Patient Medication Information: uses, side effects, how to take - Priva-Clopidogrel
ABOUT THIS MEDICATION
What the medication is used for:
You have been prescribed Priva-CLOPIDOGREL because you are at risk for experiencing unwanted blood clots (thrombi). These blood clots can lead to symptoms which present in different manners, such as strokes, unstable angina, heart attacks, or peripheral arterial disease (leg pain on walking or at rest). Priva-CLOPIDOGREL is taken to prevent further blood clots from forming thereby reducing the risk of having unstable angina, a heart attack or another stroke.
Your doctor can also prescribe Priva-CLOPIDOGREL for you if you have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (for example, warfarin) which prevent new clots from forming and prevent existing clots from growing.
You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid (ASA) or the combined use of Priva-CLOPIDOGREL and ASA for this condition. Your doctor should have prescribed Priva-CLOPIDOGREL plus ASA if you cannot take ‘oral anticoagulants’ as the combined use of Priva-CLOPIDOGREL plus ASA is more effective than ASA alone.
Be sure to talk to your doctor before taking Priva-CLOPIDOGREL if you have an elevated risk of bleeding.
This product has been prescribed for you personally and you should not pass it on to others.
What it does:
Priva-CLOPIDOGREL tablets belong to a group of medicines called antiplatelet drugs. Platelets are very small structures in blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet drugs reduce the chances of blood clots forming (a process called thrombosis).
When it should not be used:
Do not take Priva-CLOPIDOGREL if you:
- are allergic to any of the substances contained in the tablets (see below).
- are taking replaglinide, a drug used to lower blood glucose in diabetics
- have a medical condition that may cause bleeding, such as a stomach ulcer.
- have liver problems.
What the medicinal ingredient is:
Clopidogrel bisulfate
What the nonmedicinal ingredients are:
Low substituted hydroxypropyl cellulose, hypromellose, hydrogenated castor oil, lactose monohydrate, red iron oxide, mannitol, microcrystalline cellulose, polyethylene glycol titanium dioxide and triacetin.
What dosage forms it comes in:
Priva-CLOPIDOGREL comes as 75 mg tablets, available as pink colored, circular shaped, biconvex, film coated tablets debossed with ‘11’ on one side and plain on other side.
WARNINGS AND PRECAUTIONS
BEFORE you use Priva-CLOPIDOGREL talk to your doctor or pharmacist if you:
- have a medical condition that is causing 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
- are taking drugs used to treat stomach ulcers and stomach acidity (e.g. omeprazole).
are pregnant or become pregnant on PLAVIX, or you are breast-feeding.
- have recently undergone surgery (including dental surgery).
- will be having surgery. Your doctor may ask you to stop taking Priva-CLOPIDOGREL for 5-7 days before your surgery.
- have allergies to medications including prasugrel or ticlopidine.
Priva-CLOPIDOGREL is not recommended for children or adolescents below 18 years of age.
While you are on Priva-CLOPIDOGREL if you experience any excessive bleeding, do not stop taking Priva-CLOPIDOGREL but see or call your doctor right away.
If you should see another doctor or a dentist while you are using Priva-CLOPIDOGREL, you should inform them that you are using Priva-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.
Drugs that may interact with Priva-CLOPIDOGREL include:
- 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.
- Selective Serotonin Reuptake Inhibitors (SSRIs) such as fluvoxamine, fluoxetine, used to treat depression.
- Drugs use to reduce clotting such as;heparin, warfarin, abciximab, abciximab, eptifibatide and tirofiban,
- Antacids (e.g. omeprazole) used for indigestion or heartburn.
- Repaglinide, a drug used to lower blood glucose in diabetics
- Paclitaxel, used to treat many types of cancer
PROPER USE OF THIS MEDICATION
Usual dose:
Adults (including the elderly):
You should take one 75 mg tablet of Priva-CLOPIDOGREL per day, by mouth. Priva-CLOPIDOGREL can be taken with or without food. You should take your medicine regularly and at the same time each day. If you have had unstable angina or a heart attack, a one-time 300 mg dose may be administered followed by one 75 mg tablet daily.
If you have atrial fibrillation, the usual dose is Priva-CLOPIDOGREL 75 mg once daily in combination with ASA 75-100 mg once daily.
Priva-CLOPIDOGREL should be taken long term under supervision of your doctor.
Overdose:
| If you think you have taken too much Priva-CLOPIDOGREL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take a dose of Priva-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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- joint pain and/or muscle pain
- abdominal pain, diarrhea, indigestion (heartburn)
- nausea, vomiting, constipation
- 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, e.g. cutting yourself shaving, this is of no concern. However, if you are in any doubt at all, you should contact your doctor immediately.
If any of these affects you severely, tell your doctor or pharmacist
| SERIOUS EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
|---|---|---|---|---|---|---|
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
| 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 | ✓ | |||||
| SERIOUS EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| 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, syncope, pruritus, urticarial, sudden, heavy sweating, unusual paleness, palpitations, hypotension, slow heartbeat. | ✓ | |||
| Unknown | Persistent low blood sugar symptoms such as: sweating, shakiness, dizziness, headache, and blurred vision | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking Priva-CLOPIDOGREL, contact your doctor or pharmacist.
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 |
HOW TO STORE IT
Store between 15° and 30° C.
Priva-CLOPIDOGREL tablets should be stored in a safe place and be kept out of the reach 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.
MORE INFORMATION
If you want more information about Priva-CLOPIDOGREL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting Health Canada website (http://hc-sc.gc.ca/index-eng.php); Pharmapar website www.pharmapar.ca. or by calling 1-866-831-2003.
Pharmapar Inc.
1565, Boul. Lionel-Boulet,
Varennes, Quebec
J3X 1P7
Date of Preparation: September 23, 2019