Almont, 5 mg 28 pcs.

Bronchospasm, Runny nose (rhinitis), Bronchial asthma

Prevention and long-term treatment of bronchial asthma in children, including:

• preventing daytime and nighttime symptoms of the disease (for children 2 years and older);
• Treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid (for children 6 years and older);
• preventing exercise-induced bronchospasm (for children 2 years and older).

Promotion of symptoms of seasonal and year-round allergic rhinitis in children from 2 years of age.

Active ingredient

Montelukast

Composition

Active ingredient:

Montelukast 5.00 mg (in the form of montelukast sodium 5.20 mg);

Auxiliary substances:

Mannitol 201.20 mg,

microcrystalline cellulose 66.00 mg,

Hyprolose 9.00 mg,

croscarmellose sodium 9.00 mg,

Pigment Blend dye PB- 24880 (lactose monohydrate 4.50 mg, iron oxide red dye 0.50 mg) 5.00 mg

aspartame 1.50 mg,

cherry flavoring (Silarom Cherry Flavour 1219813182) 0.10 mg.

How to take, the dosage

It is taken orally 1 hour before or 2 hours after a meal. The tablet should be chewed.

In children the drug is taken under the supervision of adults.

Bronchial asthma or bronchial asthma and allergic rhinitis

For children aged 2 to 6 years, 1 chewable tablet 4 mg once daily in the evening.

For children aged 6 to 14 years, 1 chewable tablet 5 mg once daily in the evening.

Allergic rhinitis

For children aged 2 to 6 years – 1 chewable tablet 4 mg once daily

For children aged 6 to 14 years, 1 chewable tablet at a dose of 5 mg once daily on an individual basis depending on the time of greatest exacerbation of symptoms.

No dose adjustment is required within these age groups.

The therapeutic effect of Montelast to control asthma symptoms is achieved within 24 hours of administration.

The patient is advised to continue taking the drug both during periods of controlled bronchial asthma and during exacerbations of bronchial asthma.

Patients with renal insufficiency and patients with mild to moderate hepatic insufficiency do not require special dose adjustment.

There are no data on the use of montelukast in patients with severe hepatic impairment. There is no need to adjust the dose depending on the gender of the patient.

A different dosage form and dose of the drug is available for treatment of patients in other age groups – film-coated tablets, 10 mg.

Interaction

In patients who received phenobarbital concomitantly, the area under the pharmacokinetic curve “concentration-time” of montelukast decreased by about 40%, but dosage regimen adjustment is not required in these patients. Since montelukast is metabolized by CYP3A4 isoenzyme, caution should be exercised, especially in children, if montelukast is simultaneously used with inducers of CYP3A4 isoenzyme, such as phenytoin, phenobarbital and rifampicin.

Special Instructions

It is NOT recommended for the treatment of acute attacks of bronchial asthma. Patients with bronchial asthma are recommended to have emergency medications with them at all times. When an acute attack occurs, short-acting inhaled beta2-adrenomimetics should be used. Patients should consult their physician as soon as possible if they need more short-acting inhaled beta2-adrenomimetics than usual.

The drug should not be abruptly replaced with inhaled or oral GCS therapy. There is no data proving the possibility of reducing the dose of oral GCS with concomitant use.

In rare cases patients who receive anti-asthmatic drugs, including montelukast, may develop systemic eosinophilia that is sometimes accompanied by clinical signs of vasculitis, the so-called Churg-Strauss syndrome, a condition that is treated by taking systemic GCS. These cases are usually associated with dose reduction or withdrawal of oral GCS therapy. The possibility that leukotriene receptor antagonists may be associated with the development of Charge-Stross syndrome cannot be excluded or established. Therefore, physicians should be alerted to the possibility of eosinophilia, vascular rash, increased severity of pulmonary symptoms, cardiac complications, and/or neuropathy in patients. Patients who have developed the above-mentioned symptoms should be reexamined and their treatment regimen reconsidered. Treatment with the drug does not lead to prevention of bronchospasm in patients with hypersensitivity to acetylsalicylic acid, when using acetylsalicylic acid and other NSAIDs.

The drug Montelast contains aspartame, a source of phenylalanine. This drug may be harmful to patients with phenylketonuria.

The drug contains lactose monohydrate and should not be taken in patients with rare hereditary conditions: galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

Impact on driving and operating machinery

. As a rule, montelukast does not affect the ability to drive vehicles or operate other mechanisms, but very rarely in some patients drowsiness and dizziness have been noted; if these signs occur, patients are not recommended to drive vehicles and engage in other activities requiring concentration and rapid psychomotor reactions.

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Contraindications

• Hypersensitivity to the active ingredient or any excipient of the product
• children under 2 years of age (for 4 mg doses) and under 6 years of age (for 5 mg doses);
• Patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• phenylketonuria (contains aspartame).

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Side effects

Infectious and parasitic diseases: upper respiratory tract infections.

Blood and lymphatic system disorders: increased tendency to bleeding, thrombocytopenia.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, eosinophilic liver infiltration.

Psychiatric disorders: abnormal dreams (including nightmares), hallucinations, insomnia, somnambulism, irritability, anxiety, restlessness, agitation (including aggressive behavior or hostility), tremor, depression, disorientation, suicidal thoughts and behavior (suicidality).

Nervous system disorders: headache, dizziness, somnolence, paresthesia/hypoesthesia, seizures.

Cardiovascular system disorders: palpitations.

Respiratory system: nasal bleeding.

Digestive system: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.

Hepatic and biliary tract disorders: increased ALT and AST activity, hepatitis (including cholestatic, hepatocellular and mixed liver lesions).

Skin and subcutaneous tissue disorders: angioedema, tendency to haematoma, urticaria, pruritus, rash, erythema multiforme.

Muscular and connective tissue disorders: arthralgia, myalgia including muscle cramps.

General disorders: asthenia/fatigue, malaise, edema, pyrexia, thirst.

Other: In very rare cases, the development of Churg-Strauss syndrome has been reported during treatment with montelukast.

Similarities

Singular, Montelar, Montelukast, Singlon, Montelukast, Almont, Glémont