What is VYBRIQUE?

VYBRIQUE (sildenafil) oral film is a prescription medicine used to treat erectile dysfunction (ED). VYBRIQUE is not for use in women or children. It is not known if VYBRIQUE is safe and effective in women or children under 18 years of age.

IMPORTANT SAFETY INFORMATION

VYBRIQUE can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take VYBRIQUE if you take medicines called nitrates. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Do not take VYBRIQUE if you take medicines called guanylate cyclase stimulators, which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Do not take VYBRIQUE if you are allergic to sildenafil or any of the ingredients in VYBRIQUE.

Tell all your healthcare providers that you take VYBRIQUE. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took VYBRIQUE.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. VYBRIQUE does not protect you or your partner from getting sexually transmitted diseases, including Human Immunodeficiency  Virus (HIV).

VYBRIQUE can cause serious side effects including:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away because priapism can permanently damage your penis.
• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking VYBRIQUE and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking VYBRIQUE and contact a healthcare provider right away.

Before you take VYBRIQUE, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure
• have had heart surgery within the last 6 months
• have pulmonary hypertension
• have had a stroke
• have low blood pressure, or high blood pressure that is not controlled
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours
• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including NAION
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis

Tell your healthcare provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements. Tell your doctor especially if you take any of the following:

• nitrates
• guanylate cyclase stimulators, such as riociguat
• alpha-blockers, such as doxazosin. The use with VYBRIQUE can lead to a drop in blood pressure or to fainting.
• HIV protease inhibitors, such as ritonavir and saquinavir
• oral antifungal medicines, such as ketoconazole and itraconazole
• antibiotics, such as erythromycin
• medicines that treat high blood pressure
• other medicines or treatments for ED

The most common side effects of VYBRIQUE are: headache; flushing; upset stomach; stuffy or runny nose; and dizziness. Other side effects include: abnormal vision, such as changes in color vision and blurred vision; back pain; muscle pain; nausea; and rash.

These are not all of the possible side effects of VYBRIQUE. Call your doctor for medical advice about side effects.

Please see full Prescribing Information and Patient Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact IBSA Pharma Inc. at 1-800-587-3513.


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