CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity 'to the active substance or to any of the excipients. Severe heart disease and high blood pressure. Hyperthyroidism severe. The drug is contraindicated in children younger than 12 years. Do not administer during or in the following two weeks atherapies with monoamine oxidase inhibitors.
DOSAGE 1-2 drops in each nostril. If necessary, repeat up to 3-4 times a day. Do not exceed the recommended dose. If there is no complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than 5 days. The drops should be instilled into each nostril with the head tilted sideways and down.
STORAGE The bottle should be kept tightly closed and away from light as prolonged exposure to air, metals or intense light causes oxidation and a certain loss of power. Color altered solutions, although harmless, should not be used, but should be discarded. Store at a temperature not exceeding 25 degreesC. Use the product within 30 days of first opening.
WARNINGS Sympathomimetic drugs should be used with caution in patients with hypertension, heart disease including arrhythmias, thyroid diseases, diabetes mellitus and prostatic hypertrophy. In these cases, the use of nasal decongestants must be subjected to the judgment of the doctor from time to time. Rebound congestion is frequent with the use of nasal decongestants and can lead to overuse of the product. 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.
INTERACTIONS The pressor effects of phenylephrine can be enhanced by the concomitant use of tricyclic antidepressant drugs.
SIDE EFFECTS Like other nasal decongestants, the use of the drug, especially if used for longer than 5 days, can induce transient local irritation. Induced vasoconstriction may be followed by rebound vasodilation or congestion. For treatments at high doses or prolonged 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 central nervous system stimulation (headache, insomnia, tremors, dizziness, restlessness, observed with oral and parenteral preparations of phenylephrine.
PREGNANCY AND BREASTFEEDING Use with caution in the first months of pregnancy. The product should be used with caution during breastfeeding as it cannot be excluded that the drug is excreted in breast milk.
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