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Aspirin Tablets Bp 300mg

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Patient Information Leaflet

SOLUBLE ASPIRIN 300MG TABLETS

Read all of this leaflet carefully before you start

taking this medicine.

•    Keep the leaflet in a safe place because you may want 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What is Soluble Aspirin and what is it used

for?

2.    Before you take Soluble Aspirin

3.    How to take Soluble Aspirin Tablets

4.    Possible side effects

5.    How to store Soluble Aspirin Tablets

6.    Further information

1. What is Soluble Aspirin and what is it used for

•    Aspirin is an anti-inflammatory analgesic (reduces pain and inflammation) with antipyretic (reduces high temperature) properties.

•    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.

2. Before you take Soluble Aspirin

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

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

•    are suffering from stomach ulcers

•    have haemophilia (a defect in blood clotting mechanism)

•    have gout

•    have severe liver, kidney or heart failure

•    have high blood pressure

•    have intolerance to sugars (this medicine contains lactose)

•    are pregnant or breast feeding

•    have nasal polyps associated with asthma.

Important warning

•    Do not give to children under 16 except on medical advice.

•    There is a possible association between aspirin and Reyes 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 drink alcohol whilst taking this medicine.

♦    Check with your doctor or pharmacist

before taking Aspirin tablets if you:

•    have asthma or allergies

•    have a lung problem

•    are elderly

•    are planning to become pregnant.

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 (to treat gout) such as antacids, citrates, probenecid, sulphinpyrazone

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

•    antidiabetics, oral hypoglycaemics of the sulponylurea type.

•    corticosteroids (to suppress the immune system)

•    other non-steroidal anti-inflammatory drugs ( NSAIDs e.g. ibuprofen or naproxen)

•    medicines which can cause hearing problems (vancomycin)

•    sulphonalamides (drugs which hinder bacterial growth)

♦    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.

♦    Important information about some of the ingredients of your medicine

Aspirin tablets contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Soluble Aspirin

Unless otherwise directed by your doctor, the following doses should be taken.

Stir the tablet in a small glass of water until dispersed, and drink immediately.

Adults, including the elderly: 1 to 3 tablets every 3 -4 hours as required.

Children under 16 years old: Not recommended, unless advised by your doctor.

For prevention of blood clots: 1 tablet once a day

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

•    Do not take more than four doses in any 24 hour period.

•    Do not take aspirin tablets for more than 3 days without consulting a doctor.

•    If you take more tablets than you should

If you take too many tablets contact your doctor or hospital casualty department 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 a dose

If you forget to take a dose, take it as soon as you remember; then go on as before. If you see another doctor or go into the hospital, let him or the staff know what medicines you are taking.

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

4. Possible side effects

Like all the 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.

If you get any of these serious side effects, stop taking the tablets and see a doctor at once

Allergic reaction- itchy, red, blotchy, blistered skin and runny nose. Swelling of the face, lips, throat or tongue, difficulty breathing, worsening of asthma.

Gastrointestinal system-stomach ulcer or bleeding which can be severe (you may develop bloody or black tarry stools, severe stomach pain and you may vomit blood), stomach irritation (mild stomach pain, heart burn and feeling or being sick) and inflammation of the liver. Deaths have occurred.

Blood -anaemia, changes in numbers and types of blood cells and enzymes seen in blood tests. If you have an increased number of nose bleeds, longer bleeding time or notice that you bruise more easily or have more infections talk to your doctor.

Other side effects that are less serious, if they bother you talk to your doctor or pharmacist

•    Kidney - changes in the frequency of urinating or the amount urinated.

•    Ears- ringing or buzzing in the ear (tinnitus)

• Lung- bronchospasm (the contraction of air passage inside the lungs).

If any side effect becomes severe, or you notice side effects not listed in this leaflet please tell your doctor or pharmacist.

5. How to store Soluble Aspirin

•    This medicine should not be used after the expiry date stated on the pack.

•    Store the tablets below 25° C in a dry place. Protect from light and moisture.

Keep all medicines out of the reach and sight of children

Remember: Do not use Aspirin tablets after expiry date stated on the label/carton. The expiry date refers to last day of that month. Please