Rhinonorm Comfort (Spray) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Rhinonorm Comfort	Metered dose nasal spray 0.1 mg+5 mg/dose: 10 ml bottle
		Metered dose nasal spray 0.05 mg+5 mg/dose: 10 ml bottle

Dosage Form, Packaging, and Composition

Metered dose nasal spray as a transparent, almost colorless solution.

Excipients : sodium phosphate heptahydrate (disodium phosphate heptahydrate) – 0.0225 mg, potassium dihydrogen phosphate – 0.855 mg, purified water – 95.372 mg.

10 ml (90 doses) – polyethylene bottles (1) with a metered dose spray device – cardboard packs^×.

^× protective stickers may additionally be applied.

Metered dose nasal spray as a transparent, almost colorless solution.

Excipients : sodium phosphate heptahydrate (disodium phosphate heptahydrate) – 0.0225 mg, potassium dihydrogen phosphate – 0.855 mg, purified water – 95.322 mg.

10 ml (90 doses) – polyethylene bottles (1) with a metered dose spray device – 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, combinations without corticosteroids

Pharmacological Action

Combined medicinal product for topical application.

Xylometazoline belongs to the group of topical vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes constriction of the blood vessels of the nasal mucosa, restores the patency of the nasal passages, and facilitates nasal breathing. The drug’s effect usually begins within a few minutes after application and lasts up to 10 hours.

Dexpanthenol is a B group vitamin – a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A and is involved in acetylation processes, carbohydrate and fat metabolism, and in the synthesis of acetylcholine, corticosteroids, and porphyrins; it stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers. It has a regenerating, metabolic, and weak anti-inflammatory effect.

Pharmacokinetics

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

Dexpanthenol is rapidly absorbed through the skin when applied topically and is converted into pantothenic acid, which binds to plasma proteins (mainly to beta-globulin and albumin). Its concentration in blood is 0.5-1 mg/L, in blood serum – 100 µg/L. Pantothenic acid is not metabolized in the body (except for incorporation into CoA) and is excreted unchanged.

Indications

Acute respiratory diseases with symptoms of rhinitis; acute allergic rhinitis; vasomotor rhinitis; sinusitis; otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa); to facilitate rhinoscopy; to restore impaired nasal breathing after surgical interventions in the nasal cavity.

ICD codes

Dosage Regimen

For intranasal use only.

Administer 3-4 times per day into each nostril.

Limit the duration of treatment to a maximum of 5 days.

Do not exceed the recommended dosage or frequency of administration.

Before first use, prime the spray pump by pressing it several times until a fine mist is produced.

Before each application, gently blow your nose to clear the nasal passages.

Keep your head upright; do not tilt it backwards.

Close one nostril by pressing it with a finger.

Insert the tip of the spray into the open nostril.

Press down firmly on the pump while breathing in gently through your nose.

Repeat the procedure for the other nostril.

Wipe the spray tip clean after each use.

Discontinue use and consult a physician if symptoms persist or worsen after 5 days.

Avoid contamination of the spray tip by keeping it clean and not touching it with your fingers.

Adverse Reactions

With frequent and/or prolonged use: irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, swelling of the nasal mucosa, vomiting, headache, dry rhinitis, palpitations, increased blood pressure, insomnia, visual disturbances, depression (with long-term use of high doses).

Contraindications

Arterial hypertension; tachycardia; severe atherosclerosis; atrophic rhinitis; hyperthyroidism; porphyria; prostatic hyperplasia; glaucoma; surgical interventions on the meninges (in history); children under 2 years of age; children under 6 years of age (for dosage forms intended for older children and adults); simultaneous therapy with MAO inhibitors and tricyclic antidepressants; hypersensitivity to the components of the medicinal product.

With caution

Diabetes mellitus, pheochromocytoma.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is not recommended.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

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

Should not be used for more than 5 days.

Effect on ability to drive vehicles and operate machinery

During the period of use, precautions should be observed, or driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions should be avoided.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in systemic action is possible.

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.