Hypersensitivity to the active substance or any inactive component of the preparation. The preparation should not be used in the presence of untreated localized infection involving the nasal mucosa. due to the fact that corticosteroids have the ability to suppress wound healing, patients who have recently undergone surgery on the nasal cavity or have been injured cannot use nasal corticosteroids until healing occurs.
Nosebleeds generally stopped spontaneously, were minor and occurred somewhat more often than with placebo (5%), no more often than with other nasal corticosteroids, which were studied and used as active control (up to 15%), as reported in clinical studies of allergic rhinitis. the incidence of all other adverse reactions was comparable to the incidence of adverse reactions with placebo. in patients treated with nasal polyposis, the overall incidence of adverse reactions was similar to that observed in patients with allergic rhinitis.
The systemic effects of nasal corticosteroids are more likely to occur when used in high doses and over a long period.
The following are adverse reactions (≥1%) observed in clinical trials in patients with allergic rhinitis or nasal polyposis and during post-marketing use, regardless of the indication for use.
Adverse reactions are classified according to organ systems and frequency of occurrence. The incidence of adverse reactions is defined as follows: very often (≥1 / 10); often (≥1 / 100, 1/10); infrequently (≥1 / 1000, 1/100). The incidence of adverse reactions in post-marketing studies was considered unknown (cannot be estimated from the available data).
Infections and infestations: often - pharyngitis, upper respiratory tract infections 1.
From the immune system: unknown - hypersensitivity, including anaphylactic reactions, angioedema, bronchospasm and shortness of breath.
From the nervous system: often - headache.
From the side of the organ of vision: unknown - glaucoma, increased intraocular pressure, cataract, blurred vision.
On the part of the respiratory system, chest and mediastinal organs: very often - nosebleeds2; often - nosebleeds, burning sensation of the nasal mucosa, irritation of the nasal mucosa, ulceration of the nasal mucosa; unknown - perforation of the nasal septum.
From the gastrointestinal tract: often - throat irritation2; unknown - disturbances in taste and smell.
1 Has been reported when used twice a day for the treatment of nasal polyposis.
2 Has been reported infrequently when used twice daily for the treatment of nasal polyposis.
Children. In children, the frequency of reported adverse reactions in clinical trials, for example, nosebleeds (6%), headache (3%), irritation of the nasal mucosa (2%) and sneezing (2%), was comparable to that with placebo.
Special instructions
The use of the preparation in young children should be carried out with the help of adults.
The preparation should not be used in the presence of untreated local infection with involvement of the nasal mucosa in the process.
The preparation Mometasone-Teva should be used with caution or not at all in patients with active or latent tuberculosis infection of the respiratory tract, as well as in untreated fungal, bacterial, systemic viral infections.
In patients using GCS, immunity can potentially be suppressed, and they should be warned of the increased risk of infection through contact with persons with certain infectious diseases (such as chickenpox, measles), as well as the need to consult a doctor if such contact takes place.
After 12 months of treatment with mometasone furoatom, there were no signs of atrophy of the nasal mucosa; in addition, mometasone furoate contributed to the normalization of the histological picture of the nasal mucosa. As with any long-term treatment, patients who have been using the preparation for several months or longer should be periodically examined to identify possible changes in the nasal mucosa. In the event of the development of a local fungal infection of the nose or pharynx, it may be necessary to discontinue preparation therapy or conduct appropriate treatment. Irritation of the nasal and pharyngeal mucosa, which persists for a long time, may also be an indication for discontinuation of treatment.
The use of the preparation Mometasone-Teva is not recommended in the case of the development of perforation of the nasal septum.
In clinical studies, the incidence of nosebleeds was higher compared with placebo. Epistaxis was generally mild and stopped spontaneously.
Mometasone-Teva contains benzalkonium chloride as a preservative, which may cause nasal irritation.
Systemic effects of nasal corticosteroids may occur, in particular when high doses are used, intended for long-term use. These manifestations occur much less frequently than with the use of oral corticosteroids, they can be different in different patients and when taking different corticosteroids. Potential systemic effects may include Cushing's syndrome, cushingoid traits, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma, and, less commonly, a number of psychological or behavioral effects, in particular psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (in especially in children).
