ASPIRIN ENTERIC COATED TABLETS 75MG – patient leaflet, side effects, dosage

1. WHAT ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine contains aspirin. Aspirin belongs to a group of medicines called anti-platelet agents that help prevent your blood cells sticking together and forming a blood clot.

Aspirin Enteric Coated Tablets 75mg are used to prevent further heart attacks and stroke if you have previously suffered from these conditions, following bypass surgery and to control unstable angina (a type of chest pain).

As the special coating on the tablets delays the release of the active ingredient, these tablets are not suitable for short term pain relief.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN TABLETS

Do not take Aspirin Tablets if you:

• Are under 16 years of age. There is a possible

  association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal.

  For this reason, aspirin should not be given to children

  under 16 years of age unless on advice from the doctor. · Are allergic to aspirin, other non-steroidal anti-

  inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6). NSAIDs are often used for arthritis or rheumatism and pain. · Have or have ever had a stomach or intestinal ulcer · Have or have ever had a bleed in your stomach or

  intestines (you may have been sick and it contained blood or dark particles that looked like coffee grounds and/or passed blood in your stools or passed black tarry stools) · Have a blood clotting disorder (e.g. haemophilia or

  thrombocytopenia) or are taking medicines to thin your blood

• Have severe kidney or liver problems
• Have or have had gout

• Are taking methotrexate (a cancer drug which can also be

  used to treat psoriasis) at doses higher than 15mg per week.

• 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

• Have had other types of bleeding like a stroke · Are in your last 3 months of pregnancy; you must not use

  higher doses than 100mg per day (see section “Pregnancy and breast-feeding”)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aspirin Tablets if:

• You are asthmatic, have hay fever, nasal polyps or other

  chronic respiratory diseases; aspirin may induce asthma attack

• You suffer from liver or kidney diseases. This medicine

  should be avoided if the conditions are severe · You are suffering from dehydration

• You are elderly

• You suffer from low glucose-6-phosphate dehydrogenase

  (a type of glucose deficiency)

• You are diabetic, as aspirin may alter your insulin

  requirements

• You have high blood pressure (hypertension), your doctor

  will want to monitor you while taking this medicine · You have heavy menstrual periods.

• You have or have ever had problems with your stomach

  or small intestine

• You have ever had gout

You should let your doctor know you are taking aspirin, if you are going to have surgery (even minor surgery such as tooth extraction) or any blood tests. If you get any unusual bleeding symptoms, talk to your doctor.

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 "Possible side effects").

When taking acetylsalicylic acid, serious allergic reactions which may include chest pain and even heart attack (Kounis syndrome) have been reported (see section 4). Seek medical care immediately when you notice chest pain with allergic reactions (such as skin rashes, shortness of breath).

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.

This medicinal product is not suitable as a pain killer or fever reducer.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist.

Children

This medicine should not be given to children aged under 16 years unless advised by a doctor. There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal. For this reason, aspirin should not be given to children under 16 years of age unless on advice from the doctor.

Other medicines and Aspirin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Medicines to thin your blood and prevent blood clots e.g.

  warfarin, heparin, phenindione and clopidogrel · Other non-steroidal anti-inflammatory drugs (NSAIDs) to

  treat pain, reduce swollen joints, muscles and ligaments e.g. ibuprofen, diclofenac sodium

• 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).

• Medicines used to treat glaucoma e.g. acetazolamide · Medicines used to treat indigestion e.g. antacids · A medicine called mifepristone which is used as an

  emergency contraceptive

• A medicine called methotrexate (for cancer, skin

  problems, rheumatic problems, Crohn's disease) · Some anti-bacterial medicines called sulphonamides · A medicine called metoclopramide which is used to treat

  sickness, digestive conditions and certain conditions that can occur after surgery

• Medicines used to treat high blood pressure such as

  diuretics e.g. spironalactone and ACE inhibitors e.g. captopril, ramipril

• Medicines used to treat epilepsy e.g. phenytoin and

  sodium valproate

• Medicines used to treat gout e.g. probenecid and

  sulfinpyrazone

• Medicines used to treat diabetes e.g. insulin, metformin,

  glibenclamide, glipizide (sulphonylureas)

• A medicine called zafirlukst used to treat asthma · Alcohol enhances some of the effects of aspirin · Medicines for depression (selective serotonin re-uptake

  inhibitors (SSRis) such as sertraline or paroxetine) · Ciclosporin or tacrolimus (given after transplant surgery,

  or psoriasis or rheumatism)

• Lithium (for severe mental problems)

• Medicines for heart problems (e.g. digoxin) · 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 cardioprotection. · Water tablets (diuretics e.g. spironolactone and

  acetazolamide)

This medicine may interfere with thyroid function tests. Inform your doctor that you are taking this medicine if you need to have a thyroid function test.

