Rhinoxyl^® menthol (Spray) Instructions for Use

Marketing Authorization Holder

Flumed-Pharm Kp, LLC (Republic Of Moldova)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Form

Rhinoxyl® menthol

Nasal spray (with menthol scent) 0.05%: 10 ml bottle

Dosage Form, Packaging, and Composition

Nasal spray (with menthol scent) in the form of a transparent, colorless or slightly yellowish solution with a characteristic odor.

Excipients: levomenthol, racemic camphor, eucalyptus oil, sodium dihydrogen phosphate dihydrate, disodium edetate dihydrate, benzalkonium chloride solution 50%, propylene glycol, purified water.

10 ml – dark glass bottles (1) with a spray device – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

Adrenomimetic agent for topical use. It has a vasoconstrictive effect. When applied intranasally, it reduces the swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, the T_1/2 is 35 hours.

Indications

Difficulty in nasal breathing during colds, inflammation of the nasal sinuses, eustachitis, hay fever, allergic rhinitis.

To eliminate edema before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Prior to first use, prime the spray pump by pressing it several times until a full spray is produced.

For adults and children over 6 years of age, administer one spray into each nostril. The recommended frequency is two to three times per day, as needed for nasal congestion.

Do not exceed two administrations within a 24-hour period. Allow an interval of at least 10-12 hours between doses.

The maximum duration of continuous treatment is 3 to 5 days. Do not use for more than 7 consecutive days.

For children aged 2 to 6 years, use only under direct medical supervision and with a formulation specifically indicated for this age group.

This product is not recommended for children under 2 years of age.

To use, hold the bottle with your thumb at the base and your index and middle fingers on the spray actuator. Tilt your head slightly forward. Insert the tip into one nostril, pointing it away from the nasal septum. Close the other nostril with your finger. Breathe in gently through your nose while firmly and quickly pressing down on the actuator. Repeat the procedure for the other nostril.

Wipe the spray tip clean after each use. If more than a few days have passed since the last use, re-prime the pump with one spray.

Discontinue use and consult a physician if symptoms persist, worsen, or if no improvement is seen after 3 days of treatment.

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of the application wears off, the development of a strong feeling of nasal congestion (reactive hyperemia).

Systemic reactions multiple overdoses with topical application can lead to tachycardia and increased blood pressure; very rarely – anxiety, insomnia, fatigue, headaches, nausea.

Contraindications

Atrophic rhinitis, closed-angle glaucoma, hypersensitivity to oxymetazoline.

With caution

Use of MAO inhibitors and the period up to 10 days after their intake; use of drugs that promote an increase in blood pressure and the period up to 10 days after their intake; increased intraocular pressure; severe forms of cardiovascular diseases (arterial hypertension, coronary artery disease), thyrotoxicosis, diabetes mellitus, pregnancy, period of breastfeeding.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during lactation (breastfeeding).

Pediatric Use

It is used in children according to indications in appropriate dosage forms.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

Prolonged use and overdose should be avoided, especially in children.

Effect on the ability to drive vehicles and mechanisms

When used in doses exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded. In such cases, a decrease in the ability to drive vehicles and engage in other potentially hazardous activities is possible.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in blood pressure is possible.

Oxymetazoline 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

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.