Sleepex (Spray) Instructions for Use

Marketing Authorization Holder

Sagmel Inc. (USA)

ATC Code

R02AA20 (Other antiseptics)

Dosage Form

Sleepex

Topical spray: 60 ml bottle

Dosage Form, Packaging, and Composition

Topical spray in the form of a transparent, colorless or yellowish liquid, with a minty-menthol odor.

Excipients: glycerol, cetylpyridinium chloride, spearmint oil, propylene glycol, sodium saccharin, polysorbate 80, purified water.

60 ml – polypropylene bottles (1) with a sprayer – cardboard packs.

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice

Pharmacotherapeutic Group

Herbal remedy

Pharmacological Action

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice.

A mixture of essential oils with methyl salicylate has a local tonic, anti-inflammatory, and antiseptic effect when treating the pharyngeal mucosa.

Methyl salicylate stimulates and tones the flaccid muscles of the soft palate and uvula, preventing their retraction and has a local anti-inflammatory effect.

Peppermint oil and Eucalyptol, through a reflex pathway by irritating the receptors of the mucous membranes, have a moderate local analgesic and antiseptic effect.

Menthol has a local analgesic and antiseptic effect.

Pharmacokinetics

Data on the pharmacokinetics of the drug Sleepex are not available.

Indications

• To prevent or reduce the intensity of snoring manifestations (in adults);
• As part of the complex therapy of exacerbations of inflammatory processes in the pharynx (tonsillitis, pharyngitis).

ICD codes

Dosage Regimen

The drug is applied topically. Before use, remove the protective cap from the sprayer. The drug should be sprayed directly onto the back of the throat and the uvula with two presses. To achieve the best result, refrain from eating and drinking for 30 minutes before and for 30 minutes after using the drug.

For snoring, the drug is prescribed 1 time/day before bedtime. The course of treatment is 4 weeks.

For exacerbation of tonsillitis, pharyngitis – 3 times/day for 10 days.

Increasing the duration and conducting a repeated course of treatment is possible on the recommendation of a doctor.

Adverse Reactions

Possible occurrence of allergic reactions.

Contraindications

• Pregnancy;
• Lactation period (breastfeeding);
• Age under 18 years;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindication: age under 18 years.

Special Precautions

Avoid getting the drug into the eyes.

The drug is not intended for the treatment of sleep apnea (cessation of breathing) during sleep.

The absence of a reduction in snoring symptoms after use may indicate the presence of an organic pathology of the nasopharynx (deviated nasal septum, adenoids) or other undiagnosed diseases requiring consultation with a specialized specialist and specialized complex therapy.

Overdose

With prolonged use of the drug in doses significantly exceeding the recommended ones, headache and nausea may occur.

Drug Interactions

Data on the effect of the drug on the pharmacodynamics and pharmacokinetics of other drugs are not available.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 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.