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Details for: RIVASA 81 MG EC

Company: LABORATOIRE RIVA INC.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02420279RIVASA 81 MG ECACETYLSALICYLIC ACID81 MGTABLET (DELAYED-RELEASE)ORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS
PART III: CONSUMER INFORMATION ONLY

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

RIVASA 81 MG EC can help save your life in the following situations:
  • to help prevent a first heart attack in those who are at increased risk, or
  • to help prevent a second heart attack or stroke in those who have already had such an event. RIVASA 81 MG EC may help save your life if you think you are having a heart attack.

FOR PREVENTION OF A FIRST NON-FATAL HEART ATTACK (DAILY THERAPY)

Your doctor may recommend you take RIVASA 81 MG EC to help reduce the risk of a first non-fatal heart attack because you are at risk of having a heart attack. There is no evidence that this product reduces the risk of a first fatal heart attack, nor first strokes (fatal and non-fatal), nor death due to any cardiovascular problems. Your doctor will assess the appropriate balance of possible benefit of this product against the potential risk of stomach bleeding and stroke. Factors that increase your risk include high blood pressure, high cholesterol, diabetes, family history of heart disease, increased age, overweight and smoking. You should follow your doctor’s instructions carefully. Please notify your doctor if you intend to stop taking this medication.

USE DURING A HEART ATTACK

If you think you are having a heart attack, call 911 immediately, then chew or crush and swallow two RIVASA 81 MG EC. It is important to chew or crush the product, to ensure this medicine quickly works. Then get to a hospital immediately for medical attention. Inform the emergency services/hospital that you have taken RIVASA 81 MG EC. Taking RIVASA 81 MG EC at the first signs and symptoms can reduce your risk of dying from the heart attack. The signs and symptoms of a heart attack include:

  • uncomfortable pressure, fullness, squeezing or pain in the center 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 lightheadedness, 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.

FOR PREVENTION OF A SECOND HEART ATTACK OR STROKE (DAILY THERAPY)

Your doctor may recommend you take RIVASA 81 MG EC daily to help prevent a second heart attack or stroke. After having experienced a first heart attack or stroke, you can be at increased risk of experiencing a second one. You may also be at risk for heart disease and stroke because you may be overweight, a smoker, have an inactive lifestyle, high blood pressure, are under stress or have high blood cholesterol.

Following your doctor’s instructions concerning the use of RIVASA 81 MG EC and the changes in diet, exercise and lifestyle he/she may have prescribed, will provide you with your best opportunity to avoid experiencing a second heart attack or stroke. Always contact your doctor if you experience any difficulties.

PART III: CONSUMER INFORMATION ONLY

  • RIVASA 81 MG EC is for doctor supervised long-term preventative therapy.
  • RIVASA 81 MG EC may help save your life if you think you are having a heart attack.
What it does

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

RIVASA 81 MG EC belongs 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).

PART III: CONSUMER INFORMATION ONLY

RIVASA 81 MG EC is for doctor supervised long-term preventive 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 RIVASA 81 MG 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 RIVASA 81 MG EC. Taking RIVASA 81 MG 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 center 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

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

DO NOT TAKE if you:

  • are allergic to ASA, salicylates, non-steroidal antiinflammatory 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 in the unborn child or complications during delivery

PART III: CONSUMER INFORMATION ONLY

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 in the unborn child or complications during delivery
What the medicinal ingredient is

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

Acetylsalicylic acid (ASA)

PART III: CONSUMER INFORMATION ONLY

Acetylsalicylic acid (ASA)

What the non-medicinal ingredients are

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

Colloidal silica, corn starch, FD&C Blue No. 1, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, purified water, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate.

PART III: CONSUMER INFORMATION ONLY

Colloidal silica, corn starch, FD&C Blue No. 1, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, purified water, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate.

What dosage form it comes in

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

RIVASA 81 MG EC comes as enteric-coated tablets.

PART III: CONSUMER INFORMATION ONLY

RIVASA 81 MG EC comes as enteric-coated tablets.

Warnings and precautions

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

Your doctor will have asked you many questions about your health, lifestyle, and medications before recommending RIVASA 81 MG 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 an 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;
  • have severe anemia;
  • have 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 THEIR REACH. 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.

