Coolento powder sachet 4 mg 0.5 g No. 28




Kulento is a remedy for systemic use in obstructive airway diseases.
Indications for use
additional treatment of bronchial asthma in patients aged 6 months to 5 years with persistent mild to moderate asthma, inadequately controlled with inhaled corticosteroids, and with inadequate clinical control of asthma with short-acting β-adrenergic agonists used as needed; alternative treatment to low-dose inhaled corticosteroids for patients aged 2 to 5 years with persistent mild asthma, who have not had a recent serious asthma attack requiring oral corticosteroids, and who cannot use inhaled corticosteroids; prevention of asthma, the dominant component of which is exercise-induced bronchospasm, in patients aged 2 years and older.Composition
1 sachet contains montelukast (as montelukast sodium) 4 mg; excipients: mannitol (E 421), low-substituted hydroxypropylcellulose, magnesium stearate.Contraindication
Hypersensitivity to the active substance and/or to the excipients of the medicinal product.
Method of application
Dosage.
Children aged 6 months to 5 years should take 1 sachet (4 mg) once a day in the evening. No dose adjustment is required for this group of patients.
Clinical data on the efficacy of montelukast in patients with bronchial asthma aged 6 months to 2 years are limited.
In the absence of response to treatment, the use of the medicinal product should be discontinued.
The granules should be taken orally, either directly swallowed or mixed in a spoon with soft food at cold or room temperature (e.g., applesauce, ice cream, carrots, and rice).
Application features
The diagnosis of persistent bronchial asthma in children aged 6 months to 2 years should be established by a pediatrician or pulmonologist.
Patients should be advised that montelukast should never be used to treat acute asthma attacks and that they should always carry appropriate rescue medication. In the event of an acute attack, a short-acting inhaled β-agonist should be used. Patients should consult their physician as soon as possible if they require more short-acting β-agonist than usual.
You should not abruptly switch from inhaled or oral corticosteroid medications to this medication.
Pregnant women
This dosage form is used for children aged 6 months to 5 years.
Children
The drug is not recommended for use in children under 6 months of age, as the safety and effectiveness of montelukast in this age group have not been established.
Drivers
This dosage form is used for children aged 6 months to 5 years.
Overdose
In most cases of overdose, no adverse reactions were reported. The most frequently observed adverse reactions were consistent with the safety profile of montelukast and included abdominal pain, drowsiness, thirst, headache, vomiting, and psychomotor hyperactivity.
Side effects
From the nervous system: hyperkinesia.
Respiratory, thoracic and mediastinal disorders: asthma.
On the part of the digestive tract: abdominal pain, diarrhea.
Skin and subcutaneous tissue disorders: eczematous dermatitis, rash.
On the part of the body as a whole: thirst.
Storage conditions
Store at a temperature not exceeding 25°C in the original packaging and out of the reach of children.
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