Momat Rino Advance, 1 piece, 140 mcg+50 mcg/dose, metered nasal spray
As with any long-term treatment, patients using Momat Rhino Advance nasal spray for several months or longer should be periodically examined by a doctor for possible changes in the nasal mucosa, perforation of the nasal septum (very rare) and the possible development of systemic side effects. If a local fungal infection of the nose or throat develops, it may be necessary to discontinue treatment with Momat Rhino Advance nasal spray and undergo special treatment. If persistent irritation of the nasopharynx develops, it is necessary to decide on stopping therapy.
Patients who switch to treatment with Momat Rhino Advance nasal spray after long-term treatment with systemic GCS require special attention. Withdrawal of systemic corticosteroids in such patients can lead to insufficient adrenal function, the subsequent recovery of which may take up to several months. If signs of adrenal insufficiency appear, systemic corticosteroids should be resumed and other necessary measures taken.
During the transition from treatment with systemic corticosteroids to treatment with Momat Rhino Advance nasal spray, some patients may experience initial withdrawal symptoms of systemic corticosteroids (for example, joint and/or muscle pain, fatigue and depression), despite a decrease in the severity of symptoms associated with the lesion. nasal mucosa; such patients must be specifically convinced of the advisability of continuing treatment with Momat Rhino Advance nasal spray. The transition from systemic to local GCS can also reveal allergic diseases such as allergic conjunctivitis and eczema that already existed but were masked by systemic GCS therapy.
When intranasal steroids are used in doses higher than recommended, or when used in sensitive patients at recommended doses, systemic effects of corticosteroids and adrenal suppression may occur. If such changes occur, the use of Momat Rhino Advance nasal spray should be gradually discontinued in accordance with the procedures adopted for stopping the use of oral corticosteroids.
Patients undergoing treatment with corticosteroids have a potentially reduced immune reactivity and should be warned about their increased risk of infection in case of contact with patients with certain infectious diseases (for example, chicken pox, measles), as well as the need for medical advice if such contact occurs .
If signs of a severe bacterial infection appear (for example, fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), immediate medical consultation is required.
GCS for nasal and inhalation use can cause the development of glaucoma and/or cataracts. Therefore, patients with changes in vision, as well as patients with a history of elevated IOP, glaucoma and/or cataracts, should be closely monitored.
Impact on the ability to drive vehicles and engage in other activities.
In rare cases, fatigue, fatigue, dizziness and weakness, which may be a consequence of the disease itself, may develop when using Momat Rhino Advance nasal spray. In such cases, you should avoid driving a vehicle and working with complex mechanisms.
Momat Rhino Advans
The list of adverse events below is based on data from clinical studies in seasonal and perennial allergic rhinitis, as well as data from post-registration use of individual components of the drug.
Seasonal allergic rhinitis
In a clinical study conducted in 560 patients aged 12 to 65 years with seasonal allergic rhinitis. 282 patients received azelastine hydrochloride + mometasone furoate (nasal spray) for an average of 14.94 days.
Overall, the safety profile of azelastine hydrochloride + mometasone furoate nasal spray was comparable to the profiles of the individual components used as monotherapy in the study, and was also consistent with the available published data on monotherapy with the individual components of the combination. A total of 18 adverse events associated with the use of azelastine hydrochloride + mometasone furoate nasal spray were reported in 11 of 282 patients. The most common adverse events recorded in the study were headache (5 cases) and dysgeusia (5 cases). Other adverse events were drowsiness (3 cases), lethargy (2 cases), nausea (1 case), dyspepsia (1 case) and sneezing (1 case). Most of these adverse events were mild in severity, and no serious adverse events were reported during the study.
