Ryaltris

/ K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

The usual recommended dose is two actuations in each nostril twice daily (morning and evening).
For full details see prescribing information.

For the treatment of moderate to severe nasal symptoms associated with allergic rhinitis in adults and adolescents 12 years of age and older.

* Hypersensitivity to the active substances or to any of the excipients.
* Should not be used in the presence of untreated localised infection involving
the nasal mucosa, such as herpes simplex.
* Patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.

Local Nasal Effects
Instances of nasal ulceration and nasal septal perforation have been reported in
patients following the intranasal application of antihistamines.
Instances of nasal septal perforation have been reported following the intranasal application of corticosteroids.
Patients using this medical product over several months or longer should be examined periodically for possible changes in the nasal mucosa.
This medical product is not recommended in case of nasal septum perforation.
Instances of epistaxis have been reported in patients following the intranasal
application of antihistamines and corticosteroids.
In clinical studies with mometasone furoate administered intranasally, the
development of localised infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of treatment with this medical product. Patients using this medical product over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Visual disturbances
Visual disturbance may be reported with systemic and topical (including, intranasal) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Hypersensitivity Reactions
Hypersensitivity reactions, including instances of wheezing, may occur after the
intranasal administration of mometasone furoate monohydrate and olopatadine
hydrochloride. Discontinue if such reactions occur.
Antihistamine effects
Concomitant use of olopatadine (e.g. eyes drops) or other antihistaminic drugs
administered via nasal, ocular or oral route may increase the risk of antihistamine adverse effects.
For full details see prescribing information.

Common: Dysgeusia (unpleasant taste), Epistaxis, Nasal discomfort.
For full details see prescribing information.

No interaction studies have been performed.
For full details see prescribing information.

Pregnancy: There are no or limited amount of data from the use of mometasone furoate in pregnant women. There are no or limited amount of data from the use of intranasal olopatadine in pregnant women.
Lactation: It is unknown whether mometasone furoate is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast
feeding for the child and the benefit of therapy for the woman.
For full details see prescribing information.

With the nasal route of administration overdose reactions are not anticipated.
No data are available in humans regarding overdose by accidental or deliberate
ingestion.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
There is no known specific antidotes to active components.
In the case of overdose, appropriate monitoring and supportive management of the patient should be implemented.