Patient Medication Information: uses, side effects, how to take - Teva-Gemfibrozil (Teva Canada, 600 mg)
What is TEVA-GEMFIBROZIL used for?
TEVA-GEMFIBROZIL is used in combination with a change in diet and other medications to lower the level of cholesterol and triglycerides (a type of fat) in the blood. It is used to treat adults with:
- very high levels of triglyceride who are at high risk of complications such as pancreatitis
- high levels of cholesterol
How does TEVA-GEMFIBROZIL work?
TEVA-GEMFIBROZIL is a lipid regulating agent. It decreases the amount of triglycerides and cholesterol in the blood. TEVA-GEMFIBROZIL also raises high density cholesterol.
What are the ingredients in TEVA-GEMFIBROZIL?
Medicinal ingredient: Gemfibrozil
Non-medicinal ingredients: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, silicon dioxide and sodium lauryl sulfate.
TEVA-GEMFIBROZIL comes in the following dosage forms:
Tablets, 600 mg
Do not use TEVA-GEMFIBROZIL if:
- you are allergic to gemfibrozil or to any of the other ingredients in TEVA-GEMFIBROZIL.
- you have liver and renal dysfunction, including primary biliary cirrhosis.
- you have gallbladder disease.
- you are pregnant, or think you might be pregnant.
- you are breastfeeding.
- you are taking repaglinide.
- you are taking simvastatin.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-GEMFIBROZIL. Talk about any health conditions or problems you may have, including if you:
- have history of jaundice or liver disease.
- are planning to become pregnant.
- are planning to breastfeed.
- are taking medicines known as “statins”, more specifically called HMG-CoA reductase inhibitors, which are used to lower cholesterol.
Other warnings you should know about:
Check ups and testing: Your healthcare professional may do blood tests before you start TEVA-GEMFIBROZIL and regularly during your treatment. These tests will check:
- the amount of cholesterol and other fats in your blood
- your liver function
- the amount of hemoglobin, white blood cells and platelets in your blood.
Depending on your test results, your healthcare professional may adjust your dose, temporarily stop, or discontinue your treatment with TEVA-GEMFIBROZIL.
Gallstones: TEVA-GEMFIBROZIL may cause gallstones. Let your healthcare professional know if you have intense pain in the upper abdomen, pain in the right shoulder, nausea and vomiting. Your healthcare professional will perform tests to see if you have gallstones.
Muscle disorders: TEVA-GEMFIBROZIL may cause serious muscle problems called myopathy (diseases that affect the muscles that connect to your bones) and rhabdomyolysis (breakdown of damaged muscle). Rhabdomyolysis can cause kidney damage in some individuals. The risk of rhabdomyolysis is higher in some people. Tell your healthcare professional if you develop:
- an infection in the blood (sepsis)
- low blood pressure
- metabolic, endocrine or electrolyte problems
- uncontrolled seizures
- have recently had surgery or plan to have surgery
Tell your healthcare professional right away if you have any muscle pain, tenderness, soreness or weakness, especially if you also have a fever.
Fertility: TEVA-GEMFIBROZIL may impact fertility in men. Talk to your healthcare professional if this is a concern for you.
Pregnancy and birth control: TEVA-GEMFIBROZIL should not be taken during pregnancy as it may harm your unborn baby. Tell your healthcare professional if you plan to become pregnant. If you are able to become pregnant, your healthcare professional will ask you to use a highly effective birth control method while taking TEVA-GEMFIBROZIL. If you discover you are pregnant while taking TEVA-GEMFIBROZIL stop taking it and contact your healthcare professional right away.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TEVA-GEMFIBROZIL:
- anticoagulant drugs.
- colestipol, used to lower cholesterol levels in the blood.
- drugs called HMG-CoA Reductase Inhibitors that lower chosterol in the blood, such as simvastatin, rosuvastatin, atorvastatin, lovastatin, pitavastatin, and pravastatin.
- repaglinide, used to treat type 2 diabetes.
How to take TEVA-GEMFIBROZIL:
- Take TEVA-GEMFIBROZIL exactly as your healthcare professional tells you.
Take TEVA-GEMFIBROZIL in the morning and in the evening, 30 minutes before a meal.
- Carefully follow any measures that your healthcare professional has recommended for diet, exercise or weight control.
Usual dose:
The usual dose is 600 mg twice a day. The maximum dose is 1500 mg a day.
Overdose:
Signs of an overdose include:
- stomach cramps
- abnormal liver tests
- diarrhea,
- joint and muscle pain,
- nausea and vomiting.
| If you think you, or a person you are caring for, have taken too much TEVA-GEMFIBROZIL, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss taking your dose, take it as soon as you remember. But if it is almost time for you to take the next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are possible side effects from using TEVA-GEMFIBROZIL?
These are not all the possible side effects you may have when taking TEVA-GEMFIBROZIL. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Abdominal pain or discomfort
- Diarrhea
- Nausea
- Vomiting
- Dizziness
- Fatigue or a strong desire to fall asleep
- Skin rash or itch, hives
- Muscle pain
- Gas
- Gout
- Headache
- Tingling sensation or pain in the hands, arms, legs or feet
- Blurred vision
- Impotence (inability to get or keep an erection)
- Joint pain
- Photosensitivity (skin reaction to the sun)
- Constipation
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Appendicitis: constant and severe pain in the lower right-hand side of the body | √ | ||
| Chest Pain | √ | ||
| UNCOMMON | |||
| Atrial fibrillation (abnormal heart rhythm which is rapid and irregular): chest discomfort with unpleasant awareness of your heartbeat, faintness, shortness of breath, weakness | √ | ||
| RARE | |||
| Allergic Reactions: difficulty speaking, swallowing or breathing, wheezing; drop in blood pressure; feeling sick to | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat., swollen lymph glands, blisters and peeling skin | |||
Cholestasis (decrease in bile flow from the liver): jaundice (yellowing of the skin or whites of eyes), dark urine, light coloured stools | √ | ||
Depression (sad mood that won’t go away): 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). | √ | ||
Muscle Disorders: Myalgia / Myopathy / Myasthenia (Muscle pain or weakness): aching muscle, tenderness or weakness that you cannot explain Rhabdomyolysis (breakdown of damaged muscle): muscle tenderness, weakness, red-brown (tea-coloured) urine | √ | ||
Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | √ | ||
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:
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. |
Storage:
Store between 15°C and 30°C. Keep out of reach and sight of children.
If you want more information about TEVA-GEMFIBROZIL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com, or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com .