Indications for use

• addition to the basic therapy of bronchial asthma in patients aged over 15 years with persistent asthma of mild to moderate severity (in case of insufficient clinical effect of treatment with inhaled corticosteroids and short-acting β-agonists used if necessary)
• treatment of patients with aspirin-sensitive bronchial asthma and prevention of bronchospasm, induced by exercise
• treatment of allergic rhinitis in patients with bronchial asthma.

List of information required before commencement of use
Contraindications

• hypersensitivity to the active ingredient substance or any of the excipients
• pregnancy and lactation
• Children and adolescents under the age of 15 years
• hereditary intolerance galactose, Lapp lactase enzyme deficiency, glucose-galactose malabsorption.

Necessary precautions when administration
Treatment with Montelukast 10 mg depending on other treatments for asthma
When Montelukast 10 mg is used as an adjunctive therapy as adjunctive therapy to inhaled corticosteroids, the dose should not be drastically reduce the dose or discontinue inhaled corticosteroids.
Inhaled corticosteroidsLetero 10 mg should not replace inhaled corticosteroids.
General recommendations
The therapeutic effect of the drug on measures of bronchial asthma control develops within 1 day. Patients should be advised to continue taking Montelukast 10 mg even if asthma control is achieved and during periods of worsening asthma. Montelukast 10 mg should not be taken concomitantly with other medicinal products, containing the same active ingredient, montelukast.
Patients should be aware that montelukast oral montelukast is never used for the treatment of acute attacks of asthma and that they should always carry the appropriate medication with them emergency medication. Inhaled short-acting β-agonists should be used during an acute attack. short-acting β-agonists. Patients should consult their doctor as soon as possible if they need a larger dose of short-acting β-agonist than usual.
Montelukast 10 mg should not dramatically replace inhaled or oral corticosteroids.
There is no evidence that the dose of oral corticosteroids may be reduced with concomitant use of montelukast.
Systemic eosinophilia, sometimes with clinical manifestations of vasculitis characteristic of Cerge-Strauss syndrome (a condition often treated with systemic corticosteroids), may occur in patients treated with antiasthmatic drugs, including montelukast 10 mg. Sometimes these cases are associated with withdrawal or dose reduction of oral corticosteroids. A link between treatment with leukotriene receptor antagonists and the occurrence of Cherja-Strauss syndrome cannot be excluded or confirmed. However, if symptoms such as eosinophilia, vascular rash, worsening pulmonary symptoms occur, cardiac complications, and/or neuropathy, additional evaluation and reconsideration of treatment is necessary.
In patients with aspirin-sensitive asthma, treatment with montelukast does not affect the need for aspirin or other non-steroidal anti-inflammatory drugs.
Neuropsychiatric disorders
Mental disorders have been reported in adults, adolescents and children taking Montelukast 10 mg. Mental disorders include side effects such as: agitation, aggressive behavior, hostility, anxiety, depression, disorientation, impaired concentration, abnormal dreams, hallucination, insomnia, irritability, memory disturbances, restlessness, somnambulism, suicidal thoughts and attempts (including suicide), and tremor. Data from postmarketing reports are comparable to clinical data from drug therapy. Patients and healthcare professionals should be aware of the possibility of these events. Patients are advised to notify their physician if these side effects occur. The benefit-risk ratio for continuing therapy with Montelukast 10 mg should be evaluated if these adverse events occur.
Lactose
The drug Montelukast 10 mg contains lactose. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose absorption disorders are not recommended to use this drug.
Sodium
This preparation contains less than 1 mmol of sodium (23 mg) in one tablet, i.e. practically no sodium.

Interactions with other medicines and other interactions
Montelukast 10 mg can be used with other drugs that are commonly used for the prophylaxis and long-term treatment of asthma. In drug interaction studies, the recommended clinical dose of montelukast had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisolone, oral contraceptives (ethinylestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
The area under the plasma concentration curve (AUC) of montelukast was reduced by approximately 40% in patients who concomitantly administered phenobarbital.
Since montelukast is metabolized by CYP 3A4, 2C8 and 2C9, montelukast should be administered with caution, especially in children, concomitantly with CYP 3A4, 2C8 and 2C9 inducers such as phenytoin, phenobarbital and rifampicin.
Montelukast is a strong inhibitor of CYP 2C8. However, data from clinical drug interaction studies examining montelukast and rosiglitazone (a marker substrate representative of drugs metabolized predominantly via CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not expected to markedly affect the metabolism of drugs metabolized via this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide).
Laboratory studies have shown that montelukast is a substrate for CYP 2C8, and to a lesser extent for 2C9 and 3A4. Data from drug interaction studies involving montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) showed that gemfibrozil increased systemic sensitization to montelukast by 4.4-fold. No dose adjustments are required for montelukast when used concomitantly with gemfibrozil or other potential CYP 2C8 inhibitors, but physicians should be aware of the possibility of increased adverse reactions.
No clinically important drug interactions with other known CYP 2C8 inhibitors (e.g., trimethoprim) are anticipated. In addition, concomitant use of montelukast with itraconazole alone, which is a strong inhibitor of CYP3A4 does not significantly increase systemic sensitization to montelukast.

