1 INDICATIONS AND USAGE

It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including Cialis and call a healthcare provider right away. You are encouraged to report negative side effects of prescription drugs to the FDA. protect a man or his partner from sexually transmitted diseases, including HIV serve as a male form of birth control For additional information, talk to your doctor and see full Patient Information at and Prescribing Information at or visit for more information. * The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products. About Eli Lilly and Company Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.

• The Cialis patent expired in many countries by the mid-2020s.
• Generic tadalafil versions became widely accessible to patients.
• Market competition led to reduced prices for Cialis and generics.
• Lilly continues research on improved formulations of tadalafil.
• Online pharmacies sell Cialis; caution is advised to avoid counterfeits.
• The drug should only be purchased through licensed distributors.
• Awareness campaigns educate about safe use of Cialis.
• Side effect profiles remain similar between brand and generic versions.
• Pharmacovigilance monitors adverse events linked to Cialis use.
• Cialis remains an important option in ED treatment algorithms.
• The medication plays a role in men's sexual health discussions.
• Physicians frequently review Cialis use during follow-up visits.

This press release contains forward-looking statements about the potential of Cialis for the treatment of benign prostatic hyperplasia and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

• Cialis’s indication for ED is supported by large-scale meta-analyses.
• Lilly recommends medical consultation before starting Cialis.
• Drug interactions include alpha-blockers and certain antifungals.
• Cialis should be used cautiously with other blood pressure medications.
• Common side effects include back pain and muscle aches.
• Rare side effects can include vision changes or hearing loss.
• Emergency medical help is needed if an erection lasts longer than 4 hours.
• Cialis improves blood flow by inhibiting phosphodiesterase type 5.
• Sexual stimulation is required for Cialis to be effective.
• Cialis is not addictive but should be used responsibly.
• The medication comes with usage instructions and warnings.
• Ongoing research explores new therapeutic uses for tadalafil.

Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study.

12. Cialis - Clinical Pharmacology

There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study.

Adverse Reactions/Side Effects

Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Cialis® (tadalafil) Tablets Recommended for Approval for the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia in the European Union Milestone reflects Eli Lilly and Company's commitment to bring new treatment options to millions of men who experience urological conditions INDIANAPOLIS, Sept. 21, 2012 -- Eli Lilly and Company (LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Cialis® (tadalafil) Tablets Recommended for Approval for the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia in the European Union Milestone reflects Eli Lilly and Company's commitment to bring new treatment options to millions of men who experience urological conditions INDIANAPOLIS, Sept. 21, 2012 -- Eli Lilly and Company (LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack high or low blood pressure or have high blood pressure that is not controlled stroke liver or kidney problems or require dialysis retinitis pigmentosa, a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAION stomach ulcers or a bleeding problem a deformed penis shape or Peyronie's disease an erection that lasted more than 4 hours blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your healthcare provider about all the medicines you take especially if you take: medicines called "nitrates" which are often prescribed for chest pain alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. cure ED increase a man's sexual desire protect a man or his partner from sexually transmitted diseases, including HIV serve as a male cialis oral strips form of birth control For additional information, talk to your doctor and see full Patient Information at and Prescribing Information at or visit for more information. Package insert / product label Generic name: tadalafil Dosage form: tablet, film coated Drug class: Impotence medications CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and the signs and symptoms of BPH (ED/BPH) (1.3) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day (2.1).

ED: Starting dose: 10 mg as needed prior to sexual activity. CIALIS may be taken without regard to food (2.5). Administration of CIALIS to patients using any form of organic nitrate is contraindicated. CIALIS was shown to potentiate the hypotensive effect of nitrates (4.1). History of known serious hypersensitivity reaction to CIALIS or ADCIRCA® (4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1). Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9).

Drug Label Information

Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack high or low blood pressure or have high blood pressure that is not controlled stroke liver or kidney problems or require dialysis retinitis pigmentosa, a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAION stomach ulcers or a bleeding problem a deformed penis shape or Peyronie's disease an erection that lasted more than 4 hours blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your healthcare provider about all the medicines you take especially if you take: medicines called "nitrates" which are often prescribed for chest pain alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. cure ED increase a man's sexual desire protect a man or his partner from sexually transmitted diseases, including HIV serve as a male cialis oral strips form of birth control For additional information, talk to your doctor and see full Patient Information at and Prescribing Information at or visit for more information. Package insert / product label Generic name: tadalafil Dosage form: tablet, film coated Drug class: Impotence medications CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and the signs and symptoms of BPH (ED/BPH) (1.3) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability.

