Ezetimibe and Simvastatin (Page 10 of 11)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with e zetimibe and simvastatin [see Contraindications (4) and Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking e zetimibe and simvastatin.

17.1 Muscle Pain

All patients starting therapy with ezetimibe and simvastatin should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing ezetimibe and simvastatin. Patients using the 10/80-mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with the use of the 10/80-mg dose. The risk of myopathy, including rhabdomyolysis, occurring with use of ezetimibe and simvastatin is increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

17.2 Liver Enzymes

It is recommended that liver function tests be performed before the initiation of ezetimibe and simvastatin, and thereafter when clinically indicated. All patients treated with ezetimibe and simvastatin should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using ezetimibe and simvastatin. Discuss future pregnancy plans with your patients, and discuss when to stop taking ezetimibe and simvastatin if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking ezetimibe and simvastatin and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should be advised to not use ezetimibe and simvastatin. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit

Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 11-2020-06

Patient Information

Ezetimibe and Simvastatin (e zet’ i mibe and sim” va stat’ in) Tablets

Read this Patient Information carefully before you start taking ezetimibe and simvastatin tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about ezetimibe and simvastatin tablets, ask your doctor. Only your doctor can determine if ezetimibe and simvastatin tablets are right for you.

What are e zetimibe and simvastatin tablets?

Ezetimibe and simvastatin tablets are a prescription medicine that contains 2 cholesterol lowering medicines, ezetimibe and simvastatin. Ezetimibe and simvastatin tablets are used along with diet to:

  • lower the level of your “bad” cholesterol (LDL)
  • increase the level of your “good” cholesterol (HDL)
  • lower the level of fat in your blood (triglycerides)

Ezetimibe and simvastatin tablets are for patients who cannot control their cholesterol levels by diet and exercise alone.

Ezetimibe and simvastatin tablets have not been shown to reduce heart attacks or strokes more than simvastatin alone.

It is not known if ezetimibe and simvastatin tablets are safe and effective in children under 10 years of age or in girls who have not started their period (menses).

The usual dose of ezetimibe and simvastatin tablets is 10/10 mg to 10/40 mg 1 time each day.

Ezetimibe and simvastatin tablets 10/80 mg increases your chance of developing muscle damage. The 10/80 mg dose should only be used by people who:

  • have been taking ezetimibe and simvastatin tablets 10/80 mg chronically (such as 12 months or more) without having muscle damage
  • do not need to take certain other medicines with ezetimibe and simvastatin tablets that would increase your chance of getting muscle damage.

If you are unable to reach your LDL-cholesterol goal using ezetimibe and simvastatin tablets 10/40 mg, your doctor should switch you to another cholesterol-lowering medicine.

Who should not take e zetimibe and simvastatin tablets?

Do not take e zetimibe and simvastatin tablets if you take:

  • Certain anti-fungal medicines including:
    • itraconazole
    • ketoconazole
    • posaconazole
    • voriconazole
  • HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir)
  • Certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
  • Certain antibiotics, including:
    • erythromycin
    • clarithromycin
    • telithromycin
  • nefazodone
  • medicines containing cobicistat
  • A fibric acid medicine for lowering cholesterol called gemfibrozil
  • cyclosporine
  • danazol

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Also do not take e zetimibe and simvastatin tablets if you:

  • are allergic to ezetimibe or simvastatin or any of the ingredients in ezetimibe and simvastatin tablets. See the end of this leaflet for a complete list of ingredients in ezetimibe and simvastatin tablets.
  • have liver problems.
  • are pregnant or plan to become pregnant. Ezetimibe and simvastatin tablets may harm your unborn baby. If you are a woman of childbearing age, you should use an effective method of birth control to prevent pregnancy while using ezetimibe and simvastatin tablets. If you become pregnant while taking ezetimibe and simvastatin tablets, stop taking ezetimibe and simvastatin tablets and call your doctor.
  • are breastfeeding or plan to breastfeed. It is not known if ezetimibe and simvastatin passes into your breast milk. You and your doctor should decide the best way to feed your baby if you take ezetimibe and simvastatin tablets.

What should I tell my doctor before and while taking e zetimibe and simvastatin tablets?

Tell your doctor if you:

  • have unexplained muscle aches or weakness
  • have kidney problems
  • have or have had liver problems or drink more than 2 glasses of alcohol daily
  • have thyroid problems
  • are 65 years of age or older
  • are Chinese

Also see “What are the possible side effects of ezetimibe and simvastatin tablets?”

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor who prescribes ezetimibe and simvastatin tablets if another doctor increases the dose of another medicine you are taking.

Talk to your doctor before you start taking any new medicines.

Taking ezetimibe and simvastatin tablets with certain other medicines may affect each other causing side effects. Ezetimibe and simvastatin tablets may affect the way other medicines work, and other medicines may affect how ezetimibe and simvastatin tablets works.

