Important Safety Information for Zealthy Hardies

Important Safety information: Hardies is a compounded prescription drug that contains a combination of sildenafil, tadalafil, oxytocin, and vardenafil and is used to treat erectile dysfunction (ED). Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review by the FDA. Do not take Hardies more than once in any 24-hour period or within 24 hours of taking any other ED medications or PDE-5 inhibitors, such as tadalafil or sildenafil. Do not take Hardies if you take nitrates or soluble guanylate cyclase stimulators, as this can result in a sudden, dangerous drop in blood pressure. Do not use it if you are not healthy enough for sex. Seek emergency care if an erection lasts longer than 4 hours. Use caution when taking alpha-blockers or drugs used to treat high blood pressure, or if drinking more than 5 units of alcohol. Seek emergency care if a sudden loss of vision occurs in one or both eyes, or if a sudden decrease or loss of hearing occurs. The most common side effects of Hardies are headache, flushing, indigestion, abnormal vision, back pain, muscle pain, nasal congestion, dizziness, nausea, pain in limb, and rash.

What are the most common side effects of Hardies?

Headache
Flushing
Indigestion
Abnormal vision
Nasal congestion
Back pain
Muscle pain
Nausea
Dizziness
Rash
Pain in liimb

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Important Safety Information for Hardies

What is the FDA approved use of Hardies?

Your Zealthy affiliated provider may prescribe Hardies, which contains combinations of sildenafil, tadalafil, vardenafil, and oxytocin, as a compounded drug to treat erectile dysfunction.

Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review.

Who should not use Hardies?

Do not use Hardies if:

You are taking a class of medications called nitric oxide donors, including isosorbide dinitrate (Isordil), isosorbide mononitrate (Monoket), or nitroglycerine (Nitromist, Nitro-Dur, etc.) Combining sildenafil with nitrates can cause dangerously low blood pressure.
You have a known allergy to Hardies active ingredients (sildenafil, tadalafil, vardenafil).
You are taking a class of medications called soluble guanylate cyclase (GC) stimulators, such as riociguat. Sildenafil, when combined with these medications, can cause dangerously low blood pressure.

How should I take Hardies?

Place the lozenge under your tongue and let it dissolve. Take at least 15 minutes before you want to have sex. Do not chew the medication but once the product has dissolved a little bit, you can bite it in two and put it back under your tongue for more rapid melting. Note that the medication will not give you an automatic erection. You must be aroused for the medication to work. You can take the medication with or without food. However, do not eat or drink anything while the lozenge is under your tongue. Avoid excessive consumption of alcohol when using Zealthy.

You should take the medication exactly as prescribed. Do not take this medication more than once in any 24-hour period or within 24 hours of taking any other ED medications or products that contain tadalafil or sildenafil.

Consider trying the medication on your own the first time so that you know how it affects you.

If you find that the medication is not working for you, or if you have any questions about changing or stopping the medication, reach out to your Zealthy-affiliated provider for guidance.

What should I tell my Zealthy-affiliated provider before using Hardies?

Hardies have many drug interactions. It’s important to tell your Zealthy-affiliated provider about all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

Nitrates, alpha-blockers, and antihypertensives: When these medications are taken with sildenafil, a sudden drop in blood pressure can occur.
CYP3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, and erythromycin: These medications increase the amount of sildenafil in your blood stream, which can cause a sudden drop in blood pressure as well as a dangerously prolonged erection.
Alcohol: Drinking large amounts of alcohol (>5 units) when using this product can result in a sudden drop in blood pressure.

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have or have a past history of:

Cardiovascular risk that prevents you from partaking in sexual activity
Chest pain requiring treatment with nitroglycerin
Predisposition to priapism (a painful erection that lasts >4 hours)
Benign prostatic hyperplasia (BPH) and are being treated with alpha-blockers
Ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis)
Severely impaired autonomic control of blood pressure
Myocardial infarction (heart attack), stroke, or life-threatening arrhythmia
Low or high blood pressure
Cardiac failure or coronary artery disease causing unstable angina
Anterior ischemic optic neuropathy (NAION) or a “crowded” optic disc.
Bleeding disorder or ulcers
Kidney or liver disease
Pulmonary hypertension
Retinitis pigmentosa

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I or a caregiver should monitor for when taking Hardies?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You or a caregiver should carefully monitor for these side effects, especially at the beginning of treatment.

Cardiac risk of sexual activity: ED medication should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status.
Combination with other PDE-5 inhibitors: This compounded medication contains two prescription PDE-5 inhibitors, sildenafil and tadalafil. Monitor for signs of severely low blood pressure, such as dizziness, fainting, or prolonged erection. Do not take this medication more than once in any 24-hour period or within 24 hours of taking any other ED medications or products that contain tadalafil or sildenafil.
Prolonged erections: Seek immediate emergency treatment for an erection lasting more than 4 hours.
Effects on the eye: Seek medical care and stop medication if you experience a sudden loss of vision in one or both eyes. Sudden loss of vision could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
Sudden hearing loss: Stop medication and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears.
Taking this medication in combination with alpha-blockers or other blood pressure-lowering drugs: If you are taking a medication to lower your blood pressure or taking an alpha-blocker, sildenafil may increase the blood-pressure-lowering effect, leading to a sudden drop in blood pressure. When starting sildenafil, monitor carefully for signs of excessively low blood pressure, including dizziness, lightheadedness, or fainting.
Taking this medication in combination with ritonavir: If you are taking a medication called ritonavir at the same time as sildenafil, ritonavir can increase the amount of sildenafil in your system. There may be an increased risk of dangerously low blood pressure, fainting, and prolonged erection.
Effects on bleeding: Sildenafil has no effect on bleeding time when taken alone or with aspirin; however, there have been reports of bleeding with the use of sildenafil. Tell your Zealthy-affiliated provider if you have a history of bleeding disorder or ulcers.
Alcohol: Drinking large amounts of alcohol (>5 units) with sildenafil can increase the risk of a sudden drop in blood pressure.
Sexually transmitted infections: Sildenafil does not protect against sexually transmitted diseases. Use safe sex practices.