Patient Medication Information: uses, side effects, how to take - Lovastatin (AA Pharma)

What LOVASTATIN is used for:

LOVASTATIN is used:

along with a change in diet to lower the level of cholesterol and other fats (such as triglycerides) in the blood in adults with hypercholesterolemia. This is a genetic condition where high blood cholesterol is inherited from one of the parents. In these adults, a change in diet alone was not effective in lowering their blood cholesterol. In these adults, changes in diet and exercise alone were not effective in lowering their blood cholesterol.
in adults with coronary heart disease to slow the progression of atherosclerosis (buildup of fats, cholesterol and other substances) in the coronary arteries (blood vessels of the heart).

How LOVASTATIN works:

Lovastatin belongs to a class of medicines known as “statins”, more specifically called HMG-CoA reductase inhibitors. Statins block an enzyme called HMG-CoA reductase from being made in your liver, which is involved in the production of cholesterol in your body. Lovastatin is used to lower the levels of cholesterol (particularly Low Density Lipoprotein (LDL) cholesterol) and other fats in the blood. Medicines like this one are prescribed along with, and not as a substitute for, a special diet and other measures.

The ingredients in LOVASTATIN are:

Medicinal ingredient: Lovastatin

Non-medicinal ingredients: Croscarmellose sodium, D & C yellow #10 (in 40 mg tablets only), FD & C blue #1 (in 20 mg tablets only), FD & C blue #2, lactose, magnesium stearate, microcrystalline cellulose.

LOVASTATIN comes in the following dosage forms:

Tablets: 20 mg (light blue) and 40 mg (light green).

Do not use LOVASTATIN if:

you are allergic to lovastatin and any non-medicinal ingredient in the LOVASTATIN.
you have active liver disease or unexplained increase in liver enzymes.
you are pregnant, think you may be pregnant, or intend to become pregnant; if you become pregnant, stop taking LOVASTATIN immediately and talk to your healthcare professional.
you are breastfeeding or intend to breastfeed.
you are taking any of the following medicines:
- certain antifungal medicines (itraconazole, ketoconazole, posaconazole, or voriconazole),
- certain medicines used to treat HIV (indinavir, nelfinavir, ritonavir, or saquinavir),
- certain medicines used to treat hepatitis C virus (boceprevir or telaprevir),
- certain antibiotics (such as erythromycin, clarithromycin, or telithromycin¹),
- the antidepressant nefazodone,
- medicines containing cobicistat,
- cyclosporine, used to prevent organ transplant rejection.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LOVASTATIN. Talk about any health conditions or problems you may have, including if you:

have thyroid problems
regularly drink three or more alcoholic drinks daily
are taking or have previously taken any other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe
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 (Lipitor), fluvastatin (Lescol), pravastatin (Pravachol), rosuvastatin (Crestor) or simvastatin (ZOCOR), or have developed an allergy or intolerance to them
have kidney or liver problems
have high blood sugar, diabetes or are at risk of having diabetes
have undergone surgery or other tissue injury
do excessive physical exercise
are 70 years of age or older
feel weak or frail
have or have had myasthenia gravis (a disease causing general muscle weakness including the eye muscles and in some cases, muscles used for breathing) as statins may lead to occurrence of myasthenia or aggravate the condition
are lactose intolerant or have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in LOVASTATIN.

Other warnings you should know about:

Pregnancy: LOVASTATIN should not be taken during pregnancy as it may harm your unborn baby. If you are a woman who could become pregnant, talk to your healthcare professional about the potential risk

¹not marketed in canada

to the fetus and the importance of birth control methods while taking LOVASTATIN. If you become pregnant while taking LOVASTATIN, stop taking the medicine and contact your healthcare professional right away.

Hyperglycemia (high blood sugar): LOVASTATIN may lead to the development of diabetes. Your healthcare professional will monitor your blood sugar level regularly. If you have diabetes, closely monitor your blood sugar while taking LOVASTATIN and report any unusual results to your healthcare professional.

Muscle disorders: LOVASTATIN may cause muscle disorders, such as:

Myalgia (muscle pain)
Rhabdomyolysis (breakdown of damaged muscle)
Immune-Mediated Necrotizing Myopathy (IMNM) (a type of autoimmune disease that causes muscle cell death)

Tell your healthcare professional right away if you have any muscle pain, tenderness, soreness or weakness while taking LOVASTATIN.

Testing and check-ups: Your healthcare professional may do blood tests before you start LOVASTATIN and regularly during your treatment. These tests will check:

the amount of cholesterol and other fats in your blood
that your liver or muscles are working properly
the amount of sugar (glucose) in your blood

Depending on your test results, your healthcare professional may adjust your dose, temporarily stop, or discontinue your treatment with LOVASTATIN.

Surgery: Be sure to tell your healthcare professional you are taking LOVASTATIN before undergoing any major elective surgery or if you have any other new major medical issues.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

Do not use LOVASTATIN if you are taking any of the following:

certain antifungal medicines (itraconazole, ketoconazole, posaconazole, or voriconazole),
certain antibiotics (erythromycin, clarithromycin, or telithromycin),
certain medicines used to treat HIV (such as nelfinavir, ritonavir, or saquinavir),
certain medicines used to treat hepatitis C virus (boceprevir or telaprevir),
nefazodone, used to treat depression,
medicines containing cobicistat,
cyclosporine, used to prevent organ transplant rejection.

Taking LOVASTATIN with any of these medications may cause a serious drug interaction. Ask your healthcare professional if you are unsure.

The following may also interact with LOVASTATIN:

Amiodarone, used to treat an irregular heartbeat
Angiotensin-Converting Enzyme Inhibitors such as lisinopril, used to lower blood pressure
Cholestyramine, used to lower cholesterol
Propranolol, used to lower blood pressure
Colchicine, used for gout
Fibric acid derivatives (such as gemfibrozil, fenofibrate and bezafibrate), used to lower fat levels in the blood
Anticoagulants, medications that prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol
Danazol, used to treat endometriosis or fibrocystic breast disease.
Verapamil or diltiazem, used to treat high blood pressure or angina
Digoxin, used to treat heart problems
Niacin
Avoid drinking grapefruit juice while taking LOVASTATIN

How to take LOVASTATIN:

Take LOVASTATIN exactly as your healthcare professional tells you to.
Do not change the dose unless your healthcare professional tells you to.
It is recommended as a single dose with the evening meal or in two divided doses with the morning and evening meals.
Carefully follow any measures that your healthcare professional has recommended for diet, exercise or weight control.
When taking LOVASTATIN, avoid consuming grapefruit juice and large quantities of alcohol.
Keep regular appointments with your healthcare professional so that your blood can be tested and your progress checked at proper intervals.

Usual dose:

The dose of LOVASTATIN prescribed to you depends on your condition and/or your blood cholesterol level. Your healthcare professional may change your dose depending on your response to LOVASTATIN.

To lower blood cholesterol in adults with hypercholesterolemia:

The usual starting dosage is 20 mg once a day in the evening.
Your healthcare professional may adjust your dose to a maximum of 80 mg/day, taken as a single dose with the evening meal or divided doses with the morning and evening meals. Do not alter the dosage or stop taking the medicine without consulting your healthcare professional.

To slow the progression of atherosclerosis in adults with coronary heart disease:

20 mg to 80 mg per day in single or divided doses.

Overdose:

If you think you, or a person you are caring for, have taken too much LOVASTATIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss taking a tablet at its usual time, take it as soon as possible. But, if it is too close to the time of your next dose, skip the missed dose and take your next dose as scheduled. Do not take a double dose.

Possible side effects from using LOVASTATIN:

These are not all the possible side effects you may have when taking LOVASTATIN. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

Fever
Blurred vision
Constipation
Diarrhea
Gas
Stomach upset
Nausea
Pain in the abdomen
Weakness
Headache
Dizziness
Skin rash
Poor memory, memory loss or confusion
Difficulty getting and keeping an erection
Acid reflux
Hair loss
Itchy skin
Joint pain
Breathing problems including persistent cough and/or shortness of breath
Trouble sleeping or staying asleep, nightmares
Breast growth in males
Tingling sensation or pain in the hands, arms, legs or feet

LOVASTATIN can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
Very Rare
Allergic Reactions: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat			✓
Interstitial lung disease (disease that inflame or scar lung tissue): shortness of breath when rest that gets worse with exertion, dry cough			✓
Liver failure (serious disturbance of liver function): yellowing of the skin or whites of the eyes (jaundice), bleeding easily, swollen abdomen, mental disorientation or confusion, sleepiness, coma			✓
Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness		✓
Unknown
Cholestatic jaundice: yellowing of the skin, vomiting, light colored poop, pruritic		✓
Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse		✓
Hyperglycemia: (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue	✓
Muscle Disorders: Myalgia (muscle pain): aching muscles, tenderness or weakness that you cannot explain		✓
Rhabdomyolysis (breakdown of damaged muscle): muscle tenderness, weakness, red -brown (tea - coloured) urine Immune -Mediated Necrotizing Myopathy (IMNM) (a type of autoimmune disease that causes muscle cell death): progressive muscle weakness in forearms. thighs, hips, shoulders, neck and back, difficulty standing up, climbing stairs or lifting arms over the head, falling and difficulty getting up from a fall, general feeling of tiredness These muscle disorders can be accompanied with fever or feeling unwell.		✓
			✓
Myasthenia Gravis (muscle weakness): General: difficulty in speaking, chewing, and swallowing or weakness of arms and legs and in some cases, muscles used when breathing Ocular (eye): weak, drooping eyelid(s) causing vision changes			✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15°C - 30°C). Protect from light.

Keep out of reach and sight of children.

Do not use outdated medicine.

If you want more information about LOVASTATIN:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.aapharma.ca/en/); or by calling 1-877-998-9097.

Date of Authorization: 2025-07-29

Lovastatin (AA Pharma): Uses, Side Effects and Dosage