April 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

What side effects are possible with Mylan-Simvastatin?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • diarrhea
  • gas
  • headache
  • nausea
  • trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • blurred vision
  • depression
  • memory loss
  • skin rash
  • symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
  • symptoms of muscle damage (e.g., unexplained muscle pain, tenderness, or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)
  • symptoms of nerve damage (e.g., muscle weakness, decreased sensation in the hands and feet, numbness, or tingling or prickling sensations)

Stop taking the medication and seek medical attention immediately if any of the following occur:

  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • symptoms of a serious allergic reaction (e.g., swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Mylan-Simvastatin?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 24, 2013

Health Canada has issued new information concerning the use of simvastatin. To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

Previous advisories on simvastatin were issued on November 13, 2012.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.

Grapefruit juice: Drinking large quantities (more than 1 litre daily) of grapefruit juice should be avoided while taking this medication as it can increase the amount of simvastatin in the blood and increase the risk of serious side effects. Drinking small quantities (one 250 mL glass daily) does not appear to increase the risk of side effects significantly.

Kidney problems: People with decreased kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Laboratory tests show signs of harmful effects to the liver that may occur for a small percentage of people who take simvastatin. When this medication is stopped, liver function usually slowly returns to normal. Your doctor will perform regular tests to check your liver function.

This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. People with a history of liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Muscle effects: In rare cases, serious muscle pain, cramps, and weakness have been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in "statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

  • are 65 years of age or older
  • are female
  • are taking other cholesterol-lowering medications such as fibrates (e.g., gemfibrozil, fenofibrate) or niacin
  • do excessive physical exercise
  • have a family history of muscular disorders
  • have diabetes
  • have had any past problems with the muscles (pain, tenderness) after taking a statin medication
  • have hypothyroidism (low thyroid) that is not controlled with medication
  • have kidney or liver problems
  • have undergone surgery or other tissue injury
  • regularly drink 3 or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: Simvastatin should not be taken during pregnancy. If you become pregnant, stop taking this medication and contact your doctor immediately.

Breast-feeding: It is not known if simvastatin passes into breast milk. Women taking simvastatin should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children under 10 years of age or in girls who have not started menstruating.

Seniors: If you are 65 years of age or older, you may experience more side effects. Your doctor will monitor you closely while you are taking this medication.

What other drugs could interact with Mylan-Simvastatin?

There may be an interaction between simvastatin and any of the following:

  • amiodarone
  • amlodipine
  • cholestyramine
  • clarithromycin
  • colchicine
  • colestipol
  • cyclosporine
  • danazol
  • daptomycin
  • digoxin
  • diltiazem
  • dronedarone
  • erythromycin
  • fusidic acid
  • gemfibrozil
  • itraconazole
  • ketoconazole
  • nefazodone
  • niacin (nicotinic acid)
  • phenytoin
  • protease inhibitors (e.g., ritonavir, saquinavir)
  • quinine
  • rifampin
  • rifabutin
  • sildenafil
  • telithromycin
  • verapamil
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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