Details for: AG-CLOPIDOGREL
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02431971 | AG-CLOPIDOGREL | CLOPIDOGREL (CLOPIDOGREL BISULFATE) | 75 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- AG-Clopidogrel is used in adults to help prevent blood clots and reduce the risk of having conditions caused by blood clots (such as strokes, unstable angina (chest pain at rest), heart attacks, or peripheral arterial disease (leg pain on walking or at rest)).
- AG-Clopidogrel is also used in adults who have atrial fibrillation (irregular heartbeat) and cannot take medicines known as oral anticoagulants.
What it does
AG-Clopidogrel tablets belong to a group of medicines known as antiplatelet drugs. Platelets are very small structures in the blood that clump together during blood clotting. Antiplatelet drugs such as AGClopidogrel help prevent this clumping and reduce the chances of blood clots forming.
When it should not be used
- are allergic to clopidogrel bisulfate or any of the ingredients contained in the tablets.
- are taking replaglinide, a drug used to lower blood glucose.
- have a medical condition that may cause bleeding, such as a stomach ulcer.
- have liver problems.
What the medicinal ingredient is
Medicinal ingredient: Clopidogrel bisulfate
What the non-medicinal ingredients are
Non-medicinal ingredients: Crospovidone, glycerol dibehenate, iron oxide red, lactose anhydrous, lecithin (soya), macrogol, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide.
What dosage form it comes in
Tablets, 75 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Clopidogrel. Talk about any health conditions or problems you may have, including if you:
- have a medical condition that causes bleeding, such as a stomach ulcer, or a blood disorder that causes you to bleed more easily or tend to bleed longer than 10 minutes without taking any drugs.
- are taking any other medications such as:
- acetylsalicylic acid (ASA);
- other drugs used to reduce blood clotting, such as warfarin, heparin, abciximab, eptifibatide and tirofiban;
- oral antidepressants drugs (SSRIs – Selective Serotonin Reuptake Inhibitors), such as fluvoxamine, fluoxetine;
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) used to treat painful and/or inflammatory conditions of muscles or joints;
- drugs used to treat stomach ulcers and stomach acidity, such as omeprazole;
- rifampin, an antibiotic used to treat strong infections.
- have kidney problems.
- are pregnant or become pregnant while taking AG-Clopidogrel.
- are breast-feeding.
- have recently had surgery (including dental surgery), or plan on having surgery soon. Your healthcare professional may ask you to stop taking AG-Clopidogrel for 5-7 days before your surgery.
- have allergies to medications, including prasugrel or ticlopidine.
- 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 AG-Clopidogrel.
Other warnings you should know about:
AG-Clopidogrel is not recommended for children or adolescents below 18 years of age
If you experience any excessive bleeding while taking AG-Clopidogrel, do not stop taking AGClopidogrel but see or call your healthcare professional right away.
If you should see another doctor or a dentist while you are using AG-Clopidogrel, you should tell them that you are using AG-Clopidogrel.
Interactions with this medication
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 AG-Clopidogrel:
- Aspirin (ASA), used to treat pain, fever and inflammation.
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), used to treat painful and/or inflammatory conditions of the muscles or joints.
- Opioids, used to treat severe pain. While you are treated with AG-Clopidogrel, you should tell your healthcare professional before being prescribed any opioid.
- Selective Serotonin Reuptake Inhibitors (SSRIs), such as fluvoxamine and fluoxetine, used to treat depression.
- Drugs use to reduce clotting, such as heparin, warfarin, abciximab, eptifibatide, and tirofiban.
- Antacids, such as omeprazole, used for indigestion or heartburn.
- Repaglinide, used to lower blood glucose.
- Paclitaxel, used to treat many types of cancer.
- Rifampin, an antibiotic used to treat severe infections.
Proper use of this medication
How to take AG-Clopidogrel:
AG-Clopidogrel can be taken with or without food. You should take your medicine regularly and at the same time each day.
This product has been prescribed for you. You should not give it to others. AG-Clopidogrel should be taken long term, under supervision of your healthcare professional.
Usual Dose:
You should take one 75 mg tablet of AG-Clopidogrel per day, by mouth.
If you have had unstable angina (chest pain at rest) or a heart attack, a one-time 300 mg dose may be given to you, followed by one 75 mg tablet daily.
If you have atrial fibrillation (irregular heartbeat), the usual dose is AG-Clopidogrel 75 mg once daily in combination with ASA 75-100 mg once daily.
Overdose:
Missed Dose
If you forget to take a dose of AG-Clopidogrel, but remember within 12 hours of your usual time, take your tablet immediately, and then take your next tablet at the normal time. If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for the one you missed.
When using the blister format, you can check the day on which you last took a tablet of AG-Clopidogrel by referring to the calendar printed on the blister strip.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking AG-Clopidogrel. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- joint pain and/or muscle pain
- abdominal pain, diarrhea, indigestion (heartburn)
- nausea, vomiting, constipation, loss of taste, taste disturbance
- dizziness, headache
- tingling sensation in the arms and/or legs
- rash, itching
- bruising
- enlargement of breast tissue in men
If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. For minor cuts and injuries, like cutting yourself while shaving, this is of no concern. However, if you are in any doubt at all, you should contact your healthcare professional immediately.
AG-Clopidogrel can cause abnormal blood test results. Your healthcare professional 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 |
|---|---|---|---|
| COMMON | |||
| Nose bleeds | ✔ | ||
| Bleeding disorders: blood in the stool, urine or eye, vomiting blood, coughing up blood, purple spotted rash | ✔ | ||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| UNCOMMON | |||
| Fever, signs of infection, extreme tiredness | ✔ | ||
| Liver disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Bleeding in the brain: sudden, severe headache, weakness, loss of speech or vision, confusion, nausea, vomiting, seizures, loss of consciousness | ✔ | ||
| VERY RARE | |||
| Eosinophilic pneumonia: cough, fever, difficulty breathing, and sweating at night | ✔ | ||
| Kounis syndrome: a mixture of symptoms and signs of an allergic reaction and heart attack or unstable angina, with chest pain, shortness of breath, faintness, nausea, vomiting, fainting, itching, hives, sudden, heavy sweating, unusual paleness, palpitations, low blood pressure, slow heartbeat. | ✔ | ||
| UNKNOWN | |||
| Low blood sugar: sweating, shakiness, dizziness, headache, and blurred vision. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store between 15° and 30° C and protect from moisture
AG-Clopidogrel tablets should be stored in a safe place and be kept out of the reach and sight of children. Do not leave them near a radiator, on a window sill or in a humid place. Do not remove tablets from the packaging until you are ready to take them.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health- products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling 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
If you want more information about AG-Clopidogrel:
- 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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.angitapharma.ca), or by calling 450-449-9272.
This leaflet was prepared by Angita Pharma Inc. 1310 rue Nobel Boucherville, Québec J4B 5H3, Canada Last revised: April 13, 2022