Sandoz Atorvastatin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Sandoz Atorvastatin may cause 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)

They may not go away even after you stop taking Sandoz Atorvastatin.

• Tell your healthcare professional right away if you have any muscle pain, tenderness, soreness or weakness while taking Sandoz Atorvastatin.

What is Sandoz Atorvastatin used for?

Sandoz Atorvastatin is used along with changes in lifestyle, including diet, to lower the level of cholesterol and other fats (such as triglycerides) in the blood in:

• adults with high blood cholesterol

• boys and girls (who already started their period) who are 10 to less than 18 years of age with heterozygous familial hypercholesterolemia. This is a genetic condition where high blood cholesterol is inherited from one of the parents. These children have high blood cholesterol when dieting and have:

  • a family history of premature cardiovascular disease (heart and blood vessel problems); or
  • two or more other cardiovascular risk factors as determined by their healthcare professional.

Sandoz Atorvastatin is also used to lower the risk of heart attack in adults with:

• coronary heart disease. This is a heart condition that happens when the arteries of the heart become narrower and cannot deliver enough blood to the heart. This is due to a buildup of plaque (fatty deposits) inside the artery walls.
• high blood pressure who have no evidence of coronary heart disease, but have three or more risk factors as determined by their healthcare professional

Sandoz Atorvastatin is used to lower the risk of heart attack and stroke in adults with:

• type 2 diabetes and high blood pressure who have no evidence of coronary heart disease, but have other risk factors as determined by their healthcare professional.

Sandoz Atorvastatin is just part of the treatment the healthcare professional will plan with you to help keep you or your child healthy. Depending on your/your child’s health and lifestyle, the healthcare professional may recommend:

• a change in diet to:

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

Follow the instructions of your/your child’s healthcare professional carefully.

How does Sandoz Atorvastatin work?

Sandoz Atorvastatin 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. Sandoz Atorvastatin is used along with changes to your lifestyle to help control the amount of cholesterol in your blood.

Sandoz Atorvastatin can help your body:

• Decrease LDL (bad) cholesterol, triglyceride levels and other fats in the blood
• Increase HDL (good) cholesterol
• Decrease the Total Cholesterol HDL-Cholesterol Ratio (TC-HDL-C Ratio). This ratio represents the balance between good and bad cholesterol.

This in turn also reduces the risk of heart attack and stroke in adults who:

• have multiple risk factors for developing cardiovascular problems
• have coronary heart disease

What are the ingredients in Sandoz Atorvastatin?

Medicinal ingredient: atorvastatin calcium.

Non-medicinal ingredients: cellulose microcrystalline, calcium carbonate, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, polysorbate 80, magnesium stearate, hypromellose 2910, polyethylene glycol 6000 and titanium dioxide.

Sandoz Atorvastatin comes in the following dosage forms:

Tablets: 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium trihydrate).

Do not use Sandoz Atorvastatin if you/your child:

• are allergic to atorvastatin calcium or any other ingredients in Sandoz Atorvastatin or its packaging
• have active liver disease or unexplained increases in liver enzymes
• are pregnant or think you/they might be pregnant
• are breast-feeding
• are taking medicines used to treat hepatitis C, such as telaprevir, boceprevir, glecaprevir/pibrentasvir, elbasvir/grazoprevir, simeprevir, velpatasvir/sofosbuvir, ledipasvir/sofosbuvir.
• are taking cyclosporine, a medicine used to suppress your immune system

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

• have previously taken any cholesterol-lowering medicines in the past. This includes:

  • statins, such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin or simvastatin
  • fibrates such as gemfibrozil, fenofibrate and bezafibrate
  • niacin (nicotinic acid)
• have had a stroke or a mini stroke
• are currently taking any other medicines
• have kidney or liver problems
• are above 65 years of age
• regularly drink three or more alcoholic drinks daily
• have a family history of muscular disorders
• had any past problems with the muscles (pain, tenderness) after using medicines such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin or simvastatin.
• have thyroid problems
• do excessive physical exercise
• have diabetes
• have undergone surgery or other tissue injury
• feel weak or frail

Other warnings you should know about:

Sandoz Atorvastatin can cause serious side effect, including:

• Hyperglycemia (high blood sugar):

  • This may lead to the development of type 2 diabetes.
  • Your healthcare professional will monitor your blood sugar level regularly and may adjust your dose during treatment.

  • If you have diabetes, closely monitor your blood sugar while taking Sandoz

    • Atorvastatin and report any unusual results to your healthcare professional.
• Liver failure (serious disturbances of liver function)
• Allergic reactions

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

Pregnancy:

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

Breastfeeding:

• It is not known whether Sandoz Atorvastatin can pass into breast milk and harm a breastfed baby. As such, Sandoz Atorvastatin is not recommended during breastfeeding.
• Talk to your healthcare professional about ways to feed your baby while taking Sandoz Atorvastatin.

