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Patient Information Leaflet

DISPERSIBLE ASPIRIN 75MG 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 the 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.

1. WHAT DISPERSIBLE ASPIRIN IS AND WHAT IT IS USED FOR

•    Aspirin belongs to a group of drugs called non-steroidal anti-inflammatory drugs.

•    Dispersible Aspirin contains the active substance Aspirin.

•    Aspirin is an anti-platelet drug (acts by decreasing the accumulation of platelets and stops blood clots forming within the blood vessels).

•    This medicine is used to help prevent heart attacks and strokes in patients who have suffered previously from these conditions.

•    It can also be used to help prevent further heart disease in patients suffering from unstable angina and patients who have undergone bypass surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISPERSIBLE ASPIRIN

Do not take Dispersible Aspirin if you:

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

•    are suffering or have suffered from peptic ulcers

•    have haemophilia (a defect in    blood clotting mechanism)

•    have gout disease

•    have intolerance to some sugars (this medicine contains lactose)

•    are pregnant or breast feeding (unless advised by your doctor)

•    have severe liver or kidney problems

•    are taking medicines to thin the blood (anti-coagulants such as warfarin, heparin or acenocumarol)

•    are under 16 years of age (unless advised by your doctor)

Warnings and precautions

Talk to your doctor or pharmacist before taking Dispersible Aspirin if you:

•    have asthma or allergies

•    have lung problem

•    have kidney or liver problems

•    are dehydrated

•    are planning to become pregnant.

Consult your doctor before taking this medicine if using for the first time.

There is a possible association between aspirin and Reyes 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 drink alcohol whilst taking this medicine.

If you are going to take this medicine long-term to help prevent a further heart attack or stroke, you should make sure this has been discussed with your doctor who will advise you about the risks as well as the benefits of taking aspirin.

If you experience any unusual symptoms or side effects such as abnormal bleeding, passing blood in your faeces (stools/motions), passing black tarry stools, or vomit any blood or dark particles that look like coffee granules, seek immediate medical help as these may be sign of a bleed in the stomouch or intestines.

Aspirin may trigger haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency. Other medicines and Dispersible Aspirin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:

•    medicines to prevent blood clotting such as warfarin, dipyridamole and heparin

•    metoclopramide or domperidone (to prevent sickness)

•    diuretics (“water tablets”) e.g. spironolactone, Frusemide, acetazolamide (to treat high blood pressure)

•    medicines (to treat gout) such as, citrates, probenecid, sulphinpyrazone

•    methotrexate ( to treat some cancers, psoriasis and rheumatic disease)

•    antidiabetics, oral hypoglycaemics of the sulponylurea type (eg. insulin)

•    corticosteroids (to suppress the immune system) such as prednisolone

•    other non-steroidal anti-inflammatory drugs (NSAIDs e.g. ibuprofen or naproxen)

•    medicines which can cause hearing problems (vancomycin)

•    sulphonamide (drugs which hinder bacterial growth).

•    Medicines to treat epilepsy e.g. phenytoin

•    Acetazolamide (for glaucoma)

•    Iron salts (to treat iron deficiency anaemia), carbonates (to treat peptic ulcer and reflux), alkali hydroxides and antacids (medicines for indigestion or heartburn)

Pregnancy and breast-feeding

You should not take Aspirin tablets during pregnancy, especially in the last 3 months of pregnancy or whilst breast-feeding. If you are in the late stages of pregnancy and you take aspirin, it may prolong your labour and cause bleeding in you or your baby. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine should not affect your ability to drive or to operate machinery. However, if you think you are affected do not drive or operate machinery.

Dispersible Aspirin contains Lactose

Aspirin tablets contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DISPERSIBLE ASPIRIN TABLETS

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.

Stir the tablet in a small glass of water until dispersed, and drink immediately.

The recommended dose is

Adults, including the elderly:

Long term use: 1 to 2 tablets once daily.

Short term use: Your doctor may advice you to take up to 4 tablets daily If you do not get better talk to your doctor.

Children under 16 years old should not take these tablets except under medical supervision.

If you take more tablets than you should

If you take too many tablets contact your doctor or hospital casualty department IMMEDIATELY. Take with you any remaining tablets and the pack so that the medicine can be identified. 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 a dose

If you forget to take a dose, take it as soon as you remember; then go on as before. DO NOT take a double dose to make up for a forgotten dose. If you see another doctor or go into hospital, let the doctor or the hospital staff know what medicines you are taking.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all the medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of these serious side effects, stop taking the tablets and seek medical help immediately:

•    Allergic reaction- Itchy, red, blotchy, blistered skin. Nettle rash/hives, blistering or peeling and runny nose. Swelling of the face, lips, throat or tongue. Swelling and irritation inside the nose, difficulty breathing, wheezing, coughing or chest tightness and worsening of asthma.

•    Gastrointestinal system-stomach ulcer or bleeding which can be severe (you may develop bloody or black tarry stool, severe stomach pain and you may vomit blood), stomach irritation (mild stomach pain, heart burn and feeling or being sick).

•    Blood-anaemia, longer bleeding time, you bruise more easily or have more infections.

If you experience any of the following other side effects contact your doctor or pharmacist:

•    confusion

•    feeling dizzy (vertigo)

•    ringing or buzzing in the ear (tinnitus)bronchospasm (the contraction of air passage inside the lungs).

•    indigestion, feeling or being sick, diarrhoea

•    salt and water retention

•    worsening of kidney function

•    changes in liver function (seen in blood tests)

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.

5. HOW TO STORE DISPERSIBILE ASPIRIN TABLETS

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 or carton. The expiry date refers to the last day of that month.

•    Store the tablets below 25° C in a dry place. Protect from light and moisture.

Do not throw away any medicines via wastewater. 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 Dispersible Aspirin contain

•    The active ingredient is Aspirin. Each tablet contains the active ingredient aspirin BP 75mg

•    The other ingredients are: citric acid, calcium carbonate, saccharin sodium, anhydrous lactose, maize starch, purified talc and sodium lauryl sulphate.

See end of section 2 for further information on lactose.

What Dispersible Aspirin tablets look like and the contents of the pack

•    Dispersible Aspirin tablets are “White, flat circular tablets with bevel edge”.

•    Dispersible Aspirin tablet are available in pack sizes of “12, 16, 24, 25, 28, 50, 100, 250, 500 and 1000 tablets”

•    Larger packs containing more than 16 tablets are only available from a pharmacist.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.

Telephone: 02089975444 Fax:    02089975433

PL 04556 / 0013 Reference: 00130914/01

The last leaflet revised: September 2014.