Thursday 19 July 2012

Aspirin Tablets 300mg (POM)




Due to technical difficulties in printing the label-leaflet format, please find the relevant text below. Text is representative of the leaflet portion of label-leaflet spec no 50134509.




Aspirin 300mg 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.



Index



1. What Aspirin tablets are and what they are used for

2. Before you take

3. How to take

4. Possible side effects

5. How to store

6. Further information





What Aspirin tablets are and what they are used for


Aspirin tablets belong to a group of medicines which have analgesic (pain relieving), anti-inflammatory (inflammation reducing) and anti-pyretic (temperature reducing) properties.


These tablets may be used for the relief of:


  • headache, toothache, migraine, neuralgia (nerve pain), sore throat or period pains.

  • symptoms of influenza, feverishness, rheumatic pains, sciatica (nerve pain of the leg/back), lumbago (lower back pain), fibrositis (muscular rheumatism), muscular aches and pains.

The tablets may also be used to prevent blood clots especially after a heart attack or in patients with unstable angina or reduced blood flow in the brain.




Before you take



Do not take Aspirin tablets and tell your doctor if you have:


  • an allergy (hypersensitivity) to aspirin, salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) or other ingredients in the product. You may have developed difficulty breathing, a runny nose, itchy skin or swelling after taking aspirin or a NSAID previously (see section 6)

  • a stomach ulcer or a history of ulcers or indigestion


  • nasal polyps associated with asthma


  • haemophilia or other blood clotting disorder or are taking medicines to thin the blood.


Important warning:


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.



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



  • asthma or allergies


  • heart, liver or kidney problems or gout

  • an overactive thyroid gland


  • dehydration


  • anaemia or suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD) this can cause episodes of anaemia after eating certain foods such as fava beans (favism)

  • systemic lupus erythematosus (SLE) or other connective tissue disease.


Taking other medicines


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


  • medicines to prevent blood clotting such as warfarin, dipyridamole and heparin

  • metoclopramide or domperidone (to prevent sickness)

  • diuretics ("water tablets") e.g. spironolactone, frusemide, acetazolamide (to treat high blood pressure)

  • medicines which make your urine more alkaline such as antacids, citrates

  • probenecid, sulphinpyrazone (to treat gout)

  • methotrexate (to treat some cancers, psoriasis and rheumatic disease)

  • antidiabetics

  • phenytoin or sodium valproate (to treat epilepsy)

  • corticosteroids (to suppress the immune system)

  • mifepristone (to induce abortion)

  • other non-steroidal anti-inflammatory drugs - NSAIDs (eg ibuprofen or naproxen)

  • medicines which can cause hearing problems (vancomycin).



Pregnancy and breast-feeding


Avoid taking Aspirin tablets during pregnancy especially in the last 3 months of pregnancy or whilst breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.




Surgery and tests


If you need to have an operation including having your teeth removed or blood and urine tests, tell your doctor or dentist you are taking this medicine.





How to take


Always take Aspirin tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.


Avoid alcohol whilst taking this medicine.


Swallow the tablets with a glass of water.



Doses:



Adults, including the elderly
: 1 or 2 tablets every 3 to 4 hours as required. No more than 12 tablets in any 24 hour period.



Children under 16 years old
: Not recommended.



For prevention of blood clots: 1 tablet once a day.




If you take more than you should


If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include ringing in the ears, spinning sensation, fast breathing rate, changes in some of the chemicals in the body, heart or kidney failure, fever or coma.




If you forget to take the tablets


Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take more than one dose in any 4 hour period.





Possible side effects


Like all medicines, Aspirin tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.



Allergic reactions - runny nose, itchy skin, swelling of the face, lips, throat or tongue, worsening of asthma.



Gastrointestinal system - stomach ulcers or bleeding which can be severe (you may develop bloody or black tarry stools, severe stomach pain and vomit blood), stomach irritation (mild stomach pain, heartburn and feeling sick) and inflammation of the liver.



Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor.



Ears - ringing or buzzing in the ear.



Salicylism - if you take large doses for a long time you may develop symptoms of salicylism, these include: dizziness, ringing or buzzing in the ear, deafness, sweating, feeling or being sick, headache and confusion.


If you are concerned about any side-effects or have any other unusual effects, tell your doctor immediately and seek advice.




How to store


Keep out of the reach and sight of children.


Store the tablets below 25°C in a dry place.


Do not use Aspirin tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.


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.




Further information



What Aspirin tablets contain


  • The active substance (the ingredient that makes the tablets work) is 300mg aspirin (also known as acetylsalicylic acid).

  • The other ingredients are maize starch, purified talc (E553).



What Aspirin tablets look like and contents of the pack


Aspirin are white, uncoated tablets.


Pack sizes are 100 tablets.




Marketing Authorisation Holder and manufacturer



Actavis

Barnstaple

EX32 8NS

UK




This leaflet was last revised in January 2008





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