ould be advised that use of lipid-regulating agents does not reduce the importance of appropriate nutritional intake and physical activity [see Dosage and Administration (2)].
Patients should be advised not to alter VASCEPA capsules in any way and to ingest intact capsules only [see Dosage and Administration (2)].
Instruct patients to take VASCEPA as prescribed. If a dose is missed, patients should take it as soon as they remember. However if they miss one day of VASCEPA, they should not double the dose when they take it.
SPL UNCLASSIFIED SECTION
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
VASCEPA is a registered trademark of the Amarin group of companies
©2016 Amarin Pharma, Inc. Bedminster NJ 07921 All rights reserved
P00120K
2/2017
PATIENT PACKAGE INSERT
PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 2/2017
VASCEPA® (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 leaflet 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 do
