Singulyar of the tab. zhev. 5 mg No. 28

Chewable tablets "Singulyar ^® " are applied at the following indications:

• as additional treatment at bronchial asthma at patients with persistent asthma of easy and average degree which is insufficiently controlled by inhalation corticosteroids and also at insufficient clinical control of asthma by means of agonists of β-adrenoceptors of short action which apply if necessary;
• as an alternative method of treatment instead of low doses of inhalation corticosteroids for patients with persistent asthma of easy degree at which did not note the serious attacks of bronchial asthma demanding application of oral corticosteroids and also which cannot apply inhalation corticosteroids recently;
• prevention of asthma which dominating component is the bronchospasm induced by physical activity;
• relief of symptoms of seasonal and year-round allergic rhinitis.

Structure

Active ingredient - montelukast (one chewable tablet contains montelukast of sodium 5.2 mg (equivalent of montelukast of 5 mg)).

Excipients: mannitol (E 421), cellulose microcrystalline, hydroxypropyl cellulose, iron oxide red (E172), sodium of a kroskarmelloz, fragrance cherry, aspartame (E 951), magnesium stearate.

Contraindication

Hypersensitivity to any of medicine components.

Tablet to chew

before swallowing.

to Patients with asthma and allergic rhinitis (seasonal and year-round) needs to take one chewable tablet of 5 mg of 1 times a day. For relief of symptoms of allergic rhinitis time of reception is selected individually.

For treatment of asthma the dose for children aged from 6 up to 14 years makes one chewable tablet (5 mg) a day, in the evening. "Singulyar ^® " should be accepted in 1 hour prior to food or in 2 hours after a meal. There is no need for dose adjustment for this age group.

General recommendations

Therapeutic influence of medicine "Singulyar ^® " steps on indicators of control of asthma within one day. Patients should recommend to continue to take the medicament "Singulyar ^® " even if will reach control of asthma and also during the periods of exacerbation of asthma.

need for dose adjustment for patients with a renal failure or with abnormal liver functions easy and moderate severity. There are no data on patients with an abnormal liver function of heavy severity. The dosage is identical to boys and girls.

As an alternative method of treatment instead of low-dose inhalation corticosteroids at persistent asthma of easy degree

as monotherapy at patients with persistent asthma of average degree. Montelukast use as alternatives of low-dose inhalation corticosteroids at children with persistent asthma of easy degree should be considered only for patients who had no serious attacks of asthma demanding application of oral corticosteroids and who cannot apply inhalation corticosteroids lately. Persistent asthma of easy degree is defined as emergence of symptoms of asthma is more often than once a week, but is more rare than once a day, emergence of night symptoms is more often than two times a month, but normal function of lungs in the periods between episodes is more rare than once a week. If sufficient control of asthma is not reached further (usually within one month) it is necessary to define need of additional or other anti-inflammatory therapy, based on the consecutive system of treatment of asthma. It is necessary to estimate periodically a condition of patients on control of asthma.

When medicine "Singulyar ^® " is applied by

as additional therapy to inhalation corticosteroids, it is not necessary to replace with Singulyar®medicine inhalation corticosteroids sharply.

Feature of application

Pregnant women

Research on animals an adverse effect on pregnancy or embryonic/fetal development. The available data from the published prospective and retrospective cohort researches using montelukast did not establish by pregnant women who estimate significant congenital defects at children risk of the medicine connected with application. The available researches have methodological restrictions, including the small size of sample, in certain cases retrospective data collection, and incompatible groups of comparison.

Research on rats was shown that montelukast gets into milk. It is unknown, montelukast with breast milk at women is removed. This medicament can be used during feeding by a breast, only if it is considered necessary certainly.

Children

to children aged from 6 up to 14 years.

Drivers

it is not expected p that montelukast will affect ability of the patient to steer motor transport or other mechanisms. However it was very seldom reported about drowsiness or dizziness.

Any special information on overdose treatment by medicine "Singulyar ^® " is not present

. During the researches of chronic asthma, montelukast was appointed in doses to 200 mg/days to adult patients within 22 weeks, and in short-term researches - up to 900 mg/days within about one week, at the same time clinically important side reactions did not arise. At post-marketing application and at clinical trials, messages about sharp overdose by medicine "Singulyar ^® " arrived. They included intake of medicine by adults and children in the doses exceeding 1000 mg (the child has about 61 mg/kg at the age of the 42nd month). Received clinical and datas of laboratory corresponded to safety profile at adult patients and children. In most cases the overdose was not reported about side reactions. Side reactions which corresponded to a profile of safety of medicine "Singulyar ^® " were most often observed and included: abdominal pain, drowsiness, thirst, headache, vomiting and psychomotor hyperactivity.

Does not know to

whether montelukast by means of peritoneal dialysis or a hemodialysis is removed.

Side effects

Montelukast was estimated by

during clinical trials: chewable tablets of 5 mg applied about 1750 children aged from 6 up to 14 years.

during clinical trials the side below-mentioned reactions were observed by

often (from ≥ 1/100 to <1/10) at the patients receiving treatment by montelukast and also with a bigger frequency, than at the patients receiving placebo treatment.

Disturbance from nervous system: headache.

Storage conditions

to Store

in original packing at a temperature not above 30 °C, out of children's reach.

Expiration date - 2 years.