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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 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions () and Adverse Reactions ()]. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Physicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use.

For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours. For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Tadalafil tablets are effective at improving erectile function over the course of therapy. For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day. PATIENT INFORMATION Tadalafil Tablets, USP(ta DAL a fil)Dispense with Patient Information available at: this important information before you start taking tadalafil tablets and each time you get a refill. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider.

Before Using

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 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions () and Adverse Reactions ()]. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Physicians should instruct patients on the appropriate administration of tadalafil tablets to allow optimal use. For tadalafil tablets for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity.

Comparison with actions of other PDE5 inhibitors

In most patients, the ability to have sexual intercourse is improved for up to 36 hours. For tadalafil tablets for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Tadalafil tablets are effective at improving erectile function over the course of therapy. For tadalafil tablets for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day. PATIENT INFORMATION Tadalafil Tablets, USP(ta DAL a fil)Dispense with Patient Information available at: this important information before you start taking tadalafil tablets and each time you get a refill.

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You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about tadalafil tablets when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.What Is The Most Important Information I Should Know About Tadalafil Tablets?Tadalafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. You and your healthcare provider should talk about tadalafil tablets when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.What Is The Most Important Information I Should Know About Tadalafil Tablets?Tadalafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Never take tadalafil tablets with any nitrate or guanylate cyclase stimulator medicines.Do not take tadalafil tablets if you take any medicines called “nitrates.” 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 tadalafil 40mg 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 nitrite and butyl nitrite.Do not take tadalafil tablets if you take medicines called guanylate cyclase stimulators which include:•Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat. (See “Who Should Not Take Tadalafil Tablets?”)Tell all of your healthcare providers that you take tadalafil 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 tadalafil tablets.After taking a single tablet, some of the active ingredient of tadalafil tablets remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect Tadalafil Tablets?”).Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.See also “What Are The Possible Side Effects Of Tadalafil Tablets?”What Are Tadalafil Tablets?Tadalafil tablets are a prescription medicine taken by mouth for the treatment of:•men with erectile dysfunction (ED)•men with symptoms of benign prostatic hyperplasia (BPH)•men with both ED and BPHTadalafil Tablets for the Treatment of EDED is a condition where the penis does not fill with enough blood to 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 healthcare provider for help if the condition bothers him. Tadalafil tablets help 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.Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets.Tadalafil tablets do not:•cure ED•increase a man’s sexual desire•protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.•serve as a male form of birth controlTadalafil tablets are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.Tadalafil Tablets for the Treatment of Symptoms of BPHBPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.Tadalafil Tablets for the Treatment of ED and Symptoms of BPHED and symptoms of BPH may happen in the same person and at the same time.

Adverse effects

Never take tadalafil tablets with any nitrate or guanylate cyclase stimulator medicines.Do not take tadalafil tablets if you take any medicines called “nitrates.” 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 tadalafil 40mg 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 nitrite and butyl nitrite.Do not take tadalafil tablets if you take medicines called guanylate cyclase stimulators which include:•Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat. (See “Who Should Not Take Tadalafil Tablets?”)Tell all of your healthcare providers that you take tadalafil tablets.

How does tadalafil work (mechanism of action)?

If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took tadalafil tablets.After taking a single tablet, some of the active ingredient of tadalafil tablets remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect Tadalafil Tablets?”).Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.See also “What Are The Possible Side Effects Of Tadalafil Tablets?”What Are Tadalafil Tablets?Tadalafil tablets are a prescription medicine taken by mouth for the treatment of:•men with erectile dysfunction (ED)•men with symptoms of benign prostatic hyperplasia (BPH)•men with both ED and BPHTadalafil Tablets for the Treatment of EDED is a condition where the penis does not fill with enough blood to 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 healthcare provider for help if the condition bothers him. Tadalafil tablets help increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity.

What should I tell my healthcare provider before using tadalafil?

Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets.Tadalafil tablets do not:•cure ED•increase a man’s sexual desire•protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.•serve as a male form of birth controlTadalafil tablets are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.Tadalafil Tablets for the Treatment of Symptoms of BPHBPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.Tadalafil Tablets for the Treatment of ED and Symptoms of BPHED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take tadalafil tablets for the treatment of both conditions.Tadalafil tablets are not for women or children.Tadalafil tablets must be used only under a healthcare provider’s care.Who Should Not Take Tadalafil Tablets?Do not take tadalafil tablets if you:•take any medicines called “nitrates”.•use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About Tadalafil Tablets?”)•take any medicines called guanylate cyclase stimulators, such as riociguat.•are allergic to tadalafil tablets or ADCIRCA®, or any of its ingredients. See the end of this leaflet for a complete list of ingredients in tadalafil tablets. Men who have both ED and symptoms of BPH may take tadalafil tablets for the treatment of both conditions.Tadalafil tablets are not for women or children.Tadalafil tablets must be used only under a healthcare provider’s care.Who Should Not Take Tadalafil Tablets?Do not take tadalafil tablets if you:•take any medicines called “nitrates”.•use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About Tadalafil Tablets?”)•take any medicines called guanylate cyclase stimulators, such as riociguat.•are allergic to tadalafil tablets or ADCIRCA®, or any of its ingredients.

