Vicks Active Sinex (Spray) Instructions for Use

Marketing Authorization Holder

Procter & Gamble Distributor Company LLC (Russia)

Manufactured By

Procter & Gamble Manufacturing, GmbH (Germany)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Form

Vicks Active Sinex

Nasal spray 0.05%: bottle 15 ml

Dosage Form, Packaging, and Composition

Nasal spray 0.05% colorless or colorless with a yellowish tint, transparent, with a characteristic odor, without visible inclusions.

Excipients: sorbitol 70% – 5 g, sodium citrate dihydrate – 0.875 g, tyloxapol – 0.7 g, chlorhexidine digluconate 20% – 0.27 g, anhydrous citric acid – 0.2 g, aloe barbadensis leaf juice – 0.1 g, benzalkonium chloride 50% – 0.04 g, levomenthol – 0.015 g, potassium acesulfame – 0.015 g, cineole – 0.013 g, L-carvone – 0.01 g, disodium edetate – 0.01 g, sodium hydroxide solution 0.1M – to pH 5.4, distilled water – to 100 ml.

15 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – vasoconstrictor (alpha-adrenomimetic)

Pharmacological Action

Vasoconstrictor drug for topical application, alpha-adrenergic stimulant. It has a vasoconstrictive effect.

When administered intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract, which leads to easier nasal breathing and opening of the orifices of the paranasal sinuses and Eustachian tubes.

The effect of the drug appears within 5 minutes after application and lasts for 8-12 hours.

Pharmacokinetics

When applied topically, Oxymetazoline is practically not absorbed.

Indications

For relief of nasal breathing:

• For colds or viral infections of the upper respiratory tract;
• For sinusitis, rhinitis of any etiology.

ICD codes

Dosage Regimen

Apply intranasally.

Adults and children over 10 years – 1-2 sprays into each nostril, maximum 2-3 times/day.

Children from 6 to 10 years – 1 spray into each nostril, maximum 2-3 times/day.

Duration of treatment it is not recommended to use the drug for more than 7 days.

With frequent or prolonged use of the drug, the feeling of difficult nasal breathing may reappear or worsen.

If these symptoms appear, the patient should stop treatment and consult a doctor.

When spraying, do not tilt your head back and do not spray while lying down.

Adverse Reactions

Local reactions sometimes – burning or dryness of the nasal mucosa, dryness in the mouth and throat, sneezing, increased volume of nasal secretions; in rare cases – after the effect of the drug wears off, a strong feeling of nasal congestion (rebound hyperemia).

Systemic reactions increased blood pressure, headache, dizziness, palpitations, tachycardia, increased anxiety, sedative effect, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, visual impairment (if it gets into the eyes).

The preservative benzalkonium chloride, which is part of the drug, can cause swelling of the nasal mucosa.

If this happens, it is necessary to change the drug to another one that does not contain preservatives.

Contraindications

• Atrophic (dry) rhinitis;
• Taking MAO inhibitors within the previous 2 weeks and within 2 weeks after their discontinuation;
• Closed-angle glaucoma;
• Condition after transsphenoidal hypophysectomy;
• Children under 6 years of age;
• Pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to the components of the drug.

With caution the drug should be used in patients with cardiovascular diseases (arterial hypertension, coronary artery disease, chronic heart failure, tachycardia, arrhythmias), carbohydrate metabolism disorders (diabetes mellitus), thyroid dysfunction (hyperthyroidism), with pheochromocytoma, chronic renal failure, prostatic hyperplasia (urinary retention) and in patients receiving tricyclic antidepressants and bromocriptine.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

With caution: chronic renal failure.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

Do not use for more than 7 days without consulting a doctor at the recommended dose.

If symptoms worsen or no improvement occurs within 3 days, the patient should consult a doctor.

Avoid getting the drug into the eyes.

To avoid the spread of infection, the drug should be used individually.

Overdose

Symptoms nausea, increased blood pressure, tachycardia, CNS depression.

Treatment: symptomatic therapy.

Drug Interactions

With simultaneous use with MAO inhibitors (including the period within 14 days after their discontinuation) and tricyclic antidepressants, an increase in blood pressure may be observed.

The drug slows down the absorption of local anesthetics and prolongs their action.

Concomitant use of other vasoconstrictor drugs increases the risk of side effects.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.