Patient Medication Information: uses, side effects, how to take - Q-Clopidogrel
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What the medication is used for:
You have been prescribed Q-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). Q-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 Q-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 Q-CLOPIDOGREL and ASA for this condition. Your doctor should have prescribed Q-CLOPIDOGREL plus ASA if you cannot take ‘oral anticoagulants’ as the combined use of clopidogrel bisulfate plus ASA is more effective than ASA alone.
Be sure to talk to your doctor before taking Q-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:
Q-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:
- If you are allergic to any of the substances contained in the tablets (see below).
- If you have a medical condition that may cause bleeding, such as a stomach ulcer.
- If you have liver disease or damage.
What the medicinal ingredient is:
Clopidogrel bisulfate
What the nonmedicinal ingredients are: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate/sodium lauryl sulfate, microcrystalline cellulose. The pink film coating contains hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polydextrose, polyethylene glycol, titanium dioxide.
What dosage forms it comes in:
Q-CLOPIDOGREL comes as 75 tablets. Q-CLOPIDOGREL tablets are round, pink and engraved on one side with the letter M and the C27 on the other side. Q- AND PRECAUTIONS
WARNINGS AND PRECAUTIONS
BEFORE you use Q-CLOPIDOGREL talk to your doctor or pharmacist if:
- You have had an allergic reaction to any of the substances contained in the tablets.
- You have a medical condition that is causing bleeding, such as a stomach ulcer.
- You 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, or some oral antidepressant drugs [SSRIs – Selective Serotonin Reuptake Inhibitors] such as fluvoxamine, fluoxetine or Non-Steriodal Anti-Inflammatory Drugs [NSAIDS; drugs used to treat painful and/or inflammatory conditions of muscles or joints]), including those that you buy without a prescription.
- You are taking drugs used to treat stomach ulcers and stomach acidity (e.g. omeprazole).
You are pregnant or become pregnant on Q-
CLOPIDOGREL, or you are breast-feeding.
- You have a medical condition that predisposes you to bleeding.
- You have a recent serious injury.
- You have liver disease or damage. IMPORTANT: PLEASE READ
You have recently undergone surgery (including dental
surgery).
You will be having surgery. Your doctor may ask
you to stop taking Q-CLOPIDOGREL for 5-7 days before your surgery.
You have a blood disorder that makes you prone
to internal bleeding (bleeding inside any tissues, organs or joints of your body) or tend to bleed longer than 10 minutes without taking any drugs.
You have allergies to medications including
prasugrel or ticlopidine
While you are on Q-CLOPIDOGREL and you experience any excessive bleeding, do not stop taking Q-CLOPIDOGREL but see or call your doctor right away.
While you are on Q-CLOPIDOGREL it is important that you do not take any medicine other than that prescribed by your doctor. If you should see another doctor or a dentist while you are using Q-CLOPIDOGREL, you should inform them that you are using Q-CLOPIDOGREL.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Q-CLOPIDOGREL include: ASA, NSAIDS, SSRIs, heparin, warfarin, abciximab, eptifibatide and tirofiban, antacids (e.g. omeprazole).
PROPER USE OF THIS MEDICATION
Usual dose:
Adults (including the elderly):
You should take one 75 mg tablet of Q-CLOPIDOGREL per day, by mouth. Q-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 Q-CLOPIDOGREL 75 mg once daily in combination with ASA 75-100 mg once daily.
Children and adolescents:
Q-CLOPIDOGREL is not recommended for children or adolescents below 18 years of age.
Q-CLOPIDOGREL should be taken long term under supervision of your doctor.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
A large dose of tablets could put you at risk of serious bleeding, requiring emergency treatment.
Missed Dose:
If you forget to take a dose of Q-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 blister format you can check the day on which you last took a tablet of Q-CLOPIDOGREL by referring to the calendar printed on the blister strip. AND HAT TO DO ABOUT THEM
SIDE EFFECTS AND WHAT TO DO ABOUT
THEM
Very rare side effects reported with Q-CLOPIDOGREL are:
- joint pain and/or muscle pain
Contact your doctor immediately if you experience:
- Signs of liver problems such as yellowing of the skin and/or eyes (jaundice), whether or not associated with bleeding and/or confusion.
If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way your medicine works. 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.
In some cases, Q-CLOPIDOGREL may cause enlargement of breast tissue in men.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
Common
| Abdominal pain | √ | ||
| Diarrhea | √ | ||
| IMPORTANT: PLEASE READ |
| Indigestion (or heartburn) | √ | |||
| Bruising | √ | |||
| Nose bleeds | √ | |||
| Bleeding in stomach, bowels | √ | |||
| Haematuria: Blood in the urine | √ | |||
| Biliary (bile) disorders | √ | |||
Allergic Reaction: rash, hives, swelling of the face, lips, throat, difficulty swallowing or breathing | √ | |||
| Uncommon | Fever, signs of infection, extreme tiredness | √ | ||
Jaundice: signs of liver problems yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | √ | |||
| Nausea | √ | |||
| Constipation | √ | |||
| Vomiting | √ | |||
| Bleeding in the eye | √ | |||
| Dizziness | √ | |||
| Headache | √ | |||
| Tingling sensation | √ | |||
| Rash | √ | |||
| Itching | √ | |||
| Bleeding from blood vessels inside the head | √ | |||
| Very Rare | Eosinophilic Pneumonia: cough, fever, difficulty breathing, and sweating at night. | √ |
This is not a complete list of side effects. For any unexpected effects while taking Q-CLOPIDOGREL, contact your doctor or pharmacist.
HOW TO STORE IT
Q-CLOPIDOGREL tablets should be stored in a safe place and be kept out of the reach of children. Q-CLOPIDOGREL tablets should be stored between 15°C and 30°C and protected from moisture. 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 help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffet;
- By calling 1-866-234-2345 (toll-free);
By completing a Patient Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada,
Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffet.
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 can be found at:
www.qdpharmaceuticals.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, QD Pharmaceuticals ULC at: 1-800-661-3429
Revised on: August 25, 2015