Cialis

Yes

Common Side Effects of Cialis

• Headache
• Back pain
• Muscle aches
• Stomach pain or discomfort
• Indigestion
• Burping
• Acid reflux
• Flushing
• Stuffy or runny nose

Serious Side Effects of Cialis

• Vision impairment
• Irregular heartbeat or chest pain
• Shortness of breath
• Lightheadedness
• Sudden hearing loss.

Patients are urged to contact physicians for erections lasting more than four hours.

Cialis tablets are yellow, film-coated, almond-shaped tablets, available in doses of 5, 10, and 20 milligrams (mg).

Cialis for daily use comes in 2.5 mg and 5 mg.

• Recommended dosage of Cialis for ED is 10 mg, taken at least 30 minutes before sexual activity. Dosage may be increased to 20 mg or decreased to 5 mg, based of efficacy and tolerability.
• Recommended dosage for Cialis once daily for ED is 2.5 mg, taken at the same time every day. Dosage may be increased to 5 mg based on efficacy and tolerability.
• Recommended dosage for Cialis once daily for BPH is 5 mg, taken at the same time every day.
• For pulmonary arterial hypertension patients, doses of 20, 40, and 60 mg may be prescribed. Typically, after 16 weeks of treatment, a 40 mg daily dose proved effective.

For patients experiencing both ED and BPA, the recommended dose of Cialis is 5 mg, taken at the same time every day.

Cialis Overdose

Contact your physician if you experience numbness or pain during sexual activity.

Get emergency help if you experience sudden vision loss because Cialis can decrease blood flow to the optic nerve in the eye.

Missed Dose of Cialis

Patients using Cialis may not be on a dose schedule, so simply take it as needed.

Do not take extra medicine to make up for a missed dose.

CIALIS®
(See-AL-iss)
(tadalafil) Tablets

Read this important information before you start taking CIALIS and each time you get a refill. There may be new information. 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 CIALIS 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 CIALIS?

CIALIS 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 CIALIS with any nitrate or guanylate cyclase stimulator medicines.

Do not take CIALIS 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 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 CIALIS if you take medicines called guanylate cyclase stimulators which include:

• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic 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 CIALIS?”)

Tell all of your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS.

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 (see “Can Other Medicines Affect CIALIS?”).

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 CIALIS?”

What Is CIALIS?

CIALIS is 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 BPH

CIALIS for the Treatment of ED

ED 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. CIALIS 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.

Some form of sexual stimulation is needed for an erection to happen with CIALIS.

CIALIS 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 healthcare provider about ways to guard against sexually transmitted diseases.
• serve as a male form of birth control

CIALIS is only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.

CIALIS for the Treatment of Symptoms of BPH

BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.

CIALIS for the Treatment of ED and Symptoms of BPH

ED 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 CIALIS for the treatment of both conditions.

CIALIS is not for women or children.

CIALIS must be used only under a healthcare provider’s care.

Who Should Not Take CIALIS?

Do not take CIALIS 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 CIALIS?”)
• take any medicines called guanylate cyclase stimulators, such as riociguat.
• are allergic to CIALIS or ADCIRCA®, or any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS. Symptoms of an allergic reaction may include:
  • rash
  • hives
  • swelling of the lips, tongue, or throat
  • difficulty breathing or swallowing

Call 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 CIALIS?

CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is right for you. Before taking CIALIS, 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 CIALIS 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 leukemia

Can Other Medicines Affect CIALIS?

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. CIALIS 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 CIALIS?”)
• medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension
• medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), UroxatralR (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If CIALIS is 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.
• 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?

• Take CIALIS 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 CIALIS 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 CIALIS without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to CIALIS and your health condition.
• CIALIS may be taken with or without meals.
• If you take too much CIALIS, call your healthcare provider or emergency room right away.

How Should I Take CIALIS for Symptoms of BPH?

For symptoms of BPH, CIALIS is taken once daily.

• Do not take CIALIS more than one time each day.
• Take one CIALIS tablet every day at about the same time of day.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.

How Should I Take CIALIS for ED?

For ED, there are two ways to take CIALIS - either for use as needed OR for use once daily.

