eli lilly drugs cialis

Counterfeit Versions of Cialis tablets identified entering the United States

FDA is alerting consumers and health care professionals that counterfeit versions of Cialis 20 mg tablets were found in the mail on its way to a U.S. consumer. While this shipment was stopped, FDA is concerned about other possible mail shipments to consumers. FDA laboratory analysis showed the counterfeit versions contain multiple active ingredients, which if used could result in adverse effects or harm. Consumers should only buy prescription medicines from state-licensed pharmacies located in the U.S.

FDA cannot confirm that the manufacturing, quality, storage, and handling of these products follow U.S. standards because these products are from an unknown source. Therefore, these products are considered unsafe and should not be used.

FDA also recommends consumers talk to their health care professional about their condition and options for treatment if they received a counterfeit product.

FDA-approved Cialis tablets made by Eli Lilly contain the active ingredient, tadalafil, and are used for the treatment of erectile dysfunction and other approved indications. Currently, Eli Lilly’s authentic product is considered safe and effective for its intended uses. There is no indication that the legitimate supply chain is at risk, therefore consumers can be confident that prescription medicines received through legitimate state-licensed pharmacies located in the U.S. are safe and effective.

Counterfeit versions of Cialis can be identified by the following differences on the label of the bottle when compared to the authentic product. The label:

• lists “AUSTR81137” on the front of the bottle;
• does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets;
• does not include the tablet strength in a colored box;
• has different patterns and colors; it has yellow and darker green designs on the front label;
• has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle;
• lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and
• lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle.

Consumers should not use products that match one or more of the descriptions above. If you have additional information about these products, you may contact FDA at [email protected].

To date, FDA is not aware of consumer adverse events related to the use of these counterfeit versions of Cialis. Health care professionals and consumers are encouraged to report adverse events related to the use of any suspect medications to FDA’s MedWatch Adverse Event Reporting program by:

• Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
• Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178

Consumers who buy prescription medicines online should be careful. Some websites sell medicine that may not be safe to use and may put their health at risk. Go to www.fda/gov/BeSafeRx for more information about the risks, to learn the signs of websites that may sell counterfeit or otherwise unsafe medicines, and how to find legitimate licensed online pharmacies.

FDA is committed to protecting public health by working to secure the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources.

Picture of authentic bottle of Eli Lilly’s Cialis 20 mg Tablets sold in the U.S.

Eli Lilly and Company

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Contact Lilly

To speak with a healthcare professional who can provide you with additional information, about CIALIS, please call 1-800-LILLY-Rx (1-800-545-5979), Monday through Friday, 9 AM to 8 PM Eastern Time. This is an information service provided by Eli Lilly and Company. It is not meant to replace your healthcare professional's advice. Your own healthcare professional is the best source of information regarding your health.

You can also call our automated line, 24 hours/7 days a week, at 1-877-4-CIALIS
(1-877-424-2547) to hear additional information.

If you have a medical emergency, call your emergency telephone hotline (usually 911). For non-urgent medical advice, please contact your healthcare provider.

Indications: CIALIS is approved to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Taking CIALIS with finasteride when starting BPH treatment has been studied for 26 weeks. CIALIS is not for women or children.

IMPORTANT SAFETY INFORMATION FOR CIALIS

What Is The Most Important Information I Should Know About CIALIS?

Do not take CIALIS if you:take medicines called “nitrates” such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure; or use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. take medicines called guanylate cyclase stimulators such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension as the combination may cause an unsafe drop in blood pressure. 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.

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 it is already weak from a heart attack or heart disease.

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. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. Do 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 heart attack pulmonary hypertensionlow blood pressure or high blood pressure that is not controlled strokeliver or kidney problems or require dialysisretinitis pigmentosa. a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAIONstomach ulcers or a bleeding problema deformed penis shape or Peyronie’s disease an erection that lasted more than 4 hoursblood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect CIALIS?

Tell your healthcare provider about all the medicines you take, especially: medicines called "nitrates" which are often prescribed for chest pain medicines called guanylate cyclase stimulators, such as riociguat (Adempas ® ), used to treat pulmonary arterial hypertension and chronic-thromboembolic hypertension 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. Do not take both CIALIS and ADCIRCA. Do not take sildenafil citrate (Revatio ® )* with CIALIS.

How Should I Take CIALIS?

CIALIS should not be taken more than one time each day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Take CIALIS exactly as your healthcare provider prescribes it.

What Should I Avoid While Taking CIALIS?

Do not use other ED medicines or ED treatments. Do not drink too much alcohol (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. 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 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include:
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 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 .

CIALIS does not:
Cure ED, increase a man's sexual desire, protect a man or his partner from sexually transmitted diseases, including HIV or serve as a male form of birth control.

CIALIS is available by prescription only.

*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.

TD CON ISI 16SEP2015

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