The National Authority of Medicines and Health Products has issued a statement permitting the use of foreign language labeling, specifically in Italian, for the drug Quantalan, which is a 400mg cholestyramine oral suspension produced by Cheplapharm Arzneimittel GmbH, due to a stock shortage.
This medication is indicated for the relief of diarrhea from various causes, such as bile acid malabsorption, Crohn’s disease, or pseudomembranous colitis. It is also used to lower cholesterol levels and relieve itching associated with partial biliary obstruction.
Packaging will include informational leaflets in Portuguese.
To enhance accessibility, Infarmed states that Questran, a similar medication, may be dispensed with contribution on prescriptions that validly list Quantalan.
