Vardenafil Tablets

Inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for vardenafil and this class of compounds. Advise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride orally disintegrating tablets are prescribed by another healthcare provider. Inform patients to stop use of all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.

• Vardenafil should be stored at room temperature.
• Keep out of reach of children and pets.
• Notify your doctor if you experience priapism.
• Use only the prescribed dose to prevent adverse effects.

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including vardenafil hydrochloride orally disintegrating tablets, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)]. Advise patients to stop taking PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6)].

Are there any dosage adjustments for certain people?

What should I know about vardenafil before taking it?

Inform patients that vardenafil hydrochloride orally disintegrating tablets offers no protection against sexually transmitted diseases. Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. Vardenafil hydrochloride orally disintegrating tablets are available only in a single strength. PATIENT PACKAGE INSERT Vardenafil Hydrochloride (var-DEN-a-fil HYE-droe-KLOR-ide)Orally Disintegrating Tablets, USPRead the Patient Information about vardenafil hydrochloride orally disintegrating tablets before you start taking it and again each time you get a refill.

You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about vardenafil hydrochloride orally disintegrating tablets when you start taking it and at regular checkups. 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. Talk to your doctor if you 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.· Take riociguat (Adempas®), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

What side effects can this medicine cause?

What should I do if I accidentally take too much vardenafil?

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

• Vardenafil is available by prescription only.
• Common side effects include headache and flushing.
• It should be taken on an empty stomach for best results.
• Do not combine vardenafil with nitrates.

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 ed gel DISINTEGRATING TABLETS?Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him.

Vardenafil hydrochloride orally disintegrating tablets may help a man with ED get and keep an erection when he is sexually excited.Vardenafil hydrochloride orally disintegrating tablets does not:· Cure ED.· Increase a man’s sexual desire.· Protect a man or his partner from sexually transmitted diseases, including HIV.

Speak to your doctor about ways to guard against sexually transmitted diseases.· Serve as a male form of birth control.Vardenafil hydrochloride orally disintegrating tablets are only for men with ED. Vardenafil hydrochloride orally disintegrating tablets are not for women or children. Vardenafil hydrochloride orally disintegrating tablets must be used only under a doctor’s care.HOW DOES VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS WORK?When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. Vardenafil hydrochloride orally disintegrating tablets helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.WHO CAN TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Talk to your doctor to decide if vardenafil hydrochloride orally disintegrating tablets are right for you.Vardenafil hydrochloride orally disintegrating tablets have been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes.WHO SHOULD NOT TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Do not take vardenafil hydrochloride orally disintegrating tablets if you:· Take any medicines called “nitrates” (see “What important information should you know about vardenafil hydrochloride orally disintegrating tablets?”).

Side Effects

Inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for vardenafil and this class of compounds. Advise patients to contact the prescribing physician if new medications that may interact with vardenafil hydrochloride orally disintegrating tablets are prescribed by another healthcare provider. Inform patients to stop use of all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including vardenafil hydrochloride orally disintegrating tablets, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)]. Advise patients to stop taking PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

Last Reviewed Date

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6)]. Inform patients that vardenafil hydrochloride orally disintegrating tablets offers no protection against sexually transmitted diseases. Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. Vardenafil hydrochloride orally disintegrating tablets are available only in a single strength. PATIENT PACKAGE INSERT Vardenafil Hydrochloride (var-DEN-a-fil HYE-droe-KLOR-ide)Orally Disintegrating Tablets, USPRead the Patient Information about vardenafil hydrochloride orally disintegrating tablets before you start taking it and again each time you get a refill. Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. 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.

• 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.

Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a lovegra 100 mg heart attack or heart disease.WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?

Access through your organization

You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about vardenafil hydrochloride orally disintegrating tablets when you start taking it and at regular checkups. 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.

Patient resources

Talk to your doctor if you 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.· Take riociguat (Adempas®), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. (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.WHAT ARE VARDENAFIL HYDROCHLORIDE ORALLY ed gel DISINTEGRATING TABLETS?Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. Vardenafil hydrochloride orally disintegrating tablets may help a man with ED get and keep an erection when he is sexually excited.Vardenafil hydrochloride orally disintegrating tablets does not:· Cure ED.· Increase a man’s sexual desire.· Protect a man or his partner from sexually transmitted diseases, including HIV. 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.

GPhC Regulated Pharmacy

Who should not take vardenafil?

Vardenafil hydrochloride orally disintegrating tablets and other medicines may affect each other.

Related Products

Speak to your doctor about ways to guard against sexually transmitted diseases.· Serve as a male form of birth control.Vardenafil hydrochloride orally disintegrating tablets are only for men with ED. Vardenafil hydrochloride orally disintegrating tablets are not for women or children. Vardenafil hydrochloride orally disintegrating tablets must be used only under a doctor’s care.HOW DOES VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS WORK?When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. Vardenafil hydrochloride orally disintegrating tablets helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.WHO CAN TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Talk to your doctor to decide if vardenafil hydrochloride orally disintegrating tablets are right for you.Vardenafil hydrochloride orally disintegrating tablets have been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes.WHO SHOULD NOT TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?Do not take vardenafil hydrochloride orally disintegrating tablets if you:· Take any medicines called “nitrates” (see “What important information should you know about vardenafil hydrochloride orally disintegrating tablets?”).

Dosage for people with liver disease

Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. 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. 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.

Are erectile dysfunction medicines safe?

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 lovegra 100 mg 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.

Professional resources

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. 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.

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