Instruction for medical use
the Trade name
the International unlicensed
name Mometazon Lekarstvennaya a form
Spray nasal dosed 50 mkg / a dose – 140 doses
One dose contains
active agent – a mometazon furoate monohydrate in the number of equivalent 50 mkg of a mometazon of furoate (anhydrous),
excipients: disperse cellulose, glycerin, citrate sodium a dihydrate, acids lemon, polysorbate-80, a benzalkoniya chloride, water purified.
Suspension represents opaque liquid of white or almost white color.
of Antikongenstanta and other nasal drugs for topical administration. Glucocorticoids.
ATX R01AD09 code.
Pharmacokinetics Bioavailability properties of a mometazon of furoate at use in the form of nasal spray very low (
Active ingredient of the drug Nazonex of a mometazon furoate – a synthetic corticosteroid for topical administration with the significant anti-inflammatory action. Local anti-inflammatory action of a mometazon of furoate is shown in such doses at which there are no system effects.
The mechanism of anti-inflammatory and antiallergenic action of a mometazon of furoate is connected with its ability to reduce discharge of mediators of allergic reactions. It is also powerful inhibitor of products Th2 of cytokines, IL-4 and IL-5. nasal NAZONEKSâ spray shows high anti-inflammatory activity at an early and late stage of allergic reaction.
– seasonal or year-round allergic rhinitis at adults and children since 2 years
– prevention of allergic rhinitis of an average and heavy course
(it is recommended in 2 – 4 weeks prior to the expected beginning of a season of blossoming)
– exacerbation of sinusitis at adults (including senile age) and children from 12 years (supportive application at antibiotic treatment)
– treatment of symptoms of the sharp rinosinusit without symptoms of a heavy bacterial infection at adults and children since 12 years
– nasal polyps and the related symptoms, including congestion of a nose and loss of sense of smell, at patients since 18 years.
The route of administration and doses
Before the first use of nasal NAZONEKSâ spray need to be carried out its calibration by pressing of the portioning device of 6 – 7 times. After ‘calibration’ the stereotypic supply of medicinal substance at which to each pressing of the button there is an emission about 100 mg of the suspension containing 50 mkg of a mometazon (one dose) is established. If nasal spray was not used within 14 days or longer, repeated calibration is necessary.
Before each use it is necessary to stir up a spray bottle vigorously.
If the nozzle was hammered, it is necessary to remove a plastic cap, carefully pressing a white ring, it is easy to remove a nozzle and to wash it with cold flowing water, to dry up and establish on the former place.
Prevention and treatment of seasonal or year-round allergic rhinitis: to adult patients (including advanced age) and to teenagers from 12 years the recommended preventive and therapeutic dose of drug makes 2 injections (on 50 mkg everyone) in each nostril of 1 times a day (general daily dose of 200 mkg). After achievement of medical effect for maintenance therapy the reduction of a dose to 1 injection in each nostril of 1 times a day (general daily dose of 100 mkg) is reasonable.
If reduction of symptoms of a disease does not manage to be reached use of drug in the recommended therapeutic dose, the daily dose can be increased as much as possible up to 4 injections in each nostril of 1 times a day (general daily dose of 400 mkg). After reduction of symptoms of a disease the dose decline is recommended.
The beginning of clinical effect is noted within 12 hours after the first use of drug.
For children of 2 – 11 years the recommended therapeutic dose makes 1 injection (50 mkg) in each nostril of 1 times a day (general daily dose of 100 mkg).
Exacerbation of sinusitis (supportive application at antibiotic treatment)
the Adult (including advanced age) and to children from 12 years the recommended therapeutic dose makes 2 injections (on 50 mkg) in each nostril 2 times a day (general daily dose of 400 mkg).
If reduction of symptoms of a disease does not manage to be reached use of drug in the recommended therapeutic dose, the daily dose can be increased up to 4 injections in each nostril 2 times a day (general daily dose of 800 mkg). After reduction of symptoms of a disease the dose decline is recommended.
Treatment of symptoms of the sharp rinosinusit without symptoms of a heavy bacterial infection
to Adults and children aged from 12 years the recommended therapeutic dose makes 2 vspryskivaniye (50 mkg) in each nostril 2 times a day (general daily dose-400 of mkg)
Nasal polyps and the related symptoms, including congestion of a nose and loss of sense of smell
Patients from 18 years (including for patients of advanced age) – the recommended dose makes 2 injections (50 mkg) in each nostril 2 times a day (the general daily dose – 400 mkg). After achievement of clinical effect it is recommended to reduce a dose to 2 injections in each nostril of 1 times a day (the general daily dose – 200 mkg).
– a headache
– nasal bleedings (i.e. obvious bleeding and also discharge of bloody slime or clots), burning sensation in a nose, irritation and ulcer changes of a mucous membrane of a nose
– very seldom noted anaphylactic reactions and a Quincke’s disease
– isolated cases of disturbances of taste and sense of smell.
