Snuppik (Drops) Instructions for Use

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

Hemomont, LLC (Montenegro)

Quality Control Release

HEMOMONT, d.o.o. (Montenegro)

Or

HEMOFARM, A.D. (Serbia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Form

Snuppik

Nasal drops 0.01%: bottle 5 ml with dosing device

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless solution.

Excipients: sea water, citric acid monohydrate, sodium citrate dihydrate, glycerol 85%, purified water.

5 ml – polymer bottles (1) with a pump dosing 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, T_1/2 is 35 hours.

Indications

Difficulty in nasal breathing during colds, sinus inflammation, eustachitis, hay fever, allergic rhinitis.

To eliminate edema before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Prior to use, clear the nasal passages of mucus.

For adults and children over 6 years: instill 1-2 drops into each nostril.

For children aged 2 to 6 years: instill 1 drop into each nostril.

Apply the solution 2-3 times per day as needed for nasal congestion.

The maximum duration of continuous use is 3 to 5 days. Do not exceed this duration.

Avoid using the product for more than 7 days in any circumstance without medical supervision.

To prevent contamination, do not touch the dropper tip to any surface, including the nasal passages.

If symptoms persist beyond the recommended treatment period, discontinue use and consult a physician.

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, angle-closure 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 lactation (breastfeeding).

Pediatric Use

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

Avoid prolonged use and overdose, especially in children.

Effect on the ability to drive vehicles and operate machinery

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.