NASOMIXIN CM GTT 15ML 2.5MG/ML

NASOMIXIN C.M. 2.5 MG/ML NASAL GOCCE, DEVELOPMENT

active ingredients

A ml nasal solution contains: phenylphrine hydrochloride 2,5 mg. For the full list of excipients, see section 6.1

Excellent

Sodium citrate; sodium chloride; phenoxyethanol; benzalconio chloride; citric acid anidro; purified water.

Therapeutic indications

Decongestant of nasal mucosa.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Heart disease and severe arterial hypertension. Gross hyperthyroidism. Acute Angle Glaucoma Children under the age of 12. Do not administer during or in the two weeks following therapies with monoaminooxidase inhibitors (see also section 4.5).

Population

1-2 drops in each nostril, to be repeated, if necessary, up to 3-4 times a day. The drops must be instilled in each nostril with the head reclined in lateral and low position. Do not exceed the recommended doses. In particular, elderly people are more likely to experience adverse reactions. In this case it is good to consult the doctor to assess the opportunity to use lower doses of the drug. In the absence of complete therapeutic response within a few days, consult your doctor; in any case, the treatment should not be protracted for over 5 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 color, although harmless, should not be used, but should be eliminated. Store at a temperature not exceeding 25°C Use the product within 30 days of the first opening of the bottle, the excess product must be eliminated.

Warnings

Sympathomimetic drugs should be used with caution in patients with hypertension, heart disease including arrhythmias, thyroid diseases, diabetes mellitus, glaucoma and prostate hypertrophy. In these cases, the use of nasal decongestants must be subjected to the doctor’s judgment. Bounce congestion is frequent with the use of nasal decongestants and can lead to excessive use of the product. It is therefore necessary to adhere carefully to the recommended doses. Protracted use of vasoconstrictors can alter the normal function of mucosa of the nose and paranasal breasts, can cause tachyphylaxis and therefore reduced effectiveness of the drug. Abuse of nasal vasoconstrictors can induce prolonged alterations of the mucosa which may result in atrophic medicament rhinitis. Children are more sensitive to the systemic effects of sympathomimetic vasoconstrictors.

Interactions

The dietary effects of phenylphrine can be enhanced by the contemporary use of antidepressant triceclic drugs. For the possible occurrence of serious side effects, do not administer the medicine during or in the two weeks following therapies with monoaminooxidase inhibitors (see section 4.3).

Effects

Like other nasal decongestants, the use of Nasomixin C.M., especially if used for periods of more than 5 days, it can induce local transitory irritation. Induced vasoconstriction can be followed by vasodilation or “rebound” congestion. For high-dose or prolonged treatments beyond the recommended limit or in case of excessive absorption of active ingredient through inflamed mucosa, it is possible rarely the appearance of cardiovascular systemic effects (hypertension followed by rebound hypotension, sweats, bradycardia, pallor) and central nervous system stimulation (cephalea, insomnia, tremors, dizziness, restlessness). 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 professionals are required to report any adverse reaction suspected through the Italian Pharmaco Agency, Website: http://www.agenziafarmaco.gov.it/it/responsabili

Overdosing

The product, if accidentally ingested or used in excessive doses, can cause toxic phenomena. In case of overdose, arterial hypertension, tachycardia, photophobia, intense headache, thoracic oppression and, especially in children, hypothermia and severe depression of the Central Nervous System with strong sedation, requiring the adoption of adequate emergency measures.

In pregnancy the medicine should be used with caution and only after consulting the doctor. The medicinal product should be used with caution during breastfeeding since it cannot be excluded that the drug is excreted in breast milk.

Source: Farmadati