MONTELUKAST HEXAL

For children who have problems consuming a chewable tablet, a granule formulation is available (see Montelukast 4 mg granule SPC). This medicinal product is to be given to a child under adult supervision. The dosage for paediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken in the evening.

The tablets are to be chewed before swallowing. If taken in connection with food, MONTELUKAST should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary. Montelukast 4 mg chewable tablet formulation is not recommended below 2 years of age.

General recommendations. The therapeutic effect of MONTELUKAST 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 dose 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. MONTELUKAST 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. Therapy with MONTELUKAST in relation to other treatments for asthma.

4). 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age. 4 mg granules are available for paediatric patients 6 months to 5 years of age.

Method of administration:

For oral use.

Montelukast has been evaluated in clinical studies in patients with persistent asthma as follows: • 10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older • 10 mg film-coated tablets in approximately 400 adult and adolescent patients 15 years of age and older with seasonal allergic rhinitis and asthma • 5 mg chewable tablets in approximately 1750 paediatric patients 6 to 14 years of age, and • 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age.

• 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 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 Gastrointestinal 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. Adverse reactions reported in post-marketing use are listed by System Organ Class and specific Adverse Experience Term, in the table below.

Frequency categories were estimated based on relevant clinical trials. 4) pulmonary eosinophilia Very Rare Diarrhoea§§, nausea§§, vomiting§§ CommonGastrointestinal disorders Dry mouth, dyspepsia Uncommon Hepatobiliary disorders Elevated levels of serum transaminases (ALT, AST) Common Hepatitis (including cholestatic, hepato- cellular, and mixed-pattern liver injury).

Very Rare Rash§§ Common Bruising, urticaria, pruritus Uncommon Angio- oedema Rare Skin and sub-cutaneous 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 Experience Term 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 authorization of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard).

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 beta-agonist should be used.

Patients should seek their doctors’ advice as soon as possible if they need more inhalations of short-acting beta-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 antagonists 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 acetylsalicylic acid (aspirin)-sensitive asthma to avoid taking acetylsalicylic acid (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.

MONTELUKAST contains aspartame, azo colouring agent Allura Red (E 129), sodium, sucrose and ethanol. 96 mg aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine product contains azo colouring agent Allura Red (E 129). This may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say essentially ‘sodium-free’. 74 mg of sucrose per chewable tablet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicinal product. 24 microgram of alcohol (ethanol) per chewable tablet. The amount per chewable tablet of this medicinal product is equivalent to less than 1 ml beer or 1 ml wine.

The small amount of alcohol in this medicinal product will not have any noticeable effects.

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