M-Atorvastatin (Mantra Pharma, PM 00085187): Uses, Side Effects and Dosage

What is M-ATORVASTATIN used for?

M-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.

M-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 build up 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.

M-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

Serious Warnings and Precautions

• have other risk factors, as determined by their healthcare professional.

M-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 M-ATORVASTATIN work?

M-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. M-ATORVASTATIN is used along with changes to your lifestyle to help control the amount of cholesterol in your blood.

M-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 M-ATORVASTATIN?

Medicinal ingredient: atorvastatin calcium.

Non-medicinal ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, talc and titanium dioxide.

M-ATORVASTATIN comes in the following dosage forms:

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

Do not use M-ATORVASTATIN if you/your child:

• are allergic to atorvastatin calcium or any other ingredients in M-ATORVASTATIN or its packaging.
• have active liver disease or unexplained increases in liver enzymes.
• are pregnant or think you/your child 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 M-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:

M-ATORVASTATIN can cause serious side effects, 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 M-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:

• M-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 M-ATORVASTATIN. • If you discover that you are pregnant while taking M-ATORVASTATIN, stop taking the medicine and contact your healthcare professional as soon as possible.

Breastfeeding:

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

Check-ups and testing: Your healthcare professional may do blood tests before you start M-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 M-ATORVASTATIN.

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 M-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 M-ATORVASTATIN:

Take M-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 M-ATORVASTATIN. Grapefruit juice increases the level of M-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 M-ATORVASTATIN.

Usual dose:

The dose of M-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 M-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 M-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:

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 M-ATORVASTATIN?

These are not all the possible side effects you/your child may have when taking M-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.

M-ATORVASTATIN can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

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

Storage:

• Store M-ATORVASTATIN at room temperature (15 - 30^oC).
• Keep out of reach and sight of children.

If you want more information about M-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); or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.