December 19, 2014
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Mylan-Simvastatin

(simvastatin)

DIN (Drug Identification Number)

02246583 MYLAN-SIMVASTATIN 10MG TABLET
02246737 MYLAN-SIMVASTATIN 20MG TABLET
02246584 MYLAN-SIMVASTATIN 40MG TABLET
02246582 MYLAN-SIMVASTATIN 5MG TABLET
02246585 MYLAN-SIMVASTATIN 80MG TABLET

How does Mylan-Simvastatin work? What will it do for me?

Simvastatin belongs to the group of medications known as HMG CoA reductase inhibitors ("statins"). It is used in addition to diet and exercise to lower cholesterol levels.

It is also used to decrease the risk of heart attack, stroke, or death regardless of whether cholesterol levels are high or not for people who have coronary heart disease (CHD) or have other arteries in the body that are blocked, or for those who have diabetes and are over the age of 40.  It is also used to treat people who haver certain inherited cholesterol disorders. It works by blocking an enzyme that helps create cholesterol in the body. Therefore, less cholesterol is made and levels of cholesterol in the blood decrease. Simvastatin lowers the level of total cholesterol and low density lipoprotein (LDL, or "bad" cholesterol) and raises high density lipoprotein (HDL, or "good" cholesterol) levels.

The medication usually takes about 2 to 4 weeks to have a significant effect on the cholesterol level in your blood. After this time, your doctor will likely send you for a blood test to check for changes in your cholesterol levels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

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How should I use Mylan-Simvastatin?

Before or when starting simvastatin, you should be placed on a cholesterol-lowering diet. If appropriate, a health care professional will discuss an individualized program of weight control and physical exercise with you.

The starting dose of this medication depends on your medical conditions and other medications you are taking, and can range from 5 mg to 40 mg taken once daily in the evening. The maximum recommended daily dose is 80 mg, which may be required for some people who are unable to achieve a desired cholesterol level using lower doses. The maximum daily dose may be lower for people taking certain medications.

The maximum dose for children and adolescents 10 to 17 years of age with with inherited cholesterol disorders is 40 mg.

For best results in lowering your cholesterol, it is very important that you closely follow the diet suggested by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does Mylan-Simvastatin come in?

5 mg
Each buff-coloured, shield-shaped, film-coated tablet, marked with "SM" over "5" on one side and "G" on the other, contains 5 mg of simvastatin. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide.

10 mg
Each peach-coloured, shield-shaped, film-coated tablet, marked with "SM" over "10" on one side and "G" on the other, contains 10 mg of simvastatin. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide.

20 mg
Each tan-coloured, shield-shaped, film-coated tablet, marked with "SM" over "20" on one side and "G" on the other, contains 20 mg of simvastatin. Nonmedicinal ingredients: ascorbic acid, black iron oxide, butylated hydroxyanisole, citric acid, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, red iron oxide, talc, titanium dioxide, and yellow iron oxide.

40 mg
Each pink- to brick-red-coloured, shield-shaped, film-coated tablet, marked with "SM" over "40" on one side and "G" on the other, contains 40 mg of simvastatin. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide, and triacetin.

80 mg
Each pink- to brick-red-coloured, capsule-shaped, film-coated tablet, marked with "SM80" on one side and "G" on the other, contains 80 mg of simvastatin. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide, and triacetin.

Who should NOT take Mylan-Simvastatin?

Do not take simvastatin if you:

  • are allergic to simvastatin or any ingredients of the medication
  • are breast-feeding
  • are pregnant or plan to become pregnant
  • have active liver disease or unexplained increases in liver function tests
  • are taking certain other medications, such as:
    • "azole" antifungal medications (e.g., fluconazole, ketoconazole)
    • protease inhibitors (e.g., boceprevir, ritonavir, telaprevir)
    • macrolide antibiotics (e.g., erythromycin, clarithromycin)
    • medications containing cobicistat
    • nefazodone
    • gemfibrozil
    • cyclosporine
    • danazol

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