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CIALIS for ED+BPH (erectile dysfunction + symptoms of benign prostatic hyperplasia)

2 conditions, 1 medication

Only CIALIS for daily use (5 mg) is approved to treat ED and the frustrating urinary symptoms of BPH

If you're one of the many men with ED and symptoms of BPH, like needing to go frequently, day or night, CIALIS for daily use (5 mg) may treat both conditions.

Getting started with CIALIS for daily use (5 mg)

Take CIALIS for daily use (5 mg) once a day, every day at about the same time CIALIS may be taken with or without meals Do not drink alcohol in excess with CIALIS Avoid skipping doses and do not split tablets, as you may not receive an adequate dose If you miss a dose, take it when you remember, but do not take CIALIS more than once each day

You may see symptom improvement in as early as 2 weeks after beginning treatment, although it could take about 4 weeks

CIALIS for daily use (5 mg) is the recommended dose to treat both ED and the symptoms of BPH. The recommended starting dose of CIALIS for daily use for the treatment of ED is 2.5 mg.

The most important information
to know about CIALIS

Do not take CIALIS if you:Take medicines called“nitrates” A type of medicine commonly used to treat heart problems. These medicines relax and widen blood vessels. This allows more blood to flow to the heart, which makes the heart work less hard. Some recreational drugs called "poppers," like amyl nitrite and butyl nitrite, also contain nitrates. such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, as the combination may cause an unsafe drop in blood pressure; or use recreational
drugs called “poppers” A slang term for various chemical compounds, including amyl nitrite and butyl nitrite, that are used for recreational purposes. The chemical compound is inhaled to increase sexual desire. like amyl nitrite and butyl nitrite Take medicines called“guanylate cyclase stimulators” Medications used to treat pulmonary hypertension. such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension, as the combination may cause an unsafe drop in blood pressure Are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as: RashHives Swelling of the lips, tongue, or throat Difficulty breathing or swallowing

After taking a single tablet, some of the active ingredient of CIALIS 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.

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 it is already weak from a heart attack or heart disease.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

Remembering to take CIALIS

Make it part of your routine Take CIALIS for daily use with your favorite morning beverage or evening meal

Keep track of your doseDo not take CIALIS more than one time each day

Don’t wait until the last minute to get a refill Sign up for refill notices if your local pharmacy offers a prescription reminder program

Side effects with CIALIS

The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include: An erection that won't go away. If you get an erection that lasts more than 4 hours, seek immediate medical help to avoid long-term injury In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS, and call a healthcare provider right away

These are not all the possible side effects of CIALIS.

Call your healthcare provider if you experience any side effects that bother you or don't go away. And please see Important Safety Information and full Patient Information for additional information.

Indications: CIALIS is approved to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Taking CIALIS with finasteride when starting BPH treatment has been studied for 26 weeks. CIALIS is not for women or children.

IMPORTANT SAFETY INFORMATION FOR CIALIS

What Is The Most Important Information I Should Know About CIALIS?

Do not take CIALIS if you:take medicines called “nitrates” such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure; or use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. take medicines called guanylate cyclase stimulators such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension as the combination may cause an unsafe drop in blood pressure. are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing.

After taking a single tablet, some of the active ingredient of CIALIS 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.

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 it is already weak from a heart attack or heart disease.

What Should I Tell My Healthcare Provider Before Taking CIALIS?

CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. Do not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking CIALIS, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or heart attack pulmonary hypertensionlow blood pressure or high blood pressure that is not controlled strokeliver or kidney problems or require dialysisretinitis pigmentosa. a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAIONstomach ulcers or a bleeding problema deformed penis shape or Peyronie’s disease an erection that lasted more than 4 hoursblood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect CIALIS?

