Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
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.


Effects on Driving

4.7        Effects on ability to drive and use machines
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.