RYALTRIS Nasal spray, suspension Ref.[50680] Active ingredients: Mometasone Olopatadine

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 Ryaltris over several months or longer should be examined periodically for possible changes in the nasal mucosa. Ryaltris is not recommended in case of nasal septum perforation (see section 4.8).

Instances of epistaxis have been reported in patients following the intranasal application of antihistamines and corticosteroids (see section 4.8).

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 Ryaltris. Patients using Ryaltris 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 Ryaltris if such reactions occur (see section 4.8).

Immunosuppression

Persons who are using drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

Systemic Effects of Corticosteroids

Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of Ryaltris should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and some patients may experience symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression). Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

Somnolence

Like other antihistamines, olopatadine may cause somnolence in same patients when absorbed systemically.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after administration of Ryaltris. Concurrent use of Ryaltris with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Somnolence has been reported following administration of Ryaltris in clinical studies (see section 4.8).

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.

Paediatric population

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist.

Excipients

Ryaltris contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

No interaction studies have been performed with Ryaltris.

Any drug drug interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, as no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination.

Olopatadine

No interactions between olopatadine and other drugs are expected (see section 5.2).

Mometasone Furoate

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Pregnancy

Mometasone Furoate

There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Olopatadine

There are no or limited amount of data from the use of intranasal olopatadine in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).

Ryaltris should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

Breast-feeding

Mometasone Furoate

It is unknown whether mometasone furoate is excreted in human milk

Olopatadine

Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3). A risk to the newborn/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ryaltris therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are only limited data with regard to fertility. There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but no effects on fertility.

There are no clinical data concerning the effect of olopatadine on fertility.

In isolated cases dizziness, lethargy, fatigue and somnolence may occur when using Ryaltris. In these cases, the ability to drive and use machines may be impaired. Alcohol may enhance this effect.

Summary of the safety profile

The most commonly reported adverse reaction during treatment with Ryaltris was dysgeusia (a substance-specific unpleasant taste), epistaxis and nasal discomfort.

Tabulated list of adverse reactions

The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) or not known (cannot be estimated from the available data).

^* reported with the use of corticosteroids.

Systemic effects of some nasal corticosteroids may occur, particularly when administered at high doses for prolonged periods (see section 4.4).

Growth retardation has been reported in children receiving nasal corticosteroids. Growth retardation may be possible in adolescents, too (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.