As-needed

Hard Mints

Your safety is our first priority. Learn more about key medication details, side effects, and other important info about your treatment by selecting your medication below.

What is this?

This Important Safety Information summarizes the most important warnings and precautions for Tadalafil Hard Mints, a compounded prescription medication that your provider has prescribed to treat for erectile dysfunction, 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 Tadalafil Hard Mints. 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.

Tadalafil Hard Mints is compounded by licensed pharmacists and includes the active pharmaceutical ingredient, tadalafil. 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, Tadalafil Hard Mints 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.

Do not take Tadalafil Hard Mints if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas© (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level

• are allergic to tadalafil or any of the ingredients in Tadalafil Hard Mints. Inactive ingredients in the chewable tablets include: magnesium stearate, dextrose, citric acid, sucralose, wintergreen, microcrystalline cellulose, wintergreen flecks, bitterness masking powder

• are younger than 18 years of age

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sexual intercourse, seek immediate medical help.

Tadalafil can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis

• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Tadalafil Hard Mints and call your healthcare provider right away if you have any sudden vision loss

• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Tadalafil Hard Mints and contact a doctor right away

Before you take TadalafiL Hard Mints, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• have had heart surgery within the last 6 months

• have pulmonary hypertension

• have had a stroke

• have low blood pressure, or high blood pressure that is not controlled

• have a deformed penis shape

• have had an erection that lasted for more than 4 hours

• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• have ever had severe vision loss, including an eye problem called NAION

• have bleeding problems

• have or have had stomach ulcers

• have liver problems

• have kidney problems or having kidney dialysis

• have any other medical conditions

Tadalafil Hard Mints can cause small declines in your blood pressure that may cause dizziness, lightheadedness or even fainting in people sensitive to blood pressure changes. Be sure that you are well-hydrated and in a safe, controlled environment the first time that you take Tadalafil Hard Mints.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tadalafil may affect the way other medicines work, and other medicines may affect the way tadalafil works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates

• medicines called guanylate cyclase stimulators such as Adempas (riociguat)

• medicines called alpha-blockers such as Hytrin© (terazosin HCl), Flomax© (tamsulosin HCl), Cardura© (doxazosin mesylate), Minipress© (prazosin HCl), Uroxatral© (alfuzosin HCl), Jalyn© (dutasteride and tamsulosin HCl), or Rapaflo© (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of tadalafil with alpha-blockers can lead to a drop in blood pressure or to fainting

• medicines called HIV protease inhibitors, such as ritonavir (Norvir©), indinavir sulfate (Crixivan©), saquinavir (Fortovase© or Invirase©), or atazanavir sulfate (Reyataz©)

• some types of oral antifungal medicines, such as ketoconazole (Nizoral©) and itraconazole (Sporanox©)

• some types of antibiotics, such as clarithromycin (Biaxin®, telithromycin (Ketek®), or erythromycin

• other medicines that treat high blood pressure

• other medicines or treatments for ED, unless your healthcare provider has specifically instructed you that you can take your new ED medication at the same time that you are taking tadalafil.  Combining ED medications can increase the risk of side effects such as low blood pressure, dizziness, or prolonged erections and should only be done under medical supervision.

Tadalafil, which is the same ingredient found in another drug called Adcirca©. Adcirca© is used to treat a rare disease called pulmonary arterial hypertension (PAH). Tadalafil Hard Mints should not be used with Adcirca or with other PAH treatments containing tadalafil or any other PDE5 inhibitors (such as Revatio© [sildenafil]).

Tadalafil Hard Mints do not protect against sexually transmitted diseases, including HIV.

The most common side effects of tadalafil: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

Uncommon adverse events of tadalafil for once daily use or use as needed. A causal relationship of these events to tadalafil use is uncertain. Body as a whole — asthenia, face edema, fatigue, pain. Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia. Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting. Musculoskeletal — arthralgia, neck pain. Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo. Respiratory — dyspnea, epistaxis, pharyngitis. Skin and Appendages — pruritus, rash, sweating. Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids. Otologic — sudden decrease or loss of hearing, tinnitus. Urogenital — erection increased, spontaneous penile erection.

Tadalafil Hard Mints are not for females or children. If you experience signs or symptoms of an allergic reaction, stop taking Tadalafil Hard Mints and seek medical attention immediately.

Where to find more side effects information

For more information, read the written drug information that comes with your medication, ask your healthcare provider, or ask your pharmacist.

You may report side effects to the FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.

What is this?

