Eli Lilly and Company (NYSE: LLY) announced today 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 (BPH).
Cialis was approved for erectile dysfunction (ED) in the EU in 2002. Cialis for once daily use was approved to treat ED in the EU in 2007.
"With this approval, Cialis is now the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a useful therapeutic option for men and physicians."
Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration (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.
It is important to 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. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing should call their healthcare provider or get help right away.