Details for: PRIVA-ROSUVASTATIN
Company: PHARMAPAR INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02445417 | PRIVA-ROSUVASTATIN | ROSUVASTATIN (ROSUVASTATIN CALCIUM) | 5 MG | TABLET | ORAL |
| 02445425 | PRIVA-ROSUVASTATIN | ROSUVASTATIN (ROSUVASTATIN CALCIUM) | 10 MG | TABLET | ORAL |
| 02445433 | PRIVA-ROSUVASTATIN | ROSUVASTATIN (ROSUVASTATIN CALCIUM) | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication 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.
Priva-ROSUVASTATIN may be prescribed in
children 10 to 17 years of age with heterozygous
familial hypercholesterolemia (an inherited condition
causing high cholesterol levels in the blood) to lower
cholesterol levels. Children require supervision from
adult care givers during treatment with PrivaROSUVASTATIN
(adult care givers should read the
information provided below before their child begins
treatment with Priva-ROSUVASTATIN).
What it does
Priva-ROSUVASTATIN® is the brand name for
rosuvastatin that belongs to the class of medications
known as "statins", more specifically called HMGCoA
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.
Priva-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.
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.
When it should not be used
Do not take Priva-ROSUVASTATIN if you:
- Currently have liver disease.
- Are pregnant or think you might be pregnant. If you become pregnant while taking PrivaROSUVASTATIN, discontinue use immediately and discuss with your doctor, as PrivaROSUVASTATIN 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 Priva-ROSUVASTATIN. (see What the nonmedicinal ingredients are:)
- Are breast-feeding.
- Are taking a drug called cyclosporine (used, for example, after organ transplant).
What the medicinal ingredient is
Rosuvastatin calcium.
What the non-medicinal ingredients are
Lactose monohydrate, Microcrystalline cellulose,
Crospovidone, Magnesium oxide, Colloidal silicon
dioxide, Magnesium stearate, Hydroxypropyl
methylcellulose, Triacetin, Lactose, Titanium dioxide,
FD&C Red lake, FD&C Yellow Lake.
Priva-ROSUVASTATIN contains lactose and
colouring agents but does not contain gluten.
What dosage form it comes in
Priva-ROSUVASTATIN film-coated tablets are available in 4 tablet strengths: 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin (as rosuvastatin calcium)
Warnings and precautions
Pregnancy
Priva-ROSUVASTATIN should not be used by
pregnant women. Cholesterol compounds are essential
elements for the development of a fetus. Cholesterollowering
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 PrivaROSUVASTATIN
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 (LIPITOR®), fluvastatin (LESCOL®), lovastatin (MEVACOR®), pravastatin (PRAVACHOL®), rosuvastatin (CRESTOR®) or simvastatin (ZOCOR®), 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.
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, clopidogrel (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 PrivaROSUVASTATIN should be taken 2 hours apart.
- Cyclosporin (used after organ transplant).
- Fusidic acid (an antibiotic agent). Your doctor may temporarily stop your treatment of PrivaROSUVASTATIN 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 Priva-ROSUVASTATIN as a single dose.
- Remember to take Priva-ROSUVASTATIN at the same time every day. It does not matter if you take Priva-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 PrivaROSUVASTATIN, let the doctor or pharmacist know that you are taking PrivaROSUVASTATIN.
- 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 PrivaROSUVASTATIN.
Usual Dose
Adults
Treatment with Priva-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 Priva-ROSUVASTATIN
that is right for you. The maximum daily dose is 40
mg.
Children 10 to 17 years of age with heterozygous
familial hypercholesterolemia
Treatment with Priva-ROSUVASTATIN is usually
started at a dose of 5 mg once daily. After checking
the amount of lipids in your blood, your doctor may
decide to adjust your dose until you are taking the
amount of CRESTOR that is right for you. The
maximum daily dose is 10 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
Priva-ROSUVASTATIN. 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
Priva-ROSUVASTATIN 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).
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Rare | |||
| Muscle pain that you cannot explain | ✔ | ||
| Muscle tenderness or weakness, or joint pain | ✔ | ||
| Breast enlargement in women and men (gynecomastia) | ✔ | ||
| Generalized weakness, especially if you do not feel well | ✔ | ||
| Jaundice or hepatitis symptoms like brownish or discoloured urine | ✔ | ||
| Difficulty in breathing or swallowing | ✔ | ||
| Allergic reaction (symptoms include swelling in the mouth, tongue, face and throat, severe itching, rash, raised lumps (hives), blistering of the skin and mucous membranes of the lips, eyes, mouth nasal passages or genitals) | ✔ | ||
| Liver damage: yellowing of the skin or the skin or eyes, flu-like symptoms | ✔ | ||
| Inflamed pancreas (pancreatitis) symptoms, such as severe stomach pain | ✔ | ||
| Very rare | |||
| Memory loss | ✔ | ||
| Increased blood sugar: frequent urination, thirst and hunger | ✔ | ||
| Unknown | |||
| Decrease of platelets in the blood (characterized by easy or excessive bleeding such as bruising easily, nosebleed and bleeding gums) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking PrivaROSUVASTATIN, contact your doctor or pharmacist.
How to store
- 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), protect from moisture and light. 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 report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared
for health professionals can be found by contacting
Pharmapar Inc.
This leaflet was prepared by:
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal, QC H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of Preparation: August 27, 2015