MONTELUKAST TILLOMED

Posology The recommended dose for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken in the evening. General recommendations The therapeutic effect of montelukast on parameters of asthma control occurs within one day.

Montelukast may be taken with or without food. Patients should be advised to continue taking montelukast even if their asthma is under control, as well as during periods of worsening asthma. Montelukast should not be used concomitantly with other products containing the same active ingredient, montelukast.

No dosage adjustment is necessary for the elderly, or 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.

Therapy with montelukast in relation to other treatments for asthma Montelukast Tillomed can be added to a patient’s existing treatment regimen.

Inhaled corticosteroids:

Treatment with montelukast can be used as add-on therapy in patients when inhaled corticosteroids plus "as needed" short acting β-agonists provide inadequate clinical control. 4). Paediatric population Do not give montelukast 10 mg film-coated tablets to children less than 15 years of age.

The safety and efficacy of montelukast 10 mg film-coated tablets in patients younger children less than 15 years 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 for paediatric patients 2 to 5 years of age.

4 mg granules are available for paediatric patients 6 months to 5 years of age. Method of Administration Oral use.

Montelukast has been evaluated in clinical studies as follows: • 10 mg film-coated tablets in approximately 4,000 adult and adolescent asthmatic patients 15 years of age and older • 10 mg film-coated tablets in approximately 400 adult and adolescent asthmatic patients with seasonal allergic rhinitis 15 years of age and older.

• 5 mg chewable tablets in approximately 1,750 paediatric asthmatic 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 asthmatic 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 Gastrointestinal 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‡ CommonGastro-intestinal 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 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).

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 substituted abruptly 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 montelukast if such events occur.

Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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