Before taking aspirin, you should inform a healthcare professional about the medicines you are taking. If you are using aspirin regularly you should seek advice before taking any other medicine (including medicine you may have bought).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Pregnancy - last trimester

Do not take acetylsalicylic acid higher than 100 mg per day if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected.

If you take acetylsalicylic acid at low doses (up to and including 100 mg per day), you need strict obstetric monitoring as advised by your doctor.

Pregnancy – first and second trimester

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless absolutely necessary and

advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, acetylsalicylic acid can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breast-feeding

Breast-feeding women should not take Aspirin Tablets unless advised by their doctor.

Driving and using machines

These tablets are not known to cause any side effects that will affect your ability to drive or operate machinery. However, if you think you are affected do not drive or operate machinery.

Taking Aspirin Tablets with alcohol

You should not drink alcohol while taking this medicine. Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Aspirin Tablets contain lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE ASPIRIN TABLETS

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Adults, the elderly and children over 16 years of age:

The usual adult dose for long term use is one to two tablets (75mg - 150mg) once daily.

Sometimes, a higher dose may be needed, especially in the short term, and up to 4 tablets (300mg) a day may be used on the advice of a doctor.

Caution is required in elderly patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Take the tablets whole with a drink of water. Do not crush or chew the tablets.

DO NOT take indigestion remedies just before or straight after taking your medicine.

Children under 16 years of age:

Aspirin Tablets should not be taken by children under 16 years of age unless specifically advised by a doctor.

DO NOT EXCEED THE STATED DOSE

If you take more tablets than you should

If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or contact immediately the nearest casualty department. Show any left-over 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 your tablets

If you miss a dose, wait until it is time for your next dose, then go on as normal. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of these occur STOP taking the medicine and contact a doctor immediately.

Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the lips, face or body, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and dizziness, particularly when standing up, fainting or difficulties swallowing, shock or an unusual runny nose. · If you are sick and it contains blood or dark particles that look like coffee grounds

• If you pass blood in your urine, stools or pass black tarry

  stools

• If you have stomach problems including pain, indigestion

  or heartburn

• Bleeding on the brain which may cause a severe

  headache or stroke

• If you have reddening of the skin with blisters or peeling,

  high fever, or joint pains. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome

• If you are coughing up blood (haemoptysis) · If you have fatigue and shortness of breath these could be

  signs of a blood disorder such as anaemia.

These other effects are less serious. If they bother you, talk to a pharmacist:

Other side effects

Common: may affect up to 1 in 10 people

• Indigestion
• Increased tendancy for bleeding

Uncommon: may affect up to 1 in 100 people

• Hives

  • Runny nose
  • Breathing difficulty

Rare: may affect up to 1 in 1,000 people

• Severe bleeding in the stomach or intestines, brain haemorrhage; altered number of blood cells
• Inflammation of the stomach lining
• Nausea and vomiting
• Cramps in the lower respiratory tract, asthma attack
• Inflammation in the blood vessels
• Abnormal heavy or prolonged menstrual periods · Bruising with purple spots (cutaneous bleeding)

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 · Diarrhoea
• Increased bleeding time, e.g. when you have a nose bleed, bleeding gums (if bleeding is severe or lasts for a long time, talk to your doctor straight away) · Impaired kidney function
• Salt and water retention
• Impaired liver function
• High level of uric acid in the blood
• Anaemia (a reduction in the number of red blood cells which can make you look pale and feel tired) may occur due to bleeding
• Kidney stones (sharp stabbing pains in the stomach or back, with blood in the urine)
• Acute myocardial ischemia (painful heart condition caused by lack of blood flow to the heart) with or without myocardial infarction (heart attack) occurring as part of an allergic reaction (Kounis syndrome).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ASPIRIN TABLETS

Keep this medicine out of the sight and reach of children.

Do not use Aspirin Tablets after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. If you have any medicines which are out of date, return them to your pharmacist for disposal. Store below 25°C in a dry place.

Do not use Aspirin Tablets if you notice any visible signs of deterioration, such as chipped or broken tablets. Take them to your pharmacist for advice.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aspirin Tablets contain

The active substance is aspirin. Each tablet contains 75mg aspirin.

The other ingredients are lactose (see section 2), starch, sucrose (see section 2), talc, eudragit L100-55, polyethylene glycol, hydroxypropyl methylcellulose and titanium dioxide (E171).

What Aspirin Tablets looks like and the contents of the pack

Aspirin Tablets are white, enteric coated, biconvex tablets with the following markings: 75 (on one side), L (on other side). Tablet diameter: 6.5-7.0mm

Thickness: 4.1-4.6mm.

Aspirin Tablets are available in blister packs of 28 and 56 or pots of 100 tablets.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside way, Dartford, DA1 5BS, UK

Manufacturer

Valpharma SPA

Via Ranco 112, Serravalle

SM 47889, San Marino

This leaflet was last revised in August 2026.

ENV02