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

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

Depending on your test results, your healthcare professional may adjust your dose, temporarily stop or discontinue your treatment with Sandoz Atorvastatin.

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

Serious Drug Interactions

Do not take Sandoz Atorvastatin with:

• Medicines used to treat hepatitis C. These include telaprevir, boceprevir, glecaprevir/pibrentasvir, elbasvir/grazoprevir, simeprevir, ledipasvir/sofosbuvir and velpatasvir/sofosbuvir.
• Cyclosporine, a medicine used to suppress the immune system.

Inform your healthcare professional before taking Sandoz Atorvastatin with:

• Medicines used to treat HIV/AIDS. These include efavirenz, nelfinavir, lopinavir/ritonavir, tipranavir, ritonavir, saquinavir, darunavir and fosamprenavir.

Taking Sandoz Atorvastatin with any of these medicines may cause serious drug interactions. Ask your healthcare professional if you are unsure.

The following may interact with Sandoz Atorvastatin:

• Medicines used to lower blood cholesterol. These include niacin (nicotinic acid), fibrates, such as gemfibrozil, fenofibrate, and bezafibrate, and bile acid resins, such as cholestyramine and colestipol.
• Medicines used to treat bacterial infections. These include erythromycin, clarithromycin, azithromycin, fusidic acid and rifampin.
• Letermovir – used to treat a viral infection caused by the cytomegalovirus (CMV)
• Itraconazole, ketoconazole – used to treat fungal infections
• Nefazodone – used to treat depression
• Digoxin – used to treat heart conditions
• Amlodipine, quinapril, diltiazem – used to treat high blood pressure and other heart conditions
• Antacids – used to treat heartburn (indigestion)
• Cimetidine – used to treat ulcers of the stomach and intestines
• Colchicine – used to treat gout
• Birth control medication
• Hormone replacement therapy
• Grapefruit juice

How to take Sandoz Atorvastatin:

Take Sandoz Atorvastatin:

• exactly as your healthcare professional tells you
• once a day
• preferably in the evening

• with or without food. However, do not drink grapefruit juice while taking Sandoz Atorvastatin. Grapefruit juice increases the level of Sandoz Atorvastatin in your blood and makes side effects more likely.

Follow the plan your healthcare professional is recommending for diet, exercise and weight control while taking Sandoz Atorvastatin.

The 20 mg, 40mg and 80 mg tablets may be split for ease of swallowing. Tablets should not be split to provide a lower dose. Both halves (20mg) or all quarters (40mg and 80mg) of a split tablet are to be taken at the same time.

Follow the following instruction to divide the tablets:

Place a tablet on a hard, flat surface with the scored side at the top. Press with a thumb on the middle of the tablet and the tablet will break into two halves (20 mg) or in four quarters (40 mg and 80 mg).

Usual dose:

The dose of Sandoz Atorvastatin prescribed to you will depend on your condition and/or your blood cholesterol level. Your healthcare professional may change your dose depending on your response to Sandoz Atorvastatin.

To lower blood cholesterol

Adults:

• The recommended starting dose is 10 mg or 20 mg once daily, depending on your required cholesterol reduction.
• Patients who need a large reduction in blood cholesterol (more than 45%) may start at 40 mg once daily.
• The dosage range for Sandoz Atorvastatin is 10 to 80 mg once daily.
• The maximum dose is 80 mg per day.

Children and adolescents (10 to less than 18 years of age):

• The recommended starting dose is 10 mg once daily.
• The maximum recommended dose is 20 mg per day.

To prevent heart attack and stroke

Adults: The recommended dose is 10 to 80 mg once daily.

Overdose:

If you think you, or a person you are caring for, have taken too much Sandoz Atorvastatin, 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 double the dose.

What are possible side effects from using Sandoz Atorvastatin?

These are not all the possible side effects you/your child may have when taking Sandoz Atorvastatin. If you/your child experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Diarrhea
• Abdominal pain or discomfort
• Nausea
• Vomiting
• Gas
• Sore throat or stuffy nose
• Nosebleeds
• Dizziness
• Memory loss or confusion
• Loss of sensation in part of your body
• Tingling sensation or pain in the hands, arms, legs or feet
• Nightmares
• Difficulty falling asleep
• Hair loss
• Skin rash or itch
• Joint pain
• Impotence (inability to get or keep an erection)
• Breast growth in males

Sandoz Atorvastatin can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

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

Storage:

• Store Sandoz Atorvastatin between 15°C and 30°C, away from warm or damp places like the bathroom or kitchen. Protect from moisture.
• Keep out of reach and sight of children.

If you want more information about Sandoz Atorvastatin:

• 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 (Drug Product Database: Access the database; the manufacturer’s website www.sandoz.ca or by calling 1-800-361-3062.

Last Revised: NOV 16, 2025