Patient Medication Information: uses, side effects, how to take - Pro-Aas EC

ABOUT THIS MEDICATION

What the medication is used for:

PRO-AAS EC is for doctor-supervised long-term preventive
therapy.
PRO-AAS EC may help save your life if you think you are
having a heart attack.

What it does:

PRO-AAS EC is for doctor-supervised long-term preventative therapy.

USE DURING A HEART ATTACK

If you think you are having a heart attack, call 911 immediately then, chew or crush and swallow two PRO-AAS EC tablets. It is important to chew or crush the product, to ensure this medicine works quickly. Then get to a hospital immediately for medical attention. Inform the emergency services / hospital that you have taken PRO-AAS EC. Taking PRO-AAS EC, at the first signs and symptoms can reduce your risk of dying from a heart attack.

The signs and symptoms of a heart attack include:

uncomfortable pressure, fullness, squeezing or pain in the
centre of the chest that lasts more than a few minutes, or goes away quickly and comes back
pain that spreads to the shoulders, neck or arms
chest discomfort with light headedness, fainting, sweating,
nausea or shortness of breath.

Chest pain is the most common symptom in both sexes, but women may also experience other symptoms such as unusual fatigue that gets worse with activity, difficulty of breathing, heartburn/nausea and /or vomiting unrelieved by antacids, tightening and pain in the chest that may extend into the neck, jaws and shoulders, general feeling of weakness, paleness, sweating

At the hospital, the doctor will then recommend appropriate therapy.

When it should not be used:

DO NOT TAKE if you:

are allergic to ASA, salicylates, non-steroidal anti-
inflammatory drugs (NSAIDs)/pain relievers/fever reducers or other ingredients in the product
have an ulcer, history of ulcers or are prone to bleeding
have active or severe liver or kidney disease or congestive heart
failure
- have a history of asthma caused by salicylates or other
  NSAIDs
- are using methotrexate at doses of 15 mg/week or more
- are in the last trimester of pregnancy because it may cause problems to the unborn child or complications during delivery.

What the medicinal ingredient is:

Acetylsalicylic Acid (ASA)

What the non-medicinal ingredients are (alphabetically): Colloidal Silicon Dioxide, Glyceryl Stearate, Lactose Anhydrous, Methacrylic Acid Copolymer, Methylated Silica, Methylcellulose, Polydimethylsiloxane, Polysorbate 65, Pregelatinized Starch, Sodium Bicarbonate, Sodium Lauryl Sulphate, Sorbic Acid, Stearic Acid, Sulfuric Acid, Talc, Titanium Dioxide and Triethyl Citrate.

What dosage forms it comes in:

PRO-AAS EC comes as enteric-coated tablets.

WARNINGS AND PRECAUTIONS

Your doctor will have asked you many questions about your health, lifestyle, and medications before recommending PRO-AAS EC. That is why it is very important that you tell your doctor all such information. If you have forgotten to tell your doctor about any of the following, call your doctor or pharmacist before you take this medicine (or any medicine):

asthma, high blood pressure, heart disease, gout or other serious conditions
age 60 years or older
stomach problems such as heartburn
STOMACH BLEEDING WARNING: contains a NSAID which may cause severe stomach bleeding
impaired liver/kidney or impaired cardiovascular circulation
(renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events)
history of blood clotting defects
severe anemia
severe glucose-6-phosphate dehydrogenase (G6PD) deficiency
are trying to conceive, pregnant or breast-feeding or
will be having surgery in five to seven days.
CAUTION: Contains enough drug to seriously harm a child. KEEP OUT OF REACH AND SIGHT OF CHILDREN. DO NOT GIVE to children/teenagers less than 18 years of age who have chicken pox or cold/flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with ASA.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor if you are taking any prescription or nonprescription drugs including blood thinners, acetaminophen, anticonvulsants, anti-diabetic/arthritis/gout medicines, digoxin, glucocorticoids, methotrexate, selective-serotonin re-uptake inhibitors (a type of antidepressant), diuretics, ACE inhibitors (medication for high blood pressure), or if you are having 3 or more alcoholic drinks per day.

PRO-AAS EC; PRO-AAS CHEWABLE

Do not use NSAIDs (ibuprofen or naproxen) if you are taking PRO-AAS EC for preventive therapy without talking to a doctor or pharmacist, as NSAIDs may interfere with the preventive benefits of PRO-AAS EC.

PROPER USE OF THIS MEDICATION

Usual dose:

DIRECTIONS (Adults ≥ 18 years): For doctor-supervised long-term preventive therapy: 1 to 4 tablets daily, depending on your doctor’s instructions. You should take this medicine at the same time every day. This will help you to remember to take your medication. For maximum effectiveness, it is very important to take PRO-AAS EC every day as directed by your doctor. Do not take more tablets than your doctor recommends. Your doctor may tell you to take PRO-AAS EC with other medications; he or she may also tell you to eat special foods, exercise or take other steps to safeguard your health. PRO-AAS EC tablets have a special enteric coating, which allows them to pass undissolved through the stomach and into the intestine. By dissolving in the intestine rather than the stomach, the risk of stomach upset is reduced. Therefore, to maintain this protection, the tablets should not be crushed or broken.

During a heart attack: Call 911, then, crush or chew 2 tablets.

Can I continue to take PRO-AAS EC for relief of headache, fever or arthritis pain?

PRO-AAS EC is specially designed for doctor supervised long-term preventive therapy. It is a smaller dose than you would need to take for a headache or other types of pain and is unlike other pain reliever products such as acetaminophen or NSAIDs e.g., ibuprofen, naproxen. Ask your doctor or pharmacist about other PRO-AAS EC products available (or other pain relievers such as acetaminophen, ibuprofen, naproxen or salicylates) and the correct dosage for the relief of your headache, fever or arthritic pain. Always consult with your doctor or pharmacist before taking other medications.

Overdose:

If you think you, or a person you are caring for, have taken too much PRO-AAS EC, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you forget to take your medication, take it when you remember. But do not take extra medication to compensate for a missed dosage unless instructed by your doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, PRO-AAS EC may occasionally produce

unwanted side effects. You should call your doctor if you

experience: nausea, vomiting; stomach irritation, or pain; if you

notice that you are ‘bruising’ more easily than you were before

starting a daily dose of PRO-AAS EC. Regular daily use of alcohol

while on PRO-AAS EC daily therapy may increase your risk of

developing gastrointestinal bleeding. This is not a complete list of

side effects. For any unexpected effects while taking PRO-AAS

EC, contact your doctor or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Stop use and call your doctor if you experience an allergic reaction (skin rash, hives, itching, swelling of eyes, face, lips, tongue, or throat, wheezing or breathing difficulties); stomach bleeding (feel faint, bloody vomit, vomit that looks like coffee grounds, bright red blood in stools, black or tarry stools, stomach pain that does not get better); loss of hearing, ringing or buzzing in ears, or bleeding.

HOW TO STORE IT

Keep out of reach and sight of children.

Store between 15°C and 30°C.

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/health-canada/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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.

Pro Doc Ltée, Laval, Quebec, H7L 7W9

Last revised: February 27, 2023