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ALLIANCE

PATIENT INFORMATION LEAFLET

Aspirin 75mg Gastro-resistant Tablets

aspirin (acetylsalicylic acid)

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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

Aspirin 75mg Gastro-resistant Tablets contains aspirin. Aspirin is used:

• to prevent recurrence of heart attacks or strokes by thinning the blood. If someone who has previously had a heart attack or stroke takes Aspirin 75mg Gastro-resistant Tablets regularly, it reduces the risk of a blood clot occurring in the heart or brain. This can prevent further heart attacks or strokes.

If you take aspirin in high doses or over a long period of time, it can irritate your stomach lining. To prevent stomach irritation, these tablets have a special coating (called enteric) so that the aspirin is not released until it has passed through the stomach.

Aspirin is released slowly from these tablets, so Aspirin 75mg Gastro-resistant Tablets is not suitable for the short-term relief of pain, such as headaches or toothache.

Do not take Aspirin 75mg Gastro-resistant Tablets:

•    if you are allergic to aspirin or if you are allergic to any of the ingredients in Aspirin 75mg Gastro-resistant (see Section 6 Further information)

•    if you have ever had the problem of your blood not clotting properly

•    if you have ever had an ulcer in your stomach or small intestine.

Take special care with Aspirin 75mg Gastro-resistant Tablets

Before you take Aspirin 75mg Gastro-resistant Tablets tell your doctor if you:

•    think you may be dehydrated (you may feel thirsty with a dry mouth)

•    have trouble with your kidneys or liver

•    have high blood pressure

•    if you are asthmatic, aspirin may induce an asthma attack

When given to children aspirin may cause Reye’s syndrome. 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.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Aspirin 75mg Gastro-resistant Tablets.

Taking other medicines

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)

•    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)

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

•    insulin or any other drug to treat diabetes

•    corticosteroids (used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation of the intestines)

•    phenytoin or sodium valproate (used to control epilepsy)

•    sulphonamides (a type of antibiotic) such as sulfamethoxazole.

•    medicines such as acetazolamide used to treat glaucoma

•    antacids (indigestion medicine). Do not take antacids just before or after taking Aspirin 75mg Gastro-resistant Tablets as they may cause the aspirin to be released too soon.

Before using aspirin you should inform a healthcare professional about the medicines you are taking. If you are using aspirin regularly you should seek advice before taking any other medicine (including other medicines you may have bought).

Pregnancy and breast-feeding

Pregnant women should not take aspirin during pregnancy unless advised by their doctor. Regular or high dose aspirin therapy during late pregnancy can cause serious complications in the mother or baby.

Do not take Aspirin 75mg Gastro-resistant Tablets if you are breast-feeding because some of the aspirin may be in your breast milk, and could harm your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Always take Aspirin 75mg Gastro-resistant Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

• Prevention of heart attacks, angina or mini-strokes:

For your first dose - your doctor will tell you to chew two 75mg

tablets. Chewing the tablets will help the aspirin start to work quickly.

After this first dose - The usual dose is one or two 75 mg tablets each

day. Sometimes your doctor may tell you to take a higher dose.

Apart from the first dose of Nu-Seals, swallow the tablets whole with water.

Do not cut, crush or chew them as this will damage the special coating. If the coating is damaged the tablets are more likely to irritate your stomach.

If you may be taking this medicine for a long time, you should talk to your doctor about it.

What to do if you take more Aspirin 75mg Gastro-resistant Tablets than you should

If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or contact the nearest casualty department. Show any left over medicines or the empty packet to the doctor.

If you forget to take Aspirin 75mg Gastro-resistant Tablets

Do not worry. If you miss a dose, wait until it is time for your next dose, then go on as normal. DO NOT take a double dose.

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

Like all medicines, Aspirin 75mg Gastro-resistant Tablets can cause side effects, although not everyone gets them. The more common side effects of aspirin include:

•    hypersensitivity (which may mean you have skin rashes or itching, or wheezing or coughing or difficulty breathing)

•    nausea and vomiting

•    ringing in your ears

•    pain or discomfort in your stomach or lower chest after eating.

Aspirin may sometimes cause asthma or bronchospasm (narrowing of the airways that causes wheezing or difficulty breathing).

Aspirin may cause bleeding, and you must tell your doctor if you experience any unusual bleeding.

Rarely, you may suffer more serious side effects, tell your doctor immediately if you get any of the following:

•    blood in your vomit

•    blood in your urine

•    bruising with purple spots

•    coughing up blood (however small the amount)

•    any swellings

•    black stools

•    kidney stones (which can cause severe stomach or back pains).

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. How to store Aspirin 75mg Gastro-resistant Tablets_

Keep out of the reach and sight of children.

Do not use Aspirin 75mg Gastro-resistant Tablets after the use before date which is stated on the carton and blister.

Do not store above 25°C. Do not take Aspirin 75mg Gastro-resistant Tablets if you notice the appearance has changed in any way.

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

What Aspirin 75mg Gastro-resistant Tablets contains

The active ingredient in this medicine is aspirin (acetylsalicylic acid). Each

tablet of Aspirin 75mg Gastro-resistant Tablets contains 75 milligrams (mg) of aspirin.

The other ingredients are maize starch, hypromellose, talc, methacrylic acid-ethyl acrylate (1:1) copolymer dispersion 30 percent, polyethylene glycol 3350, propylene glycol, benzyl alcohol, emulsion silicone. Printing ink containing shellac, iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide (E527) and simeticone.

What Aspirin 75mg Gastro-resistant Tablets looks like and contents of the pack

Aspirin 75mg Gastro-resistant Tablets is a white tablet, with 75 on it in red. Aspirin 75mg Gastro-resistant Tablets comes in boxes of 56 tablets.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.

Aspirin 75mg Gastro-resistant Tablets is manufactured by Chanelle Medical, Loughrea, Co Galway, Ireland.

The information in this leaflet applies only to Aspirin 75mg Gastro-resistant Tablets. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

This leaflet was last approved : October 2011

Nu-Seals is a trademark of Alliance Pharmaceuticals Limited.

Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks © Alliance Pharmaceuticals Limited, 2011