PHL-Simvastatin (Pharmel, PM 00023378): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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

What the medication is used for:

Your physician has prescribed phl-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), phl-SIMVASTATIN should lessen the risk of heart attack or stroke.

You can also benefit from taking phl-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 physician 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 physician.

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.

phl-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 phl-SIMVASTATIN if you are:

• allergic to any of its components
• 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 telithromycin¹)
  • antidepressant nefazodone1
  • gemfibrozil (a fibric acid medicine for lowering cholesterol)
  • cyclosporine
  • danazol.

Ask your doctor 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, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinised starch, titanium dioxide, triacetin, iron oxide yellow (5 & 20 mg), iron oxide red (10 & 20 mg), FD&C blue No. 2 lake, FD&C red No. 40 lake, FD&C yellow No. 6 lake (40 & 80 mg).

What dosage forms it comes in:

Tablets: 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.

WARNINGS AND PRECAUTIONS

Before taking phl-SIMVASTATIN, tell your physician 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 phl-SIMVASTATIN. Discuss with the physician 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 physician the potential hazards to the fetus and the importance of birth control methods.

• become pregnant. phl-SIMVASTATIN should not be

  used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your physician.

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

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

Because taking phl-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 physician if you are taking:

• antifungal agents (such as itraconazole, ketoconazole, posaconazole, or voriconazole)
• HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and saquinavir)
• boceprevir or telaprevir (drugs used to treat hepatitis C virus infection)
• the antibiotics erythromycin, clarithromycin, telithromycin¹, and fusidic acid (intravenous1 or oral1)
• the antidepressant nefazodone1
• 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)
• grapefruit juice (which should be avoided while taking phl-SIMVASTATIN).

It is also important to tell your doctor 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. Also tell your doctor if you are taking niacin or a niacin-containing product and are Chinese.

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 physician instructed. Do not change the dose unless directed by a physician. It is usually recommended as a single dose with the evening meal. Because of the increased risk of muscle problems, the 80 mg dose is only for patients who have been taking this dose chronically 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 physician.
• 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 physician has recommended for diet, exercise or weight control.
• When taking phl-SIMVASTATIN, you should avoid consuming grapefruit juice.
• .When taking phl-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 physician 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 physician or pharmacist.

• Let your physician know if you suffer a severe injury, or

  severe infection.

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

  physician about the planned surgery; and also inform the physician 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 physician:

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 phl-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

simvastatin. This risk of muscle breakdown is greater for patients taking higher doses of phl-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 physician regularly to check your cholesterol level and to check for side effects. Your physician should do blood tests to check your liver before you start taking phl-SIMVASTATIN and if you have any symptoms of liver problems while you take phl-SIMVASTATIN.

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

HOW TO STORE IT

Store between15ºC and 30ºC.

Keep all medicines out of the reach of children.

Do not use outdated medicine.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor Pharmel Inc., at 1-888-550-6060.

Pharmel Inc.

Montréal Québec

H4P 2T4

Last revised: January 10, 2014