Teva-Fluvastatin: Uses, Side Effects and Dosage

What TEVA-FLUVASTATIN is used for:

TEVA-FLUVASTATIN is used along with a change in diet to lower the level of cholesterol and other fats (such as triglycerides) in the blood in:

• adults with high blood cholesterol. In these adults, changes in diet and exercise alone were not effective in lowering their blood cholesterol.

TEVA-FLUVASTATIN is also used to reduce the risk of heart attack, cardiac arrest, stroke or undergoing further medical procedures to treat the severe narrowing or blockage of the heart’s arteries in:

• adults who have coronary heart diseases and have previously undergone procedures to treat severely blocked arteries due to plaque buildup caused by high blood cholesterol levels.

How TEVA-FLUVASTATIN works:

TEVA-FLUVASTATIN belongs to a class of medicines known as "statins", more specifically called HMG-CoA reductase inhibitors. Statins block an enzyme called HMG-CoA reductase in your liver, which is involved in the production of cholesterol in your body. Statins are used along with changes to diet and exercise to help control the amount of cholesterol produced by the body.

TEVA-FLUVASTATIN can help your body:

• decrease LDL (bad) cholesterol and triglyceride levels.
• increase HDL (good) cholesterol levels.
• decrease the Total Cholesterol/HDL-Cholesterol Ratio (TC: HDL-C Ratio). The ratio represents the balance between good and bad cholesterol.

If levels of bad cholesterol are too high, they can cause the gradual build-up of cholesterol called plaque on the walls of the blood vessels. Over time, this plaque can build up so much that it narrows the arteries. Narrow arteries can slow or block blood flow to vital organs like the heart and brain. Blocked blood flow can result in a heart attack or stroke. By reducing bad cholesterol levels, TEVA-FLUVASTATIN reduces the risk of heart attack or stroke in adults who have risk factors, and reduces their risk of undergoing a serious medical procedure to treat severely blocked arteries due to plaque buildup.

The ingredients in TEVA-FLUVASTATIN are:

Medicinal ingredient: fluvastatin sodium.

Non-medicinal ingredients:

colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate. The capsule shell and printing ink also contains antifoam DC 1510, black iron oxide, dehydrated alcohol, gelatin, industrial methylated spirit 74 OP BP, n-butyl alcohol, red iron oxide, SDA 3A alcohol, shellac, soya lecithin, titanium dioxide, and yellow iron oxide.

TEVA-FLUVASTATIN comes in the following dosage forms:

Capsules; 20 mg and 40 mg fluvastatin (as fluvastatin sodium).

Do not use TEVA-FLUVASTATIN if:

• you are allergic to fluvastatin sodium or any of the other ingredients in TEVA-FLUVASTATIN.
• you have an active liver disease, or unexplained increases in liver enzymes.
• you are pregnant or think you might be pregnant.
• you are breast-feeding.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-FLUVASTATIN. Talk about any health conditions or problems you may have, including if you:

have taken TEVA-FLUVASTATIN or any other cholesterol-lowering medicines in the past.

• are taking any other medications, including prescription, non-prescription and natural health products.
• have a genetic condition where high blood cholesterol is inherited from one or two of the parents (homozygous or heterozygous familial hypercholesterolemia).
• have high blood sugar or diabetes, or are at risk for diabetes.

• have risk factors for muscle problems. This includes if you:

  • have had or have a family history of muscular disorders.

  • had any past problems with muscles (pain, tenderness) after using statins such as

    atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin or simvastatin.

  • currently take fibrates (such as gemfibrozil, fenofibrate and bezafibrate) or niacin

    (nicotinic acid) (used to lower fat levels in the blood).

  • have thyroid problems.
  • regularly drink three or more alcoholic drinks daily.
  • do excessive physical exercise.
  • are above 70 years of age.
  • had any past problems with your liver.
  • have kidney problems.
  • have diabetes accompanied with excess fat build-up in your liver.
  • have severe disorders affecting your metabolism or causing electrolyte or hormonal imbalances.
  • had surgery or other tissue injury.
  • have a condition that causes weakness or frailty.
  • have sepsis (severe body response to an infection).
  • have low blood pressure.
  • have epilepsy that cannot be adequately controlled with medication.

  • have any conditions or take any medicines that may increase the level of TEVA-

    FLUVASTATIN in the blood. Talk to your healthcare professional if you are unsure.

• have heart problems.
• have or have had myasthenia (a disease with general muscle weakness including the eye muscles and in some cases muscles used when breathing) as statins may aggravate the condition.

Other warnings you should know about:

TEVA-FLUVASTATIN can cause serious side effects, including:

• Hyperglycemia (high blood sugar): This may lead to the development of diabetes. Your healthcare professional will monitor your blood sugar level regularly. If you have diabetes, closely monitor your blood sugar while taking TEVA-FLUVASTATIN and report any unusual results to your healthcare professional.

• Muscle disorders such as:

  • Myalgia (muscle pain)
  • Rhabdomyolysis (breakdown of damaged muscle)
  • Immune-Mediated Necrotizing Myopathy (IMNM) (a type of autoimmune disease that causes muscle cell death)

Tell your healthcare professional right away if you have any muscle pain, tenderness, soreness or weakness while taking TEVA-FLUVASTATIN.

See the Serious side effects and what to do about them table for more information on these and other serious side effects.

Pregnancy:

• TEVA-FLUVASTATIN should not be taken during pregnancy. It could harm an unborn baby. Your healthcare professional will discuss the potential risks with you.
• If you can become pregnant, your healthcare professional will ask you to use a highly effective birth control method while taking TEVA-FLUVASTATIN.
• If you discover that you are pregnant while taking TEVA-FLUVASTATIN, stop taking the medicine and contact your healthcare professional as soon as possible.

