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PACKAGE LEAFLET: INFORMATION FOR THE USER

ASPIRIN 300MG TABLETS BP

Read all of this leaflet carefully because It contains Important Information foryou.

•    This medicine is available without prescription; however you still need to take it carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Askyour pharmacist if you need more information or advice

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information_

1. What this medicine 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, 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, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.

2. Before you take this medicine Do not take these tablets if you:

•    are allergic to Aspirin or any other non-steroidal anti-inflammatory drugs, such as Ibuprofen

•    are allergic to any of the other ingredients in the tablet (listed in section 6, Further Information)

•    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 asthmaattackafter taking Aspirin

•    have gout

•    have a stomach ulcer or a history of stomach ulcers

Take special care with this medicine

Check with your doctor or pharmacist before taking these tablets if you:

•    sufferfrom asthma

•    are dehydrated

•    sufferfrom kidneyorliver problems

•    are elderly

•    have glucose-6-phosphate dehydrogenase (G6PD) deficiency

•    are diabetic

You should let your doctor know if you are taking aspirin tablets, particularly if you are going to have an operation, as you may need to stop taking your tablets several days before the operation.

Taking other medicines

Tell your doctor or pharmacist If you are taking any medicines, Including those you buy without a prescription such as herbal remedies and health supplements from a pharmacy, supermarket or

health food shop, as they may Interact with this medicine.

Examples of medicines which can affect Aspirin are:

•    Antacids (for indigestion) or adsorbents (e.g. kaolin for diarrhoea)

•    Mifepristone (for termination of pregnancy)- do not take this medicine for 8 to 12 days after taking mifepristone

•    Other non-steroidal anti-inflammatory drugs, including aspirin, ibuprofen (to relieve pain, reduce swollen joints, muscles and ligaments),

•    Medicines to thin blood (e.g. Warfarin)

•    Medicinesfordiabetes (e.g. Glibenclamidejor insulin)

•    Medicines for epilepsy (e.g.Phenytoin and Sodium Valproate)

•    Medicines to treat gout (e.g.Probenecid and Sulphipyrazone)

•    Sulphonamide antibiotics used to treat infectionsje.g. Trimethoprim)

•    Methotrexate to reduce inflammation

•    Corticosteroids (e.g. prednisolone and hydrocortisone)

•    Medicines to treat high blood pressure (e.g. ACE-inhibitors like Lisinopril)

•    Zafirlukast(forasthma),

•    Metoclopramide (for nausea and vomiting)

•    Water tablets (diuretics e.g. spironolactone andacetazolamide)

Aspirin may affect the results of thyroid function tests. Tell your doctor or nurse if you are taking these tablets.

Pregnancy and breast-feeding

•    Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets or

are breast-feeding.

•    Always ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

•    These tablets do not usually affect the ability to drive or operate machinery.

Important information about some of the ingredients of Aspirin Tablets

•    Aspirin Tablets contains LACTOSE.

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

| 3. How to take this medicine |

•    Always take these tablets exactly as your doctor hasadvised you.

•    You should 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

Dosage:

Adults and Children over 16years of age:

•    One to three tablets to be swallowed whole with water.

•    The dose should not be taken more than every 4 hours and not more than 4 times in 24 hour period.

•    Maximum daily dose is 12 tablets (3.6g) in divided dose

•    If symptoms persist for more than 3 days consult yourdoctor.

Do not give to children under 16 years, unless on the advice of a doctor. Do not exceed the stated dose.

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 16years, unless on the advice of a doctor.

If you take more number of tablets than you should

Contact your nearest hospital casualty (A&E) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

Symptoms of an overdose: vomiting, dehydration, tinnitus, vertigo, deafness, sweating If you forget to take a dose If you forget to take a dose, skip the dose and take the next dose as usual.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR

THE FORGOTTEN DOSE._

|~4. Possible Side Effects |

Like all medicines, these tablets can cause side effects, although not everybody gets them.

STOP TAKING this medicine and tell your doctor immediately ifyousufferfromanyofthefollowing:

•    get an allergic reaction, skin rash, swelling of the face, orwheezing

•    difficulty breathing

•    are sick and it contains blood or dark particles that look like coffee grounds

•    pass blood in your stools or pass black tarry stools

The following side effects can occur during treatment with Aspirin tablets:

•    Stomach irritation

•    Skin reactions

•    a tendency to bleed or bruise more easily I S.Howtostorethismedicine |

•    Keep the medicine in a safe place where children can not see or reach.

•    Do not take your tablets after the expiry

date marked on the pack.

•    Do not store above 25°C.

• Keep the tablets in the package or container in which they were given to you in order to protect them from moisture and light.

• If you have any left over tablets, take them back to your pharmacist for safe disposal.

f 6. Further Information]

What Aspirin tablets contain

•    Each tablet contains Aspirin 300mg, as the active ingredient

•    The other ingredients are starch, lactose monohydrate and purified talc (E553b)

What the tablets look like and contents of the pack

•    Aspirin 300mg Tablets are white, round tablets which have <A> embossed on one face and a breakline on the other.

•    The blister packs are available in packs of 8,10,12 or 16 tablets.

•    Notallpacksizesmaybemarketed. Marketing Authorisation Holder

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 BP; PL 17907/0152 This leaflet was last approved in June 2008 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.