Patient Drug Information
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your healthcare provider. Always ask your healthcare provider for complete information about this product and your specific health needs. Keep this medication away from children and pets.
DRUG NAME:
This Patient Drug information is applicable to Patients receiving any of the following:
Tadalafil (tah-DA-la-fil) tablets
Sildenafil (sil-DEN-a-fil) tablets
Sildenafil – Sublingual (sil-DEN-a-fil) and Tadalafil – Sublingual (tah-DA-la-fil)*
*This is a compounded drug product. Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review.
USES: Sildenafil and tadalafil are used to treat male sexual function problems (impotence or erectile dysfunction/ED). In combination with sexual stimulation, sildenafil and tadalafil works by increasing blood flow to the penis to help a man get and keep an erection. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice “safe sex” such as using latex condoms. Consult with your provider or pharmacist for more details. Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream and the need to urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it had been so prescribed by your health care professional. Sildenafil is also available in other brands and strengths for high blood pressure in the lungs (pulmonary hypertension). Tadalafil is also available in another brand for high blood pressure in the lungs (pulmonary hypertension). Do not take this medication with any other product that contains sildenafil, tadalafil, or other similar medications for erectile dysfunction/ED or pulmonary hypertension (such as vardenafil).
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this drug and each time you get a refill. If you have any questions, ask your provider or pharmacist. To treat erectile dysfunction-ED, take this drug by mouth as directed by your provider, usually as needed. Take at least 15 minutes, but not more than 4 hours, before sexual activity. Do not take more than once daily. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your provider and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your provider if your condition does not improve.
SIDE EFFECTS: Dizziness, back pain, muscle pain, headache, stuffy nose, flushing, or stomach upset occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects last or get worse, tell your provider or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your provider has judged that the benefit to you is greater than the risk of side effects. Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea. Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking sildenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems (“crowded disk”), high blood pressure, if you are over 50, or if you smoke. Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking sildenafil and get medical help right away if these effects occur. In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur. A very serious allergic reaction to this drug is rare. However , get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your provider or pharmacist. In the US – Call your provider for medical advice about side effects. You may report side effect to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
PRECAUTIONS: Before taking this drug, tell your provider and pharmacist all your allergies. Do not take this medication if you are allergic to sildenafil or tadalafil, or if you have an allergy to one of its inactive ingredients, including Yellow Dye No. 5 and Red Dye No. 40. Coconut oil is used during processing, do not use this medication if you have a coconut allergy until you talk with your provider or pharmacist. Before using this medication, tell your provider or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie’s disease), history of painful/prolonged erection (priapism), conditions that may increase risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION). This drug may make you dizzy or cause vision problems. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your provider if you are using marijuana (cannabis). Before having surgery, tell your provider or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
DRUG INTERACTIONS: Drug interaction may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your provider and pharmacist. Do not start, stop, or change the dosage of any medicines without your provider’s approval. Some products that may interact with this drug are: riociguat, vericiguat. Sildenafil and tadalafil can cause a serious drop in your blood pressure when used with nitrates. A serious drop in blood blood pressure can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use sildenafil and tadalafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called “poppers” containing amyl nitrate, amyl nitrate, or butyl nitrite. If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your provider may start treatment with a lower dose of this drug to minimize your risk of low blood pressure. Other medications can affect the removal of sildenafil and tadalafil from your body, which may affect how this drug works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as saquinavir), mifepristone, rifampin, ritonavir, among others. Do not take this medication within 24 hours of any other product that contains sildenafil, tadalafil, or other similar medications for erectile dysfunction (ED) or pulmonary hypertension (such as vardenafil)
OVERDOSE: If someone has overdose and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Symptoms of overdose may include severe dizziness, fainting, painful/prolonged erection.
NOTES: Do not share this medication with others.
MISSED DOES: Not applicable.
STORAGE: Store in original packaging at room temperature in a dry place, away from light and moisture. This medication is sensitive to humidity. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Your medication’s effectiveness may be affected by exposure to excessive heat, freezing temperatures, or high humidity. Always store the medication according to the specific storage instructions provided on the label or packaging.
Contact the pharmacy at 877-232-2730 about any delivery concerns, including timeliness of delivery, condition of the prescription drug upon delivery, signs of damage, changes in appearance, or failure to receive the proper prescription drug product or device.