Tell your healthcare provider about all the medicines you take, especially: medicines called "nitrates" which are often prescribed for chest pain medicines called guanylate cyclase stimulators, such as riociguat (Adempas ® ), used to treat pulmonary arterial hypertension and chronic-thromboembolic hypertension alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both CIALIS and ADCIRCA. Do not take sildenafil citrate (Revatio ® )* with CIALIS.

How Should I Take CIALIS?

CIALIS should not be taken more than one time each day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Take CIALIS exactly as your healthcare provider prescribes it.

What Should I Avoid While Taking CIALIS?

Do not use other ED medicines or ED treatments. Do not drink too much alcohol (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What Are The Possible Side Effects Of CIALIS?

The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include:
An erection that won’t go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call a healthcare provider right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 .

CIALIS does not:
Cure ED, increase a man's sexual desire, protect a man or his partner from sexually transmitted diseases, including HIV or serve as a male form of birth control.

CIALIS is available by prescription only.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

TD CON ISI 16SEP2015

CIALIS for ED (erectile dysfunction)

2 CIALIS options for ED

CIALIS for daily use and CIALIS for use as needed

If your doctor decides that CIALIS is right for you, there are 2 dosing options to consider.

Learn about the 2 CIALIS options

1 low-dose tablet, once a day You can attempt sex anytime between doses* No need to plan around a pill

1 week to help improve ED You may be able to have successful intercourse in as early as 4 to 5 days

Take only as needed One 20-mg tablet works in as little as 30 minutes in some men* † One dose can work for up to 36 hours* ‡

Both CIALIS for daily use (2.5 mg, 5 mg) and CIALIS for use as needed (5 mg, 10 mg, 20 mg):
Let you choose the moment that’s right for you and your partner*Are approved to treat EDCan be effective: Regardless of age В§ For mild, moderate, or severe ED In men with health problems such as diabetes or controlled high blood pressure Do not need to be planned around mealsShould not be taken if drinking too much alcohol (for example, 5 glasses of wine
or 5 shots of whiskey)
This may cause headache or dizziness, increase in heart rate, or drop in blood pressure Should not be taken with medicines called“nitrates” A type of medicine commonly used to treat heart problems. These medicines relax and widen blood vessels. This allows more blood to flow to the heart, which makes the heart work less hard. Some recreational drugs called "poppers", like amyl nitrite and butyl nitrite, also contain nitrates. or recreational drugs
known as
“poppers,” A slang term for various chemical compounds, including amyl nitrite and butyl nitrite, that are used for recreational purposes. The chemical compound is inhaled to increase sexual desire. or with medicines called“guanylate cyclase stimulators,” Medications used to treat pulmonary hypertension. such as riociguat (Adempas В® ) || The combination can cause a sudden, unsafe drop in blood pressure Should not be taken with other ED medicinesShould not be taken more than one time each day

This information should not take the place of having a complete evaluation, including a physical examination and medical history, before starting any type of ED treatment.

* Individual results may vary. Not studied for multiple attempts per dose.

† In clinical trials, CIALIS for use as needed started to work in 30 minutes for some men who took 20 mg
of CIALIS.

‡ In clinical trials, CIALIS for use as needed was shown to improve, up to 36 hours after dosing, the ability
of men with ED to have a single successful intercourse attempt.

В§ CIALIS is only for men aged 18 or older.

|| The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

The most important information
to know about CIALIS

Do not take CIALIS if you:Take medicines called“nitrates” A type of medicine commonly used to treat heart problems. These medicines relax and widen blood vessels. This allows more blood to flow to the heart, which makes the heart work less hard. Some recreational drugs called "poppers," like amyl nitrite and butyl nitrite, also contain nitrates. such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, as the combination may cause an unsafe drop in blood pressure; or use recreational
drugs called “poppers” A slang term for various chemical compounds, including amyl nitrite and butyl nitrite, that are used for recreational purposes. The chemical compound is inhaled to increase sexual desire. like amyl nitrite and butyl nitrite Take medicines called“guanylate cyclase stimulators” Medications used to treat pulmonary hypertension. such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension, as the combination may cause an unsafe drop in blood pressure Are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as: RashHives Swelling of the lips, tongue, or throat Difficulty breathing or swallowing

After taking a single tablet, some of the active ingredient of CIALIS 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.

