PATIENT INFORMATION
VASCEPA® (pronounced vas-EE-puh) (icosapent ethyl) Capsules WHAT IS VASCEPA?
VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if VASCEPA prevents you from having a heart attack or stroke.
It is not known if VASCEPA is safe and effective in children.
Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in VASCEPA. See the end of this summary for a complete list of ingredients in VASCEPA.
Before taking VASCEPA, tell your doctor about all of your medical conditions, including if you:
• have diabetes.
• have a low thyroid problem (hypothyroidism).
• have a liver problem.
• have a pancreas problem.
• are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to VASCEPA.
• are pregnant, or planning to become pregnant. It is not known if VASCEPA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. VASCEPA can pass into your milk, and may harm your baby. Talk to your doctor about the best way to feed your baby if you take VASCEPA.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements. VASCEPA can interact with certain other medicines that you are taking. Especially tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners).
HOW SHOULD I TAKE VASCEPA?
• Take VASCEPA exactly as your doctor tells you to take it.
• Do not change your dose or stop taking VASCEPA without talking to your doctor.
• Do not take more capsules than what is prescribed by your doctor. - If you are prescribed the 0.5-gram capsules, you should not take more than 8 capsules each day. - If you are prescribed the 1-gram capsules, you should not take more than 4 capsules per day.
• Take VASCEPA capsules whole. Do not break, crush, dissolve, or chew VASCEPA capsules before swallowing.
• If you miss a dose of VASCEPA, take it as soon as you remember. However, if you miss one day of VASCEPA, do not double your dose when you take it.
• Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you VASCEPA. Stay on this diet while taking VASCEPA.
• Your doctor may do blood tests to check your triglyceride and other lipid levels while you take VASCEPA.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF VASCEPA?
If you have liver problems and are taking VASCEPA, your doctor should do blood tests during treatment. The most common side effect of VASCEPA is joint pain. As with all drugs, you may experience a serious side effect when taking VASCEPA. Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of VASCEPA. 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 VASCEPA?
• Store VASCEPA at room temperature between 68° to 77° F (20° to 25° C).
• Safely throw away medicine that is out of date or no longer needed.
Keep VASCEPA and all medicine out of the reach of children.
General information about the safe and effective use of VASCEPA. Medicines are sometimes prescribed for purposes other than those listed in Patient Information Leaflets. Do not use VASCEPA for a condition for which it was not prescribed. Do not give VASCEPA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VASCEPA that is written for health professionals.
WHAT ARE THE INGREDIENTS IN VASCEPA?
Active Ingredient: icosapent ethyl Inactive Ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water For more information, go to www.VASCEPA.com or call 1-855-VASCEPA (1-855-827-2372). This patient information has been approved by the U.S. Food and Drug Administration.
VASCEPA is a registered trademark of the Amarin group of companies. ©2016 Amarin Pharma, Inc. Bedminster NJ, 07921 All rights reserved Distributed by: Amarin Pharma, Inc. Bedminster, NJ, USA Manufactured for: Amarin Pharmaceuticals Ireland Limited Dublin, Ireland +1-855-VASCEPA (+1-855-827-2372) www.vascepa.com PP00120K 2/2017