Composition : Monas® 10 : Each film coated tablet contains Montelukast 10 mg.
Indications: Monas® is indicated for the prophylaxis and
long-term treatment of asthma in adults and children from 6 months of age.
Dosage & Administration :
Chewable Tablet 4-mg: Children 2 to 5 years: One 4 mg chewable tablet daily to be taken in the evening. Monas Sandoz Chewable Tablet 4 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.Monas Sandoz Chewable Tablets 4 mg are not recommended in children below 2 years of age.
Chewable Tablet 5-mg: Children 6 to 14 years: One 5 mg chewable tablet daily to be taken in the evening. Monas Sandoz Chewable Tablet 5 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.
Monas Sandoz Chewable Tablets 5 mg are not recommended in children below 6 years of age.
Film-Coated Tablet 10-mg: Asthma or Asthma and Concomitant Seasonal Allergic Rhinitis: Adults and Adolescents ≥15 years: One 10-mg tablet daily to be taken in the evening.
Oral Granules:
Children 6 months to 5 years: 1 sachet each evening.Missed Dose: Resume the usual schedule of 1 tablet/sachet once daily. Do not give double dose to make up for a missed dose.
Administration: For oral use.
Chewable Tablets: It should be given to a child under adult supervision. It should be taken even when the child has no symptoms or if he/she has an acute asthma attack.
If the child is taking Monas Sandoz Chewable Tablet, be sure that he/she does not take any other medicines that contain the same active ingredient, i.e. Monas.
If the child takes more Monas Sandoz Chewable Tablet than he/she should, contact the child’s physician immediately for advice.
Discontinuation of Treatment: Monas Sandoz Chewable Tablet can treat the child’s asthma only if the child continues taking it. It is important for the child to continue taking Monas Sandoz Chewable Tablet for as long as the physician prescribes. It will help control the child’s asthma.
Film-Coated Tablet 10-mg: The therapeutic effect of Monas Sandoz Film-Coated Tab 10 mg on parameters of asthma control occurs within one day. Monas Sandoz Film-Coated Tab 10 mg may be taken with or without food. Patients should be advised to continue taking Monas Sandoz even if asthma is under control, as well as during periods of worsening asthma.
Monas Sandoz Film-Coated Tab 10 mg should not be used concomitantly with other products containing the same active ingredient, Monas.
No dosage adjustment is necessary for the elderly or for the 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 Montelukas Sandoz Film-Coated Tab 10 mg in relation to other treatment for asthma. It can be added to a patient’s existing treatment regimen.
Inhaled Corticosteroids: Treatment with Monas Sandoz Film-Coated Tab 10 mg can be used as add-on therapy in patients when inhaled corticosteroids plus “as needed” short-acting β-agonist provide inadequate clinical control. Monas Sandoz Film-Coated Tab 10 mg should not be subtituted for inhaled corticosteriods.
Monas Sandoz Film-Coated Tab 10 mg should not be used in children <15 years due to the high content of active substance.
Other dosage forms with appropriate strengths are available for young children.