Roszet

Generic name: Ezetimibe And Rosuvastatin
Dosage form: tablets
Drug class: Antihyperlipidemic combinations

Usage of Roszet

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.

Roszet side effects

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.

Before taking Roszet

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.

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How to use Roszet

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.

What other drugs will affect Roszet

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.

Disclaimer

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