April 24, 2014
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RAN-Rosuvastatin

(rosuvastatin)

DIN (Drug Identification Number)

02382644 RAN-ROSUVASTATIN 5MG TABLET
02382652 RAN-ROSUVASTATIN 10MG TABLET
02382660 RAN-ROSUVASTATIN 20MG TABLET
02382679 RAN-ROSUVASTATIN 40MG TABLET

What side effects are possible with RAN-Rosuvastatin?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • difficulty sleeping
  • dizziness
  • headache
  • nausea
  • nightmares
  • sexual difficulties
  • stomach pain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • breast enlargement
  • confusion
  • hives
  • itching
  • poor memory
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • skin rash
  • symptoms of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
  • symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for RAN-Rosuvastatin?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 24, 2013

Health Canada has issued new restrictions concerning the use of rosuvastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication. The combination of alcohol and rosuvastatin increases the risk of developing liver problems.

Diabetes: Rosuvastatin, like other medications in this family, may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hypersensitivity syndrome: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of "statin" cholesterol medication. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Kidney function: If you have decreased kidney function or kidney disease,  discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. Do not use this medication if you have active liver disease or have liver function tests are higher than normal. If you have reduced liver function or a history of liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Rosuvastatin may cause decreased liver function. Consuming alcohol can increase the risk of developing liver problems. Your doctor will perform regular blood tests to check your liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Muscle damage: In rare cases, serious muscle damage been associated with the use of "statin" medications, especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

  • are of Asian ancestry (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin)
  • are over the age of 70
  • are taking other cholesterol-lowering medication such as fibrates (e.g., gemfibrozil, fenofibrate) or niacin
  • are taking other medications (as drug interactions are possible), including prescription, non-prescription, and natural health products
  • do excessive physical exercise
  • have diabetes
  • have a family history of muscular disorders
  • have had any past problems with muscles (pain, tenderness) after taking a statin
  • have kidney or liver problems
  • have thyroid problems
  • have undergone surgery or other tissue injury
  • regularly drink 3 or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: This medication should not be taken during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if rosuvastatin passes into breast milk. Women should not breast-feed while taking this medication.Children: There is limited experience with the use of this medication by children. Rosuvastatin may be used by children between 10 and 17 years of age who have certain inherited cholesterol disorders. Girls should be at least 1 year past their first menstrual period. It should be used in addition to diet, when diet alone has not provided a satisfactory reduction in cholesterol levels. The safety and effectiveness of this medication has not been established for children less than 10 years of age. If rosuvastatin is to be used by a child, the treatment should be supervised by a specialist.

Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.

What other drugs could interact with RAN-Rosuvastatin?

There may be an interaction between rosuvastatin and any of the following:

  • amiodarone
  • antacids (if taken within 2 hours of taking rosuvastatin)
  • antifungal agents (e.g. itraconazole, ketoconazole)
  • bezafibrate
  • birth control pills
  • boceprevir
  • colchicines
  • cyclosporine
  • daptomycin
  • eltrombopag
  • fenofibrate
  • fusidic acid
  • gemfibrozil
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • macrolide antibiotics (e.g., erythromycin, clarithromycin)
  • niacin (nicotinic acid)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole, pantoprazole)
  • trabectedin
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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