NRA-Rosuvastatin: Uses, Side Effects and Dosage

What is NRA-ROSUVASTATIN used for?

NRA-ROSUVASTATIN 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.
• boys and girls (who have had their period for at least a year) 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. In these children, a change in diet alone was not effective in lowering their blood cholesterol.

NRA-ROSUVASTATIN is also used in adults who have no history of heart attack or stroke but who have two or more risk factors as determined by their healthcare professional to reduce the risk of:

• heart attack
• stroke
• undergoing a procedure called coronary artery revascularization. This is a medical procedure used to treat severely blocked arteries due to plaque buildup caused by high blood cholesterol levels.

How does NRA-ROSUVASTATIN work?

NRA-ROSUVASTATIN 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.

NRA-ROSUVASTATIN 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, NRA-ROSUVASTATIN 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.

What are the ingredients in NRA-ROSUVASTATIN?

Medicinal ingredient: Rosuvastatin calcium.

Non-medicinal ingredients: For 5 mg: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, quinoline yellow aluminum lake, FD & C red No. 40, FD & C blue No. 1.

For 10, 20 and 40 mg: microcrystalline cellulose, lactose monohydrate, anhydrous lactose, crospovidone, magnesium oxide, magnesium stearate, hypromellose, triacetin, titanium dioxide, FD & C yellow No. 6, FD & C red No. 40, FD & C blue No. 1.

NRA-ROSUVASTATIN comes in the following dosage forms?

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

Do not use NRA-ROSUVASTATIN if you/your child:

• are allergic to rosuvastatin or any other ingredients in NRA-ROSUVASTATIN or its packaging.
• currently have liver disease or unexplained increases in liver enzymes.
• are pregnant or think you might be pregnant.
• are breast-feeding.
• are taking cyclosporine (used to suppress your immune system).
• are taking sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C infection).

Do not use the 40 mg tablet if you:

• are of Asian descent.

• 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.
  • have liver or kidney problems.
  • have diabetes accompanied with excess fat build-up in your liver.
  • had surgery or other tissue injury.
  • have a condition that causes weakness or frailty.
  • have any conditions or take any medicines that may increase the level of NRA-ROSUVASTATIN in the blood. Talk to your healthcare professional if you are unsure.

To help avoid side effects and ensure proper use, talk to your/your child’s healthcare professional before you/your child takes NRA-ROSUVASTATIN. Talk about any health conditions or problems you/your child may have, including if you:

• have taken NRA-ROSUVASTATIN or any other cholesterol-lowering medicines in the past.
• have heart problems.
• have high blood sugar or diabetes, or are at risk for diabetes.
• have been told that you/your child have genetic variations for the SLCO1B1 and/or ABCG2 genes. This may increase the level of NRA-ROSUVASTATIN in the blood.
• have a history of liver problems.
• are of Asian descent.
• have risk factors for muscle problems (see section “Do not use NRA-ROSUVASTATIN if” for details). Your healthcare professional will evaluate your medical condition and decide if you should take NRA-ROSUVASTATIN 40 mg.
• 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:

NRA-ROSUVASTATIN 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 NRA-ROSUVASTATIN 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 NRA-ROSUVASTATIN.

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

Pregnancy:

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

Breast-feeding:

• It is not known if NRA-ROSUVASTATIN can pass into breast milk and harm a breastfed baby. As such, NRA-ROSUVASTATIN should not be taken while breast-feeding.
• Talk to your healthcare professional about the best way to feed your baby while you are taking NRA-ROSUVASTATIN.

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

Your healthcare professional may ask you to do a genetic test if you experience side effects while taking NRA-ROSUVASTATIN. This test will determine if the side effects you are experiencing are due to your genes. These may affect the way your body processes NRA-ROSUVASTATIN.