Taking ezetimibe and simvastatin tablets with certain substances can increase the risk of muscle problems.

It is especially important to tell your doctor if you take:

  • fibric acid derivatives (such as fenofibrate)
  • amiodarone or dronedarone (drugs used to treat an irregular heartbeat)
  • verapamil, diltiazem, amlodipine, or ranolazine (drugs used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
  • grapefruit juice (which should be avoided while taking ezetimibe and simvastatin tablets)
  • colchicine (a medicine used to treat gout)
  • lomitapide (a medicine used to treat a serious and rare genetic cholesterol condition)
  • daptomycin (a drug used to treat complicated skin and bloodstream infections)
  • large doses of niacin or nicotinic acid

Tell your doctor if you are taking niacin or a niacin-containing product, as this may increase your risk of muscle problems, especially if you are Chinese.

It is also important to tell your doctor if you are taking coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).

Tell your doctor about all the medicines you take, including any prescription and nonprescription medicines, vitamins, and herbal supplements.

How should I take e zetimibe and simvastatin tablets?

  • Take ezetimibe and simvastatin tablets exactly as your doctor tells you to take it.
  • Do not change your dose or stop taking ezetimibe and simvastatin tablets without talking to your doctor.
  • Take ezetimibe and simvastatin tablets 1 time each day in the evening.
  • Take ezetimibe and simvastatin tablets with or without food.
  • While taking ezetimibe and simvastatin tablets, continue to follow your cholesterol-lowering diet and to exercise as your doctor told you to.
  • If you miss a dose, do not take an extra dose. Just resume your usual schedule.
  • Your doctor should do fasting blood tests to check your cholesterol while you take ezetimibe and simvastatin tablets. Your doctor may change your dose of ezetimibe and simvastatin tablets if needed.
  • If you take too much ezetimibe and simvastatin tablets, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of e zetimibe and simvastatin tablets?

E zetimibe and simvastatin tablets may cause serious side effects, including:

  • Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death.

    Tell your doctor 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 e zetimibe and simvastatin tablets.
    • you have muscle problems that do not go away even after your doctor has advised you to stop taking ezetimibe and simvastatin tablets. Your doctor 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 ezetimibe and simvastatin tablets
  • are 65 years of age or older
  • are female
  • have thyroid problems (hypothyroidism) that are not controlled
  • have kidney problems
  • are taking higher doses of ezetimibe and simvastatin tablets, particularly the 10/80 mg dose
  • are Chinese
  • Liver problems. Your doctor should do blood tests to check your liver before you start taking ezetimibe and simvastatin tablets and if you have any symptoms of liver problems while you take ezetimibe and simvastatin tablets. Call your doctor right away if you have the following symptoms of liver problems:
    • loss of appetite
    • upper belly pain
    • dark urine
    • yellowing of your skin or the whites of your eyes
    • feel tired or weak

The most common side effects of ezetimibe and simvastatin tablets include:

  • headache
  • increased liver enzyme levels
  • muscle pain
  • upper respiratory infection
  • diarrhea

Additional side effects that have been reported in general use with ezetimibe and simvastatin tablets or with ezetimibe or simvastatin tablets (tablets that contain the active ingredients of ezetimibe and simvastatin tablets) include:

  • allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which may require treatment right away), rash, hives; joint pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; gallstones; trouble sleeping; poor memory; memory loss; confusion; erectile dysfunction; breathing problems including persistent cough and/or shortness of breath or fever.

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of ezetimibe and simvastatin tablets. For more information, ask your doctor or pharmacist.

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

How should I store ezetimibe and simvastatin tablets?

  • Store ezetimibe and simvastatin tablets at room temperature between 20° to 25°C (68° to 77°F).
  • Keep ezetimibe and simvastatin tablets in its original container until you use it.
  • Keep ezetimibe and simvastatin tablets in a tightly closed container, and keep ezetimibe and simvastatin tablets out of light.

Keep e zetimibe and simvastatin tablets and all medicines out of the reach of children.

General Information about the safe and effective use of e zetimibe and simvastatin tablets.

Ezetimibe and simvastatin tablets works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. Ezetimibe and simvastatin tablets does not help you lose weight.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ezetimibe and simvastatin tablets for a condition for which it was not prescribed. Do not give ezetimibe and simvastatin tablets to other people, even if they have the same condition that you have. It may harm them.

This Patient Information summarizes the most important information about ezetimibe and simvastatin tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ezetimibe and simvastatin tablets that is written for health professionals.

For more information, go to www.amneal.com, or call 1-877-835-5472.

What are the ingredients in ezetimibe and simvastatin tablets?

Active Ingredients: ezetimibe, USP and simvastatin, USP

Inactive Ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

*All trademarks are the property of their respective owners.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLCBridgewater, NJ 08807

Rev. 11-2019-03

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