Patient Medication Information: uses, side effects, how to take - Jamp Prasugrel
What the medication is used for:
Your doctor prescribed JAMP Prasugrel because you
- have experienced a heart attack from a blocked artery or
- had unstable angina from a partially blocked artery.
Your doctor may have placed a stent to open the artery in your heart that caused these problems.
JAMP Prasugrel is used with ASA (Aspirin®)* to help prevent blood clots from forming within the arteries in your heart or stent, therefore reducing your risk of having a new heart attack.
What it does:
JAMP Prasugrel is in a class of prescription medications called antiplatelet agents. Antiplatelet agents reduce the ability of blood to clot. JAMP Prasugrel with aspirin reduces the risk of a future heart attack.
When it should not be used:
Do not take JAMP Prasugrel if you
- are allergic to JAMP Prasugrel or to any nonmedicinal ingredient in the formulation.
- have ever had a stroke or transient ischemic attack (TIA). A TIA, also called a “ministroke”, is a condition in which the stroke symptoms went away within 24 hours.
- have severe liver disease or damage.
- have active bleeding conditions, such as bleeding from your stomach or intestines or brain.
What the medicinal ingredient is:
Prasugrel hydrochloride
What the nonmedicinal ingredients are:
Mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium stearyl fumarate, hypromellose, triacetin, titanium dioxide, red iron oxide and yellow iron oxide.
What dosage forms it comes in:
JAMP Prasugrel is available as a 10 mg beige coloured, elongated hexagonal shaped, biconvex, film coated tablets debossed with 'PG' on one side and '10' on the other side.
JAMP Prasugrel increases the risk of bleeding.
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BEFORE you use JAMP Prasugrel, talk to your doctor, nurse or pharmacist if you:
- have a history of bleeding conditions, stomach ulcers, diverticulitis or liver problems.
- have had a recent severe injury or recent surgery (including dental procedures).
- have allergies to medications including if you have had an allergic reaction to clopidogrel or ticlopidine.
- are planning to have a surgical or dental procedure. Your doctor or dentist may ask you to temporarily stop taking JAMP Prasugrel 7 days prior to surgery due to the risk of increased bleeding. Do not stop taking JAMP Prasugrel without talking to your cardiologist.
are breastfeeding, pregnant, or are planning to get pregnant.
- are less than 18 years old.
- have kidney disease or damage.
If you experience any allergic reaction including symptoms such as swelling mainly of the face and throat (angioedema), stop taking JAMP Prasugrel and seek immediate medical attention.
It is important that you tell all of your healthcare professionals that you are taking JAMP Prasugrel.
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you regularly take, including prescription and non-prescription medicines, vitamins, minerals, natural supplements, or alternative medicines.
Drugs that may interact with JAMP Prasugrel include:
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen (Advil®, Motrin®)*, naproxen (Naprosyn®, Aleve®)*.
- Oral anticoagulants (blood thinners) such as warfarin (Coumadin™)*.
- Fibrinolytics (drugs used to dissolve blood clots during treatment for a heart attack or lung clot). Examples include streptokinase, tissue plasminogen activators (tPAs) and tenecteplase (TNKase®)*.
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
It is important to take JAMP Prasugrel exactly as prescribed by your doctor. It is also important to get your refills on time so you do not run out of medicine.
Usual dose:
Your doctor will prescribe the right dose of JAMP Prasugrel for you. JAMP Prasugrel is usually started with a single 60 mg loading dose. Then, the usual dose is 10 mg daily.
Take JAMP Prasugrel once a day by mouth, with or without food.
- Do not break your JAMP Prasugrel tablet. Talk to your healthcare professional if you have trouble swallowing pills.
- Continue taking acetylsalicylic acid (ASA) as directed by your doctor.
- Your doctor will decide how long you should take JAMP Prasugrel. Stopping JAMP Prasugrel without informing your doctor may increase the chance of a heart attack or stroke or a clot forming in your stent. Therefore you should inform your doctor immediately if you stop taking JAMP Prasugrel.
Overdose:
| If you think you have taken too much JAMP Prasugrel, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss your scheduled daily dose, take JAMP Prasugrel when you remember. If you forget your dose for an entire day, just resume taking JAMP Prasugrel at its usual dose the next day. Do not take two doses on the same day.
Like all antiplatelet medications, JAMP Prasugrel can increase the risk of bleeding. While taking JAMP Prasugrel, you may notice that you bruise more easily, are more likely to have nose bleeds, or have cuts that take longer to stop bleeding. Unlike these types of bleeding, some bleeding can be serious, even fatal. Bleeding, such as rectal bleeding or coughing up blood, should be investigated by your doctor as it may be a sign of an unsuspected tumour.
Tell your doctor about a rash that bothers you or that does not go away. If you notice any undesirable effects, especially during the first few weeks of treatments, including any not mentioned in the table below, promptly notify your doctor for assessment and follow-up.
| 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 seek immediat e medical help | |
| Only if severe | In all cases | ||
| Common | |||
| Anaemia (shortness of breath, paleness, weakness) | ✓ | ||
| Bruising (that develops without known cause or grows in size) | ✓ | ||
| Bleeding in the stomach, intestine, or rectum (red or black stools) | ✓ | ||
| Vomit blood or your vomit looks like coffee grounds | ✓ | ||
| Rash | ✓ | ||
| Blood in urine | ✓ | ||
| Bleeding or bruising from a needle puncture | ✓ | ||
| Nose bleeds | ✓ | ||
| Un- common | |||
| Bleeding in the eye | ✓ | ||
| Coughing up blood | ✓ | ||
| Gum bleeding | ✓ | ||
| Sudden severe headache | ✓ | ||
| Dizziness, lightheadedness | ✓ | ||
| Purplish spots on the skin or mucous membranes fever, yellowish colour of the eyes or skin, speech or visual changes, confusion, extreme tiredness |
| ||
| Allergic reactions (including swelling of the face and throat) | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking JAMP Prasugrel, contact your doctor or pharmacist.
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
- Keep JAMP Prasugrel in its original packaging and do not place your JAMP Prasugrel tablets in any other container.
- Store JAMP Prasugrel at room temperature between 15°C-30°C.
- Keep JAMP Prasugrel and all medicines out of the reach and sight of children.
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. |
If you want more information about JAMP Prasugrel:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by contacting the sponsor, JAMP Pharma Corporation, at: 1-866-399-9091.
1310 rue Nobel, Boucherville,
Québec, Canada, J4B 5H3
Date of Approval: July 16, 2020