Q-Rosuvastatin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What Q-ROSUVASTATIN is used for:

Your doctor has prescribed these pills to help lower your cholesterol or other fats in the blood (such as triglycerides) and lower the risk of heart attacks and strokes.

What Q-ROSUVASTATIN does:

Q-ROSUVASTATIN is the brand name for rosuvastatin that belongs to the class of medications known as "statins", more specifically called HMG-CoA reductase inhibitors. HMG-CoA reductase is an enzyme involved in regulating cholesterol levels in your body. Statins are used along with changes to diet and exercise to help control the amount of cholesterol produced by the body.

Q-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.

What is cholesterol?

Cholesterol is one of several fatty substances in the blood that the body needs to function. And it is important to our health. Our bodies use cholesterol in a number of ways; for example, to produce bile acids that help you digest fat.

High cholesterol levels may not make you feel or look sick. However, too much cholesterol in your blood can be unhealthy; it builds up on the artery

walls and can lead to the signs and symptoms of cardiovascular disease (heart disease).

There are two very different types of cholesterol.

LDL cholesterol

If levels of LDL 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.

HDL cholesterol

HDL carries the LDL cholesterol away from the blood vessel walls to the liver, where it can be removed from the body. A higher level of HDL cholesterol is good.

Important cholesterol targets

There are a few important measures that relate to your cholesterol. In addition to your HDL and LDL cholesterol, your doctor may also track your TC:HDL-C Ratio.

Lowering LDL cholesterol and Ratio

There are many things you can do, depending on your health and lifestyle, to help lower LDL cholesterol, increase HDL cholesterol and lower your TC: HDL-C Ratio. Your doctor may recommend:

• A change in your diet to control your weight and/or lower your cholesterol.
• Exercise that is right for you.
• Quitting smoking and avoiding smoky places.
• Giving up alcohol or drinking less.

Follow your doctor’s instructions carefully.

When Q-ROSUVASTATIN should not be used:

Do not take Q-ROSUVASTATIN if you:

• Currently have liver disease.

• Are pregnant or think you might be pregnant.

  If you become pregnant while taking Q-ROSUVASTATIN, discontinue use immediately and discuss with your doctor, as Q-ROSUVASTATIN should not be used by pregnant women.

• Are breast-feeding.
• Have ever had an allergic reaction to the active ingredient or any of the other ingredients in Q-

ROSUVASTATIN (see What the nonmedicinal ingredients are:).

• Are taking a drug called cyclosporine (used, for

  example, after organ transplant).

What the medicinal ingredient is:

Rosuvastatin calcium.

What the nonmedicinal ingredients are:

Cellulose microcrystalline, crospovidone, iron oxide red, lactose monohydrate, magnesium oxide, magnesium stearate, silica colloidal anhydrous. Coating: FD&C Blue #2/Indigo Carmine Aluminium Lake, FD&C Red #40/Allura Red AC Aluminium Lake, FD&C Yellow #5/Tartrazine Aluminium Lake (5 mg tablet only), FD&C Yellow #6/Sunset Yellow FCF Aluminium Lake (10 mg, 20 mg, and 40 mg tablets only), HPMC

2910/Hypromellose 15cP, lactose monohydrate, titanium dioxide, triacetin.

Q-ROSUVASTATIN contains lactose and colouring agents but does not contain gluten.

What dosage form it comes in:

Q-ROSUVASTATIN film-coated tablets are available in 4 tablet strengths: 5 mg, 10 mg, 20 mg and 40 mg.

WARNINGS AND PRECAUTIONS

Pregnancy

Q-ROSUVASTATIN should not be used by pregnant women. Cholesterol compounds are essential elements for the development of a fetus. Cholesterol-lowering drugs can harm the fetus. If you become pregnant, discontinue use immediately and tell your doctor.

If you are of childbearing age, discuss with your doctor the potential risks and the importance of birth control methods.

Before taking your Q-ROSUVASTATIN tablets, tell your doctor or pharmacist if you:

• Have thyroid problems.

• Regularly drink three or more alcoholic drinks

  daily.

• Have a family history of muscular disorders.

• Had any past problems with your muscles (pain,

  tenderness), after using an HMG-CoA reductase inhibitor (statin) such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin or simvastatin, or have developed an allergy or intolerance to them.

• Have kidney or liver problems.

