Ilmocin Nasal Decongestant Nasal Spray 10ml 0.25%

Therapeutic indications

Decongestant of the nasal mucosa.

Dosage

1–2 sprays in each nostril, to be repeated as needed up to 3–4 times a day. The spray should be administered into each nostril with the head tilted sideways and down. Do not exceed the recommended dose. Elderly subjects are more likely to experience adverse reactions. The advisability of using lower doses of the medicine should be considered. The treatment should not be continued for more than 5 days. In the absence of a complete therapeutic response within a few days, the situation should be reassessed. The solution is clear and colorless: solutions with an altered color, although harmless, should not be used, but must be eliminated.

Overdose

The medicine, if accidentally ingested or if used in excessive doses, can cause toxic phenomena. In the event of an overdose, arterial hypertension, tachycardia, photophobia, intense headache, chest tightness and, particularly in children, hypothermia and severe CNS depression with marked sedation may appear, requiring the adoption of adequate emergency measures.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Severe heart disease and high blood pressure. Severe hyperthyroidism. Acute angle glaucoma. Children under the age of 12. Do not administer during or for two weeks following monoamine oxidase inhibitor therapy (see also section 4.5).

Side effects

Below are the side effects of phenylephrine hydrochloride. Insufficient data are available to establish the frequency of the individual effects listed. Like other nasal decongestants, phenylephrine hydrochloride, especially when used for longer than 5 days, can induce transient local irritation. Induced vasoconstriction may be followed by "rebound" vasodilation or congestion. For high-dose or prolonged treatments beyond the recommended limit or in case of excessive absorption of the active ingredient through the inflamed mucous membranes, the onset of systemic cardiovascular effects is rarely possible (hypertension followed by rebound hypotension, sweating, bradycardia, pallor) and stimulation of the central nervous system (headache, insomnia, tremors, dizziness, restlessness).

Pregnancy and breastfeeding

During pregnancy, the medicine should be used with caution and only after having assessed the actual need for the medicine. The medicinal product should be used with caution during breastfeeding as it cannot be excluded that the drug is excreted in breast milk.

Special warnings

Sympathomimetic drugs should be used with caution in patients with hypertension, heart disease including arrhythmias, thyroid disease, diabetes mellitus, glaucoma and prostatic hypertrophy. In these patients it is advisable to evaluate the use of nasal decongestants on a case-by-case basis. Rebound congestion is common with the use of nasal decongestants and can lead to overuse of the drug. It is therefore necessary to strictly follow the recommended doses. The prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, can cause tachyphylaxis and therefore the reduced efficacy of the drug. The abuse of nasal vasoconstrictors can induce prolonged changes in the mucosa that can result in medicamentous atrophic rhinitis. Children are more sensitive to the systemic effects of sympathomimetic vasoconstrictors: use in children under the age of 12 is contraindicated. Important information about some of the ingredients. The presence of sodium metabisulfite and benzalkonium chloride can rarely cause severe hypersensitivity reactions and bronchospasm.

Expiry and Retention

Keep the bottle tightly closed in the original package to protect the medicine from light, as prolonged exposure to air, metals or bright light causes oxidation and some loss of potency. Solutions with an altered color, although harmless, should not be used, but should be discarded.

Active principles

100 ml of solution contain: Active ingredient : phenylephrine hydrochloride g 0.25 For the full list of excipients see section 6.1

Excipients

Sodium metabisulphite, sodium citrate, benzalkonium chloride, purified water.