Adcirca^® (tadalafil) Tablets

INDICATION

Adcirca is a prescription medication used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

IMPORTANT SAFETY INFORMATION for Adcirca

• You should discuss all of your medical conditions and all medications with your doctor before starting Adcirca.
• Do not take Adcirca if you take any medications that contain nitrates (often used for chest pain), as the combination could cause a sudden, unsafe drop in blood pressure.
• Do not take Adcirca if you are allergic to tadalafil or any other ingredient in Adcirca.
• If you experience chest pain after taking Adcirca, contact your doctor.
• Adcirca is a type of medication called a phosphodiesterase type 5 (PDE5) inhibitor. PDE5 inhibitors can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your doctor before taking Adcirca, as these conditions may be affected by the action of Adcirca.
• If you have ever had blockage in the veins of your lungs, known as pulmonary veno-occlusive disease (PVOD), Adcirca is not recommended for you.
• Taking Adcirca with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (fainting).
• Do not take Adcirca if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both Adcirca and ritonavir (Norvir) at the same time, your dose of Adcirca will need to be adjusted. Inform your doctor if you have kidney or liver problems before taking Adcirca.
• Adcirca contains the same ingredient (tadalafil) as Cialis, which is used to treat erectile dysfunction (impotence). If you are taking Adcirca, do not take Cialis or other PDE5 inhibitors.
• In rare cases, men taking PDE5 inhibitors (including tadalafil) for erectile dysfunction reported side effects such as a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. If you experience any of these side effects, seek medical attention right away.
• The most common side effects of Adcirca are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose.

For more information about Adcirca, please see the Full Prescribing Information and Patient Information, visit http://www.ADCIRCA.com, or call 1-800-545-5979.