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

The following may also interact with NRA-ROSUVASTATIN:

• medicines used to lower blood cholesterol. This includes other statins (e.g., atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin), fibrates (e.g., gemfibrozil, fenofibrate, bezafibrate), niacin (nicotinic acid), ezetimibe.
• medicines used to treat viral infections such as HIV/AIDS and hepatitis C. This includes antiviral medicines alone or in combination with atazanavir, ritonavir, lopinavir, ombitasvir, paritaprevir, dasabuvir, simeprevir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, darunavir, tipranavir.
• ketoconazole, fluconazole, itraconazole (used to treat fungal infections).
• spironolactone (used to treat high blood pressure).
• cimetidine (used to treat ulcers of the stomach and intestines).
• dronedarone (used to treat abnormal heart rhythms).
• regorafenib, darolutamide, capmatinib (used to treat cancer).
• febuxostat (used to treat and prevent high blood levels of uric acid).
• fostamatinib, eltrombopag (used to treat low blood platelets).
• teriflunomide (used to treat relapsing remitting multiple sclerosis).
• warfarin, clopidogrel (used to prevent blood clots).
• frequent use of antacids (used to treat heartburn). NRA-ROSUVASTATIN should be taken 2 hours apart.
• fusidic acid (used to treat bacterial infections). Your healthcare professional may temporarily stop your treatment with NRA-ROSUVASTATIN until your treatment with fusidic acid is complete.
• birth control pills.
• baicalin (a herbal product).
• roxadustat (medicine that increases the number of red blood cells and hemoglobin level in patients with chronic kidney disease).
• enasidenib (used to treat a condition called acute myeloid leukemia).
• tafamidis (used to treat a condition called transthyretin amyloidosis).

How to take NRA-ROSUVASTATIN:

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 NRA-ROSUVASTATIN exactly as your healthcare professional tells you. Keep taking it even if you feel well.
• Take NRA-ROSUVASTATIN once a day. Swallow each tablet whole with a drink of water.

• Remember to take NRA-ROSUVASTATIN at the same time every day. NRA-ROSUVASTATIN can be taken in the morning or evening 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 NRA-ROSUVASTATIN, let the healthcare professional or pharmacist know that you are taking NRA-ROSUVASTATIN.
• 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 NRA-ROSUVASTATIN.

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

NRA-ROSUVASTATIN 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 NRA-ROSUVASTATIN prescribed to you will depend on your medical condition and your blood cholesterol level.

To lower blood cholesterol

Adults

• The recommended starting dose is 10 mg once daily. Some people may be asked to start treatment with 5 mg once a day while others may be asked to start with 20 mg once a day.
• 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 NRA-ROSUVASTATIN that is right for you. The dosage range for NRA-ROSUVASTATIN is 5 to 40 mg once a day.
• The maximum dose is 40 mg per day.

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

• The recommended starting dose is 5 mg once daily.
• After checking the amount of cholesterol and other fats in your child’s blood, the healthcare professional may decide to adjust your child’s dose until they are taking the amount of NRA-ROSUVASTATIN that is right for them.
• The maximum dose is 10 mg per day.

To lower the risk of heart attack, stroke or undergoing coronary artery vascularization

Adults: The recommended dose is 20 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 take a double dose to make-up for a missed dose.

What are possible side effects from using NRA-ROSUVASTATIN?

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

All medicines can cause unwanted side effects. These effects are usually mild and disappear after a short time.

Side effects may include:

• joint pain, swelling of the joints
• muscle spasms or stiffness, shaking (tremors)
• abdominal, chest or back pain
• feeling weak, lack of energy
• nausea, indigestion, constipation, diarrhea, gas
• swelling of the extremities (hands, arms, legs or feet)
• tingling sensation, numbness, weakness or pain in the hands, arms, legs or feet
• sinus infection, runny or stuffy nose
• flu (fever, headache, body aches, cough)
• cough, sore throat
• memory loss, confusion
• trouble sleeping or staying asleep, nightmares
• hives, skin rash or itch
• impotence (inability to get or keep an erection)
• blood in urine
• breast growth in males
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruption)

NRA-ROSUVASTATIN 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

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:

• Keep your medicine at room temperature (15°C-30°C), away from warm or damp places like bathrooms or kitchens.
• Keep out of reach and sight of children.
• Keep your tablets in the package they came in.
• If your doctor decides to stop your treatment, return your tablets to your pharmacist for disposal.
• Do not take your tablets after the expiry date on the package.

If you want more information about NRA-ROSUVASTATIN:

• 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 website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.norapharma.ca/, or by calling 1-888-270-9874.

Nora Pharma Inc.

1565, boul. Lionel-Boulet

Varennes, QC,

Canada, J3X 1P7

Last revised: MAY 24, 2024