14 CLINICAL STUDIES

Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrate and butyl nitrate. Do not use vardenafil hydrochloride orally disintegrating tablets if you are using these drugs.

Important Notes

WHAT ARE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates.· Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension.· Have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?

Before taking vardenafil hydrochloride orally disintegrating tablets, tell your doctor about all your medical problems, including if you:· Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your doctor if it is safe for you to have sexual activity.· Have low blood pressure or have high blood pressure that is not controlled.· Have pulmonary hypertension· Have had a stroke.· Have had a seizure.· Or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome).· Have liver problems.· Have kidney problems and require dialysis.· Have retinitis pigmentosa, a rare genetic (runs in families) eye disease.· Have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION).· Have stomach ulcers.· Have a bleeding problem.· Have a deformed penis shape or Peyronie’s disease.· Have had an erection that lasted more than 4 hours.· Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia.· Have hearing problems.· Have phenylketonuria.· Have fructose intolerance.CAN OTHER MEDICATIONS AFFECT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Vardenafil hydrochloride orally disintegrating tablets and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following:· Medicines called nitrates (see “What important information should you know about vardenafil hydrochloride orally disintegrating tablets?”).• Medicines containing cobicistat.· Medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone and sotalol.· Ritonavir (Norvir®) or indinavir sulfate (Crixivan®) saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®) or other HIV protease inhibitors.· Ketoconazole or itraconazole (such as Nizoral® or Sporanox®).• Cobicistat· Erythromycin or clarithromycin.· Other medicines or treatments for ED.Patients taking these drugs should not use vardenafil hydrochloride orally disintegrating tablets.Patients taking alpha-blockers should not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may switch to vardenafil hydrochloride orally disintegrating tablets at the advice of their healthcare provider.· Medicines called alpha-blockers. Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including vardenafil hydrochloride orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to fainting.· Patients should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider.HOW SHOULD YOU TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Take vardenafil hydrochloride orally disintegrating tablets exactly as your doctor prescribes. Vardenafil hydrochloride orally disintegrating tablets comes in 10 mg orally disintegrating tablets. The dose is one vardenafil hydrochloride orally disintegrating tablet. Do not take more than one vardenafil hydrochloride orally disintegrating tablet a day.

5.8 Hepatic Impairment

Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrate and butyl nitrate. Do not use vardenafil hydrochloride orally disintegrating tablets if you are using these drugs. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates.· Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension.· Have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Before taking vardenafil hydrochloride orally disintegrating tablets, tell your doctor about all your medical problems, including if you:· Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack.

Are you currently using Vardenafil (Levitra, Staxyn)?

Ask your doctor if it is safe for you to have sexual activity.· Have low blood pressure or have high blood pressure that is not controlled.· Have pulmonary hypertension· Have had a stroke.· Have had a seizure.· Or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome).· Have liver problems.· Have kidney problems and require dialysis.· Have retinitis pigmentosa, a rare genetic (runs in families) eye disease.· Have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION).· Have stomach ulcers.· Have a bleeding problem.· Have a deformed penis shape or Peyronie’s disease.· Have had an erection that lasted more than 4 hours.· Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia.· Have hearing problems.· Have phenylketonuria.· Have fructose intolerance.CAN OTHER MEDICATIONS AFFECT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Vardenafil hydrochloride orally disintegrating tablets and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following:· Medicines called nitrates (see “What important information should you know about vardenafil hydrochloride orally disintegrating tablets?”).• Medicines containing cobicistat.· Medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone and sotalol.· Ritonavir (Norvir®) or indinavir sulfate (Crixivan®) saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®) or other HIV protease inhibitors.· Ketoconazole or itraconazole (such as Nizoral® or Sporanox®).• Cobicistat· Erythromycin or clarithromycin.· Other medicines or treatments for ED.Patients taking these drugs should not use vardenafil hydrochloride orally disintegrating tablets.Patients taking alpha-blockers should not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets.

Consumer Information Use and Disclaimer

Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may switch to vardenafil hydrochloride orally disintegrating tablets at the advice of their healthcare provider.· Medicines called alpha-blockers. Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including vardenafil hydrochloride orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to fainting.· Patients should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider.HOW SHOULD YOU TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Take vardenafil hydrochloride orally disintegrating tablets exactly as your doctor prescribes. Vardenafil hydrochloride orally disintegrating tablets comes in 10 mg orally disintegrating tablets. The dose is one vardenafil hydrochloride orally disintegrating tablet. Doses should be taken at least 24 hours apart.· If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, you should not start treatment for erectile dysfunction with vardenafil hydrochloride orally disintegrating tablets. Your doctor may prescribe a lower dose of vardenafil film-coated tablet.Take 1 vardenafil hydrochloride orally disintegrating tablet about 1 hour (60 min) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with vardenafil hydrochloride orally disintegrating tablets.

Vardenafil hydrochloride orally disintegrating tablets men enhancement pills may be taken with or without meals.Place on the tongue where it will dissolve rapidly.

• The safety profile of vardenafil is well established.
• It is not recommended for use with other ED drugs.
• Physical activity while on vardenafil may enhance effectiveness.
• Notify your doctor if you experience severe pain.

