14 CLINICAL STUDIES

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)].17.9 Sexually Transmitted DiseaseThe use of CIALIS offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.17.10 Recommended AdministrationCIALIS 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 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. Physicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates. 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 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)]. 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.

• The pill's appearance is documented in the official prescribing information.
• This document is called the package insert or label.
• The "Description" section details shape, color, and imprint.
• This information is legally required for all prescription drugs.
• The appearance description helps pharmacists verify dispensing.
• It also aids law enforcement in identifying diverted pharmaceuticals.
• Customs officials may use appearance to spot illegal shipments.
• The distinct look makes it less likely to be accidentally ingested.
• It is not attractive to children due to its plain, medicinal look.
• Child-resistant packaging further complements the safety design.
• The appearance supports the overall safe use ecosystem.

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.

Active Ingredient and Indications

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. 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). 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. 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).

Safety With Other Medications

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.

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. 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 cialis 5 price of your medicines are nitrates.

(See “Who should not take CIALIS?”)Tell all of your healthcare providers that you take CIALIS.

Release Form and Composition

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. 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. 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 cialis 5 price of your medicines are nitrates.

Related treatment guides

(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 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. 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. 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.

• Cialis pills are generally small, oval, and orange in color.
• They bear a unique imprint to identify the dose.
• The surface is glossy, smooth, and polished.
• The shape is elongated, rounded at the edges.
• Size varies slightly by dosage strength.
• They are designed for easy swallowing.
• The color and markings help distinguish generics from brand.

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. 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. 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, or have had a heart attack. 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.

12.1 Mechanism of Action

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)].17.9 Sexually Transmitted DiseaseThe use of CIALIS offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.17.10 Recommended AdministrationCIALIS 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 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. Physicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates. 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)].

Lifestyle Factors

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 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)]. 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. 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. Especially tell your healthcare provider if you take any of the cheap cialis 80mg 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. 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. 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).

12.3 Pharmacokinetics

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. 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, or have had a heart attack. 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.

Generic vs Branded

Especially tell your healthcare provider if you take any of the cheap cialis 80mg 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. 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. 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. 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).

• Cialis pills are frequently bright orange with an oval shape.
• Imprints include logos or dosage numbers.
• The surface is glossy and smooth to the touch.
• The form aids in swallowing comfortably.
• They are small, usually about 10 mm in size.
• The shape is elongated with rounded edges.
• Markings help prevent fake or counterfeit pills.