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Aspirin 75mg Tablets

Document: leaflet MAH GENERIC_PL 16201-0008 change

PACKAGE LEAFLET: INFORMATION FOR THE USER DISPERSIBLE ASPIRIN 75MG TABLETS

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 Dispersible Aspirin 75mg is and what it is used for

2.    Before you take Dispersible Aspirin 75mg

3.    How to take Dispersible Aspirin 75mg

4.    Possible side effects

5.    How to store Dispersible Aspirin 75mg

6.    Further information

1.    What Dispersible Aspirin 75mg is and what it is used for

Your medicine is called Dispersible Aspirin 75mg (called Dispersible Aspirin throughout the rest of this leaflet).

What this medicine does

Your doctor has prescribed Dispersible Aspirin to treat mild to moderate pain

Aspirin belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

2.    Before you take Dispersible Aspirin 75mg

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 Dispersible Aspirin 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 Dispersible Aspirin (see Section 6 What Dispersible Aspirin contains);

•    have or have had a stomach ulcer;

•    have a condition where your blood does not clot properly (e.g. haemophilia) or if you are taking medicine to prevent blood from clotting;

•    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 are taking this medicine for long term treatment

•    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 diabetes;

•    if you are scheduled for surgery;

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

•    if you are elderly.

Using other medicines

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

•    ACE inhibitors or Angiotensin-II Receptor antagonists e.g. captopril, enalapril maleate, 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.

•    Kaolin used to treat diarrhoea: these medicines may reduce the effect of aspirin.

•    Non-steroidal anti-inflammatory (NSAIDs) e.g. ibuprofen or diclofenac sodium, fenbufen, indometacin or piroxicam (used for pain relief and to treat inflammation): if taken with aspirin you may have more severe side effects.

•    Antacid 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.

•    Warfarin, phenindione, acenocoumarol or heparins (blood thinning medicines).

•    Corticosteroids e.g. prednisolone and betamethasone (used to treat allergy or inflammation): taking aspirin with these medicines may increase the risk of bleeding or ulcers in the stomach.

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

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

•    Methotrexate (used in the treatment of rheumatoid arthritis, Crohn’s disease and cancer): if taken with aspirin the side effects of methotrexate may become more severe.

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

•    Mifepristone (used to terminate pregnancy). Aspirin should be avoided until 8 to 12 days after mifepristone has been discontinued.

•    Sulphonamide antibiotics (e.g. co-trimoxazole).

•    Zafirlukast (for asthma).

•    Probenicid or Sulfinpyrazole (used to treat gout): if taken with aspirin these medicines may not be as effective.

•    Spironolactone (diuretic) water tablets: if taken with aspirin this medicine may not be as effective.

•    Antidiabetic drugs including insulin, sulphonylurea oral hypoglycaemics (e.g. glipizide), used to lower blood sugar levels.

   Acetazolamide used to treat glaucoma (raised pressure in the eye).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Dispersible Aspirin with food and drink

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

If you drink alcohol (wine, beer, spirits) when you are taking these tablets, it may make your stomach more sensitive to aspirin.

Pregnancy and breast-feeding

If you are pregnant, thinking of becoming pregnant, or breast- feeding, ask your doctor or pharmacist for advice before taking Dispersible Aspirin. You should not take this medicine if you are in the last three months of pregnancy or if you are breast feeding.

Driving and using machines

Dispersible Aspirin should not affect the ability to drive or use machines. However, if you feel dizzy when you start to use this medicine, do not drive or use machines until the effect has worn off. Important information about some of the ingredients of Dispersible Aspirin

This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Dispersible Aspirin 75mg

Always take Dispersible Aspirin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be dissolved in a half glass of cold water and taken before meals.

Adults (including the elderly and children over 16 years)

•    The usual dose to relieve pain is four tablets taken every four hours.

Do not take more than six doses in 24 hours.

It is important to drink plenty of fluids when suffering from colds and flu.

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 Dispersible Aspirin than you should

•    If you take more Dispersible Aspirin 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 Dispersible Aspirin

•    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, Dispersible Aspirin 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, runny nose 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.

•    unusual bleeding which may cause blood in the urine, coughing up blood or a stroke due to bleeding in the brain.

Other possible side effects:

•    stomach upset, heartburn, vomiting or feeling sick;

•    ringing or buzzing in the ear (tinnitus);

•    dizziness;

•    confusion;

•    an increased tendency to bleed;

•    unusual bruising or infections such as sore throats - this may be a sign of changes in the blood;

•    feeling very tired or severely exhausted;

•    nose bleeds (if a nose bleed is severe or lasts for a long time, talk to a doctor straight away);

•    pain in your lower abdomen or back, difficulty in passing urine - this may be a sign of kidney stones.

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 Dispersible Aspirin 75mg

Keep out of the reach and sight of children.

Do not use after the expiry date. This refers to the last day of that month and is stated on the label of the bottle and blister packs.

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 Dispersible Aspirin contain

-    The active substance is aspirin. Each tablet contains 75mg of aspirin.

-    The other ingredients are starch, sodium saccharin, lactose, citric acid, calcium carbonate, talc, sodium lauryl sulphate.

What Dispersible Aspirin look like and contents of the pack

Dispersible Aspirin are white, flat circular tablets, plain on one side and marked “F” on the other side. These tablets are available in securitainers or opaque plastic screw capped containers containing 25, 50, 100, or 1000 tablets. Also available in blister packs containing 24 and 28 tablets.

Marketing Authorisation Holder:

Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer:

Bristol Laboratories Ltd.,

Laporte Way, Luton, Beds, LU4 8WL, UK.

This leaflet was last revised in December 2013.