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 it is already weak from a heart attack or heart disease.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

Remembering to take CIALIS

If you take CIALIS for daily use, make it part of your routine by taking it with your favorite morning beverage or evening meal

If you take CIALIS for use as needed, remember to take it when the moment is right,* at least 30 minutes before sex †

Keep track of your doseDo not take CIALIS more than one time each day

Don’t wait until the last minute to get a refill Sign up for refill notices if your local pharmacy offers a prescription reminder program

* Individual results may vary. Not studied for multiple attempts per dose.

† In clinical trials, 36-hour CIALIS started to work in 30 minutes for some men who took 20 mg of 36-hour CIALIS.

Side effects with CIALIS

There may be some side effects when taking CIALIS. The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days.

Uncommon but serious side effects include:

An erection that won’t go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call a healthcare provider right away.

These are not all the possible side effects of CIALIS.

Call your healthcare provider if you experience any side effects that bother you or don't go away. And please see Important Safety Information and full Patient Information for additional information.

Indications: CIALIS is approved to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Taking CIALIS with finasteride when starting BPH treatment has been studied for 26 weeks. CIALIS is not for women or children.

IMPORTANT SAFETY INFORMATION FOR CIALIS

What Is The Most Important Information I Should Know About CIALIS?

Do not take CIALIS if you:take medicines called “nitrates” such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure; or use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. take medicines called guanylate cyclase stimulators such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension as the combination may cause an unsafe drop in blood pressure. are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing.

After taking a single tablet, some of the active ingredient of CIALIS 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.

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 it is already weak from a heart attack or heart disease.

What Should I Tell My Healthcare Provider Before Taking CIALIS?

CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. Do not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking CIALIS, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or heart attack pulmonary hypertensionlow blood pressure or high blood pressure that is not controlled strokeliver or kidney problems or require dialysisretinitis pigmentosa. a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAIONstomach ulcers or a bleeding problema deformed penis shape or Peyronie’s disease an erection that lasted more than 4 hoursblood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect CIALIS?

Tell your healthcare provider about all the medicines you take, especially: medicines called "nitrates" which are often prescribed for chest pain medicines called guanylate cyclase stimulators, such as riociguat (Adempas ® ), used to treat pulmonary arterial hypertension and chronic-thromboembolic hypertension alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both CIALIS and ADCIRCA. Do not take sildenafil citrate (Revatio ® )* with CIALIS.

How Should I Take CIALIS?

CIALIS should not be taken more than one time each day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Take CIALIS exactly as your healthcare provider prescribes it.

What Should I Avoid While Taking CIALIS?

Do not use other ED medicines or ED treatments. Do not drink too much alcohol (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What Are The Possible Side Effects Of CIALIS?

The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include:
An erection that won’t go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call a healthcare provider right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 .

CIALIS does not:
Cure ED, increase a man's sexual desire, protect a man or his partner from sexually transmitted diseases, including HIV or serve as a male form of birth control.

CIALIS is available by prescription only.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

TD CON ISI 16SEP2015

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Cialis (tadalafil) Indications

Cialis has the following indications:

  • Treatment of erectile dysfunction (ED)
  • Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
  • Treatment of patients with both erectile dysfunction, and signs and symptoms of benign prostatic hyperplasia.

