Ecotrin 81 mg Tablets

ECOTRIN contains aspirin (acetylsalicylic acid), which in low doses belongs to a group of medicines called anti-platelet agents.

ECOTRIN is taken to reduce the risk of blood clots forming and thereby prevent further:

• 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.

Do not take ECOTRIN:

• 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 (see section “Pregnancy and breast-feeding”).

Warnings and precautions

Talk to your doctor or pharmacist before taking ECOTRIN:

• 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 (see section 4 “Possible side effects”).

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.

Do not share medicines prescribed for you with any other person.

Always take ECOTRIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual adult dose is:

Adults:

One to three tablets as directed by your doctor to be taken every day, preferably at the same time each day.

Your doctor will tell you how long your treatment with ECOTRIN will last.

If you have the impression that the effect of ECOTRIN is too strong or too weak, tell your doctor or pharmacist.

If you take more ECOTRIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Show any leftover medicines or the empty packet to the doctor.

Symptoms of overdose may include ringing in ears, hearing problems, headache, dizziness, confusion, nausea, vomiting and abdominal pain. A large overdose can lead to more rapid breathing than normal (hyperventilation), fever, excess sweating, restlessness, seizures, hallucinations, low blood sugar, coma and shock.

If you forget to take ECOTRIN

If you miss a dose, wait until it is time for your next dose, then go on as normal. Do not take a double dose to make up for forgotten individual doses.

ECOTRIN can have side effects. Not all side effects reported for ECOTRIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ECOTRIN, please consult your health care provider for advice.

If any of the following happens, stop taking / using ECOTRIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• 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 (see section 2 “Children and adolescents”),
• 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.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ECOTRIN.

Store all medicines out of reach of children.

• Store at or below 25 °C in a dry place.

Do not use after the expiry date stated on the label or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).