Rhinonorm (Spray) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

Or

Merckle, GmbH (Germany)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Rhinonorm	Dosed nasal spray (for children) 35 mcg/1 dose: 20 ml bottle with a dosing device and nasal applicator
		Dosed nasal spray 140 mcg/1 dose: 20 ml bottle with a dosing device and nasal applicator

Dosage Form, Packaging, and Composition

Dosed nasal spray (for children) in the form of a transparent, almost colorless solution.

Excipients : benzalkonium chloride (as a 50% solution) – 0.028 mg (in terms of benzalkonium chloride – 0.014 mg), citric acid monohydrate – 0.035 mg, sodium citrate dihydrate – 0.182 mg, glycerol 85% – 1.68 mg, purified water – up to 68.39 mg.

20 ml – dark glass bottles (1) with a dosing spray device, nasal applicator, and protective cap – cardboard packs^×.

^× protective stickers may additionally be applied.

Dosed nasal spray in the form of a transparent, almost colorless solution.

Excipients : benzalkonium chloride (as a 50% solution) – 0.056 mg (in terms of benzalkonium chloride – 0.028 mg), citric acid monohydrate – 0.07 mg, sodium citrate dihydrate – 0.364 mg, glycerol 85% – 3.36 mg, water for injections – up to 136.71 mg.

20 ml – dark glass bottles (1) with a dosing spray device, nasal applicator, and protective cap – cardboard packs^×.

^× protective stickers may additionally be applied.

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

A vasoconstrictor agent for topical use in ENT practice. An alpha-adrenomimetic. When applied to the mucous membranes, it causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasal mucosa, and restores the patency of the nasal passages. In rhinitis, it facilitates nasal breathing.

Pharmacokinetics

When applied topically, it is practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.

Indications

To reduce swelling of the nasopharyngeal mucosa and discharge in acute allergic rhinitis, acute respiratory infections with symptoms of rhinitis, sinusitis, hay fever, otitis media; preparation of the patient for diagnostic procedures in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally. Select the appropriate dosage form based on patient age.

For the adult formulation (140 mcg/dose): Administer one spray into each nostril. Repeat up to three times daily as needed.

For the pediatric formulation (35 mcg/dose): For children aged 2 to 6 years, administer one spray into each nostril. Repeat up to two times daily as needed. For children aged 6 to 12 years, administer one spray into each nostril. Repeat up to three times daily as needed.

Do not exceed the recommended frequency or duration of use. The maximum duration of continuous use is 7 days.

Prior to first use, prime the spray pump by pressing it several times until a fine mist is produced. Tilt head slightly forward. Insert the nozzle into the nostril, pointing away from the nasal septum. Press firmly to release the spray while breathing in gently through the nose.

For pre-procedural use, administer as directed by a physician to reduce mucosal edema prior to diagnostic procedures.

Adverse Reactions

From the immune system uncommon – hypersensitivity reactions (angioedema, skin rash, itching).

From the digestive system rare – nausea, vomiting.

From the nervous system: rare – headache; very rare – insomnia, anxiety, fatigue, hallucinations and convulsions (mainly in children).

From the organ of vision very rare – blurred vision.

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

Local reactions common – irritation and/or dryness of the nasopharyngeal mucosa, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the nasal mucosa; uncommon – swelling of the nasal mucosa, nosebleeds, withdrawal syndrome. Increased swelling of the nasal mucosa (reactive hyperemia) is possible.

Contraindications

Hypersensitivity to xylometazoline; atrophic rhinitis, thyrotoxicosis; inflammatory diseases of the skin or mucous membrane of the nasal vestibule; condition after transsphenoidal hypophysectomy; patients with severe cardiovascular diseases (e.g., coronary artery disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis); patients with a history of surgical interventions on the meninges; patients receiving MAO inhibitors or other drugs that can cause an increase in blood pressure; patients with increased intraocular pressure, especially with angle-closure glaucoma; during therapy with tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants); pregnancy; pediatric age – depending on the dosage form.

With caution patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with pheochromocytoma, porphyria; patients with endocrine diseases (e.g., hyperthyroidism, diabetes mellitus); patients with prostatic hyperplasia; during lactation (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy. During lactation, use is possible only as prescribed by a doctor, after a thorough assessment of the ratio of the intended benefit for the mother to the potential risk for the child. Exceeding the recommended doses is not allowed.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug labels for xylometazoline regarding contraindications for use in children of different ages for specific dosage forms of xylometazoline. The recommended doses should not be exceeded in children.

Geriatric Use

The recommended doses should not be exceeded in elderly patients.

Special Precautions

Long-term use (more than 7 days) and overdose of sympathomimetics with a decongestant effect can lead to reactive hyperemia of the nasal mucosa. As a result, difficulty in nasal breathing occurs, which leads to the patient starting to use xylometazoline repeatedly or even constantly. This can lead to chronic swelling (medicinal rhinitis), and ultimately even to atrophy of the nasal mucosa (ozena).

In milder cases, to improve the patient’s condition, it is possible to first stop the administration of the sympathomimetic into one nostril, and after the complaints decrease, continue to administer it into the other nostril, in order to at least partially ensure nasal breathing.

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

Effect on the ability to drive vehicles and operate machinery

With long-term treatment or when using xylometazoline in higher doses, the possibility of its systemic action cannot be excluded. In case of systemic side effects, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Enhancement of the systemic action of xylometazoline is possible with simultaneous use of MAO inhibitors and tricyclic antidepressants. Simultaneous use of xylometazoline with tetracyclic antidepressants, other topical vasoconstrictors (decongestants), as well as other drugs that increase blood pressure is incompatible.

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.