Deltarinol 0.5% + 0.125% 15 ml nasal spray solution

Deltarinolo 0.5% + 0.125% 15 ml nasal spray solution is a fast-acting nasal decongestant , ideal for the treatment of nasal congestion caused by colds, rhinitis and flu symptoms. Formulated with ephedrine hydrochloride and naphazoline nitrate , two active ingredients known for their effectiveness in clearing the airways, this nasal spray acts directly on the nasal mucosa, promoting immediate relief from the annoying sensation of a blocked nose.

The practical 15 ml spray bottle allows for simple and precise application, ensuring uniform distribution of the decongestant solution inside the nasal cavities. Thanks to its specific formulation, Deltarinolo is indicated for topical use and represents an effective solution for those looking for an over-the-counter (OTC) drug to quickly combat the symptoms of nasal congestion, without the need for a medical prescription.

The combination of ephedrine hydrochloride and naphazoline nitrate works synergistically to reduce swelling of the nasal mucosa, making breathing easier and improving daily well-being. Deltarinol nasal spray is particularly suitable for those who want an effective treatment against colds and related symptoms, offering rapid and long-lasting relief.

ACTIVE INGREDIENTS

Active ingredients contained in Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - What is the active ingredient of Deltarinol 0.5% + 0.125% 15 ml nasal spray solution?

100 ml of solution contain: Active ingredients : Ephedrine hydrochloride 0.500 g; Naphazoline nitrate 0.125 g. Excipients with known effect: methyl p-hydroxybenzoate and propyl p-hydroxybenzoate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - What does Deltarinol 0.5% + 0.125% 15 ml nasal spray solution contain?

Methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium edetate, sodium phosphate monobasic, sodium phosphate, sodium hydroxide, purified water.

DIRECTIONS

Therapeutic indications Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - Why is Deltarinol 0.5% + 0.125% 15 ml nasal spray solution used? What is it used for?

Decongestant of the nasal mucosa.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - When should Deltarinol 0.5% + 0.125% 15 ml nasal spray solution not be used?

Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1, cardiac disease and severe arterial hypertension, acute angle-closure glaucoma, hyperthyroidism, prostatic hypertrophy, pheochromocytoma, diabetes mellitus, women who are pregnant or suspected to be pregnant or who are breastfeeding. The drug is contraindicated in children under 12 years of age. Do not administer during or in the two weeks following therapy with antidepressant drugs. For those who play sports: see point 4.4.

DOSAGE

Quantity and method of taking Deltarinolo 0.5% + 0.125% 15 ml nasal spray solution - How to take Deltarinolo 0.5% + 0.125% 15 ml nasal spray solution?

DELTARINOLO should be applied every 3-4 hours up to 4 times a day; a single spray is sufficient. Strictly follow 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.

CONSERVATION

Storage Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - How is Deltarinol 0.5% + 0.125% 15 ml nasal spray solution stored?

Store at a temperature not exceeding 25°C.

WARNINGS

Warnings Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - About Deltarinol 0.5% + 0.125% 15 ml nasal spray solution it is important to know that:

Prolonged use of vasoconstrictors may alter the normal function of the nasal mucosa and paranasal sinuses, also inducing addiction to the drug. Repeated applications for long periods may be harmful. Use with caution in patients with renal insufficiency and, due to the risk of urinary retention, in the elderly. Use, especially if prolonged, of topical products may give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and, if necessary, institute appropriate therapy. However, in the absence of a complete therapeutic response, within a few days, consult your doctor; in any case, treatment should not be continued for more than four days. In patients with cardiovascular disease, especially hypertensive patients, the use of nasal decongestants must be subjected to the doctor's judgment from time to time. Cardiovascular effects may be observed with the use of sympathomimetic drugs, such as DELTARINOL. There is some evidence from post-marketing data and published literature of rare cases of myocardial ischemia in association with the use of beta agonists. Patients with pre-existing serious cardiac disease (e.g. ischemic heart disease, arrhythmia or severe heart failure) taking DELTARINOLO should be advised to seek medical advice if they experience chest pain or other symptoms of worsening of the cardiac disease. Attention should be paid to the evaluation of symptoms such as dyspnea and chest pain, as they may be of respiratory or cardiac origin. Carefully adhere to the recommended doses. If accidentally ingested or if used for a long period at excessive doses, the product may cause toxic phenomena. It should be kept out of the reach of children as accidental ingestion may cause marked sedation. It should not be used orally. Avoid contact of the liquid with the eyes. Caution for those who play sports: the product contains substances prohibited for doping. Any intake other than those reported, in terms of dosage schedule and route of administration, is prohibited. Due to the presence of methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate as excipients, allergic reactions, even delayed, are possible . Ephedrine can be a substance subject to abuse.

INTERACTIONS

Interactions Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - Which medicines or foods can modify the effect of Deltarinol 0.5% + 0.125% 15 ml nasal spray solution?

The active ingredients contained in DELTARINOLO may interact negatively with antidepressant drugs. Consequently, administration of the product during or within two weeks of antidepressant drug therapy is contraindicated. Ephedrine may reduce the pharmacological efficacy of antihypertensive drugs; associated with clonidine, it may cause an increase in noradrenaline levels and an increase in blood pressure. If associated with NSAIDs, it may promote the onset of lesions affecting the gastric mucosa. Ephedrine may increase the metabolism of corticosteroids, reducing their plasma levels. Asthmatic patients being treated with such drugs should therefore avoid taking ephedra-based products. The urinary excretion of ephedrine is pH dependent; acetazolamide, antacids, ammonium chloride and sodium bicarbonate are able to alkalinize the urine, and consequently slow down the elimination of ephedrine. Concomitant use of ephedrine with digoxin, phenylpropanolamine, cyclopropane and pseudoephedrine is associated with an increased risk of cardiovascular adverse events. Reserpine, by causing norepinephrine depletion, may reduce the efficacy of ephedrine. Theophylline may cause an increased incidence of central and gastrointestinal adverse effects, which occur following the administration of ephedrine. The combination of ephedrine and caffeine may enhance the sympathomimetic effects of ephedrine.

SIDE EFFECTS

Like all medicines, Deltarinol 0.5% + 0.125% 15 ml nasal spray solution can cause side effects - What are the side effects of Deltarinol 0.5% + 0.125% 15 ml nasal spray solution?

The product may locally cause rebound sensitization and mucosal congestion. After topical use of naphazoline, systemic effects such as nausea, headache and dizziness have been reported. After administration of ephedrine, the most common adverse events reported are tachycardia, anxiety, restlessness and insomnia. Tremors, dry mouth, urination disorders, circulatory alterations in the extremities, arterial hypertension, reflex bradycardia and cardiac arrhythmias may also occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose Deltarinol 0.5% + 0.125% 15 ml nasal spray solution - What are the risks of Deltarinol 0.5% + 0.125% 15 ml nasal spray solution in case of overdose?

In case of overdose or accidental ingestion, arterial hypertension, tachycardia, photophobia, severe headache, chest tightness, psychiatric reactions and, in children, hypothermia and severe depression of the central nervous system with marked sedation may appear, requiring the adoption of adequate emergency measures.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Deltarinol 0.5% + 0.125% 15 ml nasal spray solution.

The use of the product in women who are pregnant or suspected to be pregnant or who are breastfeeding is contraindicated.

DRIVING AND USE OF MACHINERY

Taking Deltarinol 0.5% + 0.125% 15 ml nasal spray solution before driving or using machines - Does Deltarinol 0.5% + 0.125% 15 ml nasal spray solution affect driving or using machines?

DELTARINOLO does not alter the ability to drive vehicles or use machinery.