RINOCIDINA NAS GTT15ML7,5MG+3M

RINOCIDINA MG 7,5 + MG 3 NASAL GOCCE, DEVELOPMENT.

active ingredients

A 15 ml bottle contains: Active ingredients: Naphazoline nitrate: mg 7,5; Tyrosine: mg 3. Excipients with known effects: ethyl-para-hydroxybenzoate, ethyl-para-hydroxybenzoate, ethanol (96%). For the full list of excipients see paragraph 6.1.

Excellent

Glucose, purified water, ethyl-para-hydroxybenzoate, ethyl-para-hydroxybenzoate, Ethanol (96%), Polyethyleneglycol 300.

Therapeutic indications

Therapy of rhinitis and sinusitis of bacterial origin.

Contraindications

Hypersensitivity to active ingredients or substances strictly related to chemical or to any of the excipients listed in paragraph 6.1; heart disease and severe arterial hypertension, glaucoma, hyperthyroidism. Do not administer during and in the two weeks following therapy with Monoaminooxidase inhibitors (IMAO). The drug is contraindicated in children under the age of 12.

Population

3-6 drops per nostril, 3-4 times a day. Strictly stick to the recommended doses. A higher dose of the product, even if taken in a topical and short period of time, can give rise to serious systemic effects. A slight sediment does not alter the activity of the preparation. It will be enough to shake before using it.

Conservation

Store at a temperature below 25°C.

Warnings

To be used only for nasal instillations with exclusion of use in the case of deep surgical interventions. In patients with cardiovascular diseases, especially in hypertensives, the use of nasal decongestionants must be subjected to the doctor's judgement. Protracted use of vasoconstrictors can alter the normal function of the mucosa of the nose and of the paranasal breasts, also inducing addiction to the drug. Repeating applications for long periods may be harmful–so. With the use of sympathomimetic drugs, which also belongs to nafazoline, rare cases of reversible back encephalopathy/reversible syndrome from cerebral vasoconstriction have been reported. The reported symptoms include sudden occurrence of severe headache, nausea, vomiting and vision disorders. Most cases improve or resolve in a few days following appropriate treatment. The use of nafazoline must be immediately interrupted and the doctor must be consulted if signs and/or symptoms of reversible rear encephalopathy/reversible syndrome from cerebral vasoconstriction occur. Tirotricina: It can damage the sensory epithelium of the nose and for this reason there have been cases of prolonged loss of smell after use as nasal spray or instillation. Use the preparation with caution, for the danger of urinary retention, in the elderly and in the carriers of prostate hypertrophy. The use, especially if prolonged, of topical products can give rise to phenomena of awareness; in such case it is necessary to stop the treatment and, if necessary, to establish suitable therapy; in each case, treatment should not be protracted for over a week. Strictly adhere to the recommended doses. Para-hydroxybenzoate and para-hydroxybenzoate etyl:This medicine contains parahydroxybenzoates (para-hydroxybenzoate ethyl and para-hydroxybenzoate) which can cause allergic reactions (also delayed). Ethanol: This medicine contains 0.38 mg (corresponding to 0.0005 ml) of ethanol in each dosage unit (1 drop), equivalent to 9,12 mg (corresponding to 0.01 ml) of ethanol in the maximum daily dose of 24 drops per nostril. It can cause burning sensation on the damaged mucosa.

Interactions

The drug may interact with monoaminooxidase inhibitors (see paragraph 4.3).

Effects

The product can determine locally phenomena of rebound, sensitization and congestion of mucous membranes. For rapid absorption of nafazoline through inflamed mucosa, systemic effects can occur consisting of arterial hypertension, reflex bradycardia, headache, urination disorders. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The product, if accidentally ingested or used for a long period at excessive doses, can determine toxic phenomena. It should be kept away from the reach of children since acci-dental ingestion can cause marked sedation. In case of overdose may appear arterial hypertension, tachycardia, photophobia, intense headache, thoracic oppression.

In pregnant women the product should be administered in cases of actual need and under the direct control of the doctor. Use carefully in the first months of pregnancy.

Source: Farmadati