DRUG INTERACTIONS

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

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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. 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. 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

17.10 Sexually Transmitted Disease

It can also treat the signs and symptoms of BPH. Cialis for once daily use is the only medication approved to treat both ED and the signs and symptoms of BPH. Cialis for use as needed is approved to treat erectile dysfunction (ED). Cialis for use as needed should be taken before sexual activity. It may go to work quickly (in as little as 30 minutes in some men) and can work up to 36 hours.*+ The most common side effects with Cialis are headache, indigestion, back pain, muscle aches, flushing and stuffy or runny nose.

2.2 CIALIS for Once Daily Use for Erectile Dysfunction

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 two days. Not studied for multiple attempts per dose. +In clinical trials, Cialis for use as needed started to work in 30 minutes for some men who took 20 mg of Cialis for use as needed. 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

• Cialis was part of a class of drugs known as PDE5 inhibitors.
• These drugs revolutionized the treatment of erectile dysfunction.
• Lilly invested heavily in development and patent protection for Cialis.
• The medication is generally safe when used as prescribed.
• Cialis use should be avoided if heart conditions preclude sexual activity.
• The medication can have interactions with certain medications like alpha-blockers.
• Men often seek Cialis consultations to improve sexual confidence.
• Treatments like Cialis allow restoration of intimacy in relationships.
• Physician follow-up ensures optimal dosing and safety monitoring.
• Cialis’s approval marked a significant advancement in sexual medicine.
• The drug’s marketing often includes education about ED causes.
• Cialis remains a subject of scientific and clinical interest.

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

16.2 Storage

When taken as needed, Cialis was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt. Important Safety Information for Cialis® (tadalafil) tablets What Is The Most Important Information I Should Know About Cialis? take medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure use recreational drugs called "poppers" like amyl nitrite and butyl nitrite are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing 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.

2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

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. What Should I Tell My Healthcare Provider Before Taking Cialis? Only your healthcare provider and you can decide if Cialis is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. 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.

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You should not take Cialis if your healthcare provider has told you not to have sexual activity because of your health problems. 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 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 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 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. Do not take sildenafil citrate (Revatio®)* with Cialis. What Should I Avoid While Taking Cialis? Do not use other ED medicines or ED treatments while taking Cialis.

Dosage Forms and Strengths

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? 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. cure ED increase a man's sexual desire 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.

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Call your healthcare provider if you get any side effect that bothers you or one that does not go away. An erection that won't go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury. In rare instances, men taking daily cialis buy prescription ED tablets, including Cialis, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). 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.

17.8 Sudden Hearing Loss

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. 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

• Cialis tablets come with different packaging, including blister packs and bottles.
• Eli Lilly provides comprehensive patient information leaflets with Cialis.
• Cialis is sometimes prescribed off-label for Raynaud’s phenomenon.
• The medication has a bioavailability of about 80%.
• Food intake has minimal impact on Cialis absorption.
• Cialis is metabolized primarily by the liver enzyme CYP3A4.
• Dose adjustments might be necessary for patients with kidney impairment.
• Cialis’s half-life is approximately 17.5 hours, contributing to long effect.
• Lilly has faced generic competition for Cialis in many markets.
• The drug’s patent expiration allowed entry of tadalafil generics.
• Cialis is included in some clinical guidelines for ED management.
• Monitoring for rare but serious side effects is part of patient care.

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).

17.6 Priapism

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. 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.