Special Warnings
Pediatric use
In children under 15 years of age, administration of Montelukast 10 mg is contraindicated, due to the fact that the safety and efficacy of the drug in children under 15 years of age have not been established.
During pregnancy or lactation
If you are pregnant or breast-feeding, think you are pregnant, or plan to have a baby, consult your doctor or pharmacist before taking Montelukast 10 mg.
Montelukast 10 mg may be used during pregnancy or breast-feeding only if absolutely necessary.
Peculiarities of the effect of the medicinal product on the ability to drive a vehicle or potentially dangerous mechanisms
Montelukast 10 mg is not expected to affect the patient’s ability to drive motor vehicles or mechanisms. However, in rare cases, drowsiness or dizziness have been reported, in connection with which caution should be exercised when driving motor transport or potentially dangerous mechanisms.

Directions for use
Dosing regimen
For patients with asthma or with asthma and concomitant seasonal and year-round allergic rhinitis aged 15 years and older, the dose is 10 mg per day (1 tablet) in the evening.
Special patient groups
Elderly patients and patients with renal or hepatic insufficiency of mild to moderate severity do not require dose adjustment. There is no data on the use of the drug in patients with severe hepatic insufficiency. Dosage for male and female patients is the same.
Pediatric use
Chewable tablets of 5 mg are produced for the treatment of children aged 6 to 14 years, chewable tablets of 4 mg are produced for children aged 2 to 5 years.
Method and route of administration
For oral administration.
The drug is taken regardless of food intake.
With seasonal allergic rhinitis – the time of administration is determined by the patient at his discretion.
Duration of treatment
It is important to observe the duration of taking Montelukast 10 mg according to the recommendations of your doctor.

Measures to be taken in case of overdose
Seek immediate medical advice from your doctor.
In most cases of overdose, no adverse reactions have been reported. The most common symptoms reported in overdose included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
Treatment: withdrawal of the drug, symptomatic treatment.
There are no data on the possibility of montelukast excretion by peritoneal dialysis or hemodialysis.
Measures to be taken in case of missing one or more doses of the medicinal product
It is recommended to take the drug Montelukast 10 mg as prescribed by your doctor. However, if you miss a dose, you should continue taking the drug according to the usual treatment regimen - one tablet once a day.
You should not take a double dose to compensate for a missed dose.
Consult your health care professional for clarification of the way of using the medicinal product

Description of adverse reactions that occur during the standard use of the drug and measures to be taken in this case
The frequency of adverse events is determined according to the following criteria: very frequent (≥ 1/10), frequent (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000), very rare (< 1/10 000), unknown (impossible to estimate on the basis of available data).
Very common
upper respiratory tract infections

Frequently

• headache, abdominal pain
• diarrhea, nausea, vomiting
• rash
• Increased transaminase levels (ALT and AST)
• pyrexia

Infrequently

• hypersensitivity reactions, including anaphylaxis
• abnormal dreams, including nightmares, insomnia, somnambulism, agitation, including aggression and hostility, depression, psychomotor hyperreactivity, including irritability, restlessness, tremor
• dizziness, drowsiness, paresthesia/hypoesthesia, seizures
• nosebleed
• dry mouth, dyspepsia
• bruising, urticaria, itching
• arthralgia, myalgia, including muscle spasms
• asthenia/fatigue, edema
• enuresis in children

Rarely

• tendency to bleeding
• impaired concentration, memory disorders
• palpitation
• angioedema

Very rare

• eosinophilic infiltrates in the liver
• hallucinations, disorientation, suicidal intentions and behavior (including suicide attempts)
• Cherge-Strauss syndrome
• hepatitis, including cholestatic, hepatocellular, and mixed liver lesions
• erythema multiforme, erythema nodosum
• thrombocytopenia
• dysphemia

In case of adverse drug reactions, contact a health care provider, pharmacist or directly to the information database on adverse drug reactions (actions), including reports of drug ineffectiveness
If adverse drug reactions occur, contact your health care provider, pharmacist, or directly to the Adverse Drug Reactions (Actions) Information Database, including reports of drug ineffectiveness
Republican State enterprise on the Right of Economic Management National Center for Expertise of Medicines and Medical Devices of the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan
http://www.ndda.kz

Additional information
Composition of the medicinal product
One tablet contains
active substance - montelukast sodium 10.40 mg (equivalent to montelukast 10 mg),
excipients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, low-substituted hydroxypropylcellulose, magnesium stearate.
Film coating: Opadry I yellow1, purified water2.
1The composition of the film coating of Opadry I yellow is: hypromellose 6 cP (HPMC 2910) (E464), hydroxypropylcellulose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
2Expired during the film coating/drying process.

Description of appearance, odor, taste
Round-shaped, film-coated tablets of light yellow to yellow color with a pale brown tinge, biconvex, with an impressed inscription “M9UT” and “10” on one side.

Form of release and packaging
10 tablets each in a blister pack made of cold-formed aluminum foil (OPA25/Al47/PVC60) and aluminum foil.
3 blister packs together with the instruction for medical use in Kazakh and Russian languages in a carton pack.

Shelf life
3 years
Do not use after expiration date!

Storage conditions
Store in the original package at a temperature not exceeding 25 °C.
Keep out of reach of children!

Conditions of release from pharmacies
By prescription