NTR SPRAY

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active ingredients

A ml contains: Active Ingredients Fenilephrine Hydrochloride 5,000 mg Tenyldiamine Hydrochloride 1,000 mg Benzalconio Chloride 0.200 mg Excipients Aqueous buffer solution consisting of: 2H2O 2H2O 7,610 mg Sodium Chloride 5,240 mg 2–fenoxethanol 2,500 mg Citric Acid 0.090 Purified Water q.b. to ml 1,000

Excellent

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

Therapeutic indications

To relieve excessive secretion due to cold.

Contraindications

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

Population

Use for nebulizer: For greater convenience or for easier use the product is contained in a plastic nebulizer suitable for endonasal use. For maximum effectiveness, press the dispenser during an intake, after blowing the nose. The first insufflation reduces swelling in the lower parts of the nose. Repeating the operation a few minutes of interval decongest the deepest mucous membranes so as to open the nasal breasts. Repeat every 3 – 4 hours, if necessary. Use of the dropper bottle: Instill 2 – 3 drops of solution in each of the nostrils, after blowing the nose, and ensuring the deep penetration of the product, possibly repeating the operation after about ten minutes. In any case the treatment should not be protracted for over four days.

Conservation

The bottle should be kept well closed and sheltered from light as prolonged exposure to air, metals or intense light causes oxidation and a certain loss of power. Solutions with altered colour, although harmless, must therefore be thrown away. Store at a temperature not exceeding 25° C

Warnings

Use with caution and judgement of the doctor 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 raising and causing unwanted effects; in this case it is necessary to stop treatment and, if necessary, to establish suitable therapy. In patients with cardiovascular disease and especially in hypertensives, the use of nasal decongestants 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 by also inducing addiction to the drug. Repeating applications for a long time may be harmful. It is recommended not to associate other vasoconstrictors such as nasal decongestants, by mouth or nasal, for the risk of vasoconstriction (see paragraph 4.5). Children are more sensitive to the systemic effects of sympathomimetic vasoconstrictors, therefore the product must be kept away from their reach since accidental ingestion can cause severe depression of the central nervous system with strong sedation (see paragraph 4.9). Benzalconio chloride (BAC) contained as an active ingredient in NTR, especially when used for long periods, can cause a swelling of the nasal mucosa. If you suspect that reaction (continuously congested nose) should be used, if possible, another nasal medication without BAC. If this medicine for nasal use without BAC is not available, it should be considered another pharmaceutical form. It can cause bronchospasm.

Dropper bottle	Nebulizer
1. To open the bottle it is necessary to press and simultaneously unscrew. It is recommended to place the bottle on a base.	1. If the bottle is new press twice–three times the dispenser without introducing in the nostrils
2. To close the bottle screw normally.
3. For later use, follow the instructions from point 1.

The container of NTR drops consists of latex rubber. It can cause severe allergic reactions.

Interactions

With antihypertensive drugs, the effect of phenylphrine can be enhanced.

Effects

The product can determine locally phenomena of sensitization and congestion of bounce mucosa. For rapid absorption of phenylephrine through inflamed mucous membranes, 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 the address : www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

In case of overdose, arterial hypertension, tachycardia, photophobia, intense headache, chest oppression and, in children, hypothermia and severe depression of the central nervous system with strong sedation requiring the adoption of adequate emergency measures. The product, if accidentally ingested or used for a long time at excessive doses, may cause toxic phenomena. It must be kept away from the reach of children since accidental ingestion can cause marked sedation.

Do not use during pregnancy and nursing.

Source: Farmadati