Suprima-NOS (Drops) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

Contact Information

Shreya Life Sciences Pvt. Ltd. (India)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Suprima-NOS	Nasal Drops 0.1%: 10 ml, 15 ml or 25 ml bottle
		Nasal Drops 0.05%: 10 ml, 15 ml or 25 ml bottle
		Nasal Spray 0.1%: 15 ml bottle
		Nasal Spray 0.05%: 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal Drops 0.05% as a clear, colorless solution.

Excipients: benzalkonium chloride – 0.11 mg, sodium phosphate dibasic dihydrate – 3 mg, disodium edetate – 0.5 mg, sodium phosphate monobasic dihydrate – 2.8 mg, sodium chloride – 7 mg, purified water – up to 1 ml.

10 ml – plastic bottles (1) with a dropper cap – cardboard boxes.
15 ml – plastic bottles (1) with a dropper cap – cardboard boxes.
25 ml – plastic bottles (1) with a dropper cap – cardboard boxes.

Nasal Drops 0.1% as a clear, colorless solution.

Excipients: benzalkonium chloride – 0.11 mg, sodium phosphate dibasic dihydrate – 3 mg, disodium edetate – 0.5 mg, sodium phosphate monobasic dihydrate – 2.8 mg, sodium chloride – 7 mg, purified water – up to 1 ml.

10 ml – plastic bottles (1) with a dropper cap – cardboard boxes.
15 ml – plastic bottles (1) with a dropper cap – cardboard boxes.
25 ml – plastic bottles (1) with a dropper cap – cardboard boxes.

Nasal Spray 0.05% as a clear, colorless solution.

Excipients: benzalkonium chloride – 0.11 mg, sodium phosphate dibasic dihydrate – 3 mg, disodium edetate – 0.5 mg, sodium phosphate monobasic dihydrate – 2.8 mg, sodium chloride – 7 mg, purified water – up to 1 ml.

15 ml – plastic bottles (1) with a valve system and spray nozzle – cardboard boxes.

Nasal Spray 0.1% as a clear, colorless solution.

Excipients: benzalkonium chloride – 0.11 mg, sodium phosphate dibasic dihydrate – 3 mg, disodium edetate – 0.5 mg, sodium phosphate monobasic dihydrate – 2.8 mg, sodium chloride – 7 mg, purified water – up to 1 ml.

15 ml – plastic bottles (1) with a valve system and spray nozzle – cardboard boxes.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Alpha-adrenomimetic

Pharmacological Action

Vasoconstrictor drug with alpha-adrenomimetic activity for topical use in ENT practice.

It causes constriction of the blood vessels of the nasal mucosa, eliminating edema and hyperemia, restores the patency of the nasal passages and facilitates breathing.

The effect of the drug occurs a few minutes after its application and lasts up to 10 hours.

Pharmacokinetics

When applied topically, the drug is practically not absorbed, so its concentration in blood plasma is so low that it cannot be determined by modern analytical methods.

Indications

• Acute respiratory diseases with symptoms of rhinitis (runny nose);
• Acute allergic rhinitis;
• Sinusitis;
• Otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• Rhinoscopy.

ICD codes

Dosage Regimen

The drug should not be used continuously for more than 3-5 days.

Nasal Drops

Adults and children over 6 years are administered 2-3 drops of 0.1% xylometazoline solution into each nasal passage 3-4 times/day.

Children from 2 to 6 years are prescribed 0.05% xylometazoline solution, 1-2 drops into each nasal passage 1-2 times/day. Should not be used more than 3 times/day.

Rules for drug administration

Unscrew and remove the cap, and by slightly pressing the body of the bottle, instill the solution into the nose.

Nasal Spray

Adults and children over 6 years use 1 spray of 0.1% xylometazoline solution from the dispenser into each nasal passage 3-4 times/day.

Children from 2 to 6 years use 1 spray of 0.05% xylometazoline solution from the dispenser into each nasal passage 1-2 times/day. Should not be used more than 3 times/day.

Rules for drug administration

Before use, remove the protective cap and press the sprayer several times until the stream becomes even. During subsequent use, the spray dispenser can be used without prior preparation. To perform the spraying correctly, hold the sprayer vertically so that the nozzle is pointing upwards. Then place the nozzle into the nostril, quickly and sharply press the sprayer once and remove it from the nostril. During spraying, inhale a little air through the nose for optimal distribution of the drug.

Adverse Reactions

From the respiratory system with frequent and/or prolonged use – irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion; rarely – swelling of the nasal mucosa.

From the cardiovascular system palpitations, increased blood pressure.

From the central nervous system headache, insomnia, depression (with long-term use in high doses).

Other vomiting, visual impairment.

Contraindications

• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Glaucoma;
• Atrophic rhinitis;
• Hyperthyroidism;
• Surgical interventions on the meninges (in history);
• Concomitant use with MAO inhibitors;
• Concomitant use with tricyclic antidepressants;
• Pregnancy;
• Children under 6 years of age (for 0.1% solution);
• Children under 2 years of age (for 0.05% solution);
• Hypersensitivity to xylometazoline.

With caution the drug should be used in patients with diabetes mellitus, angina pectoris III-IV functional class, prostatic hyperplasia, during lactation (breastfeeding).

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy.

Suprima-NOS should be used with caution during lactation.

Pediatric Use

Contraindication: children under 6 years of age (for 0.1% solution); children under 2 years of age (for 0.05% solution).

Special Precautions

The drug should not be used for a long time, for example, in chronic rhinitis.

Effect on the ability to drive vehicles and mechanisms

Xylometazoline in doses exceeding the recommended ones may affect the ability to drive a vehicle or operate machinery.

Overdose

Symptoms intensification of side effects.

Treatment symptomatic under medical supervision.

Drug Interactions

Enhancement of the systemic effect is possible with simultaneous use with MAO inhibitors and tricyclic antidepressants.

Storage Conditions

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

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.