Descrizione Clinica
EUSPIRACT 100 MG/100 ML NASAL SPRAY
active ingredients
This medicine contains 1 mg of nitrate nafazoline per ml solution, equivalent to about 70 micrograms/supply. This medicine contains 0.1 mg of benzalconium chloride per ml solution, equivalent to 0.007 mg per dispensing. For the full list of excipients, see paragraph 6.1.Excellent
Sodium chloride, disodium edetate, sodium phosphate monobasic dihydrate, concentrated phosphoric acid, benzalconio chloride, balsamic aroma, water for injectable preparations.Therapeutic indications
Nasal decongestant in progress of cathartic acute rhinitis and pharyngitis, allergic rhinitis, acute sinusitis.Contraindications
Hypersensitivity to the active ingredient or any of the excipients. Heart disease and severe arterial hypertension. Glaucoma. Hyperthyroidism. The medicinal product is contraindicated in children under 12 years of age. Do not administer during and in the two weeks following treatment with antidepressant drugs.Population
Adults: 1-2 nebulizations in each nostril, 2-3 times a day. Method of administration When using the bottle for the first time you need to press 10 times the doser to obtain a dose corresponding to the stated in the label. After a prolonged period of non-use of the medicinal product (28 days) it is necessary to press the dose twice before taking the dose. It is recommended to clean the dispenser with a dry cloth after each use. Cleaning is necessary for hygienic reasons to remove any mucus residue from the dispenser. The execution or non-performance of cleaning operations do not affect the performance of the dispenser. Pediatric Population The medicinal product is contraindicated in children under the age of 12 (see paragraph 4.3). Strictly stick to the recommended doses. A higher dose of the product even if taken in a topical way and for a short period of time can give rise to serious systemic effects. In the absence of complete therapeutic response within a few days, consult your doctor; in any case, treatment should not be protracted for over a week.Conservation
Store in the original packaging. Don't freeze.Warnings
Carefully use in the elderly and prostate hypertrophy carriers for the danger of urinary retention. In patients with cardiovascular disease, 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. Important information about some excipients This medicine contains benzalconio chloride which can cause irritation. Benzalconio chloride (BAC) contained as a preservative in EUSPIRACT nasal spray, especially when used for long periods, can cause a swelling of the nasal mucosa. If this reaction is suspected (persistent nasal congestion), it should be used, if possible, a nasal medication without BAC. If such nasal medications without BAC were not available, it should be considered another pharmaceutical form. It can cause bronchospasm. The use, especially if prolonged, of topical products can give rise to phenomena of awareness; in this case it is necessary to stop treatment and, if necessary, to establish suitable therapy. With the use of sympathomimetic drugs, which also belongs to nafazoline, rare cases of reversible back encephalopathy/reversible syndrome from cerebral vasoconstriction have been reported. The reported symptoms include sudden occurrence of severe headache, nausea, vomiting and vision disorders. Most cases improve or resolve in a few days following appropriate treatment. The use of nafazoline must be immediately interrupted and the doctor must be consulted if signs and/or symptoms of reversible rear encephalopathy/reversible syndrome from cerebral vasoconstriction occur.Interactions
The drug can interact with antidepressant drugs.Effects
The product can determine locally phenomena of rebound of awareness and congestion of mucous membranes. For rapid absorption of nafazoline through inflamed mucosa, 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/content/come-segnalare-una-sospetta-reazione-avversa.Overdosing
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. In case of overdose, arterial hypertension, tachycardia, photophobia, intense headache, thoracic oppression and, in children, hypothermia and severe depression of the Central Nervous System with strong sedation, requiring the adoption of adequate emergency measures.In pregnancy and breastfeeding EUSPIRACT nasal spray should only be used after consulting the doctor and evaluating with him the risk/benefit ratio in your case.
Source: Farmadati