• Overdose signs include painful erections lasting over 4 hours.
• Seek immediate medical attention if overdose is suspected.
• Follow dosage directions strictly to avoid complications.

See the end of this leaflet for a complete list of ingredients in tadalafil tablets. Symptoms of an allergic reaction may include:•rash•hives•swelling of the lips, tongue, or throat•difficulty breathing or swallowingCall your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.What Should I Tell My Healthcare Provider Before Taking Tadalafil Tablets?Tadalafil tablets are not right for everyone.

• Tadalafil 5mg is primarily used to treat erectile dysfunction.
• It works by relaxing blood vessels in the penis.
• Typically taken once daily for ongoing management.

Only your tadalafil weekend pill healthcare provider and you can decide if tadalafil tablets are right for you. Before taking tadalafil tablets, tell your healthcare provider 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 healthcare provider if it is safe for you to have sexual activity.

You should not take tadalafil tablets if your healthcare provider has told you not to have sexual activity because of your health problems.•have pulmonary hypertension•have low blood pressure or have high blood pressure that is not controlled•have had a stroke•have liver problems•have kidney problems or require dialysis•have retinitis pigmentosa, a rare genetic (runs in families) eye disease•have ever had severe vision loss, including a condition called 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 leukemiaCan Other Medicines Affect Tadalafil Tablets?Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Tadalafil tablets and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines.

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Symptoms of an allergic reaction may include:•rash•hives•swelling of the lips, tongue, or throat•difficulty breathing or swallowingCall your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.What Should I Tell My Healthcare Provider Before Taking Tadalafil Tablets?Tadalafil tablets are not right for everyone. Only your tadalafil weekend pill healthcare provider and you can decide if tadalafil tablets are right for you. Before taking tadalafil tablets, tell your healthcare provider 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 healthcare provider if it is safe for you to have sexual activity. You should not take tadalafil tablets if your healthcare provider has told you not to have sexual activity because of your health problems.•have pulmonary hypertension•have low blood pressure or have high blood pressure that is not controlled•have had a stroke•have liver problems•have kidney problems or require dialysis•have retinitis pigmentosa, a rare genetic (runs in families) eye disease•have ever had severe vision loss, including a condition called 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 leukemiaCan Other Medicines Affect Tadalafil Tablets?Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Less common

Tadalafil tablets and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following*:•medicines called nitrates (see “What Is The Most Important Information I Should Know About Tadalafil Tablets?”)•medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension•medicines called alpha blockers. Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If tadalafil tablets are taken with certain alpha blockers, your blood pressure could suddenly drop.

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You could get dizzy or faint.•other medicines to treat high blood pressure (hypertension)•medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)•some types of oral antifungals such as ketoconazole (Nizoral®), itraconazole (Sporanox®)•some types of antibiotics such as clarithromycin (Biaxin®), telithromycin (Ketek®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).•other medicines or treatments for ED.•Tadalafil tablets are also marketed as ADCIRCA® for the treatment of pulmonary arterial hypertension. Do not take both sildenafil citrate (Revatio®) with tadalafil tablets.How Should I Take Tadalafil Tablets?•Take tadalafil tablets exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you.•Some men can only take a low dose of tadalafil tablets or may have to take it less often, because of medical conditions or medicines they take.•Do not change your dose or the way you take tadalafil tablets without talking to your healthcare provider. Especially tell your healthcare provider if you take any of the following*:•medicines called nitrates (see “What Is The Most Important Information I Should Know About Tadalafil Tablets?”)•medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension•medicines called alpha blockers.

• The medication can be taken with or without food.
• Common side effects include headache and flushing.
• Consult your doctor before starting tadalafil 5mg.

Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If tadalafil tablets are taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.•other medicines to treat high blood pressure (hypertension)•medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)•some types of oral antifungals such as ketoconazole (Nizoral®), itraconazole (Sporanox®)•some types of antibiotics such as clarithromycin (Biaxin®), telithromycin (Ketek®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).•other medicines or treatments for ED.•Tadalafil tablets are also marketed as ADCIRCA® for the treatment of pulmonary arterial hypertension. Do not take both sildenafil citrate (Revatio®) with tadalafil tablets.How Should I Take Tadalafil Tablets?•Take tadalafil tablets exactly as your healthcare provider prescribes it.

5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH

Other Interactions

Your healthcare provider will prescribe the dose that is right for you.•Some men can only take a low dose of tadalafil tablets or may have to take it less often, because of medical conditions or medicines they take.•Do not change your dose or the way you take tadalafil tablets without talking to your healthcare provider.