Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Montelukast 10 mg film-coated tablets is indicated in the treatment of asthma as add-on therapy in those patientswith mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Montelukast 10 mg film-coated tablets is indicated in asthma, Montelukast 10 mg film-coated tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast 10 mg film-coated tablets is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
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.
The therapeutic effect of Montelukast 10 mg film-coated tablets on parameters of asthma control occurs within one day. Montelukast 10 mg film-coated tablets may be taken with or without food. Patients should be advised to continue taking Montelukast 10 mg film-coated tablets even if their asthma is under control, as well as during periods of worsening asthma. Montelukast 10 mg film-coated tablets 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.
Montelukast 10 mg film-coated tablets can be added to a patient’s existing treatment regimen.
Treatment with Montelukast 10 mg film-coated tablets can be used as add-on therapy in patients when inhaled corticosteroids plus “as needed” short acting β-agonists provide inadequate clinical control. Montelukast 10 mg film-coated tablets should not be abruptly substituted for inhaled corticosteroids (see section 4.4).
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 children less than 15 years 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.
Oral use.
In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast. These include reports in adults and children with a dose as high as 1000 mg (approximately 61 mg/kg in a 42 month old child). The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients.
There were no adverse experiences in the majority of overdose reports. The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity.
No specific information is available on the treatment of overdose with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.
Shelf life: 2 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.
Montelukast 10 mg tablets are packed in OPA-Al-PVC/Al blister.
Pack size: Packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets in blister.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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