ZERINODEK DECONG SPR 10ML 0.1%

ZERINODEK IS A NASAL DECONGESTANT

active ingredients

100 mL solution contain: Active ingredient : xylometazoline hydrochloride 100 mg Eccipiente with known effects: benzalconio chloride. 100 g gel contains: Active ingredient : xylometazoline hydrochloride 100 mg Excipient with known effects: propile parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

ZERINODEK DECONGESTIONANTE NASALE nasal spray, solution: Potassium monobasic phosphate, sodium chloride, sodium dihydrate dibasic phosphate, polysorbate 20, disodium edetate, eucalyptol, Neroli essence, benzalconio chloride, purified water. ZERINODEK DECONGESTIONANTE NASALE nasal gel: carbomers, sodium hydroxide, propile parahydroxybenzoate, eucalyptol, Neroli essence, purified water.

Therapeutic indications

Nasal decongestant for rhinitis, cold, sinusitis.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Contraindicated in: - severe heart diseases and arterial hypertension, - glaucoma and in particular in the closed angle glaucoma, - prostatic hypertrophy, - hyperthyroidism, - patients who have undergone transfenoidal hypophysictomy or trans-nasal surgery with exposure of the harsh mother. Not to be used during and in the next two weeks to therapy with antidepressant drugs, such as triceclic antidepressants or monoamino oxidase inhibitors (iMAO) (see paragraph 4.5). The drug is contraindicated in children under 12 years of age.

Population

ZERINODEK DECONGESTIONANTE NASALE nasal spray, solutionPopulation Adults: 1 or 2 nebulizations per nostril, 2 - 3 times a day. Children over 12 years: 1 nebulization per nostril, 1 or 2 times a day. Method of administration To nebulize the preparation press the valve holding the box between the index, the average and the thumb. At first press 2 - 3 times blank (not in nostrils) to have a regular nebulization. ZERINODEK DECONGESTIONANTE NASALE nasal gel Population Adults: 1 application per nostril, 2 or 3 times a day.Children over 12 years: 1 application per nostril, 1 or 2 times a day. Method of administration Every application of gel, per nostril, must be equal to a grain of rice. It is recommended to adhere carefully to the recommended doses. In any case the treatment should not be protracted for over 4 days. If symptoms persist you should consider a clinical revaluation.

Conservation

ZERINODEK DECONGESTIONANTE NASALE nasal spray, solution Store at a temperature of less than 25°C. ZERINODEK DECONGESTIONANTE NASALE nasal gel Store at a temperature of less than 30°C.

Warnings

Patients with long-term QT syndrome treated with xylometazoline may be exposed to a greater risk of severe ventricular arrhythmias. Use with caution, for the danger of urinary retention, in the elderly. Xylometazoline should be used with caution, and only under medical advice, in patients with diabetes mellitus, hypertension, heart disorder and feocromocytoma. The repeated use of the drug for long periods may be harmful. Protracted use of vasoconstrictors can alter the normal function of nasal mucosa and paranasal breasts, also inducing drug addiction. Prolonged use should be avoided because it can occur rebound congestion with hyperemia. This may require repeated treatment with risk of chronic rhinitis and nasal mucosa atrophy. Important information about some excipients ZERINODEK DECONGESTIONANTE NASALE nasal spray, solution contains benzalconio chloride (BAC) that ZERINODEK is irritating and can cause local skin reactions. When used for long periods, it 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. ZERINODEK DECONGESTIONANTE NASALE gel contains parahydroxybenzoate propile. It can cause allergic reactions (also delayed). The use, especially if prolonged, of topical products can give rise to awareness-raising phenomena and produce undesirable effects; in this case it is necessary to stop treatment and, if necessary, to establish suitable therapy. For sportsmen: the product contains substances prohibited for doping and can determine positivity to antidoping tests.

Interactions

Not to be used in association with antidepressant drugs, such as tricyclic antidepressants or MAO inhibitors. These can in fact cause an increase in blood pressure for their effects on the cardiovascular system (see paragraph 4.3).

Effects

List of adverse reactions divided according to classification for systems and organs according to MedDRA. The following adverse reactions are classified using the following convention: very common (≥1/10); common (from ≥1/100 to respiratory pathologies, chests and mediastinic Epistassi. Frequency not noted: Immune system disorders Hypersensitivity. Diseases of the nervous system Cephalea, insomnia. Vascular diseases Hypertension. Heart disease Tachycardia, palpitations, reflex bradycardia. Respiratory, chest and mediastinic pathologies Nasal Fastidium, nasal congestion. Gastrointestinal diseases Nausea. Kidney and urinary pathologies Mental disorder. 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of excessive use, especially in children, systemic effects typical of alpha-symmetic agents may occur. Symptoms include hypertension, photophobia, nausea, dizziness, headache, insomnia, palpitations, tachycardia, arrhythmia, anxiety, chest oppression, depression of the Central Nervous System with strong sedation (which can be associated with hypothermia, bradycardia, sweating and dizziness) and which can lead to coma. In case of overdose or accidental oral intake, patients must be directed to a health facility and appropriate emergency measures must be taken.

Due to the lack of data, the use of the product during pregnancy and nursing with breast milk must be avoided. The administration should be taken into account only if the expected benefit for the mother exceeds the risk for the child.

Source: Farmadati