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CYCLOSET- bromocriptine mesylate tablet

  1. Patient Information
  2. Manufactured For:
  3. Distributed By:
  4. What Is Cycloset?
  5. Do Not Take Cycloset If You:
  6. Before Taking Cycloset, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  7. How Should I Take Cycloset?
  8. Cycloset May Cause Serious Side Effects, Including:
  9. The Most Common Side Effects Of Cycloset Include:
  10. How Should I Store Cycloset?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients should be informed of the potential risks and benefits of CYCLOSET and of alternative therapies. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.

Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, and diaphoresis. Hypotension and syncope may occur more frequently during initial therapy or with an increase in dose at any time. During early treatment with CYCLOSET, patients should be advised to make slow postural changes and to avoid situations that could predispose to serious injury if syncope was to occur.

Patients should be advised that CYCLOSET may cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur.

Women who are nursing their children should be advised to not take CYCLOSET.

Physicians should instruct their patients to read the Patient Package Insert before starting CYCLOSET therapy and to reread it each time the prescription is renewed. Patients should be instructed to inform their healthcare provider if they develop any unusual symptoms or if any known symptom persists or worsens.

Manufactured For: 

VeroScience, LLC
Tiverton, RI 02878 USA

Distributed By: 

Salix Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Printed in USA

For information for healthcare professionals, call 1-800-321-4576.

For patent information: http://veroscience.com/products/patents.html

Cycloset is a registered trademark of VeroScience LLC, Tiverton, RI 02878 USA used under license.

9625401 70014086

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 with other medicines that also help to control blood sugar.

CYCLOSET has not been studied in children.

Do Not Take Cycloset If You: 

  • are allergic to bromocriptine or any of the other ingredients in CYCLOSET
  • take ergot medicines. Ask your healthcare provider for a list of these medicines, if you are not sure
  • are breastfeeding
  • have fainting (syncopal) migraine headaches

Talk to your healthcare provider before taking CYCLOSET if you have any of these conditions.

Before Taking Cycloset, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have type 1 diabetes mellitus
  • have diabetic ketoacidosis
  • have ever passed out or fainted
  • have migraine headaches
  • have or have had low blood pressure (hypotension)
  • have or have had a mental health condition, especially a psychotic disorder
  • are pregnant or plan to become pregnant. It is not known if CYCLOSET will harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines for:

  • mental health conditions, especially anti-psychotic medicines
  • migraine or other types of headaches
  • type 2 diabetes

Ask your healthcare provider or pharmacist for a list of medicines taken for these conditions, if you are not sure.

CYCLOSET may affect the way other medicines work, and other medicines may affect how CYCLOSET works.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How Should I Take Cycloset? 

  • Take CYCLOSET exactly as your healthcare provider tells you to take it.
  • Take CYCLOSET by mouth each day.
  • Take CYCLOSET with food.
  • Take CYCLOSET within 2 hours after waking in the morning.
  • If you miss your morning dose, wait until the next morning to take your medication.
  • Do not take a double dose of CYCLOSET.
  • During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication needs may change. Contact your healthcare provider right away.
  • If you take too much CYCLOSET, call your healthcare provider or go to the nearest emergency department right away.
  • While taking CYCLOSET:
    • check your blood sugar as your healthcare provider tells you to
    • stay on your prescribed diet and exercise program
    • learn to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes

Cycloset May Cause Serious Side Effects, Including: 

  • Low blood pressure
  • Fainting
  • Severe dizziness which can be caused by postural hypotension. This can happen when your blood pressure lowers rapidly after you stand up from a lying down position.

The Most Common Side Effects Of Cycloset Include: 

  • nausea
  • headache
  • fatigue (somnolence). If you have somnolence from CYCLOSET you should not drive or use other heavy machines until the somnolence is better.
  • dizziness
  • vomiting
  • low blood sugar (hypoglycemia), especially when used with another type of diabetes medicine known as a sulfonylurea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of CYCLOSET. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Cycloset? 

Store and dispense: At 68-77 F (20-25 C) in a tight, light-resistant container.

Active ingredient: bromocriptine mesylate

Inactive ingredients: lactose, corn starch, magnesium stearate, colloidal silicon dioxide, and citric acid.

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