Entrophen: Uses, Side Effects and Dosage

What is ENTROPHEN used for?

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

How does ENTROPHEN work?

ENTROPHEN 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.

USE DURING A HEART ATTACK

If you think you are having a heart attack, call 911 immediately then, chew and swallow two ENTROPHEN tablets. It is important to chew 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 ENTROPHEN. Taking ENTROPHEN, 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 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

Serious Warnings and Precautions

• Risk in Pregnancy: Talk to your doctor if you are trying to conceive, in your first or second trimester of pregnancy or if breastfeeding.

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.

What are the ingredients in ENTROPHEN?

Medicinal ingredients: acetylsalicylic acid (ASA)

Non-medicinal ingredients: 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.

ENTROPHEN comes in the following dosage forms: Delayed release tablets 81mg

Do not use ENTROPHEN if you:

• are taking other products containing ASA, salicylates or NSAIDs / pain relievers / fever reducers
• are allergic to ASA, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs)/pain relievers/fever reducers or other ingredients in the product. Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
• 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 15mg/week or more
• are in the last trimester of pregnancy because it may cause problems in the unborn child or complications during delivery

STOMACH BLEEDING WARNING: contains a NSAID which may cause severe stomach bleeding. The symptoms are fainting, vomit blood, have bloody or black stools, have stomach pain that does not get better.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ENTROPHEN. Talk about any health conditions or problems you may have, including if you have/are:

• asthma, high blood pressure, heart disease, gout or other serious conditions
• age 60 years or older
• stomach problems such as heartburn
• impaired liver/kidney or impaired cardiovascular circulation (renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events)

• having 3 or more alcoholic drinks per day

• history of blood clotting defects
• severe anemia
• severe glucose-6-phosphate dehydrogenase (G6PD) deficiency
• trying to conceive or breast-feeding
• will be having surgery in five to seven days

Other warnings you should know about:

• The use of NSAIDs, like ENTROPHEN, in the second trimester of pregnancy should be restricted to the lowest dose necessary for shortest possible duration.
• At 20 weeks or later in pregnancy, your use of ENTROPHEN may need to be monitored by a doctor due to the rare risk of narrowing of a blood vessel in the heart or kidney problems in the unborn baby, which may result in decreased amniotic fluid volume and other complications.

• 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.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ENTROPHEN:

• blood thinners
• acetaminophen
• anticonvulsants
• anti-diabetic/arthritis/gout medicines
• digoxin
• glucocorticoids
• methotrexate
• selective serotonin re-uptake inhibitors (a type of antidepressants)
• diuretics
• ACE inhibitors (medication for high blood pressure)
• Do not use NSAIDs (i.e. ibuprofen or naproxen) if you are taking ENTROPHEN for preventive therapy without talking to a doctor or pharmacist, as NSAIDs may interfere with the preventive benefits of ENTROPHEN.

How to take ENTROPHEN:

• For doctor supervised long-term preventive therapy 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 ENTROPHEN every day as directed by your doctor. Do not take more tablets than your doctor recommends. Your doctor may tell you to take ENTROPHEN with other medications; he or she may also tell you to eat special foods, exercise or take other steps to safeguard your health. ENTROPHEN 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.

Can I Continue to Take ENTROPHEN for Relief of Headache, Fever or Arthritis Pain?

• ENTROPHEN 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 ENTROPHEN 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.

Usual dose:

Adults ≥ 18 years: For doctor supervised long-term preventive therapy: 1 to 4 tablets daily, depending on your doctor’s instructions. During a heart attack: Call 911, then, chew 2 tablets.

Overdose:

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.

What are possible side effects from using ENTROPHEN?

Like all medicines, ENTROPHEN 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 ENTROPHEN. Regular daily use of alcohol while on ENTROPHEN daily therapy may increase your risk of developing gastrointestinal bleeding.

If you think you, or a person you are caring for, have taken too much ENTROPHEN contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

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 (canada.ca/drug-device-reporting) 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.

Storage:

Store between 15-30°C. Keep out of reach and sight of children.

If you want more information about ENTROPHEN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html)or the manufacturer’s website www.pendopharm.com, or by calling 1-888-550-6060.

Date of Authorization: February 25, 2025

ENTROPHEN® is a registered trademark owned by Norwell Consumer Healthcare Inc.