Eli Lilly & Co. (LLY) announced Tuesday that the European Commission has approved Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia or BPH.
Cialis was approved for erectile dysfunction or ED in the EU in 2002. Cialis for once daily use was approved to treat ED in the EU in 2007.
Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration or FDA in October 2011 for the treatment of the signs and symptoms of BPH.
The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH).
In addition to the U.S. and EU, Cialis for once daily use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.
The company note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure.
It also should not be taken by those who are allergic to Cialis or Adcirca (tadalafil), or any of its ingredients.
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