Safety Information

This medication contains tadalafil, oxytocin, and PT-141 (bremelanotide). It may not be appropriate for everyone. Your healthcare provider will review your medical history, current medications, and health needs to determine whether this treatment is right for you.

Do not use this medication without a prescription from a licensed healthcare provider.

Do not take this medication if you:

• Take nitrates, such as nitroglycerin, or recreational drugs known as poppers (amyl nitrite or butyl nitrite).
• Have uncontrolled high blood pressure or known heart disease.
• Have been advised by your healthcare provider to avoid sexual activity for medical reasons.
• Have had an allergic reaction to any of the ingredients in this medication.

Talk to your healthcare provider before starting treatment if you have high blood pressure, heart disease, low blood pressure, liver or kidney problems, or a history of stroke or heart attack.

Tadalafil may cause side effects, including:

• Headaches
• Facial flushing
• Nasal congestion
• Dizziness
• Indigestion
• Changes in vision
• Muscle or back pain

PT-141 may cause side effects, including:

• Nausea, which is the most common
• Flushing
• Headache
• A temporary rise in blood pressure and a slower heart rate after each dose
• Darkening of the skin, gums, or facial areas with repeated use, which may not fade

Oxytocin may cause additional side effects. Discuss potential risks and interactions with your prescribing provider.

Seek medical attention if you experience severe or persistent side effects.

Blood pressure changes

Tadalafil can cause a significant drop in blood pressure, especially when taken with nitrates or certain other medications. PT-141 can cause a temporary rise in blood pressure. Never combine this medication with nitrates or poppers, and do not use it if your blood pressure is not controlled.

Prolonged erection

An erection lasting more than four hours requires immediate medical attention. Seek emergency care to prevent permanent injury.

Vision or hearing changes

Sudden vision loss or sudden hearing loss may occur. Stop taking the medication and seek immediate medical attention if either happens.

Heart-related risks

Sexual activity may put additional strain on your heart. Talk to your healthcare provider if you have a history of heart disease or other cardiovascular conditions.

Nausea

Nausea from PT-141 can be strong enough to cause vomiting. Tell your provider if it happens.

Tell your healthcare provider about all medications, supplements, and recreational substances you use before starting treatment.

Tadalafil may interact with:

• Nitrates and nitric oxide donors
• Certain blood pressure medications
• Alpha-blockers
• Other erectile dysfunction medications
• Certain antifungal and antibiotic medications

PT-141 may slow stomach emptying, which can change how other oral medications are absorbed. Tell your provider about any oral medication whose timing matters, and about any other sexual wellness or weight management treatment you use.

Do not combine this medication with other products containing tadalafil or sildenafil, or with other erectile dysfunction treatments, unless specifically directed by your healthcare provider.

Follow your healthcare provider's instructions for dosing and administration. Do not take more than prescribed or combine this medication with other erectile dysfunction treatments without medical guidance.

Your provider will determine whether this treatment is appropriate based on your individual health history.

Call 911 or seek immediate medical attention if you experience:

• Chest pain
• An erection lasting more than four hours
• Sudden vision or hearing loss
• Fainting or severe dizziness
• Difficulty breathing or signs of a severe allergic reaction

Do not take nitrates for chest pain after using tadalafil unless emergency medical professionals specifically direct you to do so. Tell emergency responders when you last took the medication.

This medication is compounded by a licensed pharmacy based on an individual prescription. Compounded medications are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness, or quality.

Pure for Men does not manufacture or compound this medication. Treatment is provided through independent, licensed healthcare providers and their pharmacy network.

Your healthcare provider can help you understand the potential benefits, risks, and side effects of your treatment. Always consult your provider before making changes to your medication.