Naphazolina Pensa 1mg/ml Decongestant Nasal Spray 15 ml

Therapeutic indications

Nasal decongestant in acute catarrhal rhinitis and pharyngitis, allergic rhinitis, acute sinusitis.

Dosage

Adults: 1–2 sprays in each nostril, 2–3 times a day. Pediatric population : The medicinal product is contraindicated in children under 12 years of age (see section 4.3). Strictly adhere to the recommended doses. A higher dosage of the product even if taken topically and for a short period of time can give rise to serious systemic effects. If there is no complete therapeutic response within a few days, consult your doctor; in any case, the treatment should not be continued for more than a week.

Overdose

The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. It should be kept out of the reach of children as accidental ingestion can cause marked sedation. In case of overdose, arterial hypertension, tachycardia, photophobia, intense headache, chest tightness and, in children, hypothermia and severe depression of the central nervous system with marked sedation may appear, which require 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. Glaucoma. Hyperthyroidism. The medicine is contraindicated in children under 12 years of age. Do not administer during and in the two weeks following therapy with antidepressant drugs.

Side effects

The product can locally determine rebound phenomena of sensitization and congestion of the mucous membranes. For rapid absorption of naphazoline through the inflamed mucous membranes, systemic effects can occur consisting of arterial hypertension, reflex bradycardia, headache, urination disturbances.

Pregnancy and breastfeeding

In pregnancy and breastfeeding, NAFAZOLINA PENSA NASALE SPRAY should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.

Special warnings

Use with caution in the elderly and in patients with prostatic hypertrophy due to the danger of urinary retention. In patients with cardiovascular diseases, especially in hypertensive patients, the use of nasal decongestants must in any case be subjected to the judgment of the doctor from time to time. The prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications over a long period of time can be harmful. Benzalkonium chloride (BAC) contained as a preservative in NAFAZOLINA PENSA NASAL SPRAY, especially when used for long periods, can cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a BAC-free nasal medicine should be used if possible. If such nasal medications without BAC are not available, another pharmaceutical form should be considered. It can cause bronchospasm. The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, institute a suitable therapy. Rare cases of posterior reversible encephalopathy / reversible cerebral vasoconstriction syndrome have been reported with the use of sympathomimetic drugs, to which naphazoline also belongs. Symptoms reported include sudden onset of severe headache, nausea, vomiting and visual disturbances. Most cases improve or resolve within days with appropriate treatment. The use of naphazoline should be discontinued immediately and the physician should be consulted if signs and / or symptoms of posterior reversible encephalopathy / reversible cerebral vasoconstriction syndrome occur.

Expiry and Retention

Store in the original packaging.

Active principles

1 ml of solution contains: Active substance: Naphazoline Nitrate 1 mg For a full list of excipients, see section 6.1.

Excipients

Sodium chloride, disodium edetate, monobasic sodium phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, balsamic flavor, water for injections.