  • Have diabetes.
  • Have undergone surgery or other tissue injury.
  • Do excessive physical exercise.

Slightly increased blood sugar can occur when you take Q-ROSUVASTATIN. You are likely to be at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure. Discuss with your doctor your risk of developing diabetes.

INTERACTIONS WITH THIS MEDICATION

Sometimes drugs can interact with other drugs, so tell your doctor or pharmacist if you are taking any other medications, including prescription, non-prescription and natural health products. In particular, tell your doctor if you are taking any of the following:

• Any other cholesterol-lowering medications such as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe.
• Warfarin (or any other drug for thinning the blood).
• Antiviral medications such as ritonavir combined with another protease inhibitor or simeprevir (used to fight infections, including the HIV infection or Hepatitis C infection).
• Antacids (frequent use) and Q-ROSUVASTATIN should be taken 2 hours apart.
• Cyclosporine (used after organ transplant).
• Fusidic acid (an antibiotic agent). Your doctor may temporarily stop your treatment of Q-ROSUVASTATIN until the treatment with fusidic acid is complete.

PROPER USE OF THIS MEDICATION

Your doctor 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.

Always follow your doctor's instructions carefully and keep taking your medicine even if you feel well.

• Swallow each tablet whole with a drink of water. Take Q-ROSUVASTATIN as a single dose.

• Remember to take Q-ROSUVASTATIN at the same time every day. It does not matter if you take Q-ROSUVASTATIN with or without food, or in the morning or evening.

• Do not change the dose or stop taking the

  medicine without first talking to your doctor.

• If you get sick, have an operation, or need

  medical treatment while you are taking Q-ROSUVASTATIN, let the doctor or pharmacist know that you are taking Q-ROSUVASTATIN.

• If you have to see a different doctor, for any

  reason, be sure to tell him/her of any medicines you might be taking, including Q-ROSUVASTATIN.

To help you keep track of your doses, Q-ROSUVASTATIN comes in a blister pack with days of the week printed on the back of the blister. Start with the tablet that matches the day of the week and continue taking them in order until they are all finished.

There are 14 days of labeled tablets in each blister, with one extra to make 15. All 15 tablets, including the one labeled “Take this tablet last”, are exactly the same. Once you have finished the 14 labeled tablets, take the one marked "Take this tablet last" before starting your next blister pack.

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

Usual dose:

Adults

Treatment with Q-ROSUVASTATIN is usually started with one 10 mg tablet taken once daily. Some people may be asked to start treatment with one 5 mg tablet taken once a day while others may be asked to start with one 20 mg tablet taken once a day.

After checking the amount of lipids in your blood, your doctor may decide to adjust your dose until you are taking the amount of Q-ROSUVASTATIN that is right for you. The maximum daily dose is 40 mg.

Overdose:

There is no specific treatment in the event of an overdose.

Missed dose:

Do not take a double dose. If you miss taking a tablet, take it as soon as you can. But if it is almost time for your next dose, skip the missed dose and just take the next dose.

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

Most people do not have side effects when taking rosuvastatin calcium. However, all medicines can cause unwanted side effects. These effects are usually mild and disappear after a short time.

Check with your doctor or pharmacist promptly if any of the following persist or become troublesome:

• Stomach pain
• Headache
• Constipation
• Dizziness
• Feeling sick

Less commonly, some people may have other side effects such as a skin rash, itching and hives.

Q-ROSUVATSTIN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Possible side effects reported with some statins: breathing problems including persistent cough and/or shortness of breath or fever; confusion, poor memory, mood problems including depression; problems sleeping including insomnia and nightmares; erectile dysfunction; numbness, tingling, weakness or pain, usually in your hands or feet, but this may also occur in other areas of your body (peripheral neuropathy).

This is not a complete list of side effects. For any unexpected effects while taking Q-

ROSUVASTATIN, contact your doctor or pharmacist.

HOW TO STORE IT

• KEEP YOUR TABLETS IN A SAFE PLACE where children cannot see or reach them. Your tablets could harm them.

• Keep your medicine at room temperature (15°C-

  30°C), away from warm or damp places like bathrooms or kitchens.

• 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.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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.

MORE INFORMATION

This document can be found at:

www.qdpharmaceuticals.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, QD Pharmaceuticals ULC at: 1-800-661-3429

Revised on: August 18, 2015