DLIANO^®S (Drops) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Healthcare, JSC (Russia)

Manufactured By

Sandoz CJS (Russia)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	DLIANO®S	Nasal drops for children 0.05%: 10 ml bottle with dropper cap
		Nasal spray 0.1%: 10 ml bottle with sprayer

Dosage Form, Packaging, and Composition

Nasal drops for children 0.05% as a clear, colorless, odorless solution.

Excipients: benzalkonium chloride – 0.11 mg, sodium dihydrogen phosphate dihydrate – 2.8 mg, disodium hydrogen phosphate dodecahydrate – 3 mg, disodium edetate – 0.5 mg, sodium chloride – 7 mg, distilled water – up to 1 ml.

10 ml – dark glass bottles (1) with a dropper cap in a sealed bag – cardboard packs.

Nasal spray 0.1% as a clear, colorless, odorless solution.

Excipients: benzalkonium chloride – 0.11 mg, sodium dihydrogen phosphate dihydrate – 2.8 mg, disodium hydrogen phosphate dodecahydrate – 3 mg, disodium edetate – 0.5 mg, sodium chloride – 7 mg, distilled water – up to 1 ml.

10 ml – bottles with a low-density polyethylene sprayer (1) with a cap equipped with a first-opening control system – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – alpha-adrenomimetic

Pharmacological Action

Vasoconstrictor drug for topical use in ENT practice. Xylometazoline belongs to the group of topical decongestants with alpha-adrenomimetic action.

Xylometazoline causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasopharyngeal mucosa.

The drug facilitates nasal breathing in rhinitis. At therapeutic concentrations, it does not irritate the mucous membrane and does not cause hyperemia.

The effect occurs within a few minutes and lasts up to 10 hours.

Pharmacokinetics

When applied topically, it is practically not absorbed; plasma concentrations are below the detection limit.

Indications

• Acute respiratory diseases with symptoms of rhinitis (runny nose);
• Acute allergic rhinitis;
• Hay fever;
• Sinusitis;
• Eustachitis;
• Otitis media (to reduce swelling of the nasopharyngeal mucosa);
• Preparation of the patient for diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Intranasally.

Nasal spray 0.1% is prescribed for adults and children over 12 years old, 1 spray from the sprayer into each nostril, should not be used more than 3 times/day.

To perform the spray correctly, hold the sprayer vertically with the nozzle pointing upwards.

Then place the nozzle into the nostril, quickly and sharply squeeze the bottle, and remove the nozzle without releasing the bottle.

During spraying, inhale a little air through the nose, which contributes to the optimal administration of the drug.

Nasal drops 0.05% are prescribed for children from 2 to 5 years old, 1-2 drops into each nostril 1-3 times/day, should not be used more than 3 times/day.

Children from 6 to 11 years old – 2-4 drops into each nostril 2-3 times/day, should not be used more than 3 times/day. The drug in children should be used under adult supervision.

Adverse Reactions

Classification of the frequency of side effects (WHO): very common >1/10; common from >1/100 to <1/10; uncommon from >1/1000 to <1/100; rare from >1/10000 to <1/1000; very rare <1/10000, including isolated reports.

From the immune system very rarely – hypersensitivity reactions (angioedema, rash, itching).

From the nervous system often – headache; rarely – insomnia, depression (with long-term use in high doses).

From the sensory organs very rarely – blurred vision.

From the cardiovascular system rarely – palpitations, increased blood pressure; very rarely – arrhythmia, tachycardia.

From the respiratory system often – irritation or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa.

From the digestive system: often – nausea; rarely – vomiting.

Local reactions often – burning sensation at the application site.

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Glaucoma;
• Atrophic rhinitis;
• Hyperthyroidism;
• Conditions after transsphenoidal hypophysectomy;
• Surgical interventions on the meninges (in history);
• Pregnancy;
• Children under 12 years of age (for nasal spray 0.1%), children under 2 years of age (for nasal drops for children 0.05%);
• Hypersensitivity to xylometazoline and other components of the drug.

With caution: diabetes mellitus, cardiovascular diseases, prostatic hyperplasia, with hypersensitivity to adrenergic drugs, accompanied by symptoms of insomnia, dizziness, cardiac arrhythmia, tremor, increased blood pressure.

Use in Pregnancy and Lactation

The drug should not be used during pregnancy.

During lactation, the drug should be used with caution. The drug should be used only after a thorough assessment of the risk-benefit ratio for the mother and fetus. It is not allowed to exceed the recommended dosage.

Pediatric Use

The use of the drug is prohibited for children under 12 years of age (for nasal spray 0.1%), and for children under 2 years of age (for nasal drops for children 0.05%).

Nasal drops 0.05% are prescribed for children from 2 to 5 years old, 1-2 drops into each nostril 1-3 times/day, should not be used more than 3 times/day.

Nasal spray 0.1% is prescribed for children over 12 years old, 1 spray from the sprayer into each nostril, should not be used more than 3 times/day.

Special Precautions

It is not recommended to use continuously for more than 10 days.

The recommended doses should not be exceeded, especially in children and the elderly.

Long-term (more than 10 days) or excessive use of the drug may cause a “rebound” effect (medication-induced rhinitis).

Influence on the ability to drive vehicles or equipment

Xylometazoline, in doses exceeding the recommended ones, may affect the ability to drive vehicles or equipment.

Overdose

Symptoms intensification of side effects, in particular, tachycardia, arrhythmia, increased blood pressure, sometimes confusion may be observed.

Treatment symptomatic, under medical supervision.

Drug Interactions

Incompatible with MAO inhibitors and tricyclic antidepressants.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°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.