The European Commission has approved Eli Lilly's 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 US 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 US 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.
Cialis is currently approved for ED in more than 100 countries throughout the world. In the United States, Cialis provides men with ED two different dosing options — Cialis for once daily use (2.5 mg and 5 mg) and Cialis for use as needed (5 mg, 10 mg and 20 mg). Cialis is not to be taken more than one time each day.
Cialis for once daily use is approved to treat ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions (ED+BPH). Cialis 5 mg for once daily use is the recommended dose to treat BPH and ED+BPH.
Cialis for once daily use can help men with ED be ready anytime between doses, so they do not have to plan sexual activity around taking a pill. It can also treat the signs and symptoms of BPH. Cialis for once daily use is the only medication approved to treat both ED and the signs and symptoms of BPH.
Cialis for use as needed is approved to treat erectile dysfunction (ED). Cialis for use as needed should be taken before sexual activity. It may go to work quickly (in as little as 30 minutes in some men) and can work up to 36 hours.