Roszet 10 mg-40 mg tablet

Generic name:
Ezetimibe/rosuvastatin - oral

Pronunciation
(e-ZET-i-mibe/roe-SOO-ya-STAT-in)

Brand name(s)
Roszet

This combination medication is used along with a proper diet to help lower "bad" cholesterol (such as LDL). Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Rosuvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush, chew, or dissolve tablets.

The dosage is based on your medical condition, response to treatment, race, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you are of Asian descent, your doctor may direct you to start with a lower dose because you may be more sensitive to its effects.

If you are taking a bile acid sequestrant (such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after taking the bile acid sequestrant. These medications may bind to ezetimibe/rosuvastatin, preventing your body from fully absorbing the drug.

Antacids containing aluminum and magnesium can reduce the absorption of this drug. If taking this type of antacid, take it at least 2 hours after this medication.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Most people with high cholesterol do not feel sick.

It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this product.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small number of people taking rosuvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks.

Tell your doctor right away if you have any serious side effects, including:

• foamy urine

This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms last after your doctor stops this drug:

• muscle pain/tenderness/weakness (especially with fever or unusual tiredness)
• signs of kidney problems (such as change in the amount of urine)

This medication may rarely cause liver problems. Tell your doctor right away if you develop symptoms of liver problems, including:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or rosuvastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• kidney disease
• alcohol use

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially muscle problems.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of rosuvastatin from your body, which may affect how rosuvastatin works. Examples include cyclosporine, gemfibrozil, certain drugs to treat hepatitis C (such as ledipasvir/sofosbuvir, sofosbuvir/velpatasvir/voxilaprevir), among others.

Do not take any red yeast rice products while you are taking ezetimibe/rosuvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking ezetimibe/rosuvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood cholesterol/triglyceride levels, liver function) should be done while you are taking this product. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle at room temperature away from light and moisture. Do not store in the bathroom. Once the bottle is opened, this medication expires after 30 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.