The tablet should be taken whole and not crushed or split.The tablet should not be taken with liquid.It should be taken immediately upon removal from the blister.Call your doctor or emergency room immediately if you accidentally took more vardenafil hydrochloride orally disintegrating tablets than prescribed.If you receive vardenafil hydrochloride orally disintegrating tablets in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing.WHAT ARE THE POSSIBLE SIDE EFFECTS OF VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?The most common side effects with vardenafil hydrochloride orally disintegrating tablets are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away.Vardenafil hydrochloride orally disintegrating tablets may uncommonly cause:· An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away.

• Vardenafil can cause temporary vision disturbances.
• Do not use if you have a recent history of heart attack.
• It should be used with caution in those with kidney issues.
• Men with liver problems should seek medical advice.

Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.· Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including vardenafil) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and call a doctor right away.Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including vardenafil. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking vardenafil hydrochloride orally disintegrating tablets and contact a doctor right away.These are not all the side effects of vardenafil hydrochloride orally disintegrating tablets.

5.9 Renal Impairment

Do not take more than one vardenafil hydrochloride orally disintegrating tablet a day. Doses should be taken at least 24 hours apart.· If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, you should not start treatment for erectile dysfunction with vardenafil hydrochloride orally disintegrating tablets. Your doctor may prescribe a lower dose of vardenafil film-coated tablet.Take 1 vardenafil hydrochloride orally disintegrating tablet about 1 hour (60 min) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with vardenafil hydrochloride orally disintegrating tablets. Vardenafil hydrochloride orally disintegrating tablets men enhancement pills may be taken with or without meals.Place on the tongue where it will dissolve rapidly.

Electroanalytical application of carbon based electrodes to the pharmaceuticals

The tablet should be taken whole and not crushed or split.The tablet should not be taken with liquid.It should be taken immediately upon removal from the blister.Call your doctor or emergency room immediately if you accidentally took more vardenafil hydrochloride orally disintegrating tablets than prescribed.If you receive vardenafil hydrochloride orally disintegrating tablets in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing.WHAT ARE THE POSSIBLE SIDE EFFECTS OF VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?The most common side effects with vardenafil hydrochloride orally disintegrating tablets are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away.Vardenafil hydrochloride orally disintegrating tablets may uncommonly cause:· An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away.

Do I need to be sexually aroused for it to work?

Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.· Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including vardenafil) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and call a doctor right away.Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including vardenafil. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking vardenafil hydrochloride orally disintegrating tablets and contact a doctor right away.These are not all the side effects of vardenafil hydrochloride orally disintegrating tablets. For fildena pill more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects.

• Vardenafil is available in tablet form, usually 5-20 mg.
• It is designed to be taken as needed, not regularly.
• Effects may vary based on age and health condition.
• Always follow your healthcare provider’s instructions.

You may report side effects to FDA at 1-800-FDA 1088.HOW SHOULD VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING Tablets BE STORED?· Store vardenafil hydrochloride orally disintegrating tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].· Keep vardenafil hydrochloride orally disintegrating tablets and all medicines out of the reach of children.GENERAL INFORMATION ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETSMedicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use vardenafil hydrochloride orally disintegrating tablets for a condition for which it was not prescribed.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Do not give vardenafil hydrochloride orally disintegrating tablets to other people, even if they have the same symptoms that you have. It may harm them.This leaflet summarizes the most important information about vardenafil hydrochloride orally disintegrating tablets. If you would like more information, talk with your healthcare provider. If you do not understand the information, or have questions, talk with your doctor or pharmacist. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?

Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke. Vardenafil hydrochloride orally disintegrating tablets contain phenylalanine which can be harmful to people who have phenylketonuria. Do not take vardenafil hydrochloride orally disintegrating tablets if you: · Take any medicines called “nitrates” (often used to control chest pain, also known as angina) · Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.

(See “Who Should Not Take Vardenafil Hydrochloride Orally Disintegrating Tablets?”) Tell all your healthcare providers that you take vardenafil hydrochloride orally disintegrating tablets.

Results and discussion

For fildena pill more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088.HOW SHOULD VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING Tablets BE STORED?· Store vardenafil hydrochloride orally disintegrating tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].· Keep vardenafil hydrochloride orally disintegrating tablets and all medicines out of the reach of children.GENERAL INFORMATION ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETSMedicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use vardenafil hydrochloride orally disintegrating tablets for a condition for which it was not prescribed. Do not give vardenafil hydrochloride orally disintegrating tablets to other people, even if they have the same symptoms that you have. It may harm them.This leaflet summarizes the most important information about vardenafil hydrochloride orally disintegrating tablets.

How is vardenafil supplied (dosage forms)?

If you would like more information, talk with your healthcare provider. If you do not understand the information, or have questions, talk with your doctor or pharmacist. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

Other Interactions

With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke. Vardenafil hydrochloride orally disintegrating tablets contain phenylalanine which can be harmful to people who have phenylketonuria. Do not take vardenafil hydrochloride orally disintegrating tablets if you: · Take any medicines called “nitrates” (often used to control chest pain, also known as angina) · Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. (See “Who Should Not Take Vardenafil Hydrochloride Orally Disintegrating Tablets?”) Tell all your healthcare providers that you take vardenafil hydrochloride orally disintegrating tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took vardenafil hydrochloride orally disintegrating tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took vardenafil hydrochloride orally disintegrating tablets. WHAT ARE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.