Accel-Clopidogrel: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

You have been prescribed ACCEL-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). ACCEL-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 ACCEL-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 ACCEL-CLOPIDOGREL and ASA for this condition. Your doctor should have prescribed ACCEL-CLOPIDOGREL plus ASA if you cannot take ‘oral anticoagulants’ as the combined use of ACCEL-CLOPIDOGREL plus ASA is more effective than ASA alone.

Be sure to talk to your doctor before taking ACCEL-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:

ACCEL-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:

castor oil, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lactose monohydrate, mannitol, microcrystalline cellulose, polyethylene glycol. The pink film coating contains lactose, hypromellose, titanium dioxide, triacetin and red iron oxide.

What dosage forms it comes in:

ACCEL-CLOPIDOGREL comes as 75 mg and 300 mg tablets. ACCEL-CLOPIDOGREL 75 mg is available as pink, round, bevel edged, biconvex, film-coated tablets imprinted in black colour with “C75” on one side and plain on the other side.

ACCEL-CLOPIDOGREL 300 mg is available as pink, capsule shaped, biconvex, film-coated tablets that are plain on both sides.

WARNINGS AND PRECAUTIONS

BEFORE you use ACCEL-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 antidepressants drugs [SSRIs – Selective Serotonin Reuptake Inhibitors] such as fluvoxamine, fluoxetine, or Non-Steroidal 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 ACCEL-

  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.

• You have recently undergone surgery (including dental

  surgery).

• You will be having surgery. Your doctor may ask you

  to stop taking ACCEL-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 ACCEL-CLOPIDOGREL and you experience any excessive bleeding, do not stop taking ACCEL-CLOPIDOGREL but see or call your doctor right away.

While you are on ACCEL-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 ACCEL-CLOPIDOGREL, you should inform them that you are using ACCEL-CLOPIDOGREL.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with ACCEL-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 ACCEL-CLOPIDOGREL per day, by mouth. ACCEL-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 ACCEL-CLOPIDOGREL 75 mg once daily in combination with ASA 75-100 mg once daily.

Children and adolescents:

ACCEL-CLOPIDOGREL is not recommended for children or adolescents below 18 years of age.

ACCEL-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 ACCEL-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 ACCEL-CLOPIDOGREL by referring to the calendar printed on the blister strip.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Very rare side effects reported with clopidogrel are:

• joint pain and/or muscle pain

Contact immediately your doctor 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.

TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking ACCEL-CLOPIDOGREL contact your doctor or pharmacist.

HOW TO STORE IT

HOW TO STORE IT

ACCEL-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.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at: www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals by Accel Pharma Inc., can be found at

www.accelpharma.com

Last revised: November 6, 2014