45mm

Dispersible Aspirin 75 mg Tablets 0155 Insert

SAME SIZE ARTWORK

430 x 130 mm

Front

Package Leaflet: Information for the user

DISPERSIBLE ASPIRIN 75MG TABLETS

Read all of this 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 has told you.

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

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

•    If you get any side effects, talk to your doctor or pharmacist. 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 feel worse._

What is in this leaflet:

1.    What Aspirin is and what it is used for

2.    What you need to know before you take Aspirin

3.    How to take Aspirin

4.    Possible side effects

5.    How to store Aspirin

6.    Contents of the pack and other information_

1. What Aspirin is and what it is used for

•    Aspirin (acetylsalicylic acid) belongs to a group of medicines called antiplatelet agents that help prevent your blood cells sticking together and forming a blood clot

•    Aspirin are principally used to prevent blood clots forming following a heart attack or stroke or to help prevent heart attacks and strokes in patients who have previously suffered from these conditions. They may have been prescribed for you if you have recently had by-pass surgery.

2. What you need to know before you take Aspirin Do not take this medicine if you:

•    are allergic to acetylsalicylic acid or any of the ingredients in this medicine (see section 6)

•    are allergic to other salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain

•    if you are under 16 years old, unless your doctor tells you to

•    have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs

•    currently have or have ever had an ulcer in your stomach or small intestine, indigestion problems or any other type of bleeding like a stroke

•    if you have a blood clotting disorder (e.g. haemophilia or thrombocytopenia) or are taking medicines to thin your blood

•    are suffering from gout

•    have severe liver or kidney problems

•    are in your last 3 months of pregnancy; you must not use doses higher than 100mg per day (see section "Pregnancy and breast-feeding”)

•    are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses higher than 15mg per week

•    have nasal polyps associated with asthma Warnings and Precautions

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

•    have kidney, liver problems

•    have higher blood pressure

•    are asthmatic, have hay fever, or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack

•    are elderly

•    have heavy menstrual periods

You must immediately seek medical advice, if your symptoms get worse or if you experience severe or unexpected side effects e.g. unusual bleeding symptoms, serious skin reactions or any other sign of serious allergy (see section "Possible side effects”).

Inform your doctor if you are planning to have an operation (even a minor one, such as tooth extraction) since acetylsalicylic acid is blood-thinning there may be an increased risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease which affects the brain and liver and can be life threatening. For this reason, Aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.

You should take care not to become dehydrated (you may feel thirsty with a dry mouth) since the use of acetylsalicylic acid at the same time may result in deterioration of kidney function.

This medicinal product is not suitable as a pain killer or fever reducer.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist.

Other Medicines and Aspirin

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effects of treatment may be influenced if aspirin is taken at the same time as other medicines for:

•    Thinning of the blood/prevention of clots (e.g. warfarin, coumarin, dipyridamole heparin, phenindione and clopidogrel)

•    Organ rejection after transplantation (e.g. ciclosporin, tacrolimus)

•    High blood pressure (e.g. diuretics and ACE-inhibitors)

•    Regulation of the heart beat (digoxin)

•    Manic-depressive illness (lithium)

•    Pain and inflammation (e.g. anti-inflammatory medicines such as ibuprofen, or steroids)

•    Gout (e.g. probenecid)

•    Epilepsy (valproate, phenytoin)

•    Glaucoma (acetazolamide)

•    Cancer or rheumatoid arthritis (e.g. methoxtrexate)

•    Diabetes (e.g. glibenclamide)

•    Zafirlukast (used for asthma)

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

•    Metoclopramide and domperidone (used for nausea and vomiting)

•    Depression (selective serotonin re-uptake inhibitors (SSRIs) such as sertraline or paroxetine)

•    Mifepristone (for termination of pregnancy)- do not take this medicine for 8 to 12 days after taking mifepristone

•    Vancomycin (used to treat infections)

•    Use 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 (corticosteroids)

•    Iron salts (for treatment of iron deficiency anaemia), carbonates (treatment of peptic ulcer and reflux), Alkali hydroxides (antacids), adsorbents (e.g. kaolin for diarrhoea)

•    Alcohol may increase the risk of side effects. Avoid alcohol whilst taking Aspirin

Before taking 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 medicine you may have bought).

