Ecotrin Side Effects

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Answer the side-effect intent for ecotrin without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Ecotrin?

Ecotrin contains the active ingredient Aspirin.

• Active ingredient — Aspirin
• Registration number — 29/2.7/0767
• Registration holder — Acino Pharma (Pty) Ltd

It is approved for:

• heart attacks
• strokes
• cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain). ECOTRIN is also used in the treatment of acute heart attack and to prevent the formation of blood clots after certain types of heart surgery in order to widen or to unblock the blood vessels

Common side effects of Ecotrin

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing
• rash or itching
• fainting
• These are all very serious side effects. If you have them, you may have had a serious reaction to ECOTRIN. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains (this could be erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome)
• unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Common side effects (may affect up to 1 in 10 people):
• feeling or being sick, diarrhoea
• indigestion
• increased tendency for bleeding. Uncommon side effects (may affect up to 1 in 100 people):
• hives
• runny nose
• breathing difficulty. Rare side effects (may affect up to 1 in 1,000 people):
• severe bleeding in the stomach or intestines, brain haemorrhage; altered number of blood cells
• cramps in the lower respiratory tract, asthma attack
• inflammation in the blood vessels
• bruising with purple spots (cutaneous bleeding)
• Reye’s syndrome (a very rare disease in children which affects the brain and liver
• abnormal heavy or prolonged menstrual periods. Not known (frequency cannot be estimated from the available data)
• ringing in your ears (tinnitus) or reduced hearing ability
• headache
• vertigo
• ulcers in stomach or small intestine and perforation
• prolonged bleeding time
• impaired kidney function, acute renal failure
• salt or water retention which may cause swelling of hands, feet, legs, stomach, breasts or face
• impaired liver function, increased liver enzymes
• high level of uric acid in the blood or low levels of sugar in the blood
• severe skin rash with a fever, swollen or enlarged lymph nodes and/or facial swelling

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to aspirin (acetylsalicylic acid) or any of the other ingredients of ECOTRIN (listed in section 6)
• If you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs)
• If you have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs
• If you currently have or have ever had an ulcer in your stomach or small intestine or any other type of bleeding like a stroke
• If you have ever had the problem of your blood not clotting properly
• If you have severe liver or kidney problems
• If you suffer from gout
• If you have severe heart problems which can cause shortness of breath and ankle swelling
• If you are in your first or last three months of pregnancy
• If you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses higher than 15 mg per week

Use with care, and tell your doctor, if

• If you have trouble with your kidneys, liver or heart
• If you have or have ever had problems with your stomach or small intestine
• If you have uncontrolled high blood pressure
• If you are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; aspirin may induce an asthma attack
• If you have ever had gout
• If you have heavy menstrual periods
• If you suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)
• If you have had a serious skin reaction to any medicine, accompanied by a fever, swollen or enlarged lymph nodes and/or facial swelling. You must immediately seek medical advice, if your symptoms get worse or if you experience severe or unexpected side effects e.g. unusual bleeding symptoms, serious skin reactions or any other sign of serious allergy. Inform your doctor if you are planning to have an operation (even a minor one, such as tooth extraction) since aspirin is blood-thinning there may be an increased risk of bleeding. Aspirin may cause Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease which affects the brain and liver and can be life threatening. For this reason, ECOTRIN should not be given to children aged under 18 years, unless on the advice of a doctor. You should take care not to become dehydrated (you may feel thirsty with a dry mouth) since the use of aspirin at the same time may result in deterioration of kidney function. Children and adolescents Aspirin should not be administered to children and adolescents younger than 18 years, unless prescribed by a doctor

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• ECOTRIN should not be taken during pregnancy unless advised by a doctor
• You should not take ECOTRIN if you are in the first or last 3 months of pregnancy, unless you are advised to do so by your doctor
• Regular or high doses of ECOTRIN during late pregnancy can cause serious complications in the mother or baby
• You should not take ECOTRIN during breastfeeding unless advised by your doctor

Interactions and medicines to check

The approved leaflet names these interactions.

• thinning of the blood/prevention of clots (e.g. warfarin, heparin, clopidogrel, alteplase)
• rejection of organ after transplantation (ciclosporin, tacrolimus)
• high blood pressure (e.g. diuretics and ACE-inhibitors)
• regulation of the heart beat (digoxin)
• manic-depressive illness (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids)
• gout (e.g. probenecid)
• epilepsy (e.g. valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week)
• diabetes (e.g. glibenclamide, insulin)
• depression (selective serotonin re-uptake inhibitors (SSRIs) such as sertraline or paroxetine)
• use as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation of the intestines (corticosteroids)
• antacids (indigestion medicine)
• metamizole (substance to decrease pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells sticking together and forming a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardio protection. ECOTRIN with food, drink and alcohol Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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