In another clinical study conducted on 220 patients with seasonal allergic rhinitis, 55 patients received azelastine hydrochloride + mometasone furoate nasal metered spray, 1 spray in each nostril twice a day in the morning and evening, 55 patients received azelastine hydrochloride + nasal metered spray. mometasone furoate 2 injections into each nostril once a day, 55 patients dosed spray mometasone furoate and 55 patients dosed spray azelastine hydrochloride. The duration of treatment with these drugs was 14 days. During the entire study period, adverse events were identified in 51 participants (23%). During the study, the following adverse events were noted: drowsiness (0.9%), bitter taste in the mouth (3.6%), headache (2.7%), nosebleeds (1.8%), burning sensation in the nose after use ( 9.5%), sneezing after use (4.1%), increased appetite (0.5%), dry nose (4.1%), abnormal test results (0.9%), swelling of the nasal mucosa ( 0.5%), nasal congestion (0.5%), rhinorrhea (0.9%), sinus arrhythmia (0.9%), redness of the hands (red spots) (0.5%), dry eyes (0.5%), 5%), hemorrhagic exanthema (0.5%), abnormal urinalysis (0.5%), swelling of the eyelids (0.5%), burning sensation in the eye area (0.5%) and loss of smell (0.5%), 5%). Mild adverse events accounted for 74.5%, and moderate adverse events accounted for 25.5% of the total number of adverse events.
Year-round allergic rhinitis
In a clinical study conducted in 150 patients with perennial allergic rhinitis. 75 patients received azelastine hydrochloride nasal metered spray + mometasone furoate, and 75 patients received combination therapy of azelastine hydrochloride nasal metered spray and mometasone furoate nasal metered spray from different devices. The duration of treatment with these drugs was 28 days. During the entire study period, 51 adverse events were reported in 23 of 150 patients (15.33%). The most common adverse events reported in the study were headache (10 cases), nosebleeds (6 cases), excessive sneezing (5 cases), and mucosal burning sensation (4 cases). Most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study. A comparative analysis of the observed adverse events in the groups revealed no differences between the groups. During the study, 94.74% (18/19) of mild adverse events and 5.26% (1/19) of moderate adverse events were observed in the group of patients receiving azelastine hydrochloride + mometasone furoate nasal metered spray.
The following are adverse drug events reported with the use of individual components of the fixed-dose combination.
According to the World Health Organization (WHO), adverse events are classified based on systemic organ classes according to the frequency of their development as follows:
| Often | ≥ 1/10 |
| often | from≥ 1/100 to |
| infrequently | from≥ 1/1000 to |
| rarely | from≥ 1/10000 to |
| very rarely |
frequency unknown - based on available data, it is not possible to determine the frequency of occurrence.
Azelastine hydrochloride
Often:
after use, a substance-specific bitter taste may be felt (often due to improper use, namely by excessively tilting the head back during use), which in rare cases can cause nausea.
Infrequently:
Mild, transient irritation of the inflamed nasal mucosa may occur, with symptoms such as burning, itching, sneezing and nosebleeds.
Very rarely:
Hypersensitivity reactions (such as rash, itching, urticaria), anaphylactoid reactions, dizziness, fatigue, drowsiness, weakness (may be due to the disease itself) have been reported.
Mometasone furoate
Adverse events associated with the use of the drug (≥1%) identified during clinical trials in patients with allergic rhinitis or nasal polyposis, and during post-registration use of the drug, regardless of the indication for use, are presented below. Overall incidence of adverse events in patients treated for acute rhinosinusitis. was comparable to the incidence in patients with allergic rhinitis and when prescribed placebo.
Nosebleeds, as a rule, were moderate and stopped on their own, the frequency of their occurrence was slightly higher than when using placebo (5%), but equal or less than when prescribing other intranasal corticosteroids, which were used as an active control (in some of In them, the incidence of nosebleeds was up to 15%). The incidence of all other adverse events was comparable to that observed with placebo.
Infectious and parasitic diseases:
often - pharyngitis, upper respiratory tract infections*
Immune system disorders:
frequency not established - hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath.
Nervous system disorders:
often - headache.
Visual disorders:
frequency not established - increased intraocular pressure, glaucoma, cataracts, blurred vision (blurred vision).
Disorders of the respiratory system, chest and mediastinal organs:
very often - nosebleeds**; often - nosebleeds (i.e. obvious bleeding, as well as the release of blood-stained mucus or blood clots), burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa; frequency not established - perforation of the nasal septum.
Gastrointestinal disorders:
often - pharyngeal irritation (feeling of irritation of the pharyngeal mucosa)**; frequency not established - disturbance of taste and smell.
* — detected with a frequency of “rarely” when using the drug 2 times a day for nasal polyposis;
** — detected when using the drug 2 times a day for nasal polyposis.
When using intranasal corticosteroids, systemic side effects may develop, especially with long-term use of intranasal corticosteroids in high doses.
If you experience the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