Aspirin with food, drink and alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breast-feeding

•    Ask your doctor or pharmacist for advice before taking this or any other medicines

•    You should not take Aspirin tablets if you are in the last 3 months of pregnancy, unless you are advised to do so by your doctor and then the daily dose should not exceed 100mg (see section "Do not take”). Regular or high doses of this medicinal product during late pregnancy can cause serious complications in the mother or baby.

•    Breast-feeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

Aspirin does not usually affect the ability to drive or operate machinery.

130 mm

430 mm

SAME SIZE ARTWORK

430 x 130 mm

Back

Aspirin Tablets Contains Lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

|    3. How to take Aspirin    ~|

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will have decided the right dose of Aspirin for you so follow his or her instructions. These tablets are suitable for adults, the elderly and young people over 16 years of age.

•    Stir the tablets in a small glass of water until dispersed and drink immediately

•    The usual dose for the long-term management of cardiovascular disease (disease affecting the blood supply to the heart) or cerebrovascular disease (disease affecting the blood supply to the brain) or following by-pass surgery is 1 to 2 tablets, once a day. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 4 tablets daily may be used on the advice of a doctor.

In general, acetylsalicylic acids (such as aspirin) should be used with caution in elderly who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Aspirin is not intended for children under 16 years of age. There is a risk of Reye's syndrome when aspirin is taken by children. Reye's syndrome is a very rare disease that can be fatal.

If you forget to take Aspirin

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 to make up for a forgotten tablet.

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

If you take more Aspirin than you should

If you or someone else accidentally takes too many tablets, tell your doctor at once. If you cannot do this, go to the nearest hospital casualty department. Take with you the container or carton and any tablets that are left so that the hospital can easily tell what medicine has been taken.

Do not take a double dose to make up for a forgotten dose.

|    4. Possible Side Effects    ~|

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Aspirin and contact a doctor immediately:

•    Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction)

•    Reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome

•    Ulcers in stomach or small intestine and perforation

•    Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools

•    Severe bleeding in the stomach and intestines

•    Cramps in the lower respiratory tract, asthma attack

•    Bleeding in the brain

Common side effects (may affect up to 1 in 10 people):

•    Indigestion

•    Increased tendency for bleeding

Uncommon side effects (may affect up to 1 in 100 people):

•    Hives

•    Runny noses

•    Breathing difficulty

Rare side effects (may affect up to 1 in 1,000 people):

•    Changes in blood cell numbers- symptoms include unexplained bruising and bleeding, infections, tiredness, fever, sore throat, mouth ulcers

•    Nausea and vomiting

•    Inflammation in the blood vessels

•    Bruising with purple spots (cutaneous bleeding)

•    Abnormal heavy or prolonged menstrual periods

Not known (frequency cannot be estimated from the available data)

•    Ringing in your ears (tinnitus) or reduced hearing ability

•    Headache

•    Spinning sensation

•    Diarrhoea

•    Prolonged bleeding time

•    Impaired kidney function

•    Salt and water retention

•    Impaired liver function

•    High level of uric acid in the blood.

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 the Yellow Card Scheme at: 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 Aspirin    \

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package Containers: Keep the container tightly closed.

•    Do not use this medicine after the expiry date which is stated on the carton.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Aspirin Tablets contain

•    Each tablet contains Aspirin 75mg, as the active ingredient

•    The other ingredients are: sodium saccharin, citric acid, calcium carbonate, maize starch, purified talc, sodium lauryl sulfate, lactose monohydrate.

What the tablets look like and contents of the pack

•    Tablets are white and flat embossed <F> on one side and plain on the other.

• The blisters are available in packs of 12, 20, 24, 28, 30, 32, 48, 56, 60, 84, 96, 98, 100 and 112 tablets.

• The containers are available in packs of 32, 50, 100, 500 and 1000 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories ltd,

Unit 3, Canalside, 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

Dispersible Aspirin 75mg Tablets; PL 17907/0155, PL 17907/0156 This leaflet was last revised in January 2016

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.

V5 27-01-2016 DO

130 mm

430 mm