MONTELUKAST PAEDIATRIC

Posology The recommended dose for paediatric patients 6 to 14 years of age is one 5 mg chewable tablet daily to be taken in the evening. If taken in connection with food, Montelukast chewable tablet should be taken 1 hour before or 2 hours after food.

No dosage adjustment within this age group is necessary.

General recommendations:

The therapeutic effect of Montelukast Chewable tablet on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma.

No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. Montelukast as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma: Montelukast is not recommended as monotherapy in patients with moderate persistent asthma.

1). Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti- inflammatory therapy based on the step system for asthma therapy should be evaluated.

Patients should be periodically evaluated for their asthma control. 4). Other available strength and pharmaceutical forms. 10 mg film-coated tablets are available for adults and adolescents 15 years of age and older. Paediatric population Do not give Montelukast 5 mg chewable tablets to children less than 6 years of age.

The safety and efficacy of Montelukast 5 mg chewable tablets in children less than 6 years of age has not been established. 4 mg chewable tablets are available for paediatric patients 2 to 5 years of age. Method of administration Oral use.

The tablets are to be chewed before swallowing.

Montelukast has been evaluated in clinical studies in patients with persistent asthma as follows: • 10 mg film-coated tablets in approximately 4,000 adult and adolescent patients 15 years of age and older • 5 mg chewable tablets in approximately 1,750 paediatric patients 6 to 14 years of age, and The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in patients treated with montelukast and at a greater incidence than in patients treated with placebo: Body System Class Adult and Adolescent Patients 15 years and older (two 12-week studies; n=795) Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615) Nervous system disorders headache headache Gastro-intestinal disorders abdominal pain With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.

Tabulated list of Adverse Reactions Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Reactions in the table below. Frequency Categories were estimated based on relevant clinical trials.

4) Very Rare Respiratory, thoracic and mediastinal disorders Pulmonary eosinophilia Very Rare diarrhoea‡, nausea‡, vomiting‡ CommonGastrointestinal disorders dry mouth, dyspepsia Uncommon elevated levels of serum transaminases (ALT, AST) CommonHepatobiliary disorders hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).

Very Rare rash‡ Common bruising, urticaria, pruritus Uncommon Angiooedema Rare Skin and subcutaneous tissue disorders erythema nodosum, erythema multiforme Very Rare Musculoskeletal, connective tissue disorders arthralgia, myalgia including muscle cramps Uncommon Renal and urinary disorders Enuresis in children Uncommon pyrexia‡ CommonGeneral disorders and administration site conditions asthenia/fatigue, malaise, oedema, Uncommon *Frequency Category: Defined for each Adverse Experience Term by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).

†This adverse experience, reported as Very Common in the patients who received montelukast, was also reported as Very Common in the patients who received placebo in clinical trials. ‡This adverse experience, reported as Common in the patients who received montelukast, was also reported as Common in the patients who received placebo in clinical trials.

§ Frequency Category: Rare Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used.

Patients should seek their doctors' advice as soon as possible if they need more inhalations of short-acting β-agonists than usual. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.

In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.

These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.

Patients who develop these symptoms should be reassessed and their treatment regimens evaluated. Treatment with montelukast does not alter the need for patients with aspirin- sensitive asthma to avoid taking aspirin and other non-steroidal anti- inflammatory drugs.

8). The symptoms may be serious and continue if the treatment is not withdrawn. Therefore the treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment. Advise patients and/or caregivers to be alert for neuropsychiatric events and instruct them to notify their physician if these changes in behaviour occur.

Important information regarding the ingredients in this medicine Montelukast 5 mg chewable tablet contains aspartame, a source of phenylalanine. 674 mg phenylalanine per dose.

Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

1.