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Important Safety Information

Roszet contains two medicines, rosuvastatin and ezetimibe, to lower cholesterol. Roszet is used:

  • Along with diet in adults with high cholesterol levels to reduce low density lipoprotein cholesterol (LDL-C) or bad cholesterol.

  • Alone or together with other LDL-lowering medicines in adults with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Roszet is not for everyone. Do not take Roszet if you are nursing, pregnant or may become pregnant, have liver problems or repeated blood tests showing possible liver problems, or are allergic to ezetimibe, rosuvastatin or any of the ingredients in Roszet.

Tell your doctor right away if you have any of the following symptoms of allergic reactions:

  • Swelling of the face, lips, tongue, and/or throat which makes it difficult to swallow or breathe

  • Breathing problems or wheezing

  • Feeling dizzy or faint

  • Rash or hives

  • Itching

Tell your doctor right away if you have muscle pain, tenderness or weakness, especially if you have a fever or feel tired. If you have muscle problems that do not go away even after your doctor told you to stop taking Roszet, your doctor may do further tests to diagnose the cause of your muscle problems.

Your doctor may do blood tests to check your liver before you start taking Roszet and if you have symptoms of liver problems while you take Roszet. Tell your doctor if you have the following symptoms of liver problems:

  • Feel tired or weak

  • Upper belly pain

  • Yellowing of your skin or the whites of your eyes

  • Loss of appetite

  • Dark urine

The most common side effects of Roszet include headache, weakness, diarrhea, dizziness, pain (back, hands, legs), nausea, constipation, joint pain, stomach pain, muscle aches and pains, common cold and flu, runny nose and sore throat, tiredness.

These are not all the possible side effects of ROSZET. Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Please see Full Prescribing Information

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