Patient leaflet - ASPIRIN 300 MG DISPERSIBLE TABLETS
Aspirin 300mg Dispersible Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
- The full name of this medicine is Aspirin 300mg Dispersible Tablets but within this leaflet it will be referred to as Aspirin Dispersible tablets.
What is in this leaflet
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1. What Aspirin Dispersible tablets are and what they are used for
2. What you need to know before you take Aspirin Dispersible tablets
3. How to take Aspirin Dispersible tablets
4. Possible side effects
5. How to store Aspirin Dispersible tablets
6. Contents of the pack and other information
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1. What Aspirin Dispersible tablets are and what they are used for
Dispersible Aspirin tablets belong to a group of medicines which have analgesic (pain relieving), antiinflammatory (inflammation reducing) and anti-pyretic (temperature reducing) properties.
These tablets may be used for the relief of:
- headache, toothache, migraine, neuralgia (nerve pain), sore throat or period pains.
- symptoms of influenza, feverishness, rheumatic pains, sciatica (nerve pain of the leg/back), lumbago (lower back pain), fibrositis (muscular rheumatism), muscular aches and pains.
2. what you need to know before you take aspirin dispersible tablets
Do not take
- if you are allergic to to acetylsalicylic acid (Aspirin), salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) or any other ingredients of this medicine (listed in section 6). You may have developed difficulty breathing, a runny nose, itchy skin or swelling after taking aspirin or a NSAID previously (see section 6)
- have a stomach ulcer or a history of ulcers or indigestion
- have bleeding in the stomach and/or intestines, or other kinds of bleeding such as bleeding from the blood vessels of the brain
- have nasal polyps associated with asthma
- have haemophilia or other blood clotting disorder or are taking medicines to thin the blood.
- have severe liver, kidney or heart failure
- are in the third trimester of pregnancy
- are taking methotrexate (more than 15mg a week)
- are a child under 16 years old.
Important warning:
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 aged under 16 years, unless on the advice of a doctor.
Check with your doctor, pharmacist or nurse
- have asthma, chronic respiratory disease or allergies
- experience heavy periods
- have hypertension (high blood pressure)
- have a history of stomach ulcers or excessive bleeding
- have heart, liver or kidney problems or gout
- have severe skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome). Treatment should be stopped immediately.
- have an overactive thyroid gland
- have dehydration
- have anaemia or suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD) this can cause episodes of anaemia after eating certain foods such as fava beans (favism)
- have systemic lupus erythematosus (SLE) or other connective tissue disease.
- are elderly
- have had any disorders affecting blood vessels in the brain
- have received a varicella (chickenpox) vaccination within the last 6 weeks
Other important warnings:
- taking painkillers for headaches too often or for too long can make them worse.
Taking other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
- medicines to prevent blood clotting such as warfarin, dipyridamole, clopidogrel and heparin
- deferasirox (for patients with excessive iron levels following blood transfusion)
- digoxin (for heart problems)
- metoclopramide or domperidone (to prevent sickness)
- diuretics “water tablets” acetazolamide (to treat high blood pressure)
- medicines which make your urine more alkaline such as antacids, citrates
- probenecid (to treat gout)
- methotrexate (to treat some cancers, psoriasis and rheumatic disease)
- medicines to treat diabetes
- phenytoin or sodium valproate (to treat epilepsy)
- corticosteroids, tacrolimus and ciclosporin (to suppress the immune system)
- mifepristone (to induce abortion)
- other non-steroidal anti-inflammatory drugs – NSAIDs used for pain (eg ibuprofen or naproxen)
- medicines which can cause hearing problems (vancomycin)
- medicines to treat high blood pressure (ACE inhibitors, Calcium channel blockers)
- medicines to treat depression such as lithium or SSRIs (e.g. paroxetine)
- varicella (chickenpox) vaccine. Aspirin should be avoid for 6 weeks after vaccination
- herbal medicines containing ginkgo biloba.
Pregnancy and breast-feeding
Avoid taking Aspirin Dispersible tablets during pregnancy especially in the last 3 months of pregnancy or whilst breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.
Aspirin Dispersible tablets contain lactose If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.
Aspirin Dispersible tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Surgery and tests
If you need to have an operation including having your teeth removed or blood and urine tests, tell your doctor or dentist you are taking this medicine.
3. how to take aspirin dispersible tablets
Always take Aspirin Dispersible tablets exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Avoid alcohol whilst taking this medicine.
Disperse the tablet(s) in a glass of water and drink.
Doses:
Adults, including the elderly : 1 or 2 tablets every 4 hours as required. No more than 8 tablets in any 24 hour period.
Children under 16 years old : Not recommended.
If you take more Aspirin Dispersible tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include ringing in the ears, hearing problems, headache, dizziness, confusion, feeling or being sick, stomach pain, high temperature, dehydration, sweating, feeling restless, fits, hallucinations, low blood sugar, severe chest pain, difficulty breathing, unconsciousness.