CIALIS for use as needed:

• Do not take CIALIS more than one time each day.
• Take one CIALIS tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking CIALIS and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take CIALIS before sexual activity. Some form of sexual stimulation is needed for an erection to happen with CIALIS.
• Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.

OR

CIALIS for once daily use is a lower dose you take every day.

• Do not take CIALIS more than one time each day.
• Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.
• Some form of sexual stimulation is needed for an erection to happen with CIALIS.
• Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.

How Should I Take CIALIS for Both ED and the Symptoms of BPH?

For both ED and the symptoms of BPH, CIALIS is taken once daily.

• Do not take CIALIS more than one time each day.
• Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.
• Some form of sexual stimulation is needed for an erection to happen with CIALIS.

What Should I Avoid While Taking CIALIS?

• Do not use other ED medicines or ED treatments while taking CIALIS.
• Do not drink too much alcohol when taking CIALIS (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?

See “What Is The Most Important Information I Should Know About 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 side effects include:

An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. 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 (shade) 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 CIALIS) 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 CIALIS, and call a healthcare provider 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 CIALIS. 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 CIALIS and contact a healthcare provider right away.

These are not all the possible side effects of CIALIS. For more information, ask your healthcare provider or pharmacist.

How Should I Store CIALIS?

Store CIALIS at room temperature between 59° and 86°F (15° and 30°C).

Keep CIALIS and all medicines out of the reach of children.

General Information About CIALIS:

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use CIALIS for a condition for which it was not prescribed. Do not give CIALIS to other people, even if they have the same symptoms that you have. It may harm them.

This is a summary of the most important information about CIALIS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIALIS that is written for health providers. For more information you can also visit www.cialis.com, or call 1-877-CIALIS1 (1-877-242-5471).

What Are The Ingredients In CIALIS?

Active Ingredient: tadalafil

Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

This Patient Information has been approved by the U.S. Food and Drug Administration

>10%

Headache (11-42%)

Myalgia (1-14%)

Respiratory tract infection (3-13%)

Nasopharyngitis (2-13%)

Dyspepsia (1-13%)

Flushing (1-13%)

Back pain (2-12%)

Nausea (10-11%)

1-10%

Nasal congestion (≤9%)

Gastroesophageal reflux disease (1-3%)

Hypertension (1-3%)

Bronchitis (≤2%)

Genitourinary tract infection (≤2%)

<1%

Amnesia

Angina pectoris

Arthralgia

Change in color vision

Conjunctival hyperemia

Dyspnea

Epistaxis

Postmarketing reports

Hypotension

Visual field defect, retinal vein occlusion, retinal artery occlusion, and non–arteritic anterior ischemic optic neuropathy (NAION)

Hearing loss

Priapism

• Cialis 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.
• Do not take Cialis 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 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.
  • Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.
• Tell all of your healthcare providers that you take Cialis. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Cialis.
• 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.
• If taking Cialis for treating ED, stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea. Sexual activity can put extra strain on your heart and worsen these symptoms.
• Seek immediate medical attention if sudden loss of vision occurs, which could be a sign of non-arteritic ischemic optic neuropathy (NAION).
• Seek immediate medical attention if sudden decrease or loss of hearing occurs.

Do not take Cialis if you:

• take any medicines called “nitrates”.
• use recreational drugs called “poppers” like amyl nitrite and butyl nitrite
• are allergic to Cialis or any of its ingredients. Symptoms of an allergic reaction may include:
  • rash
  • hives
  • swelling of the lips, tongue, or throat
  • difficulty breathing or swallowing

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

• Store Cialis at room temperature.
• Keep Cialis and all medicines out of the reach of children.

Your pharmacist can provide more information about tadalafil.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.02. Revision date: 1/18/2012.

