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ASPIRIN 300MG GASTRO-RESISTANT TABLETS

Active substance(s): ACETYLSALICYLIC ACID / ASPIRIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspirin 300mg Gastro-resistant Tablets
Aspirin

Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Taking Aspirin Tablets with food and drink
• Aspirin Tablets should be taken before meals with a drink of
water.
Pregnancy and breast-feeding
• If you are pregnant, thinking of becoming pregnant, or
breast-feeding, ask your doctor or pharmacist for advice
before taking Aspirin Tablets.
3. How to take Aspirin Tablets
Always take Aspirin Tablets exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
You must swallow the tablets whole, before meals with a drink of
water. Do not chew, crush or break the tablets.

In this leaflet:
1. What Aspirin 300mg Gastro-resistant Tablets are and what
they are used for
2. Before you take Aspirin Tablets
3. How to take Aspirin Tablets
4. Possible side effects
5. How to store Aspirin Tablets
6. Further information
1. What Aspirin 300mg Gastro-resistant Tablets are and what they are
used for
Your medicine is called Aspirin 300mg Gastro-resistant Tablets (called
Aspirin Tablets throughout the rest of this leaflet).

Adults (including the elderly and children over 16 years)
If you are taking aspirin as a painkiller, as an anti-inflammatory
medicine or for treating fever:
• The usual dose is three tablets taken three to four times daily
as required, with at least four hours in between each dose.
If you are taking aspirin to help reduce the risk of a heart attack:
• The usual dose is one tablet taken daily.
Children and Adolescents
Aspirin should not be given to children aged under 16 years of age
unless on the advice of a doctor.
If you take more Aspirin Tablets than you should
• If you take more Aspirin Tablets than your doctor has prescribed
contact your nearest hospital casualty department or doctor

Batch Number:

Expiry Date:

BARCODE POSITION

Aspirin 300mg Gastro-resistant Tablets

Each gastro-resistant tablet contains aspirin 300mg
Directions
Dosage: Use only as directed by your doctor.
You must swallow tablets whole, before meals with a drink of water.
Do not chew, crush or break the tablets.
Do not exceed the stated dose. Do not give to children aged under 16 years,
unless on the advice of a doctor.
Keep out of the reach and sight of children.
Do not store above 25°C.
POM

PL 20046/0033

MA Holder: Focus Pharmaceuticals Ltd,
Unit 5 Faraday Court, Burton upon Trent, DE14 2WX, UK

100 tablets

What this medicine does
Your doctor has prescribed Aspirin Tablets to treat one or more of the
following conditions:
• as a painkiller e.g. to relieve headache and toothache;
• to reduce fever;
• as an anti-inflammatory medicine e.g. to treat rheumatoid arthritis;
• to reduce the likelihood of having a heart attack, if you have
previously had a heart attack or have angina (severe pain in the
chest which may travel into the jaw, neck and arms).
Aspirin belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). Aspirin works by preventing the
release in the body of substances which cause pain, inflammation
and fever. Aspirin also thins the blood which helps to reduce the

immediately. Take the medicine or this leaflet with you to show
the doctor.
If you forget to take Aspirin Tablets
• If you forget to take a dose, do not worry. Take the next dose
when it is due.
• Do not take more than one dose in any 4-hour period.
• Do not take double the amount to make up for a forgotten
dose.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Aspirin Tablets can cause side effects, although
not everybody gets them.

likelihood of having a heart attack.
These tablets have been specially coated (gastro-resistant coating) to
help minimise stomach upset and feeling sick (sometimes experienced
as side effects of these tablets – see Section 4 Possible side effects).
2. Before you take Aspirin Tablets
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.
Do not take Aspirin Tablets if you:
• are allergic (hypersensitive) to aspirin or other non-steroidal
anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, or any of the other
ingredients of Aspirin Tablets (see Section 6 What Aspirin Tablets

If you experience the following side effects while taking your
medicine, you should stop taking your tablets and tell your doctor
straight away:
• allergic reaction (hypersensitivity) which may include lumpy skin
or hives, swelling of eyelids, face, lips, mouth or tongue, or sudden
wheeziness, or induce or worsen asthma attacks;
• you suffer from severe or persistent indigestion, stomach upset or
pain, you may develop ulcers or bleeding from the stomach
which can cause severe stomach pain, bloody or black tarry
stools or vomiting blood.
Other possible side effects:
• stomach upset and feeling sick;
• ringing or buzzing in the ear (tinnitus);

contain);
• have or have had a stomach ulcer;
• have a condition where your blood does not clot properly (e.g.
haemophilia);
• have or have had gout;
• are in the last 3 months of pregnancy or are breast-feeding.
Talk to your doctor or pharmacist if any of the following apply to you:
• if you have asthma, or suffer from allergies;
• if you have problems with your kidneys or liver;
• if you are dehydrated;
• if you have high blood pressure;
• if you have a lack of glucose 6-phosphate dehydrogenase (G6PD);
• if you are elderly.

• dizziness;
• confusion;
• an increased tendency to bleed;
• you may bruise more easily.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Aspirin Tablets
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the label.
Store your medicine below 25°C. Keep your medicine in the dark
and away from moisture.
Do not use if you notice that the pack is damaged. Return it to your
pharmacist.

Using other medicines
Can you take Aspirin Tablets with other medicines?
The effect of treatment may be influenced if aspirin is taken at the
same time as some other medicines for:
• Thinning of the blood/prevention of clots (e.g. warfarin)
• Organ rejection after transplantation (e.g. ciclosporin, tacrolimus)
• High blood pressure (e.g. diuretics and ACE inhibitors)
• Pain and inflammation (e.g. anti-inflammatory medicines such as
ibuprofen, or steroids)
• Gout (e.g. probenecid)
• Cancer or rheumatoid arthritis (e.g. methotrexate)
Before using aspirin you should inform a healthcare professional
about the medicines you are taking. If you are using aspirin regularly

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.
6. Further information
What Aspirin Tablets contain
- The active substance is aspirin. Each tablet contains 300mg of
aspirin.
- The other ingredients are microcrystalline cellulose, maize starch,
silica, zinc stearate, methacrylic acid copolymer, triethylcitrate,
talc, titanium dioxide (E171), iron oxide (E172), sodium hydroxide
and polyethylene glycol 6000. The tablets are marked with black
ink containing shellac, iron oxide (E172) and propylene glycol.

you should seek advice before taking any other medicine
(including other medicines you may have bought).
Make sure your doctor also knows if you are taking a medicine listed
here:
• Mifepristone (used to terminate pregnancy): if taken with aspirin
this medicine may not be as effective.
• Metoclopramide (used to treat nausea and vomiting): it may
increase the effect of aspirin.
• Adsorbents e.g. kaolin (for diarrhoea) and Antacids e.g.
aluminium hydroxide and magnesium carbonate (used to treat
indigestion): these medicines may reduce the effect of aspirin.
• Medicines known to affect the clotting of your blood: if you take

What Aspirin Tablets look like and contents of the pack
Aspirin Tablets are round, pink tablets with Aspirin 300EC in black on
one side. They are packed in tamper-evident, child-resistant plastic
packs.
Each pack of Aspirin Tablets contains 100 tablets.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Unit 5, Faraday Court,
Burton upon Trent, DE14 2WX, UK
Tel: 01283 495 280 Fax: 01283 495 290
Email: medinfo@focuspharmaceuticals.co.uk
Manufacturer
Custom Pharmaceuticals Limited, Conway Street, Hove,
Sussex, BN3 3LW

one of these medicines below with aspirin you may increase
the likelihood of bleeding.
• Antidepressants (used to treat depression) e.g. Selective
Serotonin Reuptake Inhibitors (SSRIs) (such as citalopram,
fluoxetine) or venlafaxine.
• Sibutramine (to help weight loss).
• Clopidogrel (used to prevent strokes and heart attacks).
• Iloprost (used to treat a specific type of high blood pressure under
specialist supervision).
• Angiotensin-II Receptor antagonists e.g. valsartan, losartan (used
to lower high blood pressure): taken with aspirin these medicines
may not be as effective and you may suffer from kidney
problems.

• Medicines to control epilepsy e.g. phenytoin and valproate:
aspirin may increase the effect of these medicines.
• Zafirlukast (used to prevent or treat asthma).
• Carbonic anhydrase inhibitors e.g. acetazolamide (used in the
treatment of glaucoma, epilepsy and excess water retention): if
taken with aspirin the side effects of these medicines may
become more severe.
• Cilostazol (for leg pain that occurs when walking due to poor
circulation): the dose of aspirin should not be greater than 80mg
a day.

For any information about this medicinal product, please contact the
Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please
telephone 01283 495 280 or email
medinfo@focuspharmaceuticals.co.uk.
This leaflet was last revised in March 2012.

PHARMA
POSITION

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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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