nogen Pharma

PACKAGE LEAFLET: INFORMATION FORTHE USER

Dispersible Aspirin Tablets BP 75mg

[Aspirin]

Read all ofthis leaflet carefully before you start

taking this medicine because it contains

important informationforyou.

•    This medicine is available without prescription. However, you still need to take Dispersible Aspirin Tablets carefully to get the best results from them.

•    Keep this 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1.    What Dispersible Aspirin Tablets are and what they are used for

2.    What you need to know before you take Dispersible Aspirin Tablets

3.    How to take Dispersible Aspirin Tablets

4.    Possible side effects

5.    How to store Dispersible Aspirin Tablets

6.    Contents of the pack and other information

1. WHAT DISPERSIBLE ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine contains Aspirin. Aspirin belongs to a group of medicines called anti-platelet agents that help prevent your blood cells sticking together and forming a blood clot.

Dispersible Aspirin Tablets are used to:-help prevent blood clots in people who have had a stroke, heart attack, by-pass surgery or have angina.

This medicine is not for pain relief.

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

Ifyou are taking this medicine for the first time or if you are going to take this medicine in order to prevent blood clots, you should seek advice from your doctor before you commence therapy to make sure it is suitable for you.

This medicine can be taken by adults. However, some people should not take this medicine or should seek advice from their doctor or pharmacist before taking it.

DO NOT take Dispersible Aspirin Tablets ifyou:

•    Areunder16yearsofage.Thereisa 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 under 16 years unless on the advice ofa doctor.

•    Are hypersensitive (allergic) to aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of these tablets

•    Have a history of allergic reactions to aspirin (you may have had asthma, itchy skin or a runny nose after taking medicines containing aspirin)

•    Have a stomach ulcer, or have had one in the past

•    Have gout or have a history of gout

•    Are pregnant or breast-feeding

•    Have a disease associated with an increased tendency to bleed (e.g. haemorrhagic disease)

•    Are taking a medicine to help thin your blood (e.g.warfarin)

•    Have haemophilia (an inherited bleeding disorder)

•    Have severe kidney or liver problems.

Take special care with Dispersible Aspirin Tablets

Talk tovour doctor or pharmacist or nurse before taking Dispersible Aspirin Tablets ifyou:

•    are elderly as your dose may be reduced

•    have asthma or suffer from other allergies

•    are diabetic as aspirin may alter your insulin reguirements

•    have high blood pressure (hypertension), your doctor will want to monitor you while taking this medicine

•    are dehydrated

•    suffer from a low glucose deficiency called glucose-6-phosphate dehydrogenase

•    suffer from liver or kidney disease.

Other medicines and Dispersible Aspirin

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

In particular tell your doctor if you are taking any of the following:

•    medicines to thin your blood and prevent blood clots e.g. warfarin, heparin

•    other NSAIDs to treat pain e.g. ibuprofen, diclofenac sodium

•    medicines called corticosteroids which are used to treat many conditions such as eczema, rheumatoid arthritis and inflammatory conditions e.g. hydrocortisone, prednisolone

•    medicines used to treat glaucoma e.g. acetazolamide

•    medicines used to treat indigestion e.g. antacids

•    a medicine called mifepristone which is used as an emergency contraceptive

•    a medicine called methotrexate which is used to treat psoriasis, rheumatoid arthritis and certain cancers

•    some anti-bacterial medicines called sulphonomides

•    a medicine called metoclopramide which is used to treat sickness, digestive conditions and certain conditions that can occur after surgery

•    medicines used to treat high blood pressure such as diuretics e.g. spironolactone and ACE inhibitors e.g. captopril

•    medicines used to treat epilepsy e.g. phenytoin and sodium valproate

•    medicines used to treat gout e.g probenecid and sulfinpyrazone

•    medicines used to treat diabetes e.g. insulin, metformin, glibenclamide

•    a medicine called zafirlukst used to treat asthma

•    alcohol enhances some of the effects of aspirin.

This medicine may interfere with thyroid function tests. Inform your doctor that you are taking this medicine if you need to have a thyroid function test.

Pregnancy and breast-feeding

This medicine should not be taken during pregnancy and breast-feeding.

Driving and using machines

These tablets are not known to cause any side effects that will affect your ability to drive or use machinery. However, if you feel like you are affected ao not drive or operate machinery.

Taking Dispersible Aspirin Tablets with food and drink

You should not drink alcohol while taking this medicine. Side effects may be enhanced if you do.

Important information about some of the ingredients of Dispersible Aspirin Tablets

Dispersible Aspirin Tablets contain 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. HOWTOTAKE DISPERSIBLE ASPIRIN TABLETS

These other effects are less serious. If

theybotheryou talk to a pharmacist:

•    Feeling sick, being sick, changes to the stomach lining (swelling or ulcers)

•    Feeling tired or severely exhausted

•    Increased bleeding time when you cut yourself, bleeding under the skin which may look like bruising

•    Nose bleeds (if a nose bleed is severe or lasts for a long time, talk to a doctor straight away)

•    Hearing problems (e.g. ringing in the ears), feeling dizzy (vertigo), feeling confused

•    Kidney and urinary disorders such as kidney stones. Symptoms include pain in the stomach or side of the back which can radiate towards the groin area, changes in the colour of urine, blood in the urine, chills, fever, nausea and vomiting.

Always take Dispersible Aspirin Tablets exactly as detailed here. You should check with your doctor or pharmacist if you are unsure.

For oral administration. The tablet can be swallowed with some water. If you prefer, you can also disperse the tablet in a glass ofwater before being swallowed.

Adults, elderly and children over16vears:

For long term use. One to two tablets (75-150mg) may be taken once daily.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. STORING DISPERSIBLE ASPIRIN TABLETS

A higher dose of up to four tablets (300mg) daily may be taken. This is for a short period of time and onfy on the instruction of your doctor.

Children:

These tablets are NOT for use in children under 16 years of age unless specifically advised by a doctor.

Ifyou take more Dispersible Aspirin Tablets than you should

If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

Ifyou forget to take Dispersible Aspirin Tablets

If you have forgotten to take a dose, take a dose as soon as you remember. If the next dose is due within 2 hours, take a single dose now and skip the next. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Protect from heat, light and moisture. In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dispersible Aspirin Tablets can cause side effects, although not everyone gets them.

If any of these occur STOP taking the medicine and contact a doctor immediately.

Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling oftne face, lips or throat, runny nose, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up.

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

•    If you pass blood in your urine, if you have blood in your stools or if you pass black tarry stools

•    Ifyou have stomach problems including pain, indigestion or heartburn

•    Bleeding on the brain which may cause a severe headache or stroke

•    Ifyou notice black, purple discolouration ofthe skin

•    If you are coughing up blood (haemoptysis)

•    If you have fatigue and shortness of breath which could be signs ofa blood disorder such as anaemia.

What Dispersible Aspirin Tablets contain:

Dispersible Aspirin Tablets contain the active substance Aspirin 75mg in each tablet.

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

What Dispersible Aspirin Tablets look like and contents of the pack

Dispersible Aspirin Tablets are white, flat, circular tablets with a bevelled edge and are 8mm in diameter.

Dispersible Aspirin Tablets are supplied in packs of 24, 25, 50 and 100 tablets. Not all ofthese pack sizes are marketed.

Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Clonmel Healthcare Limited,

Waterford Road, Clonmel Co Tipperary, Ireland.

This leaflet was last revised in January 2014.

SIZE :160X 270 (mm) Back