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

• Along with diet in adults with high blood 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.

It is not known if this medicine is safe and effective in children.

• Take Roszet exactly as your healthcare provider tells you to take it.
• Take Roszet 1 time each day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime.
• Tablets should be swallowed whole. Do not crush, dissolve, or chew tablets.
• Keep taking Roszet unless your healthcare provider tells you to stop. If you stop treatment, your cholesterol may rise again.
• If you miss a dose, do not take an extra dose. Take the next dose at the usual time. Do not take 2 doses of Roszet within 12 hours of each other.
• If you take too much or overdose, call the Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• See your healthcare provider regularly to check your cholesterol level and to check for side effects. Your healthcare provider may do blood tests to check your liver before, and during treatment.

Do not take Roszet if you:

• have liver problems or repeated blood tests showing possible liver problems.
• are allergic to ezetimibe or rosuvastatin or any of the other ingredients. See the end of this page for complete list of ingredients.

Before you take Roszet

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have unexplained muscle aches or weakness.
• have thyroid problems.
• have kidney problems.
• drink more than 2 glasses of alcohol daily or have had liver problems.
• have diabetes.
• are pregnant or plan to become pregnant. Roszet may harm your unborn baby. If you become pregnant, stop treatment and call your healthcare provider right away.
• are breast feeding. Roszet can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Roszet. Do not breastfeed while taking Roszet.
• are 65 years of age or older.
• are of Asian descent.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you start taking any new medicines.

Taking Roszet with certain other medicines can increase the risk of muscle problems or other side effects.

Especially tell your healthcare provider if you take medicines for:

• heartburn (such as antacids that contain aluminum and magnesium hydroxide)
• your immune system (such as cyclosporine)
• cholesterol (such as niacin or nicotinic acid, gemfibrozil, fibrates)
• infections or anti-fungals (such as itraconazole, ketoconazole, and fluconazole)
• heart failure including coumarin anticoagulants (such as warfarin)
• gout (such as colchicine)
• darolutamide (a medicine for the treatment of prostate cancer)
• regorafenib (a medicine used to treat cancer of the colon and rectum)
• anti-viral medicines including certain HIV or hepatitis C virus drugs such as:
  • lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir
  • combination of
    • sofosbuvir/velpatasvir/voxilaprevir
    • dasabuvir/ombitasvir/paritaprevir/ritonavir
    • elbasvir/grazoprevir
    • sofosbuvir/velpatasvir
    • glecaprevir/pibrentasvir and
  • all other combinations with ledipasvir including ledipasvir/sofosbuvir

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know all of the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine.

Roszet may cause serious side effects, including:

• Allergic reactions, including a severe reaction known as anaphylaxis. Tell your healthcare provider right away if you have any of the following symptoms:
  • swelling of the face, lips, tongue, and/or throat which makes it difficult to swallow or breathe
  • breathing problems or wheezing
  • feeling dizzy or fainting
  • rash or hives
  • itching
• Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely causes kidney damage that can lead to death. You have a higher chance for muscle problems if you are taking certain other medicines with Roszet. Tell your healthcare provider right away if:
  • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take Roszet.
  • you have muscle problems that do not go away even after your healthcare provider has advised you to stop taking Roszet. Your healthcare provider may do further tests to diagnose the cause of your muscle problems.

Your chances of getting muscle problems are higher if you:

• • are taking certain other medicines while you take Roszet (see Especially tell your healthcare provider if you take medicines)
  • are 65 years of age or older
  • are of Asian descent
  • have thyroid problems (hypothyroidism) that are not controlled
  • have kidney problems
  • are taking higher doses of Roszet
• Liver problems. Your healthcare provider may do blood tests to check your liver before you start treatment and if you have symptoms of liver problems while you take Roszet. Call your healthcare provider right away 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 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

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

If you also take cholestyramine, colesevelam, or colestipol: Take your ezetimibe and rosuvastatin dose 2 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your other medicines. Some drugs can increase the risk of serious muscle problems when used with ezetimibe and rosuvastatin, especially:

• colchicine, cyclosporine;

• antifungal medication - fluconazole, itraconazole, ketoconazole;

• a blood thinner - warfarin, Coumadin, Jantoven;

• cancer medicine - darolutamide, regoragenib;

• other cholesterol medications - fenofibrate, fenofibric acid, gemfibrozil, niacin, nicotinic acid;

• hepatitis C medication that contains - dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, sofosbuvir, velpatasvir, or voxilaprevir; or

• HIV/AIDS medication - atazanavir, fosamprenavir, lopinavir, ritonavir, simeprevir, tipranavir.

This list is not complete and many other drugs may affect ezetimibe and rosuvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.