ACTIFED DECONGEST SPRAY 10ML

ACTIFED DECONGESTIONANTE 1 MG/ML NASAL SPRAY, DECLARATION

active ingredients

Xilometazolina Hydrochloride 1 mg in 1 ml solution: Each spray-dose (140mcl) contains 140 mcg of xilometazoline hydrochloride. For the full list of excipients, see paragraph 6.1.

Excellent

Hyaluronate sodium, Sorbitol (E420), Glicerol (E422), Hydrogen Sodium Phosphate Dihydrate, Dihydrate Phosphate Disorder, Chloride Sodium, Water for injectable preparations.

Therapeutic indications

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

Contraindications

ACTIFED DECONGESTIONANTE should not be used: - in patients with hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; - in patients with high intraocular pressure, especially in the presence of narrow-angle glaucoma; - in patients with "dry" inflammation of nasal mucosa (Dry rhinitis); - in children under 12 years of age; - after transfenoidal hypophysiectomy or other transnasal/transoral surgery with exposure of the harsh mother; - in patients with monoaminoxydase inhibitors (IMAO) or who used these drugs in the previous 2 weeks, or in patients taking other medicines with potential hypertensive effect; - in patients with atrophic or vasomotory rhinitis.

Population

For nasal use. Adults and boys over 12 years old: A delivery in each nostril no more than three times a day. This medicine must be used for a maximum of 7 days, unless otherwise prescribed. To minimize the risk of infections, the product should not be used by more than one person and the spout should be cleaned after each use. Children: ACTIFED DECONGESTIONANTE is contraindicated in children under 12 years (see paragraph 4.3). Seniors: Same adult dosage.

Conservation

Do not store at temperature above 25°C.

Warnings

Xylometazoline, like other medicines belonging to the same pharmacological category, should be administered with caution in patients with marked reaction to sympatomic substances. The use of such substances can cause in such patients a number of disorders, such as insomnia, dizziness, tremors, arrhythmia or diary rise. Special caution is required in case of patients suffering from cardiovascular disease, hypertension, hyperthyroidism or diabetes, as well as in case of patients with prostate hypertrophy and feochromocytoma. Patients with long-term QT syndrome treated with xylometazoline may be exposed to a greater risk of severe ventricular arrhythmias. In case of prolonged treatment with xylometazoline, with the suspension of the therapy sometimes the reappearance of symptoms of rhinitis and edema of the mucous membrane is observed. In these cases, it may also be the so-called "rebound" phenomenon caused by the medicine itself, which progresses to chronic edema and nasal mucosa atrophy (Medication and dry Rinitis). To avoid this, the duration of treatment must be as short as possible (see paragraph 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 support therapy.

Interactions

The use of the product is not recommended in conjunction with antidepressants or tetracyclic drugs or inhibiting drugs of monoaminoxydase (IMAO), or in the two weeks following the use of MAO inhibitors.

Effects

The undesirable effects of this most frequently reported medicine are pinching or burning of nose and throat and dryness of the nasal mucosa. Depending on their frequency, the side effects were divided into the following categories: Very common ≥1/10; Common from ≥1/100 to   Town Not common Rare Notable Immune system disorders     Systemic allergic reactions   Psychiatric destruction     Nervosism, insomnia   Nervous System Pathology     Kefalea, dizziness   Pathologies of the eye     Transitional visual disturbances   Heart disease     Palpitation   Vascular diseases     Dietary rise   Respiratory, chest and mediastinic pathologies Pizzicore and burning of nose and throat and dryness of nasal mucosa Epistassi   Rebound effect Gastrointestinal diseases     Nausea   Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Being an imidazoline, systemic overdose of xylometazoline can cause a wide range of symptoms related to stimulation or heart depression and nervous system. Overdose cases are mainly linked to the use of the medicine in children. Among the symptoms of reported intoxication are severe paralysis of the central nervous system, sedation, dry mouth and sweating, as well as symptoms caused by the stimulation of the sympathetic nervous system (tachycardia, irregular pulse and diary rise). One drop (single dose) of xilometazoline preparation for use in adults (1 mg/ml) administered intranasally caused a 4-hour coma state in a 15-day infant. During the follow-up, the newborn is completely healed. Treatment of intoxication is nosotropic and may include administration of coal, gastric lavender and oxygen inhalation. To reduce blood pressure, 5 mg of phentolamine is slowly administered in intravenous or 100 mg per mouth. If necessary, antipyretic and anticonvulsive are administered. The use of vasopressant substances is contraindicated.

There is no data on the trans-placency passage of xilometazolina, nor its secretion in breast milk. Due to the potential systemic effect of vascular constriction, during pregnancy this medicine should not be used. During breastfeeding this medicine must be used with caution as it is not known whether or not the active ingredient is transferred to breast milk.

Source: Farmadati