Aspirin Enteric Coated Tablets 75mg
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PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all ofthis 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 or nurse has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information of 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 you feel worse after 3 days.
What is in this leaflet:
1. What Aspirin Tablets are and what they are used for
2. What you need to know before you take Aspirin Tablets
3. How to take Aspirin Tablets
4. Possible side effects
5. How to store Aspirin Tablets
6. Contents of the pack and other information
1. WHAT 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.
Aspirin Enteric Coated Tablets 75mg are used 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).
As the special coating on the tablets delays the release of the active ingredient, these tablets are not suitable for short term pain relief.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN TABLETS
Do not take this medicine 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 ofage unless on advice from the doctor.
• Are hypersensitive (allergic) to aspirin, other Non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of these tablets (see section 6)
• Have or have ever had a stomach ulcer
• Have a disease associated with an increased tendency to bleed (e.g. haemorrhagic disease)
• Have haemophilia (an inherited bleeding disorder)
• Have severe kidney or liver problems
• Are in the last three months of pregnancy
• Are taking a medicine to help thin your blood (e.g. warfarin)
• Have or have had gout.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before
taking if:
• You have asthma or suffer from allergies
• You suffer from liver or kidney diseases. This medicine should be avoided if the conditions are severe
• You are suffering from dehydration
• You are elderly
• You suffer from low glucose-6-phosphate dehydrongenase (a type of glucose deficiency)
• You are diabetic, as aspirin may alter your insulin requirements
• You have high blood pressure (hypertension), your doctorwill want to monitor you while taking this medicine.
You should let your doctor know you are taking aspirin, particularly ifyou are going to have an operation, as you may need to stop taking your tablets several days before an operation
Other medicines and Aspirin Tablets:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular:
• Medicines to thin your blood and prevent blood clots e.g. warfarin, heparin
• Other non-steroidal anti-inflammatory drugs (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 sulphonamides
• 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. spironalactone and ACE inhibitors e.g. captopril
• Medicines used to treat epilepsy e.g. phenytoin and sodium valporate
• 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 or breast-feeding. Ask your doctor or pharmacist for advice if you are pregnant or planning on becoming pregnant or are breastfeeding.
Driving and using machines
These tablets are not known to cause any side effects that will affect your ability to drive or operate machinery. However, if you think you are affected do not drive or operate machinery.
Taking Aspirin Tablets with food, drink and alcohol
You should not drink alcohol while taking this medicine. Side effects may be enhanced if you do.
Aspirin Tablets contain lactose.
Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ASPIRIN TABLETS
• Kidney and urinary disorders such as kidney stones. Symptoms include pain in the stomach or side of back which can radiate towards the groin area, changes in the colour of urine, blood in the urine, chills, fever, nausea, vomiting.
Always take this medicine exactly as your doctor has prescribed. You should check with your doctor or pharmacist if you are unsure.
Adults, the elderly and children over 16 years ofage:
The usual adult dose for long term use is one to two tablets (75mg - 150mg) once daily. Sometimes, a higherdose may be needed, especially in the short term, and up to 4 tablets (300mg) a day may be used on the advice of a doctor.
Take the tablets whole with a drink ofwater. Do not crush or chew the tablets.
DO NOT take indigestion remedies just before or straight after taking your medicine.
Children under16yearsofage:
Aspirin Tablets should not be taken by children under16years ofage unless specifically advised by a doctor.
Ifyou take more tablets than you should
If you have accidently taken one extra dose, it shouldn't cause a problem.
If you (or someone else) swallows a lot of tablets all together, or ifyou think a child has swallowed any of the tablets, contact your nearest hospital casualty department or doctor immediately.
Ifyou forget to take your tablets
Take the missed dose as soon as you remember. If your next dose is due within the next two hours, take a single dose now and skip the next dose. If you are concerned about this, consult your doctor or pharmacist.
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:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE ASPIRIN TABLETS
Keep out of the sight and reach of children.
Do not use Aspirin Tablets after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. If you have any medicines which are out ofdate, return them to your pharmacist for disposal.
Store below 25°C in a dry place.
Do not use Aspirin Tablets if you notice any visible signs ofdeterioration, such as chipped or broken tablets. Take them to your pharmacist for advice.
Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody 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 ofthe face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and dizzy particularly when standing up or an unusual runny nose.
• If you are sick and it contains blood or dark particles that look like coffee grounds
• Ifyou pass blood in your urine, stools or 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
• Ifyou are coughing up blood (haemoptysis)
• If you have fatigue and shortness of breath these could be signs of a blood disorder such as anaemia.
These other effects are less serious. If they bother you, 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
What Aspirin Tablets contain:
Each enteric coated tablet contains 75mg of aspirin.
The other ingredients are lactose, starch, sucrose, talc, eudragrit L100-55, polyethylene glycol, hydroxypropyl methylcellulose and titanium dioxide.
What Aspirin Tablets looks like and the contents of the pack
Aspirin Tablets are white, enteric coated, biconvex tablets with the following markings: 75 (on one side), L (on other side).
Tablet diameter: 6.5-7.0mm Thickness: 4.1-4.6mm.
Aspirin Tablets are available in blister packs of 28 and 56 or pots of 100 tablets.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside way, Dartford, DA1 5BS, UK
Manufacturer
Valpharma SPA
Via Ranco 112, Serravalle
SM 47889, San Marino
This leaflet was last revised in March 2015