nasal mucosa | Uncommon: Epistaxis | Not known: Rebound effect

Gastrointestinal disorders | Rare: Nausea

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-reazioni-avverse