Vicks sinex aloe nasal spray 0.05 decongestant

VICKS SINEX ALOE 0.05% SOLUTION TO NEBULIZE

1 NAME OF THE MEDICINAL PRODUCT

Vicks Sinex Aloe 0.05% nebulizer solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

• Active ingredient: oxymetazoline hydrochloride 0.0500% w/v. 1 ml of product contains 0.5 mg of oxymetazoline hydrochloride.
• Excipients with known effects: benzalkonium chloride, benzyl alcohol

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nebulizer solution (colorless aqueous solution with menthol odor for topical nasal applications).

4 CLINICAL INFORMATION

4.1 Therapeutic indications

Decongestant of the nasal mucosa, especially in case of colds.

4.2 Dosage and method of administration

Adults and children over 12 years: 1-2 sprays per nostril every 8 – 12 hours, unless otherwise indicated by your doctor. Hold the bottle upright, insert its tip into your nostril and press the sprayer quickly and firmly. After application, inhale deeply with your mouth closed.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1, prostatic hypertrophy, cardiac disease and severe arterial hypertension. Glaucoma, hyperthyroidism. Do not administer during and within two weeks of therapy with antidepressant drugs (MAOI). Inflammation or lesions of the oral mucosa or skin around the nostrils.

The drug is contraindicated in children under 12 years of age.

4.4 Special warnings and precautions for use

Use with caution in the first months of pregnancy and, due to the risk of urinary retention, in the elderly.

Use with caution also in patients with angina and diabetes. If symptoms persist, a clinical reassessment should be considered; in any case, treatment should not be continued for more than 4 consecutive days to avoid a rebound effect and rhinitis phenomena induced by the drug. Scrupulously adhere to the recommended doses. Accidental ingestion may cause marked sedation.

It should not be used orally. Avoid contact of the liquid with the eyes.

Prolonged use of vasoconstrictors can alter the normal function of the nasal mucosa and paranasal sinuses, also inducing drug addiction. Repeated applications for long periods can be harmful. 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 institute appropriate therapy.

Important information about some of the excipients

Vicks Sinex Aloe 0.05% nebuliser solution contains benzalkonium chloride which may cause bronchospasm. This medicine contains 0.01 mg benzalkonium chloride per dose (1 spray) which is equivalent to 0.2 mg/ml.

Benzalkonium chloride can cause irritation and swelling inside the nose, especially if used for long periods.

Vicks Sinex Aloe 0.05% nebuliser solution contains benzyl alcohol. This medicine contains 0.1 mg benzyl alcohol per dose (1 spray), equivalent to 2 mg/ml. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause mild local irritation.

4.5 Interactions with other medicinal products and other forms of interaction

There is a possibility of interaction between sympathomimetic amines such as oxymetazoline with anti-MAO drugs, therefore their use during or within two weeks of treatment with anti-MAO drugs is not recommended (see section 4.3).

Oxymetazoline may reduce the effectiveness of beta-blockers, methyldopa, or other antihypertensive drugs. Hypertension and arrhythmias may occur when tricyclic antidepressants are administered with sympathomimetic drugs such as oxymetazoline. Increased cardiovascular toxicity may occur when sympathomimetic drugs are administered concomitantly with antiparchinsonian drugs such as bromocriptins.

4.6 Fertility, pregnancy and breastfeeding

There are no studies on the use of the product during pregnancy and breastfeeding.

Use with caution in early pregnancy.

Administration should be considered only if the expected benefit to the mother outweighs the risk to the child.

4.7 Effects on ability to drive and use machines

No effects on the ability to drive or use machines have been observed.

4.8 Undesirable effects

The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. The product can cause local sensitization phenomena and rebound congestion of the mucous membranes. In general, no serious adverse effects have been observed. Due to rapid absorption of oxymetazoline through the inflamed mucous membranes, adverse effects may occur, divided into with the following frequencies: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (>1/10000); not known (frequency cannot be estimated from the available data).

Rare:

Eye pathologies: eye irritation, discomfort or redness.

Respiratory, thoracic and mediastinal pathologies: discomfort or irritation of the nose, mouth, or throat, sneezing.