This Important Safety Information summarizes the most important warnings and precautions for Vardenafil Hard Mints, a compounded prescription medication that your provider has prescribed to treat for erectile dysfunction, 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 Vardenafil Hard Mints. 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.

Vardenafil Hard Mints is compounded by licensed pharmacists and includes the active pharmaceutical ingredient, vardenafil. 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, Vardenafil Hard Mints 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.

Do not take Vardenafil Hard Mints if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas© (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level

• are allergic to vardenafil, or any of the ingredients in Vardenafil Hard Mints. Inactive ingredients in the chewable tablets include: magnesium stearate, dextrose, citric acid, sucralose, wintergreen, microcrystalline cellulose, wintergreen flecks, bitterness masking powder

• are younger than 18 years of age

Erectile dysfunction can sometimes be the sign of an underlying health condition such as cardiovascular disease or high cholesterol. Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sexual intercourse, seek immediate medical help.

Vardenafil can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis

• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Vardenafil Hard Mints and call your healthcare provider right away if you have any sudden vision loss

• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Vardenafil Hard Mints and contact a doctor right away

Before you take Vardenafil Hard Mints, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• have or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)

• have had heart surgery within the last 6 months

• have pulmonary hypertension

• have had a stroke or mini stroke (TIA)

• have low blood pressure, or high blood pressure that is not controlled

• have a deformed penis shape

• have had an erection that lasted for more than 4 hours

• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• have ever had severe vision loss, including an eye problem called NAION

• have bleeding problems

• have or have had stomach ulcers

• have liver problems

• have kidney problems or are having kidney dialysis have any other medical conditions

• have any other medical conditions

Vardenafil Hard Mints can cause small declines in your blood pressure that may cause dizziness, lightheadedness or even fainting in people sensitive to blood pressure changes. Be sure that you are well-hydrated and in a safe, controlled environment the first time that you take Vardenafil Hard Mints.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Vardenafil may affect the way other medicines work, and other medicines may affect the way vardenafil works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates

• medicines called guanylate cyclase stimulators such as Adempas© (riociguat)

• medicines called alpha-blockers such as Hytrin© (terazosin HCl), Flomax© (tamsulosin HCl), Cardura© (doxazosin mesylate), Minipress© (prazosin HCl), Uroxatral© (alfuzosin HCl), Jalyn© (dutasteride and tamsulosin HCl), or Rapaflo© (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Sildenafil with alpha-blockers can lead to a drop in blood pressure or fainting

• medicines called HIV protease inhibitors, such as ritonavir (Norvir©), indinavir sulfate (Crixivan©), saquinavir (Fortovase© or Invirase©), or atazanavir sulfate (Reyataz©)

• some types of oral antifungal medicines, such as ketoconazole (Nizoral©) and itraconazole (Sporanox©)

• some types of antibiotics, such as clarithromycin (Biaxin®, telithromycin (Ketek®), or erythromycin

• other medicines that treat high blood pressure

• other medicines or treatments for ED, unless your healthcare provider has specifically instructed you that you can take your new ED medication at the same time that you are taking vardenafil. Combining ED medications can increase the risk of side effects such as low blood pressure, dizziness, or prolonged erections and should only be done under medical supervision.

Vardenafil Hard Mints should not be used with pulmonary arterial hypertension (PAH) drugs that contain PDE5 inhibitors, such as REVATIO© or Adcirca©, or with other ED medicines that contain PDE5 inhibitors, such as Viagra© or Cialis©.

Vardenafil Hard Mints do not protect against sexually transmitted diseases, including HIV.

The most common side effects of Vardenafil Hard Mints include all of the common side effects for tadalafil. These include the following: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

Vardenafil Hard Mints is a prescription medicine used for the treatment of erectile dysfunction (ED). Vardenafil Hard Mints is not for females or children.

If you experience signs or symptoms of an allergic reaction, stop taking Vardenafil Hard Mints and seek medical attention immediately.

Where to find more side effects information

For more information, read the written drug information that comes with your medication, ask your healthcare provider, or ask your pharmacist.

You may report side effects to the FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.

What is this?

This Important Safety Information summarizes the most important warnings and precautions for Tadalafil + Vardenafil Hard Mints, a compounded prescription medication that your provider has prescribed to treat for erectile dysfunction, 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 Tadalafil + Vardenafil Hard Mints. 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.

Tadalafil + Vardenafil Hard Mints is compounded by licensed pharmacists and includes the active pharmaceutical ingredients, tadalafil and vardenafil. 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, Tadalafil + Vardenafil Hard Mints 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.

