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ASPIRIN 300MG TABLETS BP

Active substance(s): ASPIRIN / ASPIRIN

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ASPIRIN 300MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See
section 4.
- You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
1. What Aspirin is and what it is used for
2. What you need to know before you take Aspirin
3. How to take Aspirin
4. Possible side effects
5. How to store Aspirin
6. Contents of the pack and other information

1. What Aspirin is and what it is used for
• Aspirin belongs to a class of medicines called non-steroidal anti-inflammatory drugs. It has analgesic (pain relieving), antipyretic
(temperature reducing) and anti-inflammatory properties.
• It is used for the relief of mild to moderate pain, including headache, migraine, neuralgia (nerve pain), toothache, sore throat,
period pains, aches and pains and for relief of influenza, feverishness and feverish colds.
• It is also used for the relief of sprains, strains, rheumatic pain, sciatica (nerve pain of the leg/back), lumbago (lower back pain),
fibrositis (muscular rheumatism), muscular aches and pains, joint swelling and stiffness.

2. What you need to know before you take Aspirin
Do not take these tablets if you:
• are allergic to Aspirin or any other non-steroidal anti-inflammatory drugs, such as Ibuprofen. You may have developed
difficulty breathing, runny nose, rash, or swollen face or lips, after taking aspirin or a NSAID previously.
• are allergic to any of the other ingredients in the tablet (listed in section 6)
• have been told you suffer from haemophilia or from any disease which affects the clotting of your blood
• are taking medicines to thin your blood such as Warfarin
• are under 16 years old, unless your doctor has told you to take aspirin
• have had an asthma attack after taking Aspirin

Aspirin 300 mg Insert
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have gout
have a stomach ulcer or a history of stomach ulcers
Nasal polyps associated with asthma
severe liver or severe kidney problems or severe heart failure
are in the last 3 months of pregnancy
taking methotrexate (15mg a week)

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 e.g. for kawasaki’s Disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• suffer from asthma or other allergies
• are dehydrated (you may feel thirsty and have a headache, dry mouth and lips)
• have heart, liver or kidney problems
• are older
• 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
• have had any disorders affecting blood vessels in the brain
• have received a varicella (chickenpox) vaccination within the last 6 weeks
• are planning to become pregnant
• have heavy bleeding during your periods.
• have a history of stomach ulcers
• have chronic respiratory disease or chronic diseases
• have hypertension or diabetes
• are taking deferasirox (a medicine to remove excess iron from the body)
• have an overactive thyroid gland
• severe skin rash (steven-Johnsons syndrome)
• increased clotting time
• have risk of bleeding
Other medicines and Aspirin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
• medicines which make your urine more alkaline such as antacids, citrates

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Mifepristone (for termination of pregnancy)- do not take this medicine for 8 to 12 days after taking mifepristone
Other non-steroidal anti-inflammatory drugs, NSAIDs (such as ibuprofen or naproxen)
warfarin, coumarin, heparin, dipyridamole and clopidogrel (used to prevent blood clotting)
Medicines for epilepsy (e.g. Phenytoin and Sodium Valproate)
Medicines to treat gout (e.g. Probenecid and Sulphinpyrazone)
Methotrexate (to treat some cancers, psoriasis and rheumatic disease)
Corticosteroids (to suppress the immune system)
medicines to treat high blood pressure such as ACE inhibitors (e.g. enalapril, lisinopril, perindopril), calcium channel blockers
(e.g amlodipine, diltiazem, nifedipine)
Zafirlukast (for asthma),
Metoclopramide or domperidone ( to prevent sickness)
diuretics (“water tablets”) such as spirinolactone, furosemide, acetazolamide (to treat high blood pressure)
sulphonylureas (antidiabetics), insulin (hypoglycaemics)
Alcohol may increase the risk of side effect
Vancomycin (medicines which can cause hearing problems)
SSRIs such as sertraline or paroxetine (medicines to treat depression)
Varicella (chickenpox) vaccine. Aspirin should be avoided for 6 weeks after vaccination.
herbal medicines containing ginkgo biloba
digoxin (to treat heart problems)
lithium (to treat depression)
acetazolamide (to treat glaucoma)
cyclosporine, tacrolimus (used to prevent organ rejection)

Pregnancy, breast-feeding and fertility
Avoid taking Aspirin 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.
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.
Aspirin Tablets with food, drink and alcohol
Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.
Driving and using machines
These tablets do not usually affect the ability to drive or operate machinery.

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The recommended dose is:
Adults, including the elderly: 1 or 2 tablets every 3 to 4 hours as required. No more than 12 tablets in any 24 hour period.
Do not give to children aged under 16 years, unless on the advice of a doctor (see under ‘Important warning’ in section
2).
If you take more 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, spinning
sensation, fast breathing rate, changes in some of the chemicals in the body, heart failure, changes in body temperature resulting
dehydration, restlessness, fits, hallucination (seeing or hearing things that are not there), headache, hearing problems, confusion,
feeling or being sick, stomach pain or coma.
If you forget to take the 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, these 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:
• Difficulty breathing
• Severe allergic reactions (blistered skin, swelling of the face, lips, throat or tongue, difficulty breathing, worsening of asthma,
shock)
• 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)
• Bleeding on the brain (sudden severe headache, fits, 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) and inflammation of the stomach (gastritis)

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Aspirin may be associated with the development of a condition called Reye’s Syndrome, which causes severe liver and brain
damage.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can
help provide more information on the safety of this medicine.

Common: may affect up to 1 in 10 people
• Increase in the number of nose bleeds, longer bleeding time or notice that you bruise more easily or have more infections talk
to your doctor.
• Indigestion

5. How to store Aspirin

Uncommon: may affect up to 1 in 100 people
• Runny nose
• Itchy skin rash caused by allergic reaction- pale or red irregular raised patches with severe itching (hives)
• Shortness of breath






Rare: may affect up to 1 in 1,000 people
• Anaemia, changes in numbers and types of blood cells and enzymes seen in blood tests
• Difficulty breathing or wheezing, worsening of asthma
• Heavy periods
• Irregular red patches on the skin of the hands and arms (erythema multiforme)
• Disorder characterised by blood spots, bruising and discolouring to skin (Purpura)
• Bleeding in the skin or mucous membranes
• Red tender lumps developing under the skin (Erythema nodosum)

What Aspirin tablets contain
• Each tablet contains Aspirin 300mg, as the active ingredient
• The other ingredients are starch, lactose monohydrate and purified talc (E553b)

Not known: frequency cannot be estimated from the available data
• Hyperuricemia (high levels of uric acid in the blood)- causing crystals to deposit in joints of hands/feet causing pain (gout)
• Nosebleeds, bleeding of the gums, which may be prolonged. (Please advise doctor or dentist if surgery is planned)
• Reduction of red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia), reduction in
red blood cells which cause pale yellow skin and weakness or breathlessness (haemolytic anaemia), blood disorder resulting
in impaired blood clotting leading to an increased risk of bleeding, reduced number in red and white blood cells, blood loss,
elevated blood enzymes levels (as seen in blood test)
• Headache
• Feeling of dizziness or spinning
• Hearing loss, ringing or buzzing in the ears
• Liver problems
• Reduced kidney function, urate kidney stones
Additional side effects in children

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C. Store this medicine in the original package.
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 the tablets look like and contents of the pack
• Aspirin 300mg tablets are white, biconvex which have breakline on one side and debossed on other side
• The blister packs are available in packs of 8, 10, 12 or 16 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd, Unit 3,
Canalside, Northbridge Road, Berkhamsted, Hertfordshire, United Kingdom, HP4 1EG
Telephone: 0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
E-mail:
info@bristol-labs.co.uk
Aspirin 300mg Tablets; PL 17907/0152
This leaflet was last revised in November 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the license holder at the address (or
telephone, fax, email) above.
V7 06-12-2016 D0

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3. How to take Aspirin
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
• Swallow the tablet(s) with a glass of water and do not cut, chew or crush the tablets.

• 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.
• Hepatitis (inflammation of the liver causing yellowing of the skin or eyes or tiredness, pain in abdomen, joint or muscles)

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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