Dosage and Administration of Cialis (tadalafil)

Cialis is a selective phosphodiesterase type 5 (PDE5) inhibitor available as 2.5, 5, 10, or 20 mg tablets for oral administration

Erectile Dysfunction (used as needed)

  • For most patients the recommended starting dose is 10 mg as needed prior to anticipated sexual activity.
  • The dose may be increased to 20 mg or decreased to 5 mg based on efficacy or tolerability.
  • The maximum dosing frequency is once daily for most patients. Cialis is effective for up to 36 hours.
  • Renal dysfunction:
    • Creatinine clearance 30 to 50 ml/min: The recommended starting dose is 5 mg no more than once daily, and the maximum dose is 10 mg every 48 hours.
    • Creatinine clearance less than 30 ml/min or on hemodialysis. The maximum dose is 5 mg every 72 hours.
  • Hepatic dysfunction:
    • Mild or moderate dysfunction: Use has not been extensively evaluated. Do not exceed 10 mg daily.
    • Severe dysfunction: Use is not recommended.

Erectile Dysfunction (used daily without regard to sexual activity)

  • The recommended dose for scheduled once daily use is 2.5 mg taken at approximately the same time daily without regard to timing of sexual activity.
  • The dose may be increased to 5 mg daily based on efficacy and tolerability.
  • For patients with renal dysfunction:
    • Creatinine clearance less than 30 ml/min or on hemodialysis: Cialis is not recommended for scheduled once daily use.
  • Hepatic dysfunction:
    • Mild or moderate dysfunction: Use has not been extensively evaluated. Therefore, use with caution.
    • Severe dysfunction: Use is not recommended.

Benign prostatic hyperplasia

  • The recommended dose is 5 mg taken at approximately the same time every day.
  • Renal dysfunction:
    • Creatinine clearance 30 to 50 ml/min: Start with 2.5 mg and increase to 5 mg daily as needed and tolerated.
    • Creatinine clearance less than 30 ml/min or on hemodialysis: Cialis is not recommended for scheduled once daily use.

Combined Erectile Dysfunction and Benign prostatic hyperplasia

  • The recommended dose is 5 mg at approximately the same time every day without regard to sexual activity.
  • For patients with renal dysfunction:
    • Creatinine clearance 30 to 50 ml/min: Start with 2.5 mg and increase to 5 mg daily as needed and tolerated.
    • Creatinine clearance less than 30 ml/min or on hemodialysis: Cialis is not recommended for scheduled once daily use.
  • Hepatic dysfunction:
    • Mild or moderate dysfunction: Use has not been extensively evaluated. Therefore, use with caution.
    • Severe dysfunction: Use is not recommended.

Use with CYP3A4 inhibitors (see drug interactions)

  • Maximum dose is 10 mg every 72 hours as needed or 2.5 mg daily without regard to timing of sexual activity.

Contraindications, Warnings, and Precautions

Contraindications

  • Use of nitrates (for example, nitroglycerine, isosorbide): Cialis may increase hypotensive effects of nitrates.
  • Hypersensitivity reactions to tadalafil (Cialis or Adcirca)

Warnings and Precautions

  • Angina. Patients with angina should not use Cialis because sexual activity may precipitate angina.
  • Use of scheduled daily Cialis in combination with nitrates, alpha blockers, antihypertensives, and potent CYP3A4 inhibitors.
  • Prolonged erections and priapism
  • Sudden loss of vision: NAION (non-arteritic anterior ischemic optic neuropathy)
  • Sudden hearing loss .
  • Alpha blockers and antihypertensives: Cialis potentiates the antihypertensive effects of alpha blockers and antihypertensives.
  • Renal impairment: See dosing section.
  • Hepatic impairment: See dosing section.
  • Alcohol: Cialis potentiates the vasodilatory action of alcohol. Combining Cialis with substantial consumption of alcohol may result in orthostatic hypotension .
  • CYP3A4 inhibitors (for example, ritonavir, ketoconazole, itraconazole): Limit dose. (See drug interactions.)
  • Other PDE5 inhibitors: Cialis should not be combined with other PDE5 inhibitors.
  • Bleeding: PDE5 is found on platelets. Use of Cialis in patients with bleeding disorders or active peptic ulcers should be based on careful risk-benefit assessment and caution.

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