Important Safety Information - Enclomiphene + Tadalafil + Supplement Blend

What is this?

This Important Safety Information summarizes the most important warnings and precautions for Enclomiphene + Tadalafil + Supplement Blend, a compounded prescription medication that combines enclomiphene (used in certain men with low testosterone), tadalafil (used in certain men to enhance sexual function and/or to reduce urinary symptoms associated with enlarged prostate), Vitamin B6, Vitamin B12, L-Arginine, and Zinc Sulfate. It does not contain all possible information. Always read your prescription label and follow your healthcare provider’s instructions.

Most Serious Warnings

This medication may cause:

  • Sudden vision loss in one or both eyes (possible sign of NAION — non-arteritic anterior ischemic optic neuropathy)

  • Sudden hearing loss, sometimes with ringing or dizziness

  • Blood clots in the legs, lungs, or other parts of the body

  • Serious drops in blood pressure, especially when combined with nitrates or certain blo od pressure medicines

  • Priapism (erection lasting more than 4 hours), which can cause permanent damage to the penis

  • Hormone-sensitive cancers (e.g., prostate or breast) to grow or return Seek medical help right away if you develop any of these symptoms.

Who Should NOT Take Enclomiphene + Tadalafil + Supplement Blend

Do not take this medication if you:

  • Are taking nitrates (e.g., nitroglycerin) or guanylate cyclase stimulators (e.g., riociguat)

  • Use illicit drugs like poppers, cocaine, or methamphetamine

  • Use or have used anabolic steroids in the prior 6 months

  • Are using penile injections or intraurethral medications for ED  

  • Have active, serious heart problems such as unstable angina, high-risk arrhythmia, very recent heart attack or severe congestive heart failure

  • Have active liver disease or chronic liver dysfunction with persistently abnormal liver function tests

  • Have a history of priapism

  • Have a history of sudden hearing loss

  • Have a history of serious vision problems such as NAION (non-arteritic anterior ischemic optic neuropathy), central serous chorioretinopathy, or non-traumatic retinal disorders 

  • Have an active cancer that is not in remission, especially a hormone sensitive cancer such as prostate or breast cancer

  • Have polycythemia vera, hemochromatosis, or a high hematocrit level >54%

  • Have a history of thrombotic disorders that make you predisposed to blood clots, such as Factor V Leiden, Protein C or S deficiency, antithrombin III deficiency, prothrombin gene mutations, sickle cell anemia, antiphospholipid syndrome, or paroxysmal nocturnal hemoglobinuria

  • Have unstable psychiatric conditions for which you have been hospitalized in the past year  

  • Have active pituitary disease, dysfunction or tumors, including prolactinomas

  • Have active adrenal disease, dysfunction or tumors, including Cushing’s syndrome and Addison’s disease

  • Have known hypersensitivity to either enclomiphene, tadalafil, zinc, vitamin B6, vitamin B12, L-Arginine or any inactive ingredients

Before Taking Enclomiphene + Tadalafil + Supplement Blend, Tell Your Healthcare Provider if You:

  • Have any history of heart disease, stroke, or cardiovascular procedures

  • Have known liver conditions

  • Have blood clotting disorders or a personal/family history of blood clots

  • Have been previously diagnosed with low testosterone

  • Have a history of psychiatric illness, such as bipolar disorder, depression, or psychosis

  • Are taking medications that affect hormone levels (e.g., testosterone, clomiphene, hCG, aromatase inhibitors)

  • Are taking medications that may interact with or affect the metabolism of Enclomiphene or Tadalafil, such as nitrates, PDE5 inhibitors, certain antibiotics, HIV medications or alpha blockers

  • Are taking medications for HIV called integrase strand transfer inhibitors (INSTIs), such as Biktarvy® (bictegravir, emtricitabine, and tenofovir alafenamide), Dovato® (dolutegravir and lamivudine), Triumeq® (dolutegravir, abacavir, and lamivudine), Tivicay® (dolutegravir), Isentress® (raltegravir), Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), or Stribild® (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate)

  • Have any eye disorders or previous episodes of vision changes other than minor visual problems

  • Have ever experienced hearing loss, tinnitus, or dizziness related to medications

