RINAZINA ANTIAL SPRAY NAS 10ML

RINAZINA ANTIALLERGICA 1 MG/ML NASAL SPRAY, DEVELOPMENT

active ingredients

1 bottle contains: Active ingredient: Azelastina Hydrochloride 1 mg/mL Excipients with known effects: benzalconio chloride For the complete list of excipients, see paragraph 6.1

Excellent

Ipromellose, disodium edetate, benzalconio chloride solution, citric acid anidro, disode phosphate dodecaidrate, sodium chloride, purified water.

Therapeutic indications

Short term symptom treatment of allergic rhinitis.

Contraindications

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

Population

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

Conservation

Do not store at temperature above 25°C Store in vertical position. Don't flip.

Warnings

Do not use the medicine after 6 months from the first opening of the bottle. Benzalconio chloride (BAC) contained as preservative in RINAZINA ANTIALLERGICA, especially when used for long periods, can cause a swelling of the nasal mucosa. If this reaction is suspected (persistent nasal congestion), it should be used, if possible, a nasal medication without BAC. If such nasal medications without BAC were not available, it should be considered another pharmaceutical form. It can cause bronchospasm.

Interactions

Interactions with other frequently used drugs have not been observed at the same time.

Effects

A bitter taste sensation, typical of the drug itself, has been described, which can occur especially for an incorrect position of the head, reversed backwards, during administration. In rare cases an irritation of the nasal mucosa has been observed with possible modest bleeding. 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 www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

So far no cases of overdose poisoning have been reported. Based on experimental studies, toxic doses can lead to symptoms at the expense of the central nervous system (disease, excitement, seizures, sedation); in these cases a symptomatic treatment must be implemented. You do not know a specific antidote for Azelastine.

RINAZINA ANTIALLERGICA should not be used during pregnancy and nursing (see paragraph 4.3).

Source: Farmadati