Breast-feeding: It is not known whether TEVA-FLUVASTATIN can pass into breast milk and harm a breastfed baby. As such, TEVA-FLUVASTATIN is not recommended during breastfeeding. Talk to your healthcare professional about ways to feed your baby while taking TEVA-FLUVASTATIN.

Check-ups and testing: Your healthcare professional may do blood tests before you start TEVA-FLUVASTATIN and during your treatment. These tests will check:

• the level of CoQ10 (an antioxidant) in your blood.
• the amount of sugar (glucose) in your blood.
• that your liver or muscles are working properly.
• the amount of cholesterol and other fats in your blood.

Depending on your test results, your healthcare professional may adjust your dose, temporarily stop or discontinue your treatment with TEVA-FLUVASTATIN.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TEVA-FLUVASTATIN:

• medicines used to lower blood cholesterol. These include other statins (e.g., atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin), fibrates (e.g., gemfibrozil, fenofibrate, bezafibrate), niacin (nicotinic acid), cholestyramine, ezetimibe.
• medicines used to treat bacterial infections. These include erythromycin, clarithromycin, azithromycin, rifampin.
• medicines used to reduce stomach acid such as cimetidine, ranitidine, omeprazole (used to treat heartburn and stomach or intestinal ulcers).
• medicines used to treat depression (e.g., fluoxetine, sertraline, escitalopram).
• medicines used to suppress your immune system (e.g., cyclosporine).
• non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac (used to treat pain and inflammation).
• oral antidiabetic medications such as tolbutamide, chlorpropamide, glyburide (used to treat high blood sugar).
• ketoconazole, fluconazole, itraconazole (used to treat fungal infections).
• warfarin or other coumarin-derived medicines (used to prevent blood clots).
• amlodipine (used to treat high blood pressure and other heart conditions).
• colchicine (used to treat gout).
• phenytoin (used to control certain types of seizures).
• grapefruit and grapefruit juice.

How to take TEVA-FLUVASTATIN:

Your healthcare professional prescribed this medicine only for you. Do not give your medicine to anyone else because it may harm them, even if their symptoms are the same as yours.

• Take TEVA-FLUVASTATIN exactly as your healthcare professional tells you. Keep taking it even if you feel well.

• If your healthcare professional recommends that you take TEVA-FLUVASTATIN:

  • once a day, take it in the evening or at bedtime.
  • twice a day, take one dose in the morning and one in the evening.
• Swallow each capsule whole with a drink of water.

• Remember to take TEVA-FLUVASTATIN at the same time every day. TEVA-FLUVASTATIN can be taken with or without food.

• Do not change the dose or stop taking the medicine without first talking to your healthcare professional.

• If you get sick, have an operation, or need medical treatment while taking TEVA-

  FLUVASTATIN, let the healthcare professional or pharmacist know that you are taking TEVA-FLUVASTATIN.

• If you have to see a different healthcare professional, for any reason, be sure to tell him/her of any medicines you might be taking, including TEVA-FLUVASTATIN.

Remember to get a new prescription from your healthcare professional or a refill from your pharmacy a few days before all your capsules are taken.

TEVA-FLUVASTATIN is just part of the treatment the healthcare professional will plan with you to help keep you healthy. Depending on your health and lifestyle, the healthcare professional may recommend:

• a change in diet to:

  • control your weight.
  • reduce your intake of cholesterol and saturated fats.
• exercise that is right for you.
• quitting smoking or avoiding smoky places.
• giving up alcohol or drinking less.

Follow your healthcare professional’s instructions carefully.

Usual dose:

The dose of TEVA-FLUVASTATIN prescribed to you will depend on your medical condition and your blood cholesterol level.

To lower blood cholesterol:

• The recommended starting dose is 20 mg once daily. Some people may be asked to start treatment with 40 mg once daily while others may be asked to start with 40 mg twice daily (i.e., 80 mg daily in total).
• After checking the amount of cholesterol and other fats in your blood, your healthcare professional may decide to adjust your dose until you are taking the amount of TEVA-FLUVASTATIN that is right for you. The dosage range for TEVA-FLUVASTATIN is 20 to 80 mg per day.
• The maximum dose is 80 mg per day.

To lower the risk of heart attack, cardiac arrest, stroke or undergoing further medical procedures due to high blood cholesterol:

• The recommended dose is 40 mg twice daily.

Overdose:

If you think you, or a person you are caring for, have taken too much TEVA-FLUVASTATIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget to take a dose, take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose and take the next dose as scheduled. Do not take a double dose to make up for a missed dose.

Possible side effects from using TEVA-FLUVASTATIN:

These are not all the possible side effects you may have when taking TEVA-FLUVASTATIN. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with TEVA-FLUVASTATIN may include:

• indigestion or heartburn
• abdominal pain
• diarrhea or constipation
• nausea or vomiting
• loss of appetite
• trouble sleeping or falling asleep
• nightmares
• headache
• lack of energy
• general feeling of discomfort
• teeth problems
• influenza (flu) symptoms such as fever, chills, coughing, sore throat or stuffy nose
• joint pain or inflammation
• pink eye
• pain, numbing, burning or “pins and needles” sensation in the hands and feet
• leg pain
• itchy skin, hives, purple spots on the skin or skin sensitivity to light
• flushing
• sweating
• memory loss or confusion
• hair loss
• impotence (inability to get or keep an erection)
• breast growth in males

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting)

  for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at room temperature (15°C to 30°C) in a tight container. Protect from light and humidity.
• Keep out of reach and sight of children.

If you want more information about TEVA-FLUVASTATIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or by emailing druginfo@tevacanada.com.

Date of Authorization: 2025-07-24