If you forget to take Aspirin Dispersible tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take more than one dose in any 4 hour period.
4. possible side effects
Like all medicines, Aspirin Dispersible tablets can cause side effects, although not everybody gets them.
Stop taking this medicine and contact a doctor immediately if you have any of the following:
- Severe allergic reactions (blistered skin, swelling of the face, lips, throat or tongue, difficulty breathing, shock)
- itchy skin rash caused by allergic reaction- pale or red irregular raised patches with severe itching (hives/urticaria)
- Severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Lyells syndrome) or severe rash, blisters, or red patches on the skin (Stevens-Johnson syndrome), irregular red patches on the skin of the hands and arms (erythema multiforme)
- Bleeding on the brain (sudden severe headache, fit, changes in vision, speaking, understanding or coordination, weakness in an arm or leg
- Stomach ulcers or bleeding which can be severe (you may develop bloody or black tarry stools, severe stomach pain and vomit blood), stomach irritation (mild stomach pain, heartburn and feeling or being sick). Fatalities have occurred.
Tell your doctor, pharmacist or nurse if you notice any of the following effects or any effects not listed:
Common: may affect up to 1 in 10 people
- increased bleeding tendencies,
- indigestion
Uncommon: may affect up to 1 in 100 people
- runny nose
Rare: may affect up to 1 in 1,000 people
- anaemia, changes in numbers and types of blood cells as seen in blood tests
- difficulty breathing or wheezing, asthma attacks.
- heavy periods
- feeling or being sick
- disorder characterised by blood spots, bruising and discolouring to skin (hemorrhagic vasculitis or purpura)
- red tender lumps developing under the skin (Erythema nodosum)
Not known: frequency cannot be estimated from the available data
- nosebleeds, bleeding of the gums, which may be prolonged. (Please advise doctor or dentist if surgery is planned)
- reduction in red blood cells which cause pale yellow skin and weakness or breathlessness
- low levels of protein in the blood (can be caused by nephritic syndrome)
- reduced number of red and white blood cells, increased blood enzyme levels (as seen in blood test).
- Gout (high levels of uric acid in the blood)- causing crystals to deposit in joints of hands/feet causing pain (Hyperuricemia)
- headache
- feeling of dizziness or spinning (vertigo)
- hearing loss, Ringing or buzzing in the ears
- swelling of blood vessels resulting from loss of blood. (characterised by rash, fever, sweating, fatigue, weight loss) worsening of asthma
- liver problems including hepatitis (inflammation of the liver causing yellowing of the skin or eyes or tiredness, pain in abdomen, joint or muscles)
- reduced kidney function
- Salicylism – if you take large doses for a long time you may develop symptoms of salicylism, these include: dizziness, ringing or buzzing in the ear, deafness, sweating, feeling or being sick, headache and confusion.
Additional side effects in children
Aspirin may be associated with the development of a condition called Reye’s Syndrome, which causes severe liver and brain damage.
Gastrointestinal system and inflammation of the liver. Deaths have occurred.
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: 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
Keep out of the sight and reach of children.
Store the tablets below 25°C in a dry place.
Do not use Aspirin Dispersible tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6. Further information
What Aspirin Dispersible tablets contain
- The active substance (the ingredient that makes the tablets work) is 300mg aspirin (also known as acetylsalicylic acid).
- The other ingredients are citric acid, lactose, maize starch, saccharin sodium, calcium carbonate (E170).
What Aspirin Dispersible tablets look like and contents of the pack
Dispersible Aspirin are circular, white, uncoated tablets.
Pack sizes are 100 tablets.
Marketing Authorisation Holder and Manufacturer
Accord, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in October 2021
PARTICULARS TO APPEAR ON THE OUTER PACKAGING – LABEL LEAFLET
Label Leaflet Front Cover / Base Label
1. NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Dispersible Tablets
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 300mg Aspirin.
3. LIST OF EXCIPIENTS
Also contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS 100 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use.
Dosage: as directed by your doctor. To be dispersed in water for oral use. Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
Contains Aspirin. If you do not get better talk to your doctor
Do not give to children aged under 16 years, unless your doctor tells you to.
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Keep container tightly closed and store below 25°C in a dry place.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Accord, Barnstaple, EX32 8NS, UK
12. MARKETING AUTHORISATION NUMBER(S)
PL 0142/5519 R
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
POM
15. INSTRUCTIONS ON USE
Read the package leaflet before use
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
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18. UNIQUE IDENTIFIER – HUMAN READABLE DATA < PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]>
OTHER
Accord logo
Place dispensing label here
Barcode –
Artwork reference number
Label-leaflet size
Tablet symbol
PEEL HERE DO NOT REMOVE LEAFLET.