Consumer Information for: BIO-PRAVASTATIN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
BIO-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
BIO-PRAVASTATIN lowers the level of cholesterol, particularly Low Density Lipoprotein (LDL) cholesterol, in the blood. BIO-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
Do not use BIO-PRAVASTATIN 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 BIO- PRAVASTATIN treatment. In the event of pregnancy during treatment, BIO-PRAVASTATIN should be discontinued and the physician should be informed.
- know that you are allergic to pravastatin or any of the non-medicinal ingredients of BIO- PRAVASTATIN.
- have liver disease.
- are less than 18 years of age. The safety of BIO- PRAVASTATIN in this age group has not been established.
What the medicinal ingredient is
pravastatin sodium
What the non-medicinal ingredients are
Anhydrous Lactose, Magnesium oxide, Croscarmellose sodium, Microcrystalline Cellulose, Povidone, Crospovidone and Magnesium Stearate.
Along with the above non-medicinal ingredients tablets have colouring agents too: Ferric oxide red in 10 mg, Ferric oxide yellow in 20 mg and FD& C blue No. 1 Al. Lake & D& C yellow No. 10 Al. Lake in 40 mg tablet
What dosage form it comes in
10 mg, 20 mg and 40 mg tablets.
Warnings and precautions
Serious 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 BIO-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,
- have had any past problems with the muscles (pain, tenderness), after using an HMG-CoA reductase inhibitor ("statin") such as atorvastatin (Lipitor®)¹ fluvastatin (Lescol®)², lovastatin (Mevacor®)³, pravastatin (Pravachol®), rosuvastatin (Crestor®)4 or simvastatin (Zocor®)³, 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.
- suffer from alcohol abuse
- are 65 years of age or older.
1 Lipitor® is a registered trademark of Pfizer Ireland Pharmaceuticals.
2 Lescol® is a registered trademark of Sandoz Canada Inc.
3 Mevacor® and Zocor® are registered trademarks of Merck & Co., Inc.
4 Crestor® is a registered trademark of IPR Pharmaceuticals Inc.
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.
- BIO-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
BIO-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 BIO-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 BIO-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 BIO-PRAVASTATIN either one hour or more before or at least four hours following the resin. Taking them together causes lower amounts of BIO-PRAVASTATIN in the blood, making it less effective.
Excessive alcohol intake should be avoided when taking BIO-PRAVASTATIN. Tell your doctor if you regularly drink three or more alcoholic drinks daily.
Proper use of this medication
- Do not change the dose unless directed by a doctor.
- BIO-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 BIO- 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 BIO-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 BIO-PRAVASTATIN (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
Usual adult dose:
The recommended starting dose is 20 mg once daily at bed time. Patients who require a large dose reduction in cholesterol may be started at 40 mg once daily. The dose of 80 mg once daily should be reserved for patients who do not achieve their treatment goal with lower doses. BIO- PRAVASTATIN may be taken without regard to meals.
Overdose
If you think you have taken too much BIO- PRAVASTATIN contact your doctor, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.
Side effects and what to do about them
Side effects may include:
- abdominal pain, constipation, diarrhea, nausea, indigestion
- headache, dizziness
- skin rashes
- persistent cough
- trouble sleeping, insomnia, nightmares
- sexual problems
- depression, anxiety, nervousness
Muscle effects
Side effects such as muscle pain, muscle strains, tears and rupture, 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 BIO-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.
BIO-PRAVASTATIN can also cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Muscle pain that you cannot explain | ✔ | ||
| Muscle tenderness or muscle weakness, or muscle cramping | ✔ | ||
| Generalized weakness, especially if you do not feel well (i.e. fever or fatigue) | ✔ | ||
| Brownish or discoloured urine | ✔ | ||
| Symptoms of liver problems (upper belly pain, dark urine, itchy skin, nausea or vomiting, loss of appetite, pale stools, yellowing of skin or the whites of your eyes) | ✔ | ||
| Cough and/or shortness of breath | ✔ | ||
| Severe skin reaction with fever, sore mouth or throat, blistering and/or peeling of your skin or mucous membranes | ✔ | ||
| Uncommon | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Memory problems: poor memory, forgetfulness, confusion, memory loss | ✔ | ||
| Common | |||
| Vision problems, blurred vision | ✔ | ||
| Unknown | |||
| Increased Blood Sugar: Frequent urination, thirst and hunger | ✔ | ||
| Chest pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking BIO- PRAVASTATIN, contact your doctor or pharmacist.
How to store
BIO-PRAVASTATIN should be stored at room temperature (15-30°C). Protect from moisture and light.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
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 plus the full product monograph, prepared for health professionals is available by contacting the sponsor Biomed Pharma at 1-888-731-6703 or info@biomed-pharma.ca.
This leaflet was prepared by
Biomed Pharma
1B-9450 Boulevard Langelier,
Montreal, Quebec
H1P 3H8
Date of Revision: August 12, 2020
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