5mg SKYN® arise™ elite

IMPORTANT SAFTEY INFORMATION

Tadalafil FOR ONCE DAILY USE is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED)

WARNINGS AND PRECAUTIONS

Patients should not use TADALAFIL FOR ONCE DAILY USE if sex is inadvisable due to cardiovascular status.

Use of TADALAFIL FOR ONCE DAILY USE with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension.

Caution is advised when TADALAFIL FOR ONCE DAILY USE is used as a treatment for ED in men taking alpha-blockers.

Patients should seek emergency treatment if an erection lasts >4 hours. Use TADALAFIL FOR ONCE DAILY USE with caution in patients predisposed to priapism.

Patients should stop TADALAFIL FOR ONCE DAILY USE and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). TADALAFIL FOR ONCE DAILY USE should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION.

Patients should stop TADALAFIL FOR ONCE DAILY USE and seek prompt medical attention in the event of sudden decrease or loss of hearing.

DOSAGE AND ADMINISTRATION

The recommended starting dose of TADALAFIL FOR ONCE DAILY USE is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

The TADALAFIL FOR ONCE DAILY USE dose may be increased to 5 mg, based on individual efficacy and tolerability.

CONTRAINDICATIONS

Administration of TADALAFIL FOR ONCE DAILY USE to patients using any form of organic nitrate is contraindicated. TADALAFIL FOR ONCE DAILY USE was shown to potentiate the hypotensive effect of nitrates.

History of known serious hypersensitivity reaction to TADALAFIL or ADCIRCA®.
Administration with guanylate cyclase (GC) stimulators, such as riociguat.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.

To report SUSPECTED ADVERSE REACTIONS, call or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information in this site is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.