Do not take Tadalafil + Vardenafil Hard Mints if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas© (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level

• use recreational drugs called “poppers” like amyl nitrate or butyl nitrate

• are allergic to tadalafil, vardenafil, or any of the ingredients in Tadalafil + Vardenafil Hard Mints. Inactive ingredients in the chewable tablets include: magnesium stearate, dextrose, citric acid, sucralose, wintergreen, microcrystalline cellulose, wintergreen flecks, bitterness masking powder

• have, or any family members have, a rare heart condition known as prolongation of the QT interval (long QT syndrome)

• Are younger than 18 years of age

Erectile dysfunction can sometimes be the sign of an underlying health condition such as cardiovascular disease or high cholesterol. Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sexual intercourse, seek immediate medical help.

Tadalafil +Vardenafil Hard Mints can cause serious side effects. Rarely reported side effects include:

• An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis

• Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Vardenafil Hard Mints and call your healthcare provider right away if you have any sudden vision loss

• Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Vardenafil Hard Mints and contact a doctor right away

Before you take Tadalafil + Vardenafil Hard Mints, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• have had heart surgery within the last 6 months

• have pulmonary hypertension

• have had a stroke or mini stroke (TIA)

• have low blood pressure, or high blood pressure that is not controlled

• have a deformed penis shape

• have had an erection that lasted for more than 4 hours

• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy NAION

• have any bleeding disorders

• have or have had stomach ulcers

• have liver problems

• have kidney problems or are having kidney dialysis have any other medical conditions

Tadalafil + Vardenafil Hard Mints can cause small declines in your blood pressure that may cause dizziness, lightheadedness or even fainting in people sensitive to blood pressure changes. Be sure that you are well-hydrated and in a safe, controlled environment the first time that you take Tadalafil + Vardenafil Hard Mints.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tadalafil + Vardenafil Hard Mints may affect the way other medicines work, and other medicines may affect the way Tadalafil + Vardenafil Hard Mints work, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates

• medicines called guanylate cyclase stimulators such as Adempas© (riociguat)

• medicines called alpha-blockers such as Hytrin© (terazosin HCl), Flomax© (tamsulosin HCl), Cardura© (doxazosin mesylate), Minipress© (prazosin HCl), Uroxatral© (alfuzosin HCl), Jalyn© (dutasteride and tamsulosin HCl), or Rapaflo© (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Sildenafil with alpha-blockers can lead to a drop in blood pressure or fainting

• medicines that treat abnormal heart beat. These include quinidine, procainamide, amiodarone and sotalol

• medicines called HIV protease inhibitors, such as ritonavir (Norvir©), indinavir sulfate (Crixivan©), saquinavir (Fortovase© or Invirase©), or atazanavir sulfate (Reyataz©)

• some types of oral antifungal medicines, such as ketoconazole (Nizoral©) and itraconazole (Sporanox©)

• some types of antibiotics, such as clarithromycin (Biaxin©), telithromycin (Ketek©), or erythromycin

• other medicines that treat high blood pressure

• other medicines or treatments for ED

Tadalafil + Vardenafil Hard Mints should not be used with pulmonary arterial hypertension (PAH) drugs that contain PDE5 inhibitors, such as Revatio© or Adcirca©, or with other ED medicines that contain PDE5 inhibitors, such as Viagra© or Cialis©.

Tadalafil + Vardenafil Hard Mints do not protect against sexually transmitted diseases, including HIV.

The most common side effects of Tadalafil + Vardenafil Hard Mints include all of the common side effects for tadalafil and vardenafil. These include the following: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; muscle pain; nausea; dizziness; rash.

Uncommon adverse events of tadalafil for once daily use or use as needed. A causal relationship of these events to tadalafil use is uncertain. Body as a whole — asthenia, face edema, fatigue, pain. Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia. Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting. Musculoskeletal — arthralgia, neck pain. Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo. Respiratory — dyspnea, epistaxis, pharyngitis. Skin and Appendages — pruritus, rash, sweating. Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids. Otologic — sudden decrease or loss of hearing, tinnitus. Urogenital — erection increased, spontaneous penile erection.

Tadalafil + Vardenafil Hard Mints is a prescription medicine used for the treatment of sexual dysfunction. Tadalafil + Vardenafil Hard Mints is not for females or children.

If you experience signs or symptoms of an allergic reaction, stop taking Tadalafil + Vardenafil Hard Mints and seek medical attention immediately.

Where to find more side effects information

For more information, read the written drug information that comes with your medication, ask your healthcare provider, or ask your pharmacist.

You may report side effects to the FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.