Rosuvastatin; Ezetimibe Oral Tablets

What is this medication?

ROSUVASTATIN; EZETIMIBE (roe SOO va sta tin; ez ET i mibe) is a combination of 2 medicines to treat cholesterol. Rosuvastatin is a statin. It lowers bad cholesterol levels in the blood. Ezetimibe blocks the absorption of cholesterol from the stomach. They are used with lifestyle changes, like diet and exercise.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ROSZET

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asian descent
• diabetes (high blood sugar)
• drink more than 2 alcoholic drinks every day
• kidney disease
• liver disease
• muscle cramps, pain
• muscle injury
• thyroid disease
• an unusual or allergic reaction to rosuvastatin, ezetimibe, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew the medicine. Swallow the tablets whole. You can take this medicine with or without food. If it upsets your stomach, take it with food.

Take antacids with magnesium and aluminum in them at a different time of day than this medicine. Take this medicine 2 hours AFTER the antacid.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• herbal medicines like red yeast rice

This medicine may also interact with the following medications:

• alcohol
• antacids containing aluminum hydroxide or magnesium hydroxide
• birth control pills
• certain antibiotics like erythromycin and clarithromycin
• certain antivirals for HIV or hepatitis like atazanavir, cobicistat, darunavir, elbasvir, elvitegravir, fosamprenavir, glecaprevir, grazoprevir, ledipasvir, pibrentasvir, ritonavir, velpatasvir, and voxilaprevir
• certain medicines for cholesterol like colsevelam, colestipol, cholestyramine, fenofibrate, fenofibric acid, gemfibrozil, and niacin
• certain medicines for fungal infections like ketoconazole and itraconazole
• colchicine
• cyclosporine
• darolutamide
• digoxin
• grapefruit juice
• regorafenib
• rifampin
• supplements like black cohosh and St. John's wort
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

Your health care provider may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your health care provider.

Do not become pregnant while taking this medicine. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your health care provider for more information.

If you are going to need surgery or other procedure, tell your health care provider that you are using this drug.

Taking this drug is only part of a total heart healthy program. Your health care provider may give you a special diet to follow. Avoid alcohol. Avoid smoking. Ask your health care provider how much you should exercise.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• confusion
• depressed mood
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• joint pain
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• loss of memory
• muscle injury (dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain; back pain)
• redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your doctor or health care provider if they continue or are bothersome):

• constipation
• diarrhea
• dizziness
• headache
• nausea
• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 to 77 degrees F). Keep this medicine in the original container. Get rid of any unused medicine after the expiration date.

To get rid of the medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.