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Administration

Oral Administration

Administer orally without regard to meals.1 2 70

May be administered as-needed (just prior to [e.g., ≥0.5 hours before] anticipated sexual activity) or on a daily basis (at approximately the same time every day) for treatment of ED; take entire dose and do not split tablets.1 Because of prolonged duration of action (up to 36 hours),1 2 4 7 9 13 timing of administration relative to anticipated sexual activity is less important than with relatively short-acting drugs for ED.3 9

Administer as a once-daily dose at approximately the same time every day in patients with BPH with or without coexisting ED.1

When used for the treatment of PAH, administer as a once-daily dosage.70 Take entire dose at one time and not as divided doses throughout the day.70

Dosage

Adults

As-needed therapy: Usual initial dosage is 10 mg just prior to anticipated sexual activity.1 (See Oral Administration under Dosage and Administration.) Depending on effectiveness and tolerance, may increase dose to 20 mg or decrease to 5 mg.1 Concomitant use with HIV protease inhibitors or with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) requires dosage adjustment.1 49 50 52 53 62 63 64 65 66 200 (See Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.)

Maximum recommended dosing frequency is once daily for most patients.1 2

Once-daily therapy: Initially, 2.5 mg once daily.1 2 Depending on effectiveness and tolerance, may increase dosage to 5 mg once daily.1

Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) requires dosage adjustment.1 (See Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.)

5 mg once daily.1

Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) requires dosage adjustment.1 200 (See Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.)

5 mg once daily.1

Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) requires dosage adjustment.1 200 (See Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.)

40 mg once daily.70

Concomitant use with ritonavir or other HIV protease inhibitors that are potent inhibitors of CYP3A requires dosage adjustment.49 50 52 53 62 63 64 65 66 200 (See Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.)

Special Populations

Hepatic Impairment

As-needed use for ED: In patients with mild or moderate hepatic impairment (Child-Pugh class A or B), maximum dosage is 10 mg once daily.1 2

Once-daily use for BPH and/or ED: Use with caution in patients with mild or moderate hepatic impairment.1

Treatment of PAH: Consider a reduced initial dosage of 20 mg once daily in patients with mild or moderate hepatic cirrhosis (Child-Pugh class A or B).70

Use not recommended in any patient with severe hepatic impairment (Child-Pugh class C).1 70 (See Hepatic Impairment under Cautions.)

Renal Impairment

As-needed use for ED: For patients with Clcr 30–50 mL/minute, reduce initial dosage to 5 mg administered no more frequently than once daily; maximum dosage 10 mg no more frequently than once every 48 hours.1 For patients with Clcr<30 mL/minute or those undergoing hemodialysis, maximum dosage 5 mg no more frequently than once every 72 hours.1

Once-daily use for ED: Dosage adjustments not necessary in patients with Clcr ≥30 mL/minute.1 Use not recommended in patients with Clcr <30 mL/minute or those on hemodialysis.1

Once-daily use for BPH with or without ED: For Clcr 30–50 mL/minute, initial dosage of 2.5 mg once daily recommended; may increase to 5 mg once daily based on patient response and tolerance.1 Use not recommended in patients with Clcr <30 mL/minute or those on hemodialysis.1

Treatment of PAH: Reduce initial dosage to 20 mg once daily in patients with mild (Clcr 51–80 mL/minute) or moderate (Clcr 31–50 mL/minute) renal impairment; may increase to 40 mg once daily based on patient response and tolerance.70 Avoid use in severe renal impairment (Clcr <30 mL/minute and those on hemodialysis).70

Geriatric Patients

No dosage adjustments necessary based solely on age.1

• Selective inhibitor of phosphodiesterases (PDEs), with the greatest selectivity for PDE type 5, the principal isoenzyme involved in the metabolism of cGMP to GMP in the corpora cavernosa of the penis.1 3 4 8

• PDE type 5 also found in smooth muscle of the prostate and bladder, as well as in vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, cerebellum, and pancreas.1 84

• Enhances the effect of nitric oxide by inhibiting PDE type 5-mediated hydrolysis of cGMP, resulting in vascular relaxation.1 3

• Potentiates accumulation of cGMP only when cGMP production in the penis is increased by sexual arousal.1 2 No effect on erectile function in the absence of sexual stimulation.1 2

• Exact mechanism of action in reducing symptoms of BPH not established, but may be related to smooth muscle relaxation and increased vascular perfusion of the lower urinary tract (i.e., bladder, prostate).1 80 81 84 89

• Modest peripheral vasodilation at usual dosages.1 4 5

• Although pharmacologically related to other PDE type 5 inhibitors (e.g., sildenafil, vardenafil), tadalafil has a longer elimination half-life and longer duration of action.3 4 Also exhibits less affinity for PDE type 6 receptor involved in phototransduction in the retina.4 13 No effects on intraocular pressure or pupillometry; changes in color vision reported rarely.1

This section provides information on the proper use of a number of products that contain tadalafil. It may not be specific to Cialis. Please read with care.

