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Active substance(s): ASPIRIN

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PATIENT lNFORMATION LEAFLET ASPIRIN ENTERIC COATED TABLETS 75mg What you should know about Aspirin Enteric Coated Tablets Please read (his carefully before you start to take your medicine. This leaflet provides a summary of the information available about it. If you would like further information, have any questions or are not sure about anything, ask your doctor or pharmacist. The name of your medicine is Aspirin Enteric Coated Tablets 75mg. What is in your medicine? Each tablet contains 75mg of aspirin with an enteric coating. Aspirin taken at low dose can prevent certain components in the blood (platelets) from clotting which may help to reduce the changes of strokes or further heart attacks. As the special coating on the tablets delays the release of the active ingredient, these Tablets are not suitable for short term pain relief. Each Aspirin Enteric Coated Tablet contains aspirin BP 75mg as the active ingredient. They also contain lactose, starch, sucrose, talc, Eudragit L (polymcthacrylatcs), polyethylene glycol, Hydroxypropyl methylcellulose and titanium dioxide (E17J), These tablets are supplied to the pharmacist in packs containing* 28, 56, 100 or 1,000 tablets. Your pharmacist will dispense the appropriate number of tablets for your requirements. The product licence holder is: Ennogen Pharma Limited, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, United Kingdom. The manufacturer is: Valpharma SA, Via Ranco 112, 478SSJ Scrravalle, San Marino, Italy. Uses Aspirin Enteric Coated Tablets 75mg arc useful to prevent further heart attacks and stroke if you have previously suffered from these conditions, following bypass surgery and to control unstable angina (a type of chest pain), Before taking your medicine You should seek advice from your doctor before you commence therapy for the first time. Your doctor will be able to advise on the relative benefits and risks of long-term therapy with aspirin for you. You should also till your doctor if: you are, or might be, pregnant or breast-feeding, you have experienced sensitivity lo aspirin, other non-steroidal anti inflammatory drugs (NSAI Ds), or any of the other ingredients in this medicine, you have diabetes, you have ever had a stomach ulcer, you are a child under 16 years of age (see below), you have any form of bleeding disorder such as haemophilia, or you suffer from liver disease or kidney problems. It is very important that you tell your doctor if you are taking any other medication, especially phenytoin or sodium Valproate (for epilepsy), anti-coagulants, such as warfarin or heparin (to prevent blood clots), Other NSAID painkillers such as diclofenac sodium or ibuprofen, corticosteroids, such as hydrocortisone (for eczema, rheumatoid arthritis, and inflammatory conditions), diuretics (water tablets) such as bendrofluaxide, hydrochlorthiazide, or spironolactone, sulphonamides (to treat infections), or probenecid (used mainly to treat gout), metoclopramide (for digestive disorders, sickness and certain conditions which occur after surgery), antacids (for indigestion), or methotrexate (used for psoriasis, rheumatoid arthritis and tumours). You should also tell your doctor if you are taking any medicines you can buy without a prescription. Aspirin Enteric Coated Tablets 75mg are not intended for children under 16 years of age. 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. Taking your medicine Always follow your doctor's instructions as to how and when to take your medicine, your pharmacist may be able to advise if you are not sure. Exactly how many tablets, and how often you must taken them, will be written on the label. Please read it carefully, The recommended dose is given below. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with your doctor, if you have not already done so. Adults, the elderly and children 16 years and over: the usual adult dose for long term use is one to two (75-150mg) tablets once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to four tablets (300mg) a day may be used on the advice of a doctor. Take the tablets whole with a drink of water, do not crush or chew, Do not take indigestion remedies just before or straight after taking your medicine. Children under 16 years of age: Aspirin Tablets arc not recommended. If you wish to discontinue treatment with Aspirin Enteric Coated Tablets, discuss [his with your doctor before stopping treatment because these arc pan of a long-term preventative treatment. If you have forgotten to take your medicine, take it 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 accidentally take one extra dose, this should nut present a problem, If you or someone else has taken a larger number of extra tablets, contact a doctor or hospital accident and emergency department straight away.

As with all medicines you may experience some unwanted effects whilst taking Aspirin Tablets including indigestion or stomach irritation. Rarely, bleeding from the gut may occur. If you enough up or vomit any blood or pass dark, tarry stools, contact your doctor straight away. Other effects which may occur include nausea, vomiting, diarrhea, ringing in the ears, dizziness or unsteadiness. Rarely, blood changes may occur. If there is a tendency to bruise easily or bleed from the gums or elsewhere, see your doctor. If you suffer with any allergic reactions such as skin rashes or itching, wheezing, difficulty in breathing, or an unusual runny nose, contact your doctor straight away. If you have any of these effects and they become severe or upsetting, or you experience any other unpleasant effects which you think could be caused by this medicine, you should contact your doctor or pharmacist for advice. Storing vnur medicine Do not take Aspirin Enteric Coated Tablets after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for advice before taking them, Aspirin Tablets should be stored below 25C in a dry place. If you notice any visible signs of deterioration, such as chipped or broken tablets, take them to your pharmacist for advice before taking them. Date of revision: September 2012. Keep all medicines out of the reach and sight of children, Your medicines can harm them. REMEMBER this medicine is for you. Never give it to others. It may harm them even if their symptoms are the same as yours. This leaflet applies to Aspirin Enteric Coated Tablets 75mg only.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.