SINGULAIR PAEDIATRIC

Posology This medicinal product is to be given to a child under adult supervision. The recommended dose for paediatric patients 6 months to 5 years of age is one sachet of 4 mg granules daily to be taken in the evening. No dosage adjustment within this age group is necessary.

Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited. Patients should be evaluated after 2 to 4 weeks for response to montelukast treatment. Treatment should be discontinued if a lack of response is observed.

The Singulair 4 mg granules formulation is not recommended below 6 months of age. , applesauce, ice cream, carrots and rice). The sachet should not be opened until ready to use. After opening the sachet, the full dose of Singulair granules must be administered immediately (within 15 minutes).

If mixed with food, Singulair granules must not be stored for future use. Singulair granules are not intended to be dissolved in liquid for administration. However, liquids may be taken subsequent to administration. Singulair granules can be administered without regard to the timing of food ingestion.

General recommendations The therapeutic effect of Singulair on parameters of asthma control occurs within one day. Patients should be advised to continue taking Singulair 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. Singulair 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 that 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. Singulair as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.

Patients should be evaluated after 2 to 4 weeks of treatment with montelukast. If satisfactory response is not achieved, an additional or different therapy should be considered. 4). 10 mg film-coated tablets are available for adults and adolescents 15 years of age and older.

Paediatric population Do not give Singulair 4 mg granules to children less than 6 months of age. The safety and efficacy of Singulair 4 mg granules in children less than 6 months of age has not been established. 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.

4 mg chewable tablets are available as an alternative formulation for paediatric patients 2 to 5 years of age. Method of administration Oral use.

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  4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age, and  4 mg granules in 175 paediatric patients 6 months to 2 years of age.

Montelukast has been evaluated in a clinical study in patients with intermittent asthma as follows:  4 mg granules and chewable tablets in 1,038 paediatric patients 6 months to 5 years of age 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) Paediatric Patients 2 to 5 years old (one 12-week study; n=461) (one 48-week study; n=278) Paediatric Patients 6 months up to 2 years old (one 6-week study; n=175) Nervous system disorders headache headache hyperkinesia Respiratory, thoracic, and mediastinal disorders asthma Gastro- intestinal disorders abdominal pain abdominal pain diarrhoea Skin and subcutaneous tissue disorders eczematous dermatitis, rash General disorders and administration site conditions thirst 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.

Cumulatively, 502 paediatric patients 2 to 5 years of age were treated with montelukast for at least 3 months, 338 for 6 months or longer, and 534 patients for 12 months or longer. With prolonged treatment, the safety profile did not change in these patients either.

The safety profile in paediatric patients 6 months to 2 years of age did not change with treatment up to 3 months. 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‡ CommonGastro-intestinal disorders dry mouth, dyspepsia Uncommon Hepatobiliary disorders elevated levels of serum transaminases (ALT, AST) Common hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).

Very Rare rash‡ Common bruising, urticaria, pruritus Uncommon angioedema Rare Skin and subcutaneous tissue disorders erythema nodosum, erythema multiforme Very Rare Musculoskeletal and 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 Reaction by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), 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). Patients and physicians should be alert for neuropsychiatric events. Patients and/or caregivers should be instructed to notify their physician if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Singulair if such events occur.

Aspartame Singulair contains aspartame, a source of phenylalanine. 674 mg phenylalanine per dose. It may be harmful for patients with phenylketonuria. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

36 mg benzyl alcohol per tablet. Benzyl alcohol may cause anaphylactoid reactions. Risk is increased in young children (age <3 years) due to accumulation. Products containing benzyl alcohol should not be used for more than 1 week in children under 3 years of age, unless medically necessary and no alternative treatments are available.

High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

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