Compounded Oral Tablet with Vitamins

Patient Drug Information
Compounded Oral Tablet with Vitamins
For the treatment of erectile dysfunction (ED) and/or premature ejaculation (PE)

About your medication: Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions.

Your compounded medication’s ingredients were customized to your prescription. 

This is a compounded prescription product and has not been approved by the FDA. The FDA does not verify the safety or effectiveness of compounded drugs.

Important Information: 
This should only be taken by the patient whose name appears on the prescription label.

• Active Ingredients and Common Side Effects
  • Tadalafil is a phosphodiesterase-5 (PDE-5) inhibitor used to treat sexual dysfunction in men.

• Tadalafil’s most common side effects when taken daily are headaches, dyspepsia and nasal congestion.

• Vitamin B1 (Thiamine Hydrochloride) is a vitamin used to supplement the diet.
  • Vitamin B1 is generally well tolerated, with no significant side effects when taken orally.
• Vitamin B3 (Niacinamide) is a vitamin used to supplement the diet.
  • Vitamin B3 is generally well tolerated, but when taken in excess, side effects may include flushing, redness, burning, tingling, or itching of the skin which may lead to headache, rashes, or dizziness.
• Vitamin B5 (Calcium Pantothenate) is a vitamin used to supplement the diet.
  • Vitamin B5 is generally well tolerated, with no significant side effects when taken orally.
• Vitamin B6 (Pyridoxine Hydrochloride) is a vitamin used to supplement the diet.
  • Vitamin B6 is generally well tolerated, but when taken in excess, side effects may include extreme sensitivity to sunlight, nausea, heartburn, and painful skin patches.
• Vitamin B12 (Cyanocobalamin) is a B vitamin used to supplement the diet.
  • Vitamin B12 is generally well tolerated, with no significant side effects when taken orally.
• Vitamin C (Ascorbic Acid) is an antioxidant and vitamin used to supplement the diet.
  • Vitamin C is generally well tolerated, but when taken in excess, side effects may include diarrhea, upset stomach, or throwing up.
• Calcium (Calcium Carbonate) is a mineral used to supplement the diet.
  • Calcium is generally well tolerated, but when taken in excess, side effects may include constipation, bloating, gas and nausea.
• Magnesium (Magnesium Oxide) is a mineral used to supplement the diet.
  • Magnesium is generally well tolerated, but when taken in excess, side effects may include diarrhea, nausea, and abdominal cramping.
• Potassium and Chloride (Potassium Chloride) is a mineral used to supplement the diet.
  • Potassium chloride is generally well tolerated in people who are healthy and have normal kidney function.
• Zinc (Zinc Sulfate Monohydrate) is a mineral used to supplement the diet.
  • Zinc is generally well tolerated, but when taken in excess, side effects may include indigestion, diarrhea, headache, nausea, or throwing up.

• Directions for Use
  • Take one tablet by mouth once daily with or without food.

• Storage
  • Store your compounded medication at room temperature (between 68 and 77 degrees F) in the packaging provided by the pharmacy until you need it. Keep out of reach of children.
  • Under certain circumstances a prescription drug’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity.

• Precautions and contraindications
  • Do not take this medication if you are allergic to any of its components.
  • Due to potential for a dangerous drop in blood pressure, tadalafil must not be taken with nitrates or nitrate medications. Examples of nitrates include nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate, sodium nitroprusside, amyl nitrate, creatine nitrate, and arginine nitrate. Take extra precautions when consuming pre-workout supplements that may contain beet root extract and other organic nitrates. Before taking a supplement, check with your pharmacist or healthcare provider to ensure the product does not contain nitrates.
  • Tell your doctor if you are on an alpha-blocker medication prior to starting this medication. These medications include but are not limited to doxazosin, prazosin, terazosin, tamsulosin, alfuzosin ER, silodosin, and phenoxybenzamine.
  • Do not take this medication if on guanylate cyclase stimulators such as riociguat.
  • Do not take this medication if your doctor or other healthcare provider has advised you that the cardiovascular activity of sex is not safe for you.
  • Do not take this medication if you have ever experienced hearing or vision loss after taking ED medication in the past.
  • Large doses (>2000 mg per day) of Vitamin C can increase your risk of kidney stones.
  • Large doses (> 1000 mg per day) of Vitamin B3 may cause side effects that include low blood pressure, extreme tiredness, high blood sugar, nausea, heartburn, abdominal pain, blurred or impaired vision.
  • Taking very high doses of zinc is likely unsafe and might cause stomach pain, vomiting, and many other problems. Do not take this compounded tablet if you are taking other medications or supplements that include zinc.
  • Do not take high doses of potassium if you are taking certain medications called potassium sparing diuretics such as spironolactone, eplerenone, triamterene, amiloride or have kidney disease.

• Missed Dose
  • If you miss a dose, 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. Check your prescription label for the correct dose prescribed by your medical provider.

• Additional Information
  • Our pharmacy may use imprinted codes stamped into your tablet for pill identification purposes. These codes do not align with generic drug imprinting defined by the FDA. If you have questions about your compounded tablet’s unique imprint code, please contact the pharmacy using the number on the label of your prescription product.
     

Questions

This written information may not cover all possible information. If you have any questions, talk to your pharmacist or medical provider.

A local or a toll-free telephone service is available, staffed by a registered pharmacist, to answer questions about your medication. You can find the number for the pharmacy on the label of your prescription product.

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