Document: label-leaflet MAH GENERIC_PL 20046-0033 change

• label-leaflet MAH GENERIC_PL 20046-0033
• leaflet MAH BRAND_PL 16853-0063
• leaflet MAH BRAND_PLPI 15184-1540
• leaflet MAH BRAND_PLPI 21828-0616
• leaflet MAH GENERIC_PL 16853-0063

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspirin 300mg Gastro-resistant Tablets

Aspirin

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Aspirin 300mg Gastro-resistant Tablets are and what they are used for

2.    Before you take Aspirin Tablets

3.    How to take Aspirin Tablets

4.    Possible side effects

5.    How to store Aspirin Tablets

6.    Further information

1. What Aspirin 300mg Gastro-resistant Tablets are and what they are used for

Your medicine is called Aspirin 300mg Gastro-resistant Tablets (called Aspirin Tablets throughout the rest of this leaflet).

What this medicine does

Your doctor has prescribed Aspirin Tablets to treat one or more of the following conditions:

•    as a painkiller e.g. to relieve headache and toothache;

•    to reduce fever;

•    as an anti-inflammatory medicine e.g. to treat rheumatoid arthritis;

•    to reduce the likelihood of having a heart attack, if you have previously had a heart attack or have angina (severe pain in the chest which may travel into the jaw, neck and arms).

Aspirin belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin works by preventing the release in the body of substances which cause pain, inflammation and fever. Aspirin also thins the blood which helps to reduce the

likelihood of having a heart attack.

These tablets have been specially coated (gastro-resistant coating) to help minimise stomach upset and feeling sick (sometimes experienced as side effects of these tablets - see Section 4 Possible side effects).

2. Before you take Aspirin Tablets

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.

Do not take Aspirin Tablets if you:

• are allergic (hypersensitive) to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, or any of the other ingredients of Aspirin Tablets (see Section 6 What Aspirin Tablets contain);

•    have or have had a stomach ulcer;

•    have a condition where your blood does not clot properly (e.g. haemophilia);

•    have or have had gout;

•    are in the last 3 months of pregnancy or are breast-feeding.

Talk to your doctor or pharmacist if any of the following apply to you:

•    if you have asthma, or suffer from allergies;

•    if you have problems with your kidneys or liver;

•    if you are dehydrated;

•    if you have high blood pressure;

•    if you have a lack of glucose 6-phosphate dehydrogenase (G6PD);

•    if you are elderly.

Using other medicines

Can you take Aspirin Tablets with 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)

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).

Make sure your doctor also knows if you are taking a medicine listed here:

•    Mifepristone (used to terminate pregnancy): if taken with aspirin this medicine may not be as effective.

•    Metoclopramide (used to treat nausea and vomiting): it may increase the effect of aspirin.

•    Adsorbents e.g. kaolin (for diarrhoea) and Antacids e.g. aluminium hydroxide and magnesium carbonate (used to treat indigestion): these medicines may reduce the effect of aspirin.

•    Medicines known to affect the clotting of your blood: if you take

one of these medicines below with aspirin you may increase the likelihood of bleeding.

•    Antidepressants (used to treat depression) e.g. Selective Serotonin Reuptake Inhibitors (SSRIs) (such as citalopram, fluoxetine) or venlafaxine.

•    Sibutramine (to help weight loss).

•    Clopidogrel (used to prevent strokes and heart attacks).

•    Iloprost (used to treat a specific type of high blood pressure under specialist supervision).

•    Angiotensin-II Receptor antagonists e.g. valsartan, losartan (used to lower high blood pressure): taken with aspirin these medicines may not be as effective and you may suffer from kidney problems.

Medicines to control epilepsy e.g. phenytoin and valproate: aspirin may increase the effect of these medicines.

Zafirlukast (used to prevent or treat asthma).

Carbonic anhydrase inhibitors e.g. acetazolamide (used in the treatment of glaucoma, epilepsy and excess water retention): if taken with aspirin the side effects of these medicines may become more severe.

Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose of aspirin should not be greater than 80mg a day.

Taking Aspirin Tablets with food and drink

•    Aspirin Tablets should be taken before meals with a drink of water.

Pregnancy and breast-feeding

•    If you are pregnant, thinking of becoming pregnant, or breast-feeding, ask your doctor or pharmacist for advice before taking Aspirin Tablets.

3. How to take Aspirin Tablets

Always take Aspirin Tablets exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

You must swallow the tablets whole, before meals with a drink of

water. Do not chew, crush or break the tablets.

Adults (including the elderly and children over 16 years)

If you are taking aspirin as a painkiller, as an anti-inflammatory medicine or for treating fever:

•    The usual dose is three tablets taken three to four times daily as required, with at least four hours in between each dose.

If you are taking aspirin to help reduce the risk of a heart attack:

•    The usual dose is one tablet taken daily.

Children and Adolescents

Aspirin should not be given to children aged under 16 years of age unless on the advice of a doctor.

If you take more Aspirin Tablets than you should

•    If you take more Aspirin Tablets than your doctor has prescribed contact your nearest hospital casualty department or doctor

immediately. Take the medicine or this leaflet with you to show the doctor.

If you forget to take Aspirin Tablets

•    If you forget to take a dose, do not worry. Take the next dose when it is due.

•    Do not take more than one dose in any 4-hour period.

•    Do not take double the amount to make up for a forgotten

dose.

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

4. Possible side effects

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

If you experience the following side effects while taking your

medicine, you should stop taking your tablets and tell your doctor

straight away:

•    allergic reaction (hypersensitivity) which may include lumpy skin or hives, swelling of eyelids, face, lips, mouth or tongue, or sudden wheeziness, or induce or worsen asthma attacks;

•    you suffer from severe or persistent indigestion, stomach upset or pain, you may develop ulcers or bleeding from the stomach which can cause severe stomach pain, bloody or black tarry stools or vomiting blood.

Other possible side effects:

•    stomach upset and feeling sick;

•    ringing or buzzing in the ear (tinnitus);

•    dizziness;

•    confusion;

•    an increased tendency to bleed;

•    you may bruise more easily.

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

5. How to store Aspirin Tablets

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the label.

Store your medicine below 25°C. Keep your medicine in the dark and away from moisture.

Do not use if you notice that the pack is damaged. Return it to your pharmacist.

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

6. Further information What Aspirin Tablets contain

-    The active substance is aspirin. Each tablet contains 300mg of aspirin.

-    The other ingredients are microcrystalline cellulose, maize starch, silica, zinc stearate, methacrylic acid copolymer, triethylcitrate, talc, titanium dioxide (E171), iron oxide (E172), sodium hydroxide and polyethylene glycol 6000. The tablets are marked with black ink containing shellac, iron oxide (E172) and propylene glycol.

What Aspirin Tablets look like and contents of the pack

Aspirin Tablets are round, pink tablets with Aspirin 300EC in black on one side. They are packed in tamper-evident, child-resistant plastic packs.

Each pack of Aspirin Tablets contains 100 tablets.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited, Unit 5, Faraday Court,

Burton upon Trent, DE14 2WX, UK Tel: 01283 495 280 Fax: 01283 495 290 Email: medinfo@focuspharmaceuticals.co.uk Manufacturer

Custom Pharmaceuticals Limited, Conway Street, Hove,

Sussex, BN3 3LW

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone 01283 495 280 or email medinfo@focuspharmaceuticals.co.uk.

This leaflet was last revised in March 2012.