Ecotrin

Aspirin comes as a regular tablet, a delayed-release tablet, a chewable tablet, a powder, a gum, and a rectal suppository.

It's typically taken every four to six hours to treat fever and pain. It's usually taken once a day to lower the risk of a heart attack or stroke. Typical dosages range from 50 milligrams (mg) to 6,000 mg, daily.

You should swallow the delayed-release tablets with a full glass of water. These tablets don't work immediately after they are taken, so you shouldn't use them for quick pain relief.

The chewable tablets can be crushed, chewed, or swallowed whole. You should drink a full glass of water right after taking this form of the medication.

Aspirin Overdose

Symptoms of an aspirin overdose include stomach pain, nausea and vomiting, and ringing in the ears (tinnitus).

If you suspect an overdose, contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Aspirin

If you miss a dose of aspirin, take it as soon as you remember.

However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule. Don't double up on doses to make up for a missed one.

Ecotrin is part of the drug class:

• Salicylic acid and derivatives

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or an NSAID. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, naproxen, or an NSAID.

Ask your doctor before using aspirin if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use aspirin if you are also using any of the following drugs:

• a blood thinner (warfarin, Coumadin, Jantoven), or other medication used to prevent blood clots; or

• other salicylates such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

This list is not complete. Other drugs may interact with aspirin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

• Changes in behavior
• drowsiness or tiredness (severe)
• fast or deep breathing

• Any loss of hearing
• bloody urine
• confusion
• convulsions (seizures)
• diarrhea (severe or continuing)
• difficulty in swallowing
• dizziness, lightheadedness, or feeling faint (severe)
• drowsiness (severe)
• excitement or nervousness (severe)
• fast or deep breathing
• flushing, redness, or other change in skin color
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased sweating
• increased thirst
• nausea or vomiting (severe or continuing)
• shortness of breath, troubled breathing, tightness in chest, or wheezing
• stomach pain (severe or continuing)
• swelling of eyelids, face, or lips
• unexplained fever
• uncontrollable flapping movements of the hands (especially in elderly patients)
• vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal or stomach pain, cramping, or burning (severe)
• bloody or black, tarry stools
• headache (severe or continuing)
• ringing or buzzing in ears (continuing)
• skin rash, hives, or itching
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps, pain, or discomfort (mild to moderate)
• heartburn or indigestion
• nausea or vomiting

• Trouble in sleeping, nervousness, or jitters (only for products containing caffeine)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

• If you take Ecotrin on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Feeling confused.
• Very bad headache.
• Ringing in ears.
• Hearing loss.
• Very bad belly pain.
• Feeling agitated.
• Seizures.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Ecotrin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ecotrin (aspirin modified-release tablets). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Ecotrin.

Review Date: October 4, 2017

Applies to aspirin: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, oral gum, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release, rectal suppository

Gastrointestinal

Common (1% to 10%): Dyspepsia,
Frequency not reported: GI bleeding, ulceration, perforation, nausea, vomiting, pancreatitis, gastric irritation, GI erosions, gastritis, melena, hematemesis, gingival bleeding[Ref]

Renal

Frequency not reported: Interstitial nephritis, papillary necrosis, renal insufficiency and failure[Ref]

Hematologic

Common (1% to 10%): Increased bleeding tendencies
Rare (0.01% to 0.1%): Aplastic anemia agranulocytosis, thrombocytopenia
Frequency not reported: Prolongation of prothrombin time, disseminated intravascular coagulation, coagulopathy, antepartum and postpartum bleeding, anemia[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions including shock
Frequency not reported: Urticaria, angioedema, skin rashes[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Steven-Johnson syndrome, Lyell's syndrome, erythema nodosum, erythema multiforme
Frequency not reported: Purpura, hives[Ref]

Hepatic

Frequency not reported: Transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, hepatic insufficiency[Ref]

Metabolic

Frequency not reported: Thirst, dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis, hypoglycemia, hyperglycemia, hyperuricemia, salt and water retention[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hemorrhagic vasculitis
Frequency not reported: Dysrhythmias, hypotension, tachycardia[Ref]

Nervous system

Frequency not reported: Cerebral edema, coma headache, subdural or intracranial hemorrhage, seizures, lethargy, dizziness[Ref]

Other

Frequency not reported: Fever, hypothermia, hearing loss, tinnitus (at high doses), hearing disturbances[Ref]

Musculoskeletal

Frequency not reported: Rhabdomyolysis[Ref]

Respiratory

Frequency not reported: Hyperpnea, pulmonary edema, tachypnea, epistaxis, dyspnea, bronchospasm, asthma[Ref]

General

The more commonly experienced adverse effects include indigestion, dyspepsia, bleeding, and bruising.[Ref]

Genitourinary

Rare (0.01% to 0.1%): Menorrhagia
Frequency not reported: Proteinuria[Ref]

Psychiatric

Frequency not reported: Agitation, confusion[Ref]

Some side effects of Ecotrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.