• Is a new, FDA-approved prescription medicine for adults with type 2 diabetes
• Is a new class of antidiabetic treatment that may lower your blood sugar, without increasing insulin
• Can be used alone or as an add-on to other antidiabetic medicines
• Has demonstrated cardiovascular (such as heart attack or stroke) safety
• Has demonstrated no significant weight gain

Although the exact way that CYCLOSET works is not completely understood, it is known that it mimics the action of dopamine, a neurochemical messenger, at specific dopamine receptors in the brain. In clinical studies, CYCLOSET significantly lowered blood sugar and improved HbA1C in adult patients with type 2 diabetes. CYCLOSET has demonstrated cardiovascular safety. In a year-long clinical study with 3,070 patients, CYCLOSET showed no increase in serious events such as heart attack or stroke. In the same study, CYCLOSET also demonstrated overall safety.

CYCLOSET tablets are taken once daily by mouth within 2 hours after waking in the morning. When you start taking CYCLOSET, you will take 1 tablet a day. Over the coming weeks, you will gradually increase this dose to a maintenance dose between 2 to 6 tablets daily.

What is CYCLOSET:

CYCLOSET is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. CYCLOSET may be taken alone or in combination with other medications that also help control blood sugar. CYCLOSET has not been studied in children.

CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.

Important Safety Information

People who should NOT take CYCLOSET. CYCLOSET should not be taken by patients who take ergot medicines. A healthcare provider or pharmacist can provide a list of these medications. CYCLOSET should not be taken by anyone who is allergic to bromocriptine or any other ingredient of CYCLOSET. Patients with syncopal (fainting) migraine headaches should not take CYCLOSET, because it may cause very low blood pressure. Women who are breastfeeding should not take CYCLOSET. It may prevent them from producing milk. Some breastfeeding women taking bromocriptine, the active ingredient in CYCLOSET, have had strokes.

Warnings for patients taking CYCLOSET. CYCLOSET can cause very low blood pressure (hypotension) and fainting, especially when patients are starting treatment or have increased the dose of CYCLOSET. Patients taking medicines for high blood pressure (hypertension) should be careful when taking CYCLOSET because they may cause blood pressure to drop too much. CYCLOSET may worsen psychotic disorders or reduce the effectiveness of medicines that treat psychosis. CYCLOSET may cause sleepiness. Patients taking CYCLOSET who feel sleepy should not drive a car or operate other heavy machinery until they feel alert. Patients who are taking dopamine antagonist medications should talk to their healthcare provider before taking CYCLOSET. The combined use of these medicines is not recommended.

Safety of CYCLOSET. No antidiabetic drug, including CYCLOSET, has ever been proven to reduce the risk of having a heart attack or other cardiovascular problem such as stroke. However, a 52-week study showed that CYCLOSET did not increase the risk of major cardiovascular events. In clinical studies, the most common side effects that seemed to be caused by CYCLOSET were nausea, fatigue, dizziness, vomiting and headache.

To report a Product Adverse Event or Product Complaint: (877) 757-0666 Monday - Friday, 9:00am - 7:00pm Eastern Time

Note: 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.

For full prescribing information, please see CYCLOSET Prescribing Information (Consumers or patients, please refer to section 17.2 on pages 12-13).

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