Ntr - nasal drops to relieve excessive secretion due to cold - solution 15 ml

Product Description

Composition

One ml contains: Active ingredients Phenylephrine hydrochloride 5,000 mg Tenyldiamine hydrochloride 1,000 mg Benzalkonium chloride 0,200 mg Excipients Buffered aqueous solution consisting of: sodium citrate 2H2O 7,610 mg sodium chloride 5,240 mg 2-phenoxyethanol 2,500 mg citric acid 0,090 mg purified water to 1,000 ml

Excipients

Buffered aqueous solution consisting of: sodium citrate 2H2O; sodium chloride; 2-phenoxyethanol; citric acid; purified water.

Therapeutic indications

To relieve excessive secretion due to colds.

Contraindications

Hypersensitivity to the active ingredients, or to any of the excipients; severe heart disease and arterial hypertension; glaucoma, hyperthyroidism. Do not use the product in children under 12 years of age. Do not administer during and within two weeks of treatment with antidepressant drugs. Do not administer during pregnancy and breastfeeding.

Dosage

Using the dropper bottle: Instill 2–3 drops of solution in each nostril, after blowing your nose, and ensure that the product penetrates deeply, possibly repeating the operation after about ten minutes. In any case, treatment should not be continued for more than four days.

Warnings and Precautions

Use with caution and at the doctor's discretion due to the risk of urinary retention, in the elderly and in those with prostatic hypertrophy. Use of topical products, especially if prolonged, may give rise to sensitization phenomena and cause side effects; in this case, it is necessary to discontinue treatment and, if necessary, institute appropriate therapy. In patients with cardiovascular disease and especially in hypertensive patients, the use of nasal decongestants should be subject to the doctor's discretion. Prolonged use of vasoconstrictors can alter the normal function of the nasal mucosa and paranasal sinuses, also leading to drug addiction. Repeated applications for a long period of time may be harmful. It is recommended not to combine it with other vasoconstrictors such as nasal decongestants, whether oral or nasal, due to the risk of vasoconstriction (see section 4.5). Children are more sensitive to the systemic effects of sympathomimetic vasoconstrictors; therefore, the product should be kept out of their reach, as accidental ingestion can cause severe central nervous system depression with marked sedation (see section 4.9). Benzalkonium chloride (BAC), the active ingredient in NTR, especially when used for long periods, can cause swelling of the nasal mucosa. If this reaction is suspected (continuously congested nose), another nasal medicinal product without BAC should be used, if possible. If such a nasal medicinal product without BAC is not available, another pharmaceutical form should be considered. May cause bronchospasm.

The NTR drops container is made of latex rubber. May cause serious allergic reactions.

Interactions

The effect of phenylephrine may be enhanced with antihypertensive drugs.

Undesirable effects

The product may cause local rebound sensitization and mucosal congestion. Rapid absorption of phenylephrine through inflamed mucosa may cause systemic effects such as arterial hypertension, reflex bradycardia, headache, and urinary disorders. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Do not use during pregnancy and breastfeeding.