Very rare:

Heart disease: tachycardia, palpitations, increased blood pressure, reflex bradycardia.

Central nervous system disorders: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache.

Gastrointestinal disorders: nausea.

Kidney and urinary disorders: urination disorders.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

4.9 Overdose

Symptoms

Symptoms of moderate or acute overdose may include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmias, hypertension, dyspnea, cardiac arrest, photophobia, headache, severe chest tightness and, in children, severe Central Nervous System depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnea and loss of consciousness requiring the adoption of adequate emergency measures.

Treatment

Treatment should be symptomatic. In more serious cases, intubation and artificial respiration are required.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: nasal decongestants and other preparations for topical use, plain sympathomimetics, ATC code: R01AA05

Vicks Sinex Aloe is a drug based on the vasoconstrictor and decongestant properties of oxymetazoline hydrochloride aided by the well-known balsamic properties of Menthol and Eucalyptol, and is used to relieve the unpleasant symptoms related to nasal mucosal congestion, such as a blocked nose and hypersecretion, typical of colds and flu.

The solution is administered without the use of propellant gases, but rather through the simple mechanical action exerted by pressing on the nebulizer.

5.2 Pharmacokinetic properties

The route of administration by Nasal Nebulizer, the small quantity administered with the single dose, and the fact that the dosage is repeated every 8 – 12 hours, mean that the levels of oxymetazoline eventually absorbed and placed in circulation, rarely reach values of pharmacological significance. In any case, oxymetazoline is immediately metabolized by the enzymatic systems, in particular by Mono-Amino-Oxidase, then conjugated and inactivated at the hepatic level, and, therefore, excreted almost entirely by the kidneys, in the form of metabolites and, only to a minimal extent, unchanged.

5.3 Preclinical safety data

The toxicity of Vicks Sinex Aloe is very low, so much so that DL₅₀ orally in mice and rats could not be determined. In fact, this DL₅₀ is greater than 5 ml/kg, which is the maximum dose practicable for the animal. This means that at this dose none of the animals died; the administration of higher doses causes death by mechanical and non-toxic causes. Chronic oral toxicity was determined in two animal species (rat and beagle dog) by administering as the maximum dose, 0.132 ml/kg/day of Vicks Sinex Aloe for a duration of 3 months. These doses, which represent more than 10 times the human therapeutic dose, repeated for 90 days, did not show toxic effects. Another group for each of the two animal species (rats and dogs) was treated in the same way and with the same doses by oral route for two months. The same animals were then treated by nasal inhalation of nebulized Vicks Sinex Aloe for 15 minutes a day for a further 30 days. The behavior and growth of the animals of the first and second groups were normal, the haematoserological tests provided normal data and, after sacrifice, no damage to the main organs was found during the necropsy and histological examination.

Preclinical data suggest that benzalkonium chloride is capable of producing a concentration- and time-dependent toxic effect on the cilia of the nasal mucosal epithelium, including irreversible immobility and may induce histopathological changes of the nasal mucosa.

6 PHARMACEUTICAL INFORMATION

6.1 List of excipients

Levomenthol, sodium citrate, anhydrous citric acid, benzalkonium chloride solution, disodium edetate, eucalyptol (cineole), non-crystallizing liquid sorbitol, aloe vera, acesulfame potassium, L-carvone, polysorbate 80, benzyl alcohol and purified water.

6.2 Incompatibility

No incompatibilities with other drugs are reported.

6.3 Period of validity

3 years.

The shelf life after first opening of the nebulizer bottle is 3 months.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of the container

15 ml glass nebulizer bottle with dispenser, equipped with 15 ml cap.

6.6 Special precautions for disposal and handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

PROCTER & GAMBLE Srl - Viale Giorgio Ribotta 11 - 00144 Rome.

8 MARKETING AUTHORISATION NUMBER(S)

Vicks Sinex Aloe 0.05% nebulizing solution AIC n. 023198029

9 DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

Date of first authorization: 03 August 1990

Most recent renewal date: June 01, 2010

10 DATE OF REVISION OF THE TEXT

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11 DOSIMETRY

12 INSTRUCTIONS FOR PREPARING RADIOPHARMACEUTICALS