English to Russian Medical Medical: Pharmaceuticals

The MAH concludes that amlodipine safety information should be updated to include this possible risk.
The changes proposed for the amlodipine CDS are additions to Section 4.5 as follows (text to be added is underlined)
4.5.
Interaction with other medicinal products and other forms of interaction
Special Studies:
Effect of Amlodipine on Other Agents
Mechanistic Target of Rapamycin (mTOR) Inhibitors
mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates.
Amlodipine is a weak CYP3A inhibitor.
With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.