Momixon spray nasal suspension 50 mcg / dose, 140 doses — Made in Poland — Free Delivery

Product description

Nasal spray "Momikson" is used for the following indications:

• treatment of seasonal or perennial allergic rhinitis in adults and children over 3 years of age;
• treatment of nasal polyps in patients over 18 years of age.

Compound

The active ingredient is mometasone furoate monohydrate (one spray dose contains mometasone furoate monohydrate 0.05173 g, which is equivalent to mometasone furoate 50 mcg).

Excipients: benzalkonium chloride solution, glycerin, polysorbate 80, microcrystalline cellulose, croscarmellose sodium, citric acid, monohydrate, sodium citrate, purified water.

Contraindications

hypersensitivity to the active substance or to any of the components of the preparation;

the preparation should not be used if there is an untreated localized infection involving the nasal mucosa (for example, herpes simplex);

Because corticosteroids have the effect of inhibiting wound healing, patients who have recently had nasal surgery or who have been injured should not be given a nasal corticosteroid until healing has taken place.

Mode of application

Before using a new vial of the preparation, it should be calibrated. Calibration is carried out by approximately 10 pushes of the dosing device, during which a stereotyped delivery of the preparation  is established, in which approximately 100 mg of a suspension containing 50 μg of mometasone (one dose) is emitted with each press. If the nasal spray is not used for 14 days or longer, a second “spray” with two presses must be observed before subsequent use until a complete delivery is observed.

Shake the bottle vigorously before each use.

A used bottle, as well as a bottle that was opened two months ago, should be thrown away.

Treatment of seasonal or year-round allergic rhinitis: for adults (including the elderly) and children over 12 years of age, it is recommended that the prophylactic and therapeutic dose of the preparation is 2 injections (50 μg each) into each nostril once a day (total daily dose - 200 μg). After achieving a therapeutic effect for maintenance therapy, it is advisable to reduce the dose to one injection into each nostril 1 time per day (total daily dose - 100 mcg).

If the weakening of the symptoms of the disease cannot be achieved by using the preparation at the recommended therapeutic dose, the daily dose can be increased to the maximum - 4 injections into each nostril 1 time per day (total daily dose - 400 mcg). After the symptoms of the disease have subsided, a dose reduction is recommended.

For children 3-11 years old, the recommended therapeutic dose is one injection (50 mcg) into each nostril 1 time per day (total daily dose - 100 mcg).

The preparation showed a clinically significant onset of action within 12 hours of first use in some patients with seasonal allergic rhinitis. However, the full benefit of the treatment cannot be obtained in the first 48 hours, so the patient must continue to use it regularly to achieve the full therapeutic effect.

Nasal polyps. Usually, the recommended initial dose of the preparation is 2 injections (50 mcg) into each nostril 1 time per day (total dose - 200 mcg). If after 5-6 weeks of using the preparation there is no improvement, the daily dose of the preparation can be increased to two doses of the spray in each nostril 2 times a day (total dose - 4 00 mcg).

The lowest dose should be used to effectively control symptoms. If after 5-6 weeks of using the preparation 2 times a day there is no improvement, the patient's condition should be re-evaluated and the possibility of changing the treatment should be considered.

Application features

Pregnant

Special studies of the effect of the preparation in pregnant women have not been carried out. Like other corticosteroids for intranasal use, the preparation Momixon is used by pregnant and lactating women only if the expected benefit from its use outweighs the potential risk to the mother, fetus or infant. Infants whose mothers have used corticosteroids during pregnancy should be carefully examined for possible adrenal hypofunction.

Children

When conducting studies in children in whom mometasone furoate was used in a daily dose of 100 mcg for a year, growth retardation was not observed. The safety and efficacy of Momixon in the treatment of nasal polyps in children and adolescents under the age of 18, seasonal or perennial allergic rhinitis in children under 3 years of age have not been investigated.

Overdose

Due to the fact that the systemic bioavailability of the preparation is <1% (according to the results of the sensitive lower quantitation method it is 0.25 pg / ml), it is unlikely that in case of an overdose, other measures will be required, except for monitoring the patient's condition, followed by the use of the preparation at the recommended dose.

Inhalation or oral administration of excessive doses of corticosteroids can lead to inhibition of the function of the hypothalamic-pituitary-adrenal system.

Side effects

Bleeding from the nose usually stops on its own and has a slight exacerbation, was observed more often compared with placebo (5%), but the incidence was similar or less compared to nasal corticosteroids used in the control group (up to 15%) in clinical trials in patients with allergic rhinitis. The incidence of other side effects was comparable to placebo. In patients undergoing treatment for nasal polyps, the overall incidence of side effects was comparable to that found in patients with allergic rhinitis.

The following side effects caused by the use of the preparation are classified according to the frequency of their development: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); rarely (≥ 1/10000 to <1/1000); very rare (<1/10000); the frequency is unknown (cannot be estimated from the available data).

Infections and parasitic infestations: often - pharyngitis, upper respiratory tract infections.

From the immune system: the frequency is unknown - hyperesthesia, including anaphylactic reactions, angioedema, bronchospasm and shortness of breath.

From the nervous system: often - headache.

From the side of the organs of vision: the frequency is unknown - glaucoma, increased intraocular pressure, cataract.

From the respiratory system, chest and mediastinum: very often - nosebleeds; often - nosebleeds, burning sensation in the nose, irritation of the nasal mucosa, nasal ulcers; frequency unknown - perforation of the nasal septum.

From the digestive system: often - throat irritation; frequency unknown = impairment of taste and smell.

In children, the incidence of adverse events, including nosebleeds (6%), headache (3%), nasal irritation (2%) and sneezing (2%), was comparable to that with placebo.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Shelf life is 2 years.

The shelf life after opening the bottle is 2 months.