24 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

ASPIRIN 75MG GASTRO-RESISTANT TABLETS

Read all of this leaflet carefully because it contains important information for you.

•    This medicine is available without prescription; however you still need to take it carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information_

1. What this medicine is and _what it is used for_

•    Aspirin is a non-steroidal anti-inflammatory drug (NSAID). It helps prevent blood cells sticking together.

•    It can be used to help prevent further heart attacks and strokes in patients who have a history of these conditions. It can also be taken after bypass surgery. It should not be used for pain relief.

2. Before you take this medicine Do not take these tablets if you:

•    are allergic to Aspirin or any other non-steroidal anti-inflammatory drugs, such as ibuprofen (see symptoms of an allergic reaction in Section 4, Possible side effects)

•    are allergic to any of the other ingredients in the tablet (listed in section 6, Further Information)

•    have been told you suffer from haemophilia or from any disease which affects the clotting of your blood

•    are taking medicines to thin your blood such as Warfarin

•    are under 16 years old, unless your doctor has told you to take Aspirin

•    have gout

•    have a stomach ulcer or a history of stomach ulcer

Take special care with this medicine

Check with doctor or pharmacist before taking these tablets if you:

•    have kidney or liver problems

•    suffer from asthma or allergic disease

•    are elderly

•    are dehydrated

•    have been told you have glucose-6-galactose dehydrogenase (G6PD) deficiency

•    are going to have surgery, as you may need to stop taking your tablets several days before the surgery. Do not stop taking this medicine without seeking the advice of your doctor first.

•    are taking insulin for your diabetes

•    have high blood pressure

Taking other medicines Tell your doctor or pharmacist if you are taking any medicines, including those you buy without a prescription such as herbal remedies and health supplements from a pharmacy, supermarket or health food shop as they may interact with this medicine.

Examples of medicines which can affect Aspirin are:

•    Medicines to thin the blood (e.g. Warfarin)

•    Other non-steroidal anti-inflammatory drugs including aspirin, ibuprofen (to relieve pain, reduce swollen joints, muscles and ligaments)

•    Corticosteroids used to treat inflammatory conditions (e.g. prednisolone and hydrocortisone)

•    Carbonic anhydrase inhibitors (e.g. Acetazolamide used as a diuretic and to treat glaucoma)

•    Antacids (for indigestion) or adsorbents (e.g. kaolin for diarrhoea)

•    Mifepristone (for termination of pregnancy) - do not take this medicine for 8 to l2 days after taking mifepristone

•    Methotrexate, used to reduce inflammation in conditions like rheumatoid arthritis

•    Sulphonamide antibiotics used to treat infections (e.g. Co-trimoxazole)

•    Metoclopramide (for nausea and vomiting)

•    Medicines to treat high blood pressure (e.g. ACE - inhibitors like Lisinopril)

•    Medicines for epilepsy (e.g. Phenytoin and Sodium

Valproate)    _E

•    Water tablets (diuretics e.g. spironolactone)

•    Medicines for diabetes (e.g. Glibenclamide or insulin)

•    Zafirlukast (for asthma)

•    Medicines to treat gout (e.g. Probenecid and Sulphinpyrazone)

Aspirin may affect the results of thyroid function tests.

Tell your doctor or nurse if you are taking these

tablets.

Taking this medicine with Alcohol

•    Do NOT drink alcohol whilst taking this medicine.

Pregnancy and breast-feeding

•    Do not take this medicine if you are pregnant or think you have become pregnant or intend to become pregnant whilst taking these tablets or are breast feeding.

•    Always ask your doctor or pharmacist for advice before taking this or any other medicine.

Driving and using machines

•    These tablets do not usually affect the ability to

drive or operate machinery.    ®

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SAME SIZE ARTWORK 210 x 128 mm Front

_3. How to take this medicine_

•    Always take these tablets exactly as your doctor has advised you.

•    You should check with your doctor or pharmacist if you are not sure.

•    Swallow the tablet(s) with a small glass of water and do not cut, chew or crush it.

•    Do not take any medications for indigestion either immediately before or after taking this medicine.

Dosage:

Adults, elderly and children over 16 years: Take one or two tablets once daily.

Do not give to children aged under 16 years, unless on the advice of a doctor 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.

If you take more number of tablets than you should

Contact your nearest hospital casualty (A&E) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take a dose

If you forget to take a dose, skip the dose and take

the next dose as usual.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE.

4. Possible Side Effects

Like all medicines, these tablets can cause side effects, although not everybody gets them.

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

•    unexplained wheezing, shortness of breath, runny nose, swelling of the lips, face or neck, skin rash or itching, as these may be signs of an allergic (hypersensitivity) reaction

•    pass blood in your faeces (stools/motions), pass black tarry stools, or vomit blood or dark particles that look like coffee grounds

STOP TAKING this medicine and tell your doctor if you develop

•    indigestion or heartburn, or abdominal pain (pains in your stomach)

The following side effects can also occur during treatment with Aspirin tablets:

•    sometimes, the blood may become too thin and this can cause nose bleeds, blood in the urine, bruising more easily and purple spots, coughing up blood, and bleeding into the brain

•    anaemia (a reduction in the number of red blood cells which can make you look pale and feel tired) may occur due to bleeding

•    ringing in the ears (tinnitus)

•    skin reactions

•    nausea (feeling sick) and vomiting

•    kidney stones (sharp stabbing pains in the stomach or back, with blood in the urine)

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 Yellow Card Scheme Website: 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 this medicine

•    Keep the medicines in a safe place where children can not see or reach.

•    Do not take your tablets after the expiry date marked on the pack.

•    Do not store above 25°C.

•    Keep the tablets in the package or container in which they were given to you in order to protect from moisture and light.

•    If you have any left over tablets, take them back to your pharmacist for safe disposal.

6. Further Information

What Aspirin Gastro-resistant tablets contains:

•    Each gastro-resisitant tablet contains aspirin 75mg, as the active ingredient

•    The other ingredients are: potato starch, calcium hydrogen phosphate dehydrate E341, microcrystalline cellulose E460, talc E553b, methacrylic acid - ethylacrylate-copolymer (containing sodium lauril sulphate and polysorbate 80), macrogol, simeticone.

What the tablet looks like and contents of the pack

•    Tablets are white circular tablet, plain on both faces.

•    These tablets are available in blister packs of 28 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Name and address: Bristol Laboratories Ltd,

Unit 3, Canal side, Northbridge Road, Berkhamsted, Hertfordshire, United Kingdom, HP4 1EG Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Aspirin 75mg Gastro-resistant Tablets;

PL 17907/0158

This leaflet was revised in May 2015.

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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SAME SIZE ARTWORK

210 x 128 mm

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210 mm