Patient resources

Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day (2.1). ED: Starting dose: 10 mg as needed prior to sexual activity. CIALIS may be taken without regard to food (2.5). Administration of CIALIS to patients using any form of organic nitrate is contraindicated. CIALIS is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CIALIS was shown to potentiate the hypotensive effect of nitrates (4.1). History of known serious hypersensitivity reaction to CIALIS or ADCIRCA® (4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1). Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9).

6.1 Clinical Trials Experience

CIALIS is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism (5.3). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism (5.3). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). CIALIS should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION (5.4, 6.2).

• Cialis use requires awareness of potential allergic reactions.
• The medication is contraindicated in severe liver impairment.
• Medication adherence improves clinical outcomes with Cialis.
• Dosage may be adjusted based on therapeutic response.
• Cialis effectiveness can decline if underlying health worsens.
• Not all men respond equally to tadalafil treatment.
• Cialis may help in cases of mixed ED and BPH symptoms.
• The medication does not protect against sexually transmitted infections.
• Cialis is not recommended during pregnancy or breastfeeding (not indicated).
• It is essential to disclose all medications to a healthcare provider before use.
• Drug resistance is not a concern with Cialis.
• Lilly updates prescribing information periodically based on research.

Patients should stop CIALIS and seek prompt medical cialis soft tabs 20mg attention in the event of sudden decrease or loss of hearing (5.5). Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14).

5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use

The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day. When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1).

ketoconazole, ritonavir) increase CIALIS exposure (2.7, 5.10, 7.2) requiring dose adjustment: CIALIS for use as needed: no more than 10 mg every 72 hoursCIALIS for once daily use: dose not to exceed 2.5 mg CIALIS for use as needed: no more than 10 mg every 72 hours CIALIS for once daily use: dose not to exceed 2.5 mg Hepatic Impairment (2.6, 5.8, 8.6): Mild or Moderate: Dosage adjustment may be needed.

17.3 Cardiovascular Considerations

It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including Cialis and call a healthcare provider right away. You are encouraged to report negative side effects of prescription drugs to the FDA. protect a man or his partner from sexually transmitted diseases, including HIV serve as a male form of birth control For additional information, talk to your doctor and see full Patient Information at and Prescribing Information at or visit for more information. * The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company.

6.2 Postmarketing Experience

The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products. About Eli Lilly and Company Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. This press release contains forward-looking statements about the potential of Cialis for the treatment of benign prostatic hyperplasia and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. Renal Impairment (2.6, 5.7, 8.7): Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed.

• Cialis prescription guidelines emphasize age and health status evaluation.
• The medication is contraindicated in men advised against sexual activity.
• Prior to Cialis, medical history should be reviewed thoroughly.
• Cialis enables more spontaneous and confidence-building intimacy.
• Treatment success is higher with proper adherence to dosing schedules.
• Patient-reported outcome measures monitor Cialis effectiveness.
• Cialis has been featured in numerous clinical practice guidelines.
• Fertility effects of Cialis have been studied but show no major risk.
• The drug is usually well tolerated across diverse populations.
• Treatment discontinuation can occur due to side effects or lack of efficacy.
• Lilly offers educational resources for healthcare professionals.
• Cialis complements lifestyle modification for ED treatment.

Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies (14.3)]. Do not split CIALIS tablets; entire dose should be taken. The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing.

Highlights of Prescribing Information

CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies (14.3)]. Do not split CIALIS tablets; entire dose should be taken. The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.

12.2 Pharmacodynamics

The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration. The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.

14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)

CIALIS should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION (5.4, 6.2). Patients should stop CIALIS and seek prompt medical cialis soft tabs 20mg attention in the event of sudden decrease or loss of hearing (5.5). Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14). Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1).

Pulmonary arterial hypertension

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1). ketoconazole, ritonavir) increase CIALIS exposure (2.7, 5.10, 7.2) requiring dose adjustment: CIALIS for use as needed: no more than 10 mg every 72 hoursCIALIS for once daily use: dose not to exceed 2.5 mg CIALIS for use as needed: no more than 10 mg every 72 hours CIALIS for once daily use: dose not to exceed 2.5 mg Hepatic Impairment (2.6, 5.8, 8.6): Mild or Moderate: Dosage adjustment may be needed. Renal Impairment (2.6, 5.7, 8.7): Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day. When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks. The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.