When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to rosuvastatin, you have active liver disease, or you are pregnant or breastfeeding.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take 2 doses within 12 hours.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how rosuvastatin works. Tell your doctor if you are taking any of the following:
  
  • A blood thinner, such as warfarin
  • Cimetidine
  • Cyclosporine
  • Medicine to treat an infection, such as erythromycin, fluconazole, itraconazole, ketoconazole, atazanavir/ritonavir, or lopinavir/ritonavir
  • Niacin (Vitamin B3)
  • Spironolactone
• If you need to take an antacid that contains aluminum and magnesium, take the antacid at least 2 hours after you take rosuvastatin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have kidney disease, diabetes, an underactive thyroid, a history of liver disease, or muscle pain or weakness. Tell your doctor if you usually have more than 2 drinks of alcohol per day.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, cloudy urine, painful urination
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Muscle pain, tenderness, or weakness
• Swelling in your hands, ankles, or feet
• Unusual tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088