Pravastatin (Sorres Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PRAVASTATIN is available only with your physician's prescription. It is to be used as an adjunct to a medically recommended and carefully supervised diet for the long-term treatment of hypercholesterolemia and is not a substitute for such a diet. This has been shown to decrease the chances of experiencing a first or second heart attack, or stroke, and may help prevent heart disease if caused by cholesterol clogging the blood vessels, or slow the progression of atherosclerosis (hardening) of the arteries that nourish your heart, so-called coronary heart disease (CHD). In addition, depending on your condition, your physician may recommend an appropriate regimen of exercise, weight control and other measures.

What it Does:

PRAVASTATIN lowers the level of cholesterol, particularly Low Density Lipoprotein (LDL) cholesterol, in the blood.

PRAVASTATIN reduces cholesterol production by the liver and induces some changes of cholesterol transport and disposition in the blood and tissues.

When it should not be used:

• If you are pregnant, since its use in the event of pregnancy may

  harm the unborn. Only female patients who are highly unlikely to conceive can be candidates for PRAVASTATIN treatment. In the event of pregnancy during treatment, PRAVASTATIN should be discontinued and the physician should be informed.

• If you know that you are allergic to pravastatin or any of the

  non-medicinal ingredients of PRAVASTATIN.

• If you have liver disease.

• In adolescents and children since the safety of PRAVASTATIN

  in this age group has not been established.

What the medicinal ingredient is:

Pravastatin sodium

What the important non-medicinal ingredients are:

Colloidal silicon dioxide, copovidone, croscarmellose sodium, D&C yellow No. 10 aluminum lake (40 mg only), dibasic calcium phosphate, FD&C blue No. 1 aluminum lake (40 mg only), iron oxide red (10 mg only), iron oxide yellow (20 mg only), lactose, magnesium stearate, microcrystalline cellulose, polyethylene

glycol.

What dosage forms it comes in:

Tablets: 10 mg, 20 mg and 40 mg

WARNINGS AND PRECAUTIONS

Use only as specifically directed. Do not alter the dosage unless ordered to do so by your physician. Check with your physician before discontinuing medication since this may result in an increase of your blood lipids.

Before taking PRAVASTATIN, tell your doctor or pharmacist if you:

• are breast-feeding or intend to breast-feed,
• have thyroid problems,
• have a family history of muscular disorders,
• had any past problems with the 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,
• diabetes,
• have undergone surgery or other tissue injury,
• do excessive physical exercise.

RTANT: PLEASE READ

Pregnancy

Before using this medication, discuss the following with your doctor:

• Cholesterol compounds are essential elements for the development of a fetus.
• Cholesterol-lowering drugs can harm the fetus. If you are of child-bearing age, discuss with your doctor the potential hazards to the fetus and the importance of birth control methods.
• PRAVASTATIN should not be used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your doctor.

Slightly increased blood sugar can occur when you take HMG-CoA reductase inhibitor (“statin”). Discuss with the doctor your risk of developing diabetes

INTERACTIONS WITH THIS MEDICATION

PRAVASTATIN may interact with other drugs, including those you take without a prescription. You must tell your doctor or pharmacist about all drugs, including prescription and non-prescription, herbal products and supplements, you are taking or planning to take before you take PRAVASTATIN.

You should tell your doctor if you are taking other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin, or ezetimibe. If you take these drugs and PRAVASTATIN together, you may be at an increased risk of myopathy (muscle disease with aching or weakness).

If you are taking a bile acid-binding resin (such as cholestyramine, colestipol), your doctor will recommend that you take PRAVASTATIN either one hour or more before or at least four hours following the resin. Taking them together causes lower amounts of PRAVASTATIN in the blood, making it less effective.

If you are taking cyclosporine, your doctor may need to adjust the dose of PRAVASTATIN.

Excessive alcohol intake should be avoided when taking PRAVASTATIN. Tell your doctor if you regularly drink three or more alcoholic drinks daily.

P

PROPER USE OF THIS MEDICATION

PER USE OF THIS MEDICATION

• Do not change the dose unless directed by a doctor.

• PRAVASTATIN should be taken as a single dose at bedtime,

  as prescribed by your physician.

• Your physician will monitor your clinical condition and your

  blood tests at regular intervals. It is important to have these check-ups done on schedule. Please keep your appointments accurately.

• Notify your physician about any illness which may develop

  during your treatment with PRAVASTATIN and about any new prescription or non-prescription medication you may take. If you require medical help for other reasons, inform the attending physician that you are taking PRAVASTATIN,

• Notify your physician if you are going to have major surgery or

  have sustained a severe injury,

• Notify your physician of any muscle pain, tenderness or

  weakness developing during treatment with PRAVASTATIN (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

Usual dose:

The recommended starting dose is 20 mg once daily at bed time. Patients who require a large dose reduction in LDL-C may be started at 40 mg once daily. A dose of 80 mg once daily should be reserved for patients who do not achieve their treatment goal with lower doses. PRAVASTATIN may be taken without regard to meals.

Overdose:

There is no specific recommended therapy for overdose with PRAVASTATIN.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication may cause unwanted effects.

Check with your physician as soon as possible if any of the following side effects occurs: aching muscles, muscle cramping, tiredness or weakness, fever and blurred vision.

Muscle effects

Side effects such as myalgia (muscle pain), myopathy (muscle disease with aching or weakness), rhabdomyolosis (a muscle wasting disease), associated tenderness, and rare cases of rhabdomylosis leading to kidney failure have been reported with other drugs of this class, known as HMG-CoA reductase inhibitors ("statins"), including PRAVASTATIN.

As these muscle problems are on rare occasions serious, you should contact your physician promptly if you experience any of the side effects listed in the Table below.

Possible side effects reported with some statins: breathing problems including persistent cough and/or shortness of breath or fever, mood problems including depression, problems sleeping including insomnia and nightmares and sexual problems.

Poor memory, confusion and memory loss have also been reported with all statins.

PRAVASTATIN can also cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Other side effects may occasionally occur which usually do not require stopping treatment. They may come and go during treatment without any particular danger, but you should mention them to your physician, without undue delay, if they become persistent or bothersome. Such adverse experiences include abdominal pain, constipation, diarrhea, nausea, headache, dizziness and skin rashes.

This is not a complete list of side effects. For any unexpected effects while taking PRAVASTATIN, contact your doctor or pharmacist.

Store between 15 °C and 30 °C. Protect from moisture and light.

REPORTING SUSPECTED 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 3 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, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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 obtained by contacting Sorres Pharma Inc. at 1-888-550-6060.

Sorres Pharma Inc.

Montreal Canada

H4P 2T4

Last revised: September 10, 2013

HOW TO STORE IT