After the use of intranasal corticosteroids, cases of increased intraocular pressure have been reported.
Patients switching to nasal spray treatment after prolonged therapy with systemic corticosteroids should be carefully monitored. Discontinuation of systemic corticosteroids in these patients may cause adrenal insufficiency. If these patients show signs and symptoms of adrenal insufficiency or withdrawal syndrome (for example, joint and / or muscle pain, fatigue and depression), despite the disappearance of nasal symptoms, the use of systemic corticosteroids should be resumed along with other treatments and appropriate measures taken. With such a transition, pre-existing allergic conditions, such as allergic conjunctivitis and eczema, may also appear, the manifestation of which was previously suppressed by therapy with systemic GCS. With long-term treatment with Mometasone-Teva, there were no signs of suppression of the function of the hypothalamic-pituitary-adrenal system.
The use of doses in excess of the recommended ones can provoke clinically significant adrenal suppression. If there is evidence of the use of doses exceeding the recommended ones during periods of stress or planned operations, the likelihood of using additional systemic GCS should be considered.
The safety and efficacy of Mometasone-Teva when used to treat unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely cover the nasal cavity have not been studied.
For unilateral polyps that have an unusual or asymmetrical appearance, especially with ulcers and bleeding, further evaluation is necessary.
It is recommended to regularly measure the height of children receiving long-term treatment with nasal corticosteroids. If growth is slowed down, therapy should be revised in order to reduce the dose of nasal corticosteroids, if possible, to the minimum dose at which effective control of symptoms is maintained. In addition, the patient should be referred to a pediatrician for consultation.
Although the preparation controls nasal symptoms in most patients, the simultaneous use of appropriate concomitant therapy can lead to an additional reduction in the severity of other symptoms, in particular from the eye.
Such patients need to be specially convinced of the advisability of continuing the spray treatment. A change in therapy may also reveal allergic diseases (such as allergic conjunctivitis, eczema, etc.), which developed earlier and were masked by systemic GCS therapy.
It was reported that when using mometasone furoate in children at a daily dose of 100 μg for 1 year, growth retardation was not observed.
Patients should be warned to seek immediate medical attention if signs or symptoms of severe bacterial infection develop, such as fever, severe one-sided facial pain or toothache, orbital or periorbital swelling / edema, or worsening after initial improvement.
Long-term use of benzalkonium chloride can cause swelling of the nasal mucosa. In the event of such a reaction (constantly stuffy nose), if possible, preparations for nasal use without preservatives should be used; however, if such medicines are not available, a different dosage form should be chosen.
Use during pregnancy and lactation. Special studies of the preparation with the participation of pregnant women have not been conducted.
Like other corticosteroids for intranasal use, Mometasone-Teva is used in pregnant women and women who are breastfeeding only if the expected benefit from its use justifies the potential risk to the mother, fetus or infant. Infants whose mothers used GCS during pregnancy should be carefully examined for possible adrenal hypofunction.
It is not known whether mometasone furoate is excreted in breast milk. As with the use of other nasal corticosteroids, it is necessary to stop breastfeeding or stop / abstain from mometasone furoate nasal spray therapy, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.
There are no clinical data on the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but there is no effect on fertility.
The ability to influence the reaction rate when driving or working with other mechanisms. Unknown.
Interactions
The preparation was used concurrently with loratadine, with no effect on the plasma concentration of loratadine or its main metabolite, and mometasone furoate was not detected in the blood plasma even at the minimum concentration. the combination therapy was well tolerated by the patients.
Data on interactions with other preparations are not presented.
Overdose
Due to the fact that the systemic bioavailability of the drpreparation g is insignificant (1%), it is unlikely that in case of an overdose, other measures will be required, besides monitoring the patient's condition, followed by the use of the preparation at the recommended dose.
Inhalation or oral administration of excessive doses of GCS can lead to inhibition of the function of the hypothalamic-pituitary-adrenal system.
Storage conditions
At a temperature not exceeding 25 ° c. do not freeze.