Ryaltris spray is used for seasonal allergic rhinitis.
Active ingredient: olopatadine hydrochloride and mometasone furoate.
1 dose contains 665 mcg of olopatadine hydrochloride equivalent to 600 mcg of olopatadine and mometasone furoate monohydrate equivalent to 25 mcg of mometasone furoate.
Excipients: microcrystalline cellulose and sodium carboxymethyl cellulose; sodium phosphate, heptahydrate; sodium carboxymethyl cellulose; sodium chloride, benzalkonium chloride 50% solution of benzalkonium chloride, Trilon B; polysorbate 80 hydrochloric acid; sodium hydroxide water for injection.
Hypersensitivity to olopatadine hydrochloride, mometasone furoate or other components of the preparation.
Having an untreated localized infection of the nasal mucosa.
Due to the inhibitory effect of corticosteroids on wound healing, patients who have recently suffered from nasal septal ulcers, nasal surgery or nasal trauma should not use Ryaltris until complete recovery.
The preparation is intended for intranasal use only.
Adults and children over 12 years of age, the recommended dose is 2 injections into each nostril 2 times a day.
After intranasal use of antihistamines, cases of ulceration in the nasal cavity and perforation of the nasal septum have been reported.
After intranasal use of corticosteroids, isolated cases of perforation of the nasal septum have been reported.
After intranasal use of antihistamines and corticosteroids, cases of epistaxis have been reported.
In clinical studies of mometasone furoate, which was administered intranasally, in some cases the development of a localized fungal infection of the nose and throat (Candida albicans) was observed. In case of a fungal infection, the use of the drug Ryaltris should be discontinued and appropriate treatment initiated. Patients who have been using Ryaltris for several months or longer should be periodically examined for Candida infection or other signs of adverse effects on the nasal mucosa. No cases of Candida infection have been reported in clinical trials of Ryaltris .
Pregnancy
Special studies of the action of the preparation Ryaltris during pregnancy and lactation have not been carried out.
Children
There is insufficient clinical experience with the use of the preparation in children under the age of 12, so it should not be used in patients of this age category.
Drivers
During the treatment of Ryaltris, patients should be warned about the need to refrain from work that requires increased concentration of attention and speed of reactions, for example, operating mechanisms or driving vehicles.
No cases of overdose with Rialtris have been reported. Accordingly, there is no data on the consequences of acute or chronic overdose. Ryaltris contains a combination of olopatadine hydrochloride and mometasone furoate; therefore, the risks associated with an overdose of individual components described below apply to Ryaltris .
An acute overdose of this dosage form is unlikely, since one vial of Rialtris, intended for use for 30 days (240 doses), contains approximately 160 mg of olopatadine hydrochloride and 6 mg of mometasone furoate.
Olopatadine hydrochloride: Symptoms of an antihistamine overdose may include drowsiness in adults and first agitation and hyperactivity, followed by drowsiness in children. There is no specific antidote for olopatadine hydrochloride. In case of overdose, symptomatic and supportive treatment is recommended.
Mometasone furoate: due to the low systemic bioavailability and the absence in clinical studies of acute systemic manifestations associated with the use of the preparation, it is unlikely that an overdose will require other therapy than observation. Intranasal administration of 1600 mg (8 times the recommended daily dose of mometasone furoate in Ryaltris ) daily for 29 days in healthy volunteers did not show an increase in the frequency of side effects. In a study involving volunteers who used single intranasal doses of 4000 mcg and oral inhalation doses of 8000 mcg, no adverse reactions were observed. Chronic overdose of any of the corticosteroids can lead to symptoms of hypercortisolism.
The safety data described below reflects the use of Ryaltris in 3,062 patients with seasonal allergic rhinitis in clinical trials of 2 weeks duration.
From the nervous system: dysgeusia, often; dizziness, lethargy, drowsiness, anxiety, insomnia are rare.
Infections and invasions: pharyngitis, respiratory tract infections - rarely.
Respiratory, chest and mediastinal disorders: cough, dry nose, nasal discomfort, throat irritation, wheezing - rarely.
From the gastrointestinal tract: dry mouth, abdominal discomfort, vomiting - rarely.
On the part of the skin and subcutaneous tissue: rash, itching, contact dermatitis - often.
After intranasal use of corticosteroids in some cases, side effects may be observed, namely:
from the immune system: immediate allergic reactions (eg bronchospasm, shortness of breath), anaphylactic reactions, angioedema
on the part of the organs of vision: glaucoma, increased intraocular pressure, cataracts, blurred vision.
In a long-term clinical safety study (52 weeks of treatment), 593 patients with perennial allergic rhinitis reported the following side effects when using Ryaltris: allergic reactions, conjunctivitis, eye discomfort, diarrhea, nausea, constipation, headache and fatigue.
No specific preparation interaction studies have been conducted with a combination of fixed doses of olopatadine hydrochloride and mometasone furoate in the form of a nasal spray. It is expected that any preparation interactions of this combination will be similar to those of the individual components, since the pharmacokinetic interaction of olopatadine and mometasone furoate, used in combination, is not observed.
Store at a temperature not exceeding 25 ° C. Do not freeze. Do not refrigerate. Keep out of the reach of children.
Shelf life is 2 years.
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