Antiallergic Rinazine 1mg/ml nasal spray 10ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Short-term symptomatic treatment of allergic rhinitis.

ACTIVE INGREDIENTS

1 bottle contains: Active ingredient: Azelastine hydrochloride 1 mg/mL Excipients with known effects: benzalkonium chloride For the complete list of excipients, see section 6.1

EXCIPIENTS

Hypromellose, disodium edetate, benzalkonium chloride solution, anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Children under six years of age. Pregnant and breastfeeding women (see section 4.6)

DOSAGE

One spray (0.14 mg) dosed in each nostril 1 or 2 times a day, equal to 0.28 - 0.56 mg of azelastine hydrochloride per day. The 5 ml bottle ensures the total delivery of 36 sprays. The 10 ml bottle ensures the total delivery of 72 sprays. During application the head must be kept in an upright position.

CONSERVATION

Do not store above 25°C. Store in an upright position. Do not turn upside down.

WARNINGS

Do not use the medicine after 6 months from first opening the vial. This medicinal product contains 0.0175 mg of benzalkonium chloride per single spray, equivalent to 0.125 mg/ml. Prolonged use of Benzalkonium chloride (BAC) contained as a preservative in RINAZINA ANTIALLERGICA can cause edema of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a medicinal product for nasal use without BAC should be used, if possible. If such medicinal products for nasal use without BAC are not available, another pharmaceutical form should be considered. May cause bronchospasm.

INTERACTIONS

No interactions have been observed with other drugs frequently used at the same time.

SIDE EFFECTS

A sensation of bitter taste has been described, typical of the drug itself, which can occur above all due to an incorrect position of the head, thrown back, during administration. In rare cases, irritation of the nasal mucosa with possible modest bleeding has been observed. 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.

OVERDOSE

No cases of poisoning due to overdose have been reported so far. Based on experimental studies, toxic doses can lead to symptoms affecting the central nervous system (malaise, excitement, convulsions, sedation); in these cases symptomatic treatment must be implemented. There is no known specific antidote for azelastine.

PREGNANCY AND BREASTFEEDING

RINAZINA ANTIALLERGICA must not be used during pregnancy and breastfeeding (see section 4.3).

EFFECTS ON DRIVING ABILITY

No particular negative effects on vigilance are to be expected with the use of RINAZINA ANTIALLERGICA.