PART III: CONSUMER INFORMATION ONLY

Your doctor will have asked you many questions about your health, lifestyle, and medications before recommending RIVASA 81 MG 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 an 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 THEIR REACH. 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 serious illness reported to be associated with ASA.

Interactions with this medication

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

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 reuptake inhibitors (a type of antidepressant), diuretics, ACE inhibitors (medication for high blood pressure), or are having 3 or more alcoholic drinks per day. NSAIDs (i.e. ibuprofen or naproxen) may interfere with the heart protective benefits of RIVASA 81 MG EC. Patients should talk to their doctor if they are on an RIVASA 81 MG EC regimen and take NSAIDs for pain.

PART III: CONSUMER INFORMATION ONLY

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 reuptake inhibitors (a type of antidepressants), diuretics, ACE inhibitors (medication for high blood pressure), or if you are having 3 or more alcoholic drinks per day. Do not use NSAIDs (e.g., ibuprofen or naproxen) if you are taking RIVASA 81 MG EC for preventive therapy without talking to a doctor or pharmacist, as NSAIDs may interfere with the preventive benefits of RIVASA 81 MG EC.

Proper use of this medication
PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS
PART III: CONSUMER INFORMATION ONLY

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

Usual Dose

DIRECTIONS (Adults ≥ 18 years): During a heart attack:
Call 911, then chew or crush 2 – RIVASA 81 MG EC tablets.
For prevention of a first heart attack or for the prevention of a second heart attack or stroke: Take 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 RIVASA 81 MG EC every day as directed by your doctor. Do not take more tablets than your doctor recommends. Your doctor may tell you to take RIVASA 81 MG EC with other medications; he or she may also tell you to eat special foods, exercise or take other steps to safeguard your health.

For daily therapy RIVASA 81 MG EC, tablets should be swallowed whole for the medicine to work properly. RIVASA 81 MG EC tablets have a special coating, enteric coating, which allows the tablets to pass undissolved through the stomach and on into the intestine. By dissolving in the intestine rather than the stomach, the risk of stomach upset is reduced in those with a sensitive stomach. Therefore, to maintain this protection, the tablets should not be crushed or broken.

Can I Continue to Take RIVASA 81 MG EC for Relief of Headache, Fever or Arthritis Pain?
RIVASA 81 MG EC is specially designed to reduce your risk of dying during a heart attack, to help prevent a first heart attack in those who are at increased risk and to help prevent a second heart attack or stroke. 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 ASA 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

In case of overdose call a doctor or 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.

PART III: CONSUMER INFORMATION ONLY

Usual Dose

DIRECTIONS (Adults ≥ 18 years): For doctor supervised long-term preventative therapy: Take 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 RIVASA 81 MG EC every day as directed by your doctor. Do not take more tablets than your doctor recommends. Your doctor may tell you to take RIVASA 81 MG EC with other medications; he or she may also tell you to eat special foods, exercise or take other steps to safeguard your health. RIVASA 81 MG EC tablets have a special coating, 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 RIVASA 81 MG EC for relief of headache, fever or arthritis pain?
RIVASA 81 MG EC is specially designed for doctor supervised long-term preventative 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 acetylsalicylic acid 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

In case of overdose call a doctor or 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

PART III: CONSUMER INFORMATION ONLY PROVIDED BY HEALTH CARE PROFESSIONALS

Like all medicines, RIVASA 81 MG EC may occasionally produce unwanted side effects. You should call your doctor if you experience any of the following: nausea, vomiting; stomach irritation, or pain; if you notice that you are ‘bruising’ more easily than you were before starting a daily dose of RIVASA 81 MG EC. Regular daily use of alcohol while on RIVASA 81 MG 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 RIVASA 81 MG 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.

PART III: CONSUMER INFORMATION ONLY

Like all medicines, RIVASA 81 MG 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 RIVASA 81 MG EC. Regular daily use of alcohol while on RIVASA 81 MG 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 RIVASA 81 MG 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

Keep out of reach of children.

Store at room temperature, 15-30°C.

Reporting side effects

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.

More information

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor:

Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Canada
J7C 3V4
1-800-363-7988
www.labriva.com

This leaflet was prepared by Laboratoire Riva Inc.

Last Revised: March 6, 2020

Date modified: