Mylan-Simvastatin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

MYLAN-SIMVASTATIN is the brand name for the substance - simvastatin, available only on prescription from your doctor.

What the medication is used for:

Your doctor has prescribed MYLAN-SIMVASTATIN to lower the levels of cholesterol and fatty substances called triglycerides in your blood and to reduce the health risks associated with Coronary Heart Disease (CHD).

Elevated cholesterol can cause CHD by clogging the blood vessels (atherosclerosis) that carry oxygen and nutrients to the heart.

If you have CHD or other signs of atherosclerosis such as previous stroke, symptoms of peripheral vascular disease, or diabetes (regardless of the amount of cholesterol in your blood), MYLAN-SIMVASTATIN should lessen the risk of heart attack or stroke.

You can also benefit from taking MYLAN-SIMVASTATIN if you have high levels of cholesterol with or without associated high triglycerides (primary hypercholesterolemia, or combined hyperlipidemia) and homozygous familial hypercholesterolemia (high cholesterol inherited from both parents).

As part of your treatment plan to lower cholesterol, and depending on your health and lifestyle, your doctor, nurse or pharmacist may recommend a diet to reduce cholesterol and other measures such as exercise and weight control.

Safety and effectiveness have been studied in 10-17 year old boys and in girls, who had started their menstrual period at least one year before (see Proper Use of this Medication). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor, nurse or pharmacist.

What it does:

Simvastatin is one of the class of medicines known as HMG-CoA reductase inhibitors. They inhibit, in other words block, an enzyme that is necessary for the body to make cholesterol. In this way, less cholesterol is produced in the liver. Medicines like this one are prescribed along with, and not as a substitute for, a special diet and other measures. Simvastatin is used to lower the levels of cholesterol [particularly low-density lipoprotein cholesterol (LDL-C)] and fatty substances called triglycerides in your blood.

MYLAN-SIMVASTATIN reduces the amount of cholesterol in your blood. Elevated cholesterol can cause CHD by clogging the blood vessels that carry oxygen and nutrients to the heart.

When it should not be used:

Do not take MYLAN-SIMVASTATIN if you are:

• allergic to simvastatin or any non-medicinal ingredient in the formulation
• diagnosed with active liver disease

• pregnant or breast-feeding

• taking any of the following medicines:

  • certain antifungal medicines (such as itraconazole, ketoconazole, posaconazole or voriconazole)
  • HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and saquinavir)
  • certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
  • certain antibiotics (such as erythromycin, clarithromycin, or telithromycin)
  • antidepressant nefazodone
  • medicines containing cobicistat
  • gemfibrozil (a fibric acid medicine for lowering cholesterol)
  • cyclosporine
  • danazol.

Ask your doctor, nurse or pharmacist if you are not sure if your medicine is listed above.

What the medicinal ingredient is:

Simvastatin

What the nonmedicinal ingredients are:

Ascorbic acid, butylated hydroxyanisole, citric acid, dehydrated alcohol, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Tablets 5 mg contain polydextrose; 5, 10, 40 and 80 mg - triacetin; 5 and 20 mg - polyethylene glycol; 5, 10, 20, 40 and 80 mg - red iron oxide; 5, 10 and 20 mg - yellow iron oxide; 20 mg - black iron oxide.

What dosage forms it comes in:

Tablet 5 mg (buff), 10 mg (peach), 20 mg (tan), 40 mg (brick red) and 80 mg (brick red).

WARNINGS AND PRECAUTIONS

Before taking MYLAN-SIMVASTATIN, tell your doctor, nurse or pharmacist if you:

• are pregnant, intend to become pregnant, are breast-feeding

  or intend to breast-feed

• have thyroid problems
• regularly drink three or more alcoholic drinks daily

• are taking any other cholesterol lowering medication such

  as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe

• are taking any other medications, including prescription,

  nonprescription and natural health products as drug

  interactions are possible

• have a family history of muscular disorders

• had any past problems with the muscles (pain, tenderness),

  after using an HMG-CoA reductase inhibitor (“statin”)

  such as atorvastatin, fluvastatin, lovastatin, pravastatin or

  rosuvastatin, or have developed an allergy or intolerance to

  them

• have kidney or liver problems

• have diabetes. Slightly increased blood sugar can

  occur when you take simvastatin. Discuss with your doctor,

  nurse or pharmacist your risk of developing diabetes

• have undergone surgery or other tissue injury
• do excessive physical exercise

• are of childbearing age. Cholesterol compounds are

  essential elements for the development of a fetus.

  Cholesterol-lowering drugs can harm the fetus. If you are

  of childbearing age, discuss with your doctor,

  nurse or pharmacist the potential hazards to the fetus and

  the importance of birth control methods.

• become pregnant. MYLAN-SIMVASTATIN should not

  be used by pregnant women. If you become pregnant,

  discontinue use immediately and discuss with your

  doctor, nurse or pharmacist.

• are Asian.

When starting or increasing the dose of MYLAN-SIMVASTATIN, or at any time, if you experience any unexplained muscle pain, tenderness or weakness, you must report promptly to your doctor, nurse or pharmacist.

Be sure to tell your doctor, nurse or pharmacist you are taking MYLAN-SIMVASTATIN before undergoing any major elective surgery or if you have any other new major medical issues.

INTERACTIONS WITH THIS MEDICATION

You should tell your doctor, nurse or pharmacist about all drugs that you are using or plan to use, including those obtained without a prescription, while taking MYLAN-SIMVASTATIN. You should also tell any doctor who is prescribing a new medication for you that you are taking MYLAN-SIMVASTATIN.

Because taking MYLAN-SIMVASTATIN with any of the following drugs or substances can increase the risk of muscle

problems (see Side effects of this medicine - and what you should do), it is particularly important to tell your doctor, nurse or pharmacist if you are taking:

• antifungal agents (such as itraconazole, ketoconazole, posaconazole or voriconazole)
• HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and saquinavir)
• Hepatitis C antiviral agents (such as boceprevir, telaprevir, elbasvir or grazoprevir)
• the antibiotics erythromycin, clarithromycin, telithromycin, and fusidic acid (intravenous or oral)
• the antidepressant nefazodone
• medicines containing cobicistat
• cyclosporine (immunosuppressant)
• danazol

• fibrates/fibric acid derivatives (bezafibrate and

  gemfibrozil) (drug to treat lipids problems)

• amiodarone (a drug used to treat an irregular heartbeat)
• verapamil, or diltiazem, or amlodipine (drugs used to treat high blood pressure, angina, or other heart conditions)
• lomitapide (a drug used to treat a serious and rare genetic cholesterol condition)
• daptomycin (a drug used to treat complicated skin and skin structure infections and bacterial infections in the blood, including certain heart valve infections)
• grapefruit juice (which should be avoided while taking simvastatin).

It is also important to tell your doctor, nurse or pharmacist if you are taking corticosteroids, anticoagulants (drug that prevents blood clots, such as warfarin), colchicine (a medicine used for gout), digoxin (a drug used to treat heart problems), niacin, or fenofibrate, another fibric acid derivative.

Some of these have already been listed in the above section “When it should not be used”.

PROPER USE OF THIS MEDICATION

Usual Dose:

• Take your medication exactly as your doctor, nurse or pharmacist instructed. Do not change the dose unless directed by your doctor. It is usually recommended to be taken with the evening meal. Because of the increased risk of muscle problems, taking 80 mg each day is only recommended for patients who have been taking this amount for a long time with no muscle problems or for patients at high risk of heart disease problems who have problems taking other statins. It is important to continue taking the tablets as instructed. Do not alter the dosage or stop taking the medicine without consulting your doctor, nurse or pharmacist.
• For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.
• Carefully follow any measures that your doctor, nurse or pharmacist has recommended for diet, exercise or weight control.

• When taking MYLAN-SIMVASTATIN, you should

  avoid consuming grapefruit juice.

• When taking MYLAN-SIMVASTATIN concurrently

  with cholestyramine or any other resin, an interval of at

  least two hours should be maintained between the two

  drugs.

• Keep your appointments regularly with your

  doctor, nurse or pharmacist so that your blood can be tested

  and your progress checked at proper intervals.

• Avoid drinking large quantities of alcohol.

• Do not start taking any other medicines unless you have

  discussed the matter with your doctor, nurse or

  pharmacist.

• Let your doctor, nurse or pharmacist know if you

  suffer a severe injury, or severe infection.

• If you have to undergo any kind of surgery, tell your

  doctor, nurse or pharmacist about the planned

  surgery; and also inform the doctor in charge that

  you are taking this medicine.

Overdose:

Missed Dose:

If you miss taking a tablet at its usual time, take it as soon as possible. But, if it is too close to the time of your next dose: take only the prescribed dose at the appointed time. Do not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication may cause unwanted effects.

The following side effects that may occur, generally do not require medical attention, and may come and go during treatment. If any of the following persist or become troublesome, do check with your doctor, nurse or pharmacist:

Constipation, diarrhea, gas, stomach upset, nausea

Pain in the abdomen

Headache

Skin rash

Poor memory

Memory loss

Confusion

Trouble sleeping

Depression

Erectile dysfunction

Breathing problems including persistent cough and/or

shortness of breath or fever.

Possible side effects reported with other statins:

Sleep disturbances, including nightmares.

Side effects such as myalgia (muscle pain), myopathy (muscle disease with aching or weakness) [that in very rare cases may not go away after stopping MYLAN-SIMVASTATIN], rhabdomyolysis (a muscle wasting disease or muscle breakdown), associated tenderness, and rare cases of muscle breakdown resulting in kidney damage that can lead to death have been reported with other drugs of this class, known as HMG-CoA reductase inhibitors (“statins”), including MYLAN-SIMVASTATIN. This risk of muscle breakdown is greater for patients taking higher doses of MYLAN-SIMVASTATIN, particularly the 80 mg dose. This risk of muscle breakdown is also greater for older patients (65 years of age and older), female patients, patients with abnormal kidney function, and patients with thyroid problems.

See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor should do blood tests to check your liver before you start taking MYLAN-SIMVASTATIN and if you have any symptoms of liver problems while you take MYLAN-SIMVASTATIN.

MYLAN-SIMVASTATIN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking MYLAN-SIMVASTATIN, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store your tablets at room temperature (15^oC - 30^oC), in the original package, away from heat and direct light, and out of damp places, such as the bathroom or kitchen.

Keep all medicines out of the reach and sight of children.

Do not use outdated medicine.

Reporting Side Effects

MORE INFORMATION

If you want more information about MYLAN-SIMVASATIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling Mylan Pharmaceuticals ULC at 1-844-596-9526

To report an adverse event related to MYLAN-SIMVASTATIN, please contact 1-844-596-9526

Etobicoke, Ontario M8Z 2S6

Last revised: July 31, 2019

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-844-596-9526 www.mylan.ca