Use tadalafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with tadalafil. Read the directions carefully before you start using tadalafil and each time you get a refill of your medicine.

You may take this medicine with or without food.

Swallow the Cialis® tablet whole. Do not split, break, or crush it.

When using this medicine for erectile dysfunction, the ability to have sexual activity may be improved for up to 36 hours after taking the tablet.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of benign prostatic hyperplasia (daily use):
    • Adults—5 milligrams (mg) as a single dose, no more than once a day, taken at the same time each day.
    • Children—Use is not recommended.
  • For treatment of erectile dysfunction (as needed):
    • Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose if needed.
    • Children—Use is not recommended.
  • For treatment of erectile dysfunction (daily use):
    • Adults—2.5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity. Your doctor may adjust your dose if needed.
    • Children—Use is not recommended.
  • For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):
    • Adults—5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity.
    • Children—Use is not recommended.
  • For treatment of pulmonary arterial hypertension:
    • Adults—40 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (Cialis) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not take this medicine with other drugs used to treat a change in sex ability.
• Talk with your doctor before you drink alcohol.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Very bad and sometimes deadly side effects like a heartbeat that does not feel normal, heart attack, stroke, and very bad high blood pressure have happened with this medicine (Cialis). Talk with the doctor.
• A very bad eye problem has rarely happened with this medicine. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
• If you are 65 or older, use this medicine (Cialis) with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• This medicine is not approved for use in women. If you are a woman using this medicine, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

Potential for Pharmacodynamic Interactions with Cialis

Nitrates Administration of Cialis to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, Cialis was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken Cialis, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of Cialis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration (2.7), Contraindications (4.1), and Clinical Pharmacology (12.2)].

Alpha-Blockers Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including Cialis, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)].

Antihypertensives PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)].

Alcohol Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with Cialis can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].

Potential for Other Drugs to Affect Cialis

[See Dosage and Administration (2.7) and Warnings and Precautions (5.10)].

Antacids Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.

H2 Antagonists (e.g. Nizatidine) An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.

Cytochrome P450 Inhibitors Cialis is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.

CYP3A4 (e.g., Ketoconazole) Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.7)].

Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.

HIV Protease inhibitor Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.7)].

Cytochrome P450 Inducers Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.

CYP3A4 (e.g., Rifampin) Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. No dose adjustment is warranted. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of Cialis for once daily use; the magnitude of decreased efficacy is unknown.

Potential for Cialis to Affect Other Drugs

Aspirin Tadalafil did not potentiate the increase in bleeding time caused by aspirin.

Cytochrome P450 Substrates Cialis is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.

CYP1A2 (e.g. Theophylline) Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.

CYP2C9 (e.g. Warfarin) Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.

CYP3A4 (e.g. Midazolam or Lovastatin) Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin.

P-glycoprotein (e.g. Digoxin) Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.

How Supplied

Cialis (tadalafil) is supplied as follows:

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Cialis (tadalafil) relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. Do not take Cialis while also taking Adcirca, unless your doctor tells you to.

Cialis is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Cialis can be taken with or without food.

Do not break or split a tablet. Swallow it whole.

For erectile dysfunction, take Cialis just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with this medicine can cause side effects.

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Applies to tadalafil: oral tablet

General

The most commonly reported adverse reactions were headache, nausea, dyspepsia, back pain, myalgia, flushing, nasopharyngitis, and pain in the extremity. These adverse reactions were dose dependent, transient, and generally mild or moderate.[Ref]

Cardiovascular

Most patients that experienced side effects such as myocardial infarction, sudden cardiac death, stroke, palpitations, and tachycardia had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity.[Ref]