– hypersensitivity to active agent or to any of inactive components of nasal spray.
nasal NAZONEKS® spray was appointed along with loratadiny, at the same time changes of plasma concentration of a loratadin or its main metabolite were not noted and also furoate was not defined in blood of a mometazon. These drugs patients transferred the combined therapy well.
There are no data on interaction with other drugs.
instructions NAZONEKS should not be applied in the presence of not treated local infection with involvement in process of a mucous membrane of a nose.
Because corticosteroids slow down healing of wounds, it is not necessary to appoint such drugs for topical intranasal administration by the patient which transferred surgery or an injury of a nose before full healing of wounds recently.
NAZONEKS should be applied with care or not to apply at patients with an active or latent tuberculosis infection of a respiratory path and also in not treated fungal, bacterial infection, a system viral infection or in herpes simplex infection with damage of eyes.
After 12-month treatment NAZONEKSOM there were no symptoms of a mucosal atrophy of a nose, besides, a mometazona furoate contributed to normalization of a histologic picture of a mucous membrane of a nose. The patients applying NAZONEKS within several months and longer have to have periodically examination regarding detection of possible changes of a mucous membrane of a nose. In case of development of a local fungal infection of a nose or a throat it is necessary to stop therapy NAZONEKSOM or be carried out special treatment. The irritation of a mucous membrane of a nose and throat remaining for a long time can also be the indication to the termination of treatment NAZONEKSOM.
At long-term treatment NAZONEKSOM of signs of oppression of function gipotalamo – the hypophysial and adrenal system was not observed. Careful medical observation of the patients passing to treatment with the NAZONEX nasal spray after long therapy by corticosteroids of systemic action is necessary. The termination of reception of corticosteroids of systemic action at such patients can result in insufficiency of function of bark of adrenal glands that can demand therapy resuming by system corticosteroids and uses of other corresponding treatment.
During transition from treatment by corticosteroids of systemic action to treatment NAZONEKSOM some patients, along with simplification of nasal symptoms, can have symptoms of cancellation of corticosteroids (for example, joint and/or muscles pain, feeling of fatigue and a depression). Such patients need to be convinced specially of expediency of continuation of treatment by NAZONEKS spray. Change of therapy can also reveal allergic diseases (such as allergic conjunctivitis, eczema, etc.) which developed earlier and masked therapy by corticosteroids of systemic action.
The patients applying corticosteroids can potentially have reduced immune responsiveness and have to be warned about the increased risk of infection in case of contact with sick some infectious diseases (for example, chicken pox, measles) and also about need of consultation of the doctor if such contact happened.
It is necessary to warn patients about need of the immediate address to the doctor in case of signs or symptoms of a heavy bacterial infection, such as fervescence, severe unilateral pain in a face or a toothache, an orbital or periorbital swelling / puffiness, or aggravation of symptoms after preliminary improvement.
Children. Use of drug for children of younger age has to be carried out by means of adults.
When carrying out placebo – the controlled clinical trials at the children applying NAZONEKS in a daily dose of 100 mkg within a year, the growth inhibition of children was not noted.
Safety and efficiency NAZONEKSA at treatment of nasal polyps at children and teenagers were not investigated 18 years, rinosinusit symptoms – at children aged up to 12 years, seasonal or year-round allergic rhinitis – at children under 2 years are younger.
The period of pregnancy and feeding
Special researches of effect of drug at pregnant women were not conducted by a breast. After intranasal use of drug in the maximum therapeutic dose mometazon is not defined in blood plasma even in the minimum concentration. Therefore, it is possible to expect that influence of drug on a fruit will be insignificant, and potential reproductive toxicity – very low. However, as well as other corticosteroids to intranasal use, NAZONEKS it is applied at the pregnant women and women nursing only if the expected advantage of its use justifies potential risk for mother, a fruit or the child. Babies whose mothers during pregnancy applied corticosteroids should be examined carefully regarding possible hypofunction of adrenal glands.
Influence on ability to run transport or potentially dangerous mechanisms
In the recommended dose NAZONEKS® spray does not affect ability to run transport or potentially dangerous mechanisms.
Owing to small (≤ 0.1%) system bioavailability of the drug NAZONEKSâ overdose is improbable. In case of overdose the observation of the patient with the subsequent use of drug in the recommended dose is necessary.
A form of release and packing
Spray nasal dosed 50mkg/dose – 140 standard doses in polyethylene bottle No. 1 together with the instruction for medical use in the state and Russian languages enclosed in a cardboard box.
To Store storage conditions at a temperature not above +25 °C. Not to freeze!
To store out of children’s reach!
A period of storage
not to use drug after the expiration date specified on packing.
According to the prescription
the Producer: N.V. Labo’s Shering-Plau, Heyst – op – den – Berg, Belgium,
own branch of the Shering-Plau Corporation/the USA.
Distributor: Shering-Plau Central East AG, Lucerne, Switzerland.
The address, ph. / fax of representation in Kazakhstan: Almaty, Ablaykhan Ave. 81, ph. 279-67-63, ph. / fax 279-62-73