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 your provider has prescribed to treat for testosterone deficiency and to enhance sexual function and/or to reduce urinary symptoms associated with enlarged prostate, if deemed clinically appropriate. It does not contain all possible information. You will also receive a medication guide or patient drug information sheet with your medication when it arrives from the pharmacy which contains full information about Enclomiphene + Tadalafil + Supplement Blend. You should read all of the information that comes with your prescription before taking your medication and at each refill. It’s important to take your medication as directed by your provider and to always read your prescription label and follow your healthcare provider's instructions.

Enclomiphene + Tadalafil + Supplement Blend is compounded by licensed pharmacists and includes the active pharmaceutical ingredients, 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. Unless otherwise indicated, the safety information below is based on the known safety profiles of these active ingredients as used in the compounded medication.

Like all compounded medications, Enclomiphene + Tadalafil + Supplement Blend is not FDA approved. This means that the safety, effectiveness, and quality of this medication has not been verified by the FDA, as the FDA does not verify the safety, effectiveness, and quality of any compounded drugs.

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 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.