Aspirin tablet 75 mg – patient leaflet, side effects, dosage

1 What Aspirin Tablets are and what they are used for

Aspirin Tablets contain acetylsalicylic acid, which in low doses belongs to a group of medicines called anti-platelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are involved in thrombosis. When a blood clot occurs in an artery it stops the blood flowing and cuts off the oxygen supply. When this happens in the heart it can cause a heart attack or angina; in the brain it can cause a stroke.

Aspirin Tablets are 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).

Aspirin Tablets are 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.

2 What you need to know before you take Aspirin Tablets

Do not take Aspirin Tablets if you

• are allergic to acetylsalicylic acid or any of the ingredients of this medicine (listed in section 6)
• are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain
• 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
• currently have or have ever had an ulcer in your stomach or small intestine or any other type of bleeding like a stroke
• have ever had the problem of your blood not clotting properly
• have severe liver or kidney problems
• suffer from gout
• have severe heart problems which can cause shortness of breath and ankle swelling
• are in your last 3 months of pregnancy; you must not use higher doses than 100mg per day (see section “Pregnancy and breast-feeding”)
• are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses higher than 15mg per week.

Warnings and precautions

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

• have trouble with your kidneys, liver or heart
• have or have ever had problems with your stomach or small intestine
• have uncontrolled high blood pressure
• are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack
• have ever had gout
• have heavy menstrual periods
• suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

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 acetylsalicylic acid is

blood-thinning there may be an increased risk of bleeding.

Acetylsalicylic acid 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, Aspirin Tablets should not be given to children aged under 16 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 acetylsalicylic acid 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.

Other medicines and Aspirin Tablets

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

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as some other medicines for:

• 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 15mg 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 cardioprotection.

Aspirin Tablets with alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

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.

Acetylsalicylic acid should not be taken during pregnancy unless advised by a doctor.

You should not take Aspirin Tablets if you are in the last 3 months of pregnancy,

unless you are advised to do so by your doctor and then the daily dose should not exceed 100mg (see section “Do not take Aspirin Tablets”). Regular or high doses of this medicinal product during late

pregnancy can cause serious complications in the mother or baby.

You should not take acetylsalicylic acid during breast-feeding unless advised by your doctor.

Driving and using machines

Aspirin Tablets should not affect your ability to drive and use machines.

3 How to take Aspirin Tablets

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

Prevention of heart attacks, strokes or cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain):

• The recommended dose is 75-150mg once daily.

Prevention of the formation of blood clots after certain types of heart surgery:

• The recommended dose is 75-300mg once daily.

Acute heart attack:

• The recommended dose is 150-300mg, taken as soon as possible after onset of symptoms.

Elderly

As for adults. In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Acetylsalicylic acid should not be administered to children and adolescents younger than 16 years, unless prescribed by a doctor (see section 2 “Warnings and precautions”).

Method of administration

The tablets should be swallowed with sufficient fluid (1/2 glass of water).

If you take more Aspirin 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 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

Front Side

Package leaflet: Information for the user

Aspirin 75mg Tablets

acetylsalicylic acid

(6007350) Date : 02/03/2021, 04/03/2021 (1), 09/03/2021, 11/03/2021 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 Aspirin Tablets

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 a forgotten tablet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

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

If you notice any of the following serious side effects, stop taking Aspirin Tablets and contact a doctor immediately:

• Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction).
• 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.

Other side effects include:

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 noses
• 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.

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 Website: 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 store above 25°C.

Do not take this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

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 acetylsalicylic acid. Each tablet contains 75mg of acetylsalicylic acid.

The other ingredients are: microcrystalline cellulose, maize starch, colloidal anhydrous silica, stearic acid.

What Aspirin Tablets look like and contents of the pack

Aspirin 75mg Tablets are oval, white, biconvex tablets 9.0 x 5.0mm, debossed with KM on one side and plain on the other side.

Pack sizes: Blister packs: 28 tablets.

Marketing Authorisation Holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturer

Accord-UK Limited, Whiddon Valley, Barnstaple, EX32 8NS, United Kingdom

Accord Healthcare Limited, Ground Floor, Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, United Kingdom

This leaf let was last revised in March 2021

If you would like a leaf let with larger text, please contact 01271 385257.

Back Side

INP113 10 5026 0 6007350

(6007350) Date : 02/03/2021, 04/03/2021 (1), 09/03/2021, 11/03/2021