  • Have been diagnosed with any form of cancer

  • Have abnormal PSA or hematocrit lab results

  • Are taking supplements marketed for testosterone or libido (e.g., DHEA, Tongkat Ali, Tribulus)

  • Take supplements that contain zinc, especially those with >25 mg of elemental zinc)

Possible Side Effects

Common:

  • Headache

  • Flushing

  • Decreased libido

  • Dizziness

  • Nasal congestion

  • Back or muscle pain

  • Hot flashes

  • Nausea or stomach upset

  • Fatigue (rare)

  • Mood changes or irritability (rare)

  • Breast tenderness or enlargement (rare)

Serious (seek medical care immediately):

  • Vision changes or sudden vision loss

  • Sudden decrease or loss of hearing, possibly with dizziness or ringing

  • Priapism (erection lasting more than 4 hours)

  • Signs of blood clots (leg swelling, chest pain, shortness of breath)

  • Severe or persistent headaches

  • Mood changes, depression, mania, or new psychiatric symptoms

  • Signs of liver problems (yellowing skin/eyes, dark urine, abdominal pain)

  • Severe drop in blood pressure (lightheadedness, fainting)

  • Swelling, rapid weight gain, or fluid retention

  • New or worsening cancer symptoms

While Taking Enclomiphene + Tadalafil + Supplement Blend

Tell your healthcare provider immediately if you:

  • Start any new medication, especially nitrates, guanylate cyclase stimulators, strong CYP3A4 inhibitors, or other PDE5 inhibitors

    • As-needed ED medications, such as sildenafil, tadalafil, vardenafil and avanafil, may or may not be safe to use while you are taking Enclomiphene + Tadalafil, depending on your medical history and the dose of the as-needed ED medication. This is only permissible under direct medical supervision. Do not combine as-needed ED medications with Enclomiphene + Tadalafil unless your prescribing a medical provider has specifically instructed that it is safe for you to do so.

  • Experience chest pain or symptoms during sexual activity

  • Plan surgery, including dental procedures

  • Resume or start testosterone, anabolic steroids, or hormone-modifying supplements

  • Miss doses consistently or notice reduced treatment effectiveness

Enclomiphene + Tadalafil + Supplement Blend contains 30 mg of zinc sulfate, providing approximately 6.8 mg of elemental zinc per dose.To ensure optimal nutrient balance and avoid excessive zinc intake:

  • Check your multivitamin and other supplements for zinc content.

  • Avoid taking additional high-dose zinc supplements (especially those with >25 mg of elemental zinc) unless recommended by a healthcare provider.

  • Maintain a balanced diet with natural sources of zinc, such as lean meats, shellfish, nuts, and seeds.

  • Consult your healthcare provider before use if you have concerns about zinc intake or long-term supplementation.

Enclomiphene + Tadalafil + Supplement Blend contains essential B vitamins at levels safe for daily use. If you have specific health concerns or take additional supplements, consult your healthcare provider.

Pregnancy and Fertility

  • Do not take if you are pregnant or may become pregnant. This medication may harm an unborn baby.

  • Not approved for use in women.

Overdose

In case of overdose, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

Missed Dosage

If you miss a dose of a daily medication, take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for the missed dose. Do not take more than the maximum allowable dose indicated on your prescription in a 24 hour period. Check your prescription label for the correct dose prescribed by your medical provider.

Storage

  • Store at room temperature, away from heat and moisture

  • Keep out of reach of children

Medication Disposal

Do not flush unused medication down the toilet or pour in the sink or drain.

Dispose according to local regulations.

Preferred: Use a DEA drug take-back site. If none are available:

  1. Mix medication (liquid or pills—do not crush) with an unappealing substance like dirt, cat litter, or used coffee grounds.

  2. Place in a sealed plastic bag.

  3. Throw away in household trash.

  4. Remove personal information from the bottle before recycling or discarding.

Telemedicine Disclosure: This prescription was issued via telemedicine. If you experience any concerning symptoms, contact your prescribing clinician or seek emergency care.

Disclaimer: This summary does not include all information about Enclomiphene + Tadalafil + Supplement Blend. For more details, speak with your healthcare provider or pharmacist.