16 HOW SUPPLIED/STORAGE AND HANDLING

Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease.

12.3 Pharmacokinetics

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.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.

How does tadalafil work (mechanism of action)?

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. (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 tablet 5 mg 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 erectile dysfunction (ED) in men.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.

Long-term use

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 EDincrease a man's sexual desireprotect 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 controlCIALIS is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomyCIALIS 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?”)What Should I Tell My Healthcare Provider Before Taking CIALIS?CIALIS is not right for everyone. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].

• Cialis 10 mg offers a discreet, flexible option for ED.
• Cialis 20 mg is preferred by men seeking a stronger effect.
• Both doses can be effective if used correctly.
• The medication helps by relaxing blood vessels in the penis.
• Consult your doctor for the best dose based on health status.
• Cialis onsets faster when taken on an empty stomach.
• Overdosing on Cialis may increase the risk of side effects.
• Cialis 10 mg is ideal for men just starting treatment.
• Safe use involves monitoring for adverse reactions.
• Higher doses should be used only under medical supervision.

Physicians should discuss with patients the potential for CIALIS to augment the blood-pressure-lowering effect of alpha blockers and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing CIALIS for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol.

Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

What Are the Differences Between Tadalafil and Cialis?

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:are allergic to CIALIS or ADCIRCA any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS.have heart problems such as angina, heart failure, irregular heartbeats, roman cialis price 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 low blood pressure or have high blood pressure that is not controlledhave had a strokehave liver problemshave kidney problems or require dialysishave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including a condition called NAIONhave stomach ulcershave a bleeding problemhave a deformed penis shape or Peyronie's diseasehave had an erection that lasted more than 4 hourshave blood cell problems such as sickle cell anemia, multiple myeloma, or leukemiaCan Other Medicines Affect CIALIS?Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Does tadalafil interact with foods or drinks?

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 alpha blockers. 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.

CIALIS for Use as Needed for Erectile Dysfunction

You could get dizzy or faint.other medicines to treat high blood pressure (hypertension)medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)ketoconazole (Nizoral®)itraconazole (Sporanox®)erythromycinother medicines or treatments for ED.CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take 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.There are two ways to take CIALIS: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. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors [see Clinical Studies (6.2)]. Therefore, physicians should inform patients that 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 [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. CIALIS is available in two dosing regimens; therefore, physicians should instruct patients on the appropriate administration to allow optimal use. For CIALIS for use as needed, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the cialis pastile ability to have sexual intercourse is improved for up to 36 hours. For CIALIS for once daily use, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. PATIENT PACKAGE INSERT Patient InformationCIALIS®(See-AL-iss)(tadalafil) tabletsRead this important information before you start taking CIALIS 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.

• Bioavailability of tadalafil is not affected by the 10mg vs 20mg dose.
• Excretion is primarily via feces for both dosage strengths.
• 10mg daily may be covered differently by insurance than 20mg packs.
• 20mg tablets are physically larger due to higher drug content.
• Both are Schedule 4 prescription drugs in many countries.
• PDE5 inhibition from both doses also relaxes other smooth muscles.
• Men with cardiovascular disease need stress testing before use.
• The medication does not cure ED; it treats the symptom.

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.Do not take CIALIS if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina.

More about Cialis (tadalafil)

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.ORCIALIS for once daily use: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.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).

How to avoid Cialis side effects

What are the dosage options for tadalafil?

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. (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 tablet 5 mg 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.

• Cialis 10 mg is often used for occasional use.
• Cialis 20 mg is sometimes preferred for unpredictable sexual activity.
• Dosing should be based on effectiveness and tolerance.
• Starting with 10 mg is common before increasing to 20 mg if needed.
• Taking Cialis with or without food doesn’t significantly affect absorption.
• Cialis 20 mg may be more effective but risks more side effects.
• Consistent use of the medication can improve erectile function.
• The maximum recommended dose is 20 mg per day.
• Dose adjustments depend on age, health, and response.
• Use Cialis exactly as prescribed to avoid complications.

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 erectile dysfunction (ED) in men.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.

5.13 Counseling Patients About Sexually Transmitted Diseases

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 EDincrease a man's sexual desireprotect 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 controlCIALIS is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomyCIALIS 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.

• Cialis 10 mg offers a lower-cost option for some users.
• Cialis 20 mg provides a more potent effect for challenging ED.
• Always follow medical advice for choosing between doses.
• The medication enhances blood flow to the penis.
• Timing of the dose is flexible, but 30 minutes pre-activity is typical.
• Avoid grapefruit or grapefruit juice when taking Cialis.
• Cialis’s effect duration makes it convenient for spontaneous activity.
• Regular use can improve confidence and quality of life.
• Dosing adjustments should be made gradually and safely.
• Safety is paramount—report side effects to your doctor immediately.

(See “What Is The Most Important Information I Should Know About CIALIS?”)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:are allergic to CIALIS or ADCIRCA any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS.have heart problems such as angina, heart failure, irregular heartbeats, roman cialis price 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 low blood pressure or have high blood pressure that is not controlledhave had a strokehave liver problemshave kidney problems or require dialysishave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including a condition called NAIONhave stomach ulcershave a bleeding problemhave a deformed penis shape or Peyronie's diseasehave had an erection that lasted more than 4 hourshave blood cell problems such as sickle cell anemia, multiple myeloma, or leukemiaCan 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 alpha blockers. 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.

5.7 Renal Insufficiency

Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)]. Physicians should discuss with patients the potential for CIALIS to augment the blood-pressure-lowering effect of alpha blockers and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing CIALIS for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

Are you currently using Tadalafil (Cialis, Adcirca, and others)?

Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors [see Clinical Studies (6.2)]. Therefore, physicians should inform patients that 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 [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. CIALIS is available in two dosing regimens; therefore, physicians should instruct patients on the appropriate administration to allow optimal use. For CIALIS for use as needed, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity.

What Are the Side Effects of Cialis and Tadalafil?

In most patients, the cialis pastile ability to have sexual intercourse is improved for up to 36 hours. For CIALIS for once daily use, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. PATIENT PACKAGE INSERT Patient InformationCIALIS®(See-AL-iss)(tadalafil) tabletsRead this important information before you start taking CIALIS 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. You could get dizzy or faint.other medicines to treat high blood pressure (hypertension)medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)ketoconazole (Nizoral®)itraconazole (Sporanox®)erythromycinother medicines or treatments for ED.CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take 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.There are two ways to take CIALIS: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.ORCIALIS for once daily use: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.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).