Snup^® (Spray) Instructions for Use

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

Ursapharm Arzneimittel, GmbH (Germany)

Or

Famar Health Care Services Madrid, S.A.U. (Spain)

Or

Hemomont, LLC (Montenegro)

Quality Control Release

HEMOMONT, d.o.o. (Montenegro)

Or

HEMOFARM, A.D. (Serbia)

Or

Stada Arzneimittel, AG (Germany)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Snup®	Metered-dose nasal spray 45 mcg/1 dose: 15 ml bottle (150 doses) with spray system
		Metered-dose nasal spray 90 mcg/1 dose: 15 ml bottle (150 doses) with spray system

Dosage Form, Packaging, and Composition

Metered-dose nasal spray in the form of a colorless, transparent solution.

Excipients: sea water, potassium dihydrogen phosphate, purified water.

15 ml (150 doses) – polyethylene bottles (1) with spray system – cardboard packages.

Metered-dose nasal spray in the form of a colorless, transparent solution.

Excipients: sea water, potassium dihydrogen phosphate, purified water.

15 ml (150 doses) – polyethylene bottles (1) with spray system – cardboard packages.

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

Xylometazoline belongs to the group of topical vasoconstrictors (decongestants) with alpha-adrenomimetic activity.

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

The effect of the drug occurs 5-10 minutes after its application and lasts up to 12 hours.

Pharmacokinetics

When applied topically, the drug is practically not absorbed, so its concentration in the blood plasma is very low (not detectable by modern analytical methods).

Indications

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

ICD codes

Dosage Regimen

Intranasally.

Snup^® metered-dose nasal spray 45 mcg/dose

Children aged 2 to 5 years: 1 spray into each nostril 1-3 times/day.

Adults and children from 6 years: 1-2 sprays into each nostril 2-3 times/day.

Should not be used more than 3 times/day.

Snup^® metered-dose nasal spray 90 mcg/dose

Adults and children from 6 years: 1 spray into each nostril 2-3 times/day.

Should not be used more than 3 times/day.

In children, the drug should be used under adult supervision.

The last spray is recommended to be performed immediately before bedtime.

Before use, it is necessary to clear the nasal passages.

When applying, insert the nozzle into the nasal cavity and press once on the rim. Hold the bottle vertically. Do not spray horizontally or downwards. Immediately after spraying, a light inhalation through the nose is recommended. After use, close the bottle with the protective cap.

Each bottle should be used individually.

After completion of therapy, the drug can be re-prescribed only after several days.

The duration of use in children should be discussed with a doctor.

If improvement does not occur after treatment, or symptoms worsen, or new symptoms appear, the patient should consult a doctor.

The drug should be used only according to the indications, method of application, and doses specified in the instructions.

Adverse Reactions

Classification of the frequency of adverse reactions: very common (>1/10); common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10000 to <1/1000); very rare (<1/10000).

Immune system disorders very rare – hypersensitivity reactions (angioedema, rash, itching).

Nervous system disorders common – headache; rare – insomnia, depression (with long-term use in high doses); very rare – anxiety, fatigue, paresthesia, hallucinations and convulsions (mainly in children).

Sense organ disorders very rare – blurred vision.

Cardiovascular system disorders rare – palpitations, increased blood pressure; very rare – tachycardia, arrhythmia.

Respiratory system disorders common – irritation and/or dryness of the nasal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa; rare – after application of the drug, increased swelling of the nasal mucosa (reactive hyperemia), nosebleed may be observed.

Gastrointestinal system disorders common – nausea; rare – vomiting.

Local reactions common – burning at the application site.

If the patient experiences or worsens the above side effects, or notices any other side effects, they should inform the doctor.

Contraindications

• Hypersensitivity to xylometazoline and any other component of the drug;
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Increased intraocular pressure, especially angle-closure glaucoma;
• Atrophic rhinitis;
• Hyperthyroidism;
• Surgical interventions on the meninges (in history);
• Inflammatory diseases of the skin or mucous membrane of the nasal vestibule;
• Conditions after transsphenoidal hypophysectomy;
• Pregnancy;
• Children under 6 years of age (for metered-dose nasal spray 90 mcg/dose);
• Children under 2 years of age (for metered-dose nasal spray 45 mcg/dose).

Do not use during therapy with MAO inhibitors (including 14 days after their discontinuation), tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants), as well as other drugs that increase blood pressure.

With caution

Diabetes mellitus, severe cardiovascular diseases (including coronary artery disease, angina), prostatic hyperplasia, pheochromocytoma, porphyria, breastfeeding period, with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with long QT syndrome.

Use in Pregnancy and Lactation

During pregnancy, the use of the drug is contraindicated.

During breastfeeding, the drug should be used only after a thorough assessment of the risk-benefit ratio for the mother and child, it is not allowed to exceed the recommended dose. During breastfeeding, before using the drug Snup^®, it is necessary to consult a doctor.

Pediatric Use

Contraindication: children under 6 years of age (for metered-dose nasal spray 90 mcg/dose); children under 2 years of age (for metered-dose nasal spray 45 mcg/dose).

Special Precautions

The sea water, which is part of the drug, helps to maintain the normal physiological state of the nasal mucosa due to its ability to improve the function of the ciliated epithelium and normalize mucus production in the goblet cells of the mucosa.

It is not recommended to use continuously for more than 7 days.

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

Long-term (more than 7 days) use or overdose of xylometazoline can cause a weakening of the therapeutic effect of the drug, and also increases the risk of reactive hyperemia and atrophy of the nasal mucosa.

Patients with long QT syndrome receiving Xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

If the medicine has expired, it should not be disposed of in sewage or on the street. It is necessary to place the medicine in a trash container. These measures will help protect the environment.

Influence on the ability to drive vehicles and mechanisms

When the dosing regimen is followed, Xylometazoline does not affect concentration and the speed of psychomotor reactions.

Overdose

Symptoms of drug overdose, the clinical picture is an alternation of phases of CNS excitation (anxiety, agitation, hallucinations, convulsions) with phases of CNS depression (decreased body temperature, lethargy, drowsiness, coma). The following symptoms may also occur: miosis, mydriasis, increased sweating, increased body temperature, pallor, cyanosis, nausea and vomiting, tachycardia, bradycardia, cardiac arrhythmias, cardiac arrest, palpitations, increased blood pressure, decreased blood pressure up to shock, pulmonary edema, respiratory depression and apnea, psychogenic disorders.

In children with overdose, dominant central effects with convulsions, coma and bradycardia, apnea, as well as increased blood pressure followed by arterial hypotension are observed.

Treatment is symptomatic, under medical supervision.

In case of accidental ingestion of the drug – administration of activated charcoal, gastric lavage.

In case of severe overdose, intensive therapy in a hospital is indicated. In serious cases, non-selective alpha-blockers to reduce blood pressure, antipyretics, intubation and mechanical ventilation may be used.

Drug Interactions

Concomitant use of xylometazoline with MAO inhibitors, tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants), as well as other drugs that increase blood pressure, may lead to an increase in blood pressure, therefore the simultaneous use of these drugs is contraindicated. If the patient is taking the above or other medicines (including over-the-counter), before using the drug Snup^®, a doctor should be consulted.

Storage Conditions

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

Shelf Life

Shelf life – 5 years. Do not use after the expiration date.

After opening the bottle, the drug should be used within 12 months.

Dispensing Status

The drug is available without a prescription.

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.