Very common (10% or more): Flushing (up to 14%)
Common (1% to 10%): Hypertension, hot flush
Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Unstable angina pectoris, postural hypotension, ventricular arrhythmia
Postmarketing reports: Myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported in temporal association with the use of this drug.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 13%), nausea (up to 11%)
Common (1% to 10%): Diarrhea, gastroesophageal reflux disease, abdominal pain, gastroenteritis, constipation
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Dry mouth, dysphagia, esophagitis, gastritis, loose stools, nausea, upper abdominal pain, hemorrhoidal hemorrhage, rectal hemorrhage[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 14%), back pain (up to 12%), pain in extremity (up to 11%)
Common (1% to 10%): Pain in limb, musculoskeletal stiffness
Uncommon (0.1% to 1%): Arthralgia, muscle spasm
Frequency not reported: Neck pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 42%)
Common (1% to 10%): Dizziness (1%)
Rare (less than 0.1%): Transient global amnesia, transient ischemic attacks
Frequency not reported: Hypesthesia, somnolence, syncope, paraesthesia
Postmarketing reports: Migraine, seizure and seizure recurrence[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 13%), upper and lower respiratory tract infection (up to 13%)
Common (1% to 10%): Nasal congestion (including sinus congestion), cough, influenza, pulmonary hypertension, rhinitis
Uncommon (0.1% to 1%): Dyspnea, epistaxis
Frequency not reported: Pharyngitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia (including uterine bleeding)
Uncommon (0.1% to 1%): Penile hemorrhage, hematospermia
Rare (less than 0.1%): Prolonged erections
Frequency not reported: Erection increased, spontaneous penile erection
Postmarketing reports: Priapism[Ref]

Other

In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited.[Ref]

Common (1% to 10%): Peripheral edema, fatigue, edema
Uncommon (0.1% to 1%): Tinnitus
Rare (less than 0.1%): Facial edema
Frequency not reported: Vertigo, asthenia, pain
Postmarketing reports: Cases of sudden decrease or loss of hearing have been reported in temporal association with the use of this drug.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, urticaria, hyperhidrosis (sweating)
Rare (less than 0.1%): Angioedema
Frequency not reported: Pruritus
Postmarketing reports: Stevens-Johnson syndrome, exfoliative dermatitis[Ref]

Ocular

Most of the patients with NAION, but not all, had underlying anatomic or vascular risk factors, including but not necessarily limited to: Low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.[Ref]

Uncommon (0.1% to 1%): Ocular hyperemia, eye pain, eyelid edema
Rare (less than 0.1%): Changes in color vision
Frequency not reported: Blurred vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increased
Postmarketing reports: Visual field defect, retinal vein occlusion, and retinal artery occlusion. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported in temporal association with the use of this drug.[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria
Frequency not reported: Renal impairment[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests, GGTP increased[Ref]

Some side effects of Cialis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• A headache, dyspepsia, back pain, nasal congestion, and flushing are the most commonly reported side effects.
• Other side effects include a drop in blood pressure, muscle or limb pain, or conjunctivitis.
• Rarely, may decrease blood flow to the optic nerve causing sudden vision loss. The risk is greater in people aged older than 50, with diabetes, heart disease, high blood pressure, high cholesterol, who smoke, or with certain pre-existing eye problems.
• Rarely, may cause other side effects including hearing loss or lead to painful erections lasting longer than four to six hours. See your doctor immediately if this happens.
• May not be suitable for some people including those with angina, chest pain, or other heart conditions, liver or kidney problems, blood or bleeding disorders, stomach ulcers, certain eye conditions, or a physical deformity of the penis (such as Peyronie's disease).
• May interact with some medications including nitrates - use of Cialis and nitrates is contraindicated because of the severe hypotension that can develop. May also interact with other medications including ketoconazole or ritonavir; dosage adjustment is recommended.
• The dosage of Cialis may need reducing in men with kidney disease. Once daily use may not be recommended in men with severe kidney disease.
• A lower dosage of Cialis is recommended in men with mild-to-moderate liver disease;.Cialis should be avoided with severe liver disease.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

• Peak plasma concentrations of Cialis are reached within 30 minutes to six hours (average time two hours) of a dose. Effects of 'as needed' Cialis last for up to 36 hours.
• The recommended starting dose for once daily Cialis for ED is 2.5mg; once daily Cialis for BPH, 5mg; and 'as needed' Cialis, 10mg. The dosage may be adjusted based on individual response.

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