Snup^® Extra (Spray) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Takeda GmbH (Germany)

Or

Curida AS (Norway)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Xylometazoline (Rec.INN registered by WHO)

Ipratropium bromide (Rec.INN registered by WHO)

Dosage Form

Snup® Extra

Dosed nasal spray 84 mcg+70 mcg/1 dose: 10 ml (60 doses) bottle with dosing device

Dosage Form, Packaging, and Composition

Dosed nasal spray in the form of a clear, colorless or slightly colored liquid.

Excipients: disodium edetate dihydrate, glycerol (85%), concentrated hydrochloric acid, sodium hydroxide, purified water.

10 ml – plastic bottles with a pump dosing device (1) – cardboard packs.

Clinical-Pharmacological Group

Decongestant drug

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics, combinations without corticosteroids

Pharmacological Action

Combined drug for topical use in ENT practice.

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

It causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasopharyngeal mucosa. It facilitates nasal breathing in rhinitis.

Ipratropium bromide has an anticholinergic effect.

When used intranasally, it reduces the secretion of the glands of the nasal mucosa, stopping a “runny” nose due to competitive inhibition of cholinergic receptors located in the nasal epithelium.

In therapeutic concentrations, it does not irritate the nasal mucosa and does not cause hyperemia.

The effect of the drug occurs within 5-10 minutes and lasts for 6-8 hours.

Pharmacokinetics

When used intranasally, ipratropium bromide and Xylometazoline hydrochloride are poorly absorbed and are present in the blood plasma in insignificant amounts.

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

The drug is used intranasally.

One spray of Snup^® Extra contains about 70 mcg of xylometazoline hydrochloride and 84 mcg of ipratropium bromide.

Adults over 18 years old – 1 spray into each nostril 2-3 times/day. At least 6 hours should pass between two sprays. The drug should not be used more than 3 times/day.

It is not recommended to use the drug for more than 5-7 days.

Before the first use of the spray, press the pump dosing device several times until a full dose is released.

With further use, additional activation of the dosing device is not required.

If uneven dosing of the spray is observed or the break in using the drug was more than 9 days, it is necessary to press the pump dosing device several times again to activate it until a full dose is released.

It is recommended to stop treatment immediately after the symptoms are relieved, even if this occurs earlier than 7 days (maximum duration of therapy), in order to minimize the risk of adverse events.

Experience of use in elderly patients (over 70 years old) is limited.

Adverse Reactions

Classification of the frequency of adverse reactions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000), including isolated reports and reactions with unknown frequency (cannot be estimated from the available data).

Immune system disorders frequency unknown – hypersensitivity reactions (anaphylactic reaction, angioedema, rash, itching, laryngospasm).

Nervous system disorders common – taste disturbance, headache; uncommon – smell disorders, dizziness, tremor; very rare – insomnia, convulsions, hallucinations.

Eye disorders uncommon – eye irritation, dry eye; frequency unknown – increased intraocular pressure, mydriasis, eye pain, photopsia, worsening of angle-closure glaucoma, impaired visual acuity, pupil dilation, halo effect (presence of rainbow circles around a light source in the field of vision).

Cardiac and vascular disorders uncommon – palpitations, supraventricular tachycardia, arterial hypertension; very rare – arrhythmic pulse; frequency unknown – atrial fibrillation.

Respiratory, thoracic and mediastinal disorders very common – epistaxis, irritation and/or dryness of the nasal mucosa; common – burning sensation, tingling, nasal hypersecretion, sneezing, nasal congestion (with frequent and/or prolonged use of the drug), dry throat, throat irritation, rhinalgia, rhinorrhea; uncommon – ulcer of the nasal mucosa, sneezing, pharyngeal pain, cough, dysphonia; frequency unknown – discomfort in the paranasal sinus area, laryngospasm, pharyngeal edema.

Gastrointestinal disorders common – dry mouth; uncommon – dyspepsia, nausea; frequency unknown – difficulty swallowing.

Skin and subcutaneous tissue disorders frequency unknown – itching, skin rash, urticaria.

Renal and urinary disorders frequency unknown – difficulty urinating.

General disorders and administration site conditions uncommon – discomfort, fatigue; frequency unknown – chest discomfort, thirst.

If any of the side effects listed in the instructions get worse, or if other side effects not listed in the instructions are noticed, the patient should inform the doctor.

