Rinetazon^® Kombo (Spray) Instructions for Use

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Lek Pharmaceuticals, d.d. (Slovenia)

ATC Code

R01AD59 (Mometasone in combination with other drugs)

Active Substances

Azelastine (Rec.INN registered by WHO)

Mometasone (Rec.INN registered by WHO)

Dosage Form

Rinetazon® Kombo

Dosed nasal spray 140 mcg/dose+50 mcg/dose

Dosage Form, Packaging, and Composition

Dosed nasal spray

10 g (60 doses) – bottles – cardboard packs – Over-the-Counter
17 g (120 doses) – bottles – cardboard packs – Over-the-Counter
18 g (140 doses) – bottles – cardboard packs – Over-the-Counter

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other preparations for topical use; corticosteroids

Pharmacological Action

A combined preparation with anti-allergic and anti-inflammatory action for topical use.

Azelastine is a histamine H₁-receptor blocker, a phthalazinone derivative. It has antihistamine, anti-allergic, and membrane-stabilizing effects, reduces capillary permeability and exudation, inhibits the release of inflammatory mediators from mast cells (histamine, serotonin, leukotrienes, platelet-activating factor, etc.) that cause bronchospasm and contribute to the development of the early and late stages of allergic reactions and inflammation.

Mometasone is a synthetic topical glucocorticosteroid. It exerts anti-inflammatory and anti-allergic effects when used in doses that do not cause systemic effects. It inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which leads to a decrease in the release of arachidonic acid and, consequently, suppression of the synthesis of arachidonic acid metabolites – cyclic endoperoxides, prostaglandins. Prevents marginal neutrophil accumulation, which reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, leading to a reduction in infiltration and granulation processes. Reduces inflammation by reducing the formation of chemotaxis substance (effect on late allergic reactions), inhibits the development of an immediate-type allergic reaction (due to inhibition of the production of arachidonic acid metabolites and reduced release of inflammatory mediators from mast cells).

Indications

Seasonal allergic rhinitis in adults (from 18 years of age).

ICD codes

Dosage Regimen

Administer the preparation intranasally.

Prime the spray pump before first use by releasing several actuations into the air until a fine mist appears.

Shake the bottle gently before each use.

Blow your nose to clear the nasal passages prior to administration.

Tilt your head slightly forward and insert the nozzle into one nostril.

Close the opposite nostril by pressing with a finger.

Press down firmly on the pump to release one dose while breathing in gently through the nose.

Repeat this procedure for the other nostril.

The standard dosage for adults is one spray (140 mcg azelastine hydrochloride / 50 mcg mometasone furoate) into each nostril twice daily, in the morning and in the evening.

Wipe the nozzle clean after each use and replace the dust cap.

Do not exceed the prescribed dosage.

The recommended treatment duration is two weeks.

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

Avoid contact with eyes; rinse thoroughly with water if contact occurs.

Adverse Reactions

Nervous system disorders: headache, dizziness.

Respiratory system disorders: nosebleeds, nasal cavity discomfort (burning sensation, itching), ulceration of the nasal mucosa, sneezing, pharyngitis, sinusitis, upper respiratory tract infections.

Digestive system disorders: dysgeusia, nausea.

Skin and subcutaneous tissue disorders: rash, skin itching, urticaria.

Allergic reactions: hypersensitivity, anaphylactoid reactions.

Other: irritation of the pharyngeal mucosa, fatigue, drowsiness, weakness.

With long-term use of glucocorticosteroids in high doses, the development of systemic side effects is possible, including glaucoma and cataract.

Contraindications

Recent surgery or nasal trauma with damage to the nasal mucosa – until the wound has healed (due to the inhibitory effect of glucocorticosteroids on the healing process); children and adolescents under 18 years of age (due to lack of relevant data); hypersensitivity to azelastine and mometasone.

With caution: respiratory tuberculosis (active and latent); untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye involvement (as an exception, the use of the preparation for these infections may be possible as prescribed by a doctor); untreated infection involving the nasal mucosa.

Use in Pregnancy and Lactation

Adequate and well-controlled studies of the preparation in pregnant women have not been conducted.

In experimental studies, azelastine hydrochloride had a toxic effect on the fetus in mice, rats, and rabbits.

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

Pediatric Use

The use of the preparation is contraindicated in children and adolescents under 18 years of age (due to lack of relevant data).

Drug Interactions

Azelastine – no clinically significant interaction with other medicinal products was identified with the intranasal use of azelastine.

Mometasone furoate – combined therapy with loratadine was well tolerated by patients. No effect of the preparation on the concentration of loratadine or its main metabolite in blood plasma was noted.

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.