Rinazina Decongestant Nasal Spray 15ml 0.1%

INDICATIONS

Nasal decongestant during acute catarrhal rhinitis and pharyngitis, allergic rhinitis, acute sinusitis.

ACTIVE INGREDIENTS

1 ml of solution contains: Active ingredient: naphazoline nitrate 1 mg Excipients with known effects: benzalkonium chloride For the full list of excipients, see section 6.1.

EXCIPIENTS

RINAZINA 1 mg/ml nasal drops, solution: sodium chloride, disodium edetate, monobasic sodium phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, purified water. RINAZINA 1 mg/ml nasal spray, solution: sodium chloride, disodium edetate, monobasic sodium phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, balsamic aroma, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Severe heart disease and arterial hypertension. Glaucoma. Hyperthyroidism. The medicine is contraindicated in children under 12 years of age. Do not administer during and in the two weeks following therapy with antidepressant drugs.

DOSAGE

Nasal drops: Adults: 2-3 drops in each nostril, 2-3 times a day Nasal spray: Adults: 1-2 sprays in each nostril, 2-3 times a day. Pediatric population: The medicine is contraindicated in children under 12 years of age (see section 4.3). Carefully follow the recommended doses. A higher dosage of the product, even if taken topically and for a short period of time, can give rise to serious systemic effects. In the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than a week.

CONSERVATION

RINAZINA 1 mg/ml nasal spray, solution: This medicinal product does not require any special storage conditions. RINAZINA 1 mg/ml nasal drops, solution: Store below 25°C. Store upright.

WARNINGS

Use with caution in the elderly and in those with prostatic hypertrophy due to the risk of urinary retention. In patients with cardiovascular diseases, especially in hypertensive patients, the use of nasal decongestants must in any case be subject to the doctor's judgment from time to time. The prolonged use of vasoconstrictors can alter the normal function of the mucosa of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications over a long period of time can be harmful. RINAZINA nasal drops and nasal spray contain 0.1 mg/ml of benzalkonium chloride. Benzalkonium chloride (BAC) contained as a preservative in RINAZINA nasal drops and nasal spray can cause irritation and swelling of the nasal mucosa, especially if used for long periods. 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. The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, institute suitable therapy. Rare cases of posterior reversible encephalopathy/reversible cerebral vasoconstriction syndrome have been reported with the use of sympathomimetic drugs, to which naphazoline also belongs. Reported symptoms include sudden onset of severe headache, nausea, vomiting and vision disturbances. Most cases improve or resolve within a few days following appropriate treatment. The use of naphazoline should be discontinued immediately and a doctor should be consulted if signs and/or symptoms of posterior reversible encephalopathy/reversible cerebral vasoconstriction syndrome occur.

INTERACTIONS

The drug may interact with antidepressant drugs.

SIDE EFFECTS

The product can locally cause rebound phenomena of sensitization and congestion of the mucous membranes. Due to rapid absorption of naphazoline through inflamed mucous membranes, systemic effects consisting of arterial hypertension, reflex bradycardia, headache, urination disorders may occur. 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

The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. It should be kept out of the reach of children as accidental ingestion can cause severe sedation. In case of overdose, arterial hypertension, tachycardia, photophobia, intense headache, chest tightness and, in children, hypothermia and severe depression of the Central Nervous System with marked sedation may appear, which require the adoption of adequate emergency measures.

PREGNANCY AND BREASTFEEDING

During pregnancy and breastfeeding, RINAZINA must be used only after consulting your doctor and evaluating with him the risk/benefit ratio in your case.

EFFECTS ON DRIVING ABILITY

There are no known side effects on the ability to drive or use machines.