Contraindications

• Hypersensitivity to xylometazoline, ipratropium bromide or any of the excipients of the drug;
• Hypersensitivity to atropine or similar compounds (hyoscyamine, scopolamine);
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Hyperthyroidism;
• Glaucoma;
• Atrophic rhinitis;
• Condition after transsphenoidal hypophysectomy;
• Condition after surgical interventions on the meninges (in history);
• Pregnancy;
• Breastfeeding period;

• Use of monoamine oxidase (MAO) inhibitors (including 14 days after their discontinuation), tricyclic or tetracyclic antidepressants;
• Age under 18 years.

With caution: diabetes mellitus; severe cardiovascular diseases (including coronary artery disease, angina); prostatic hyperplasia; pheochromocytoma; porphyria; bladder neck obstruction; interureteric fold stenosis; hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure; long QT syndrome.

Caution is recommended in the treatment of patients prone to nosebleeds, paralytic ileus and patients with cystic fibrosis.

Caution is recommended when using the drug in patients with a history of immediate-type hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, laryngeal edema and anaphylactic reactions.

Rare cases of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) have been described during therapy with sympathomimetic drugs.

Symptoms included sudden onset of severe headache, nausea, vomiting and visual disturbances.

In most cases, the condition improved or the phenomenon resolved within a few days after appropriate treatment.

If symptoms of PRES or RCVS develop, Snup^® Extra should be discontinued immediately and medical attention should be sought.

If the patient has one of the above diseases, a doctor’s consultation is necessary before using the drug Snup^® Extra.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Experience of use in elderly patients (over 70 years old) is limited.

Special Precautions

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

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

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

Long-term use of xylometazoline can cause swelling of the nasal mucosa and increased secretion, which is due to the development of increased sensitivity of cells to the active substances of the drug, the so-called “rebound” effect.

Avoid getting the drug into the eyes or around the eyes.

In case of contact, temporary blurred vision, irritation, pain, redness of the eyes may occur, and an exacerbation of angle-closure glaucoma may develop.

In case of contact with the eyes, rinse them thoroughly with cold water and consult a doctor if there is eye pain or blurred vision.

If the symptoms of the disease worsen or the patient’s condition does not improve within 3 days of treatment with Snup^® Extra, it is necessary to consult a doctor.

Effect on the ability to drive vehicles and operate machinery

In case of development of systemic side effects (headache, palpitations, increased blood pressure, visual impairment), it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms after intranasal use of the drug, acute overdose is unlikely, because the absorption of the drug is extremely insignificant.

In case of xylometazoline overdose, the clinical picture is characterized by: dizziness, nausea, sweating, decreased body temperature, headache, bradycardia, accommodation disturbance, arterial hypertension, respiratory depression, coma, convulsions.

Arterial hypertension may be replaced by arterial hypotension.

Treatment symptomatic therapy should be carried out under medical supervision.

With excessive use of ipratropium bromide, overdose is unlikely due to the extremely insignificant absorption of the substance into the blood, but dry mouth, accommodation disturbance, tachycardia may develop.

Treatment is symptomatic.

Significant overdose can cause symptoms associated with the anticholinergic effect of the drug on the central nervous system, including hallucinations, for the elimination of which cholinesterase inhibitors are prescribed.

Appropriate supportive measures should be taken for any suspected overdose.

If necessary, immediate symptomatic treatment under medical supervision is indicated.

These measures should include monitoring the patient for 6 hours.

In case of severe poisoning with cardiac arrest, resuscitation should continue for at least 1 hour.

Drug Interactions

Simultaneous use of the drug with MAO inhibitors, tri- and tetracyclic antidepressants, as well as taking these drugs within the previous 2 weeks is contraindicated.

Simultaneous use within the previous 2 weeks of tri- and tetracyclic antidepressants and sympathomimetic drugs may enhance the sympathomimetic effect of xylometazoline, therefore it is contraindicated.

Sympathomimetic drugs cause the release of catecholamines, including norepinephrine, which has a vasoconstrictive effect, as a result of which blood pressure increases.

With a significant increase in blood pressure, treatment with Snup^® Extra should be discontinued and symptomatic treatment should be carried out.

With concomitant administration of other drugs with anticholinergic activity, the anticholinergic effect of ipratropium bromide may be enhanced.

Simultaneous use of beta-2-agonists with ipratropium bromide may lead to an increased risk of acute glaucoma in patients with a history of angle-closure glaucoma.

The above interactions were studied individually for both active substances included in the drug Snup^® Extra.

In combination for both active substances, the above interactions have not been studied.

Storage Conditions

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

Shelf Life

The shelf life is 3 years. Do not use after the expiration date

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.