Largix Tablet: Each coated tablet contains Rupatadine 10 mg as Fumarate INN.
Largix Syrup: Each 5 ml contains Rupatadine 5 mg as Fumarate INN.
Largix® is a preparation of Rupatadine Fumarate which is a second generation non-sedating, selective and long-acting histamine H1 receptors and platelet-activating factor (PAF) antagonist. Rupatadine has dual mechanism. Both histamine and PAF cause bronchoconstriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Largix® shows better therapeutic effect than an isolated antihistamine. It also suppresses the release of several inflammatory mediators in response to allergens by inhibiting the degranulation of mast cells, and reducing the release of cytokines including tumour necrosis factor (TNFα) from mast cells and monocytes.
Adults and adolescents (above 12 years)
Largix® Tablet: 10 mg (one tablet) once daily.
Children age 2-11 years
Largix® Syrup
Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) of syrup once a day with or without food.
Children weighing 25 kg or more: 1 teaspoonful (5 ml) of syrup once a day with or without food.
Children less than 2 years
The use of Rupatadine below the age of 2 years is not recommended.
Patients with renal and hepatic insufficiency
The use of Rupatadine in patient with renal and hepatic insufficiency is not recommended.
Reduces absorption of ketoconazole, itraconazole, and iron salts; increases plasma levels of digoxin (monitor digoxin concentrations); methotrexate levels may increase.
Rupatadine is contraindicated in patients with known hypersensitivity to Rupatadine or to any of the components of this product.
Common: Sleepiness, headache, dizziness, dry mouth, asthenia, fatigue.
Overdose
If accidental ingestion of very high doses occurs, then symptomatic treatment should be given together with the required supportive measures.
Category B2. Limited data show no adverse pregnancy outcomes; use only if expected benefits outweigh fetal risks. Lactation: Excretion in human milk unknown; use during lactation only if benefits outweigh risks.
Store below 25°C in a cool, dry place. Protect from light and moisture. Keep away from the reach of children.