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Dispersible Aspirin 75mg tablets

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.

Index

T| What Dispersible Aspirin tablets are and what they are used for Before you take How to take "4 Possible side effects T| How to store "6| Further information

What Dispersible Aspirin tablets are and what they are used for

Dispersible Aspirin tablets belong to a group of medicines which have analgesic (pain relieving), anti-inflammatory (inflammation reducing) and anti-pyretic (temperature reducing) properties.

Aspirin also acts on the blood helping to prevent the formation of blood clots.

These tablets may be used to help prevent heart attacks and stroke in patients who have previously suffered such events, in patients who have unstable angina and following by-pass surgery.

_2 Before you take

Do not take Dispersible Aspirin tablets and tell your doctor if you have:

•    an allergy (hypersensitivity) to aspirin, salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) or other ingredients in the product. You may have developed difficulty breathing, a runny nose, itchy skin or swelling after taking aspirin or a NSAID previously (see section 6)

•    a stomach ulcer or a history of ulcers or

indigestion

•    nasal polyps associated with asthma

•    haemophilia or other blood clotting disorder or are taking medicines to thin the blood.

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 or pharmacist before taking Dispersible Aspirin tablets if you have:

•    asthma or allergies

•    heart, liver or kidney problems or gout

•    an overactive thyroid gland

•    dehydration

•    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)

•    systemic lupus erythematosus (SLE) or other connective tissue disease

•    uncontrolled high blood pressure.

Taking other medicines

Please tell your doctor or pharmacist if you are

taking or have recently taken or any other medicines, including medicines obtained without a prescription or are using aspirin regularly.

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, dipyridamole, clopidogrel)

•    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, sulphinpyrazone)

•    cancer or rheumatoid arthritis (e.g. methotrexate)

Other medicines such as:

•    metoclopramide or domperidone (to prevent sickness)

•    diuretics ("water tablets") e.g. spironolactone, frusemide, acetazolamide (to treat high blood pressure)

•    medicines which make your urine more alkaline such as antacids, citrates

•    antidiabetics

•    phenytoin or sodium valproate (to treat epilepsy)

•    mifepristone (to induce abortion)

•    medicines which can cause hearing problems (vancomycin)

Continued top of next column    Continued over page

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•    mifepristone (to induce abortion)

•    medicines which can cause hearing problems (vancomycin)

•    kaolin (to treat diarrhoea)

•    medicines to treat depression such as venlafaxine or SSRIs (eg fluoxetine, paroxetine)

•    cilostazol (to treat intermittent claudication (limping))

•    iloprost (to treat high blood pressure)

•    zafirlukast (to prevent asthma)

•    silbutramine (appetite suppressant).

Pregnancy and breast-feeding

Avoid taking Dispersible 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.

Sugar intolerance

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.

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.

How to take

Always take Dispersible Aspirin tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Avoid alcohol whilst taking this medicine.

Disperse the tablet(s) in a glass of water and drink.

Doses:

Adults: The usual dose for long-term use is 1-2 tablets (75-150mg) once a day. In some circumstances a higher dose may be appropriate, especially in the short-term, and up to 4 tablets (300mg) a day may be used on the advice of a doctor.

Children under 16 years old: Not recommended.

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 or kidney failure, fever 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, Dispersible Aspirin tablets can cause side effects, although not everybody gets them.

Stop taking Dispersible Aspirin and contact your doctor at once

if you experience the following signs of an allergic reaction: runny nose, itchy skin, swelling of the face, lips, throat or tongue, difficulty breathing, worsening of asthma.

Tell your doctor if you notice any of the following side effects or

notice any other effects not listed:

Gastrointestinal system - 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 sick) and inflammation of the liver.

Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor.

Ears - ringing or buzzing in the ear.

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.

If you are concerned about any side-effects or have any other unusual effects, tell your doctor immediately and seek advice.

5| How to store

Keep out of the reach and sight of children.

Store the tablets below 25°C in a dry place.

Do not use Dispersible Aspirin 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.

4 Further information

What Dispersible Aspirin tablets contain

•    The active substance (the ingredient that makes the tablets work) is 75mg aspirin (also known as acetylsalicylic acid).

•    The other ingredients are citric acid, lactose, maize starch, saccharin sodium, calcium carbonate (E170).

What Dispersible Aspirin tablets look like and contents of the pack

Dispersible Aspirin are white, uncoated tablets.

Pack sizes are 1000 tablets.

Marketing Authorisation Holder and manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in November 2008

Actavis

Actavis, Barnstaple, EX32 8NS, UK