24 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

DISPERSIBLE ASPIRIN 75MG TABLET BP

Read all of this leaflet carefully because it contains important information for you.

•    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.

•    Ask your 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 meddne

6.    Further information

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

•    Aspirin is a non-steroidal anti-inflammatory drug (NSAID). It helps prevent blood cells sticking together.

•    It can be used to help prevent further heart attacks and strokes in patients who have a history of these conditions. It can also be taken after by-pass surgery.

2. Before you lake this medicine

Do not take these tablets if you:

•    are allergic to Aspirin or any other non-steroidal antiinflammatory drugs, such as Ibuprofen (see symptoms of an allergic reaction in Section 4, Possible side effects)

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

•    have been fold you suffer from haemophilia or from any disease which affects the clotting of your blood

•    are taking meddnes to thin your blood such as Waiterin

•    have gout

•    have a stomach ulcer, a history of stomach ulcers or suffer from indigestion

•    have nasal polyps associated with asthma Important warning:

There is a possible association between aspirin and Reye's syndrome when give to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason, aspirin should not be given to children under 16 years of age, unless on the advice of a doctor.

Take special care with this medicine

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

•    have kidney or liver problems

•    are dehydrated

•    suffer from asthma or allergic disease

•    are elderly

•    have anaemia (reduction in number of red blood cells in your blood)

•    have been told you have glucose-6-phosphate dehydrogenase (G6PD) deficiency

•    are taking insulin for your diabetes

•    have cardiac failure (which can cause increasing breathlessness and fluid retention)

•    have a connective tissue disorder like systemic lupus erythematosus (SLE) as there is a risk of worsening liver and kidney problems

•    have an overactive thyroid gland, which causes test heart beat, sweating and weight loss

You should let your doctor know if you are taking aspirin tablets, particularly if you are going to have an operation, including having dental work, 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:

•    Medicines to thin the blood (e.g. Warfarin and dipyridamole)

•    Other non-steroidal anti-inflammatory drags, like ibuproten (used to relieve pain and swelling)

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

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

•    Medicines for diabetes (e.g. Glibendamide or insulin)

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

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

•    Sulphonamide antibiotics used to treat infections (e.g. Co-trimoxazole)

•    Methotrexate used to reduce inflammation

•    Corticosteroids used to reduce inflammation (e.g.    e

prednisolone and hydrocortisone)    Jj

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

•    Zafiriukast (used for asthma)

•    Metodopramide and domperidone (used for nausea and vomiting)

•    Diuretics to make you pass more water e.g. spironolactone and furosemide

•    Acefazolamide used to treat glaucoma

•    \tenoomydn (used to treat infections)

•    Alcohol may increase the risk of side effects. Avoid alcohol whilst taking Aspirin.

Aspirin may affect the results of thyroid function teste, and

some urine sugar teste. Tell your doctor or nurse if you are

having these tests.

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-feedng. |

•    Ask your doctor or pharmacist for advise before taking |

this or any other medicines.

Driving and using machines

•    Aspirin does 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 betore taking this medicinal product.

|    3.Howtotakethismedicine    |

•    Always take these tablets exactly as your doctor has advised you.

•    You should check with your doctor or pharmacist if you are not sure.

•    Swallow the tablet® with a glass of water and do not cut, chew or crush the tablets

Dosage:

Adults and Children over 16years of age:

•    The usual dose for long teim use is one or two tablets once daily dissolved in water.

•    In some circumstances your doctor may advise a higher dose of up to 4 tablets daily.

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

If you take more Dispersible Aspirin 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.

If you forget to take Dispersible Aspirin

If you miss 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.

I    4. Possible Side Effects    |

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

STOP TAKING this medicine and seek immediate medical help if you suffer fiom any of the following:

•    unexplained wheezing, worsening of asthma, shortness of breath, runny nose, swelling of the lips, face, or neck, skin rash or itching, as these may be signs of an allergic (hypersensitivity) reaction

•    pass blood in your faeces (stools/motions), pass black tarry stools, or vomit blood or dark particles that look like coffee grounds

STOP TAKING this medicine and tell your doctor if you experience:

•    indigestion or heartburn or abdominal pain (pains in your stomach)

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

•    a tendency to bleed or bruise more easily, changes in numbers and types of blood cells. You must tell your doctor if you experience any unusual bleeding.

•    ringing in your ears (tinnitus)

•    skin rashes

•    inflammation of the liver (hepatitis) - particularly in patients with systemic lupus erythematosus

•    salicylism - if you take large doses tor a long time, you may develop symptoms of salicylism, which include dizziness, deafness, sweating, nausea (feeling sick), vomiting, headache and contosion.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

I    5. How to store this medicine    |

•    Keep the medicine it 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 then take them back to your pharmacist tor safe disposal.

|    6. Further information    1

What Dispersible Aspirin Tablets contain

•    Each tablet contains Aspirin 75mg, as the active ingredient

•    The other ingredients are: sodium saccharin E954, citric add E330, caldirt carbonate E170, maize starch, purified talc E553b, sodum lauryl sulphate, lactose monohydrate.

•    The sodium content is less than 0.1 mg per tablet What the tablets look like and contents of the pack

•    Tablets are white, round in shape which have <F> embossed on one face and are plain on the other.

•    The blisters are available in packs of 12,20,24,28,30, 32,48, 56,60, 84, 96, 98 and 100 tablets.

•    The containers are available in containers of 32,50 and 100 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder Name and address: Bristol Laboratories ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

United Kingdom, HP41EG Telephone:    0044(0)1442200922

Fax:    0044 (0)1442 873717

E-mail:    into@bristol-labs.co.uk

Dispersible Aspirin 75mg Tablets BP; PL 17907/0155 This leaflet was last approved in March 2009 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fox, email) above. |

128 mm