2 DOSAGE AND ADMINISTRATION

CIALIS is not for women or children. CIALIS must be used only under a healthcare provider's care.

use recreational drugs called “poppers” like amyl nitrite and butyl nitrite.

12.2 Pharmacodynamics

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.

How is tadalafil supplied (dosage forms)?

Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines 40mg cialis price 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 chronic-thromboembolic pulmonary hypertension. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.

5.8 Hepatic Impairment

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?”). See also “What Are The Possible Side Effects Of CIALIS?” CIALIS is a prescription medicine taken by mouth for the treatment of: men with symptoms of benign prostatic hyperplasia (BPH) 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. (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.

Warnings & Precautions

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including CIALIS, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (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. Physicians should instruct patients on the appropriate administration of CIALIS to allow optimal use. For CIALIS for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity.

7.3 Potential for CIALIS to Affect Other Drugs

In most patients, the ability to have sexual intercourse is improved for up to 36 hours. For CIALIS for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Cialis is effective at improving erectile function over the course of therapy. For CIALIS for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day. Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA Read this important information before you start taking CIALIS and each time you get a refill.

Dive Brief:

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? See the end of this leaflet for a complete list of ingredients in CIALIS.

8.1 Pregnancy

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. Symptoms of an allergic reaction may include:rashhivesswelling of the lips, tongue, or throatdifficulty breathing or swallowing swelling of the lips, tongue, or throat Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

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.

• Cialis is a medication used primarily to treat erectile dysfunction (ED).
• It contains the active ingredient tadalafil.
• Cialis is produced by Eli Lilly and Company.
• It works by relaxing muscles and increasing blood flow to certain areas.
• Cialis can also treat symptoms of benign prostatic hyperplasia (BPH).
• The effects of Cialis can last up to 36 hours.
• It is available in various doses, including 2.5 mg, 5 mg, 10 mg, and 20 mg.
• Cialis is taken orally, usually 30 minutes before sexual activity.
• Common side effects include headache, flushing, and indigestion.
• Cialis should not be combined with nitrates to avoid dangerous blood pressure drops.
• It was first approved by the FDA in 2003.
• Cialis can be prescribed for daily use or as needed.

Ask your healthcare provider if it is safe for you to have sexual activity.

• Cialis dosages allow flexibility: starting doses vary per patient need.
• Low-dose daily Cialis supports continuous readiness for sexual activity.
• Higher doses are typically used for occasional use prior to intercourse.
• Cialis clinical trials involved thousands of participants worldwide.
• Lilly’s research focused on minimizing adverse effects and maximizing efficacy.
• Cialis can alleviate symptoms of BPH by relaxing bladder muscles.
• Studies confirmed Cialis improves overall sexual satisfaction scores.
• The drug has a favorable safety profile compared to some alternatives.
• Lilly Armed Cialis with extensive marketing campaigns globally.
• Patient adherence improves if side effects are well managed.
• Cialis is contraindicated in patients with severe cardiovascular disease.
• The drug is monitored for post-marketing surveillance of safety.

have low blood pressure or have high blood pressure that is not controlled have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including a condition called NAION 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 Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily 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. protect a man or his partner from sexually transmitted diseases, including HIV. CIALIS and other medicines may affect each other.

• Tadalafil is chemically distinct from sildenafil, the active ingredient in Viagra.
• Cialis is often known as the "weekend pill" due to its long effect.
• The medication’s efficacy depends on adequate sexual arousal.
• Drug comparisons show Cialis’s side effect profile is favorable.
• Lilly’s patient assistance programs can reduce cost barriers.
• Daily low-dose Cialis may improve endothelial function in some patients.
• The drug is contraindicated with nitrates used for chest pain.
• Care should be taken when driving or performing tasks after taking Cialis.
• Cialis does not cause immediate permanent changes in sexual function.
• The medication's role in female sexual dysfunction remains unclear.
• Cialis has changed perceptions of male sexual health treatments.
• Safety reviews continue as new data emerge internationally.

Always check with your healthcare provider before starting or stopping any medicines.

5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

In this study, the effect of CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint. “See FDA-approved patient labeling (Patient Information)” Physicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of CIALIS with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)]. Physicians should discuss with patients the contraindication of CIALIS with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension.

5.1 Cardiovascular

Patients should be counseled that the concomitant use of CIALIS with GC stimulators may cause blood pressure to drop to an unsafe level. 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.

7.2 Potential for Other Drugs to Affect CIALIS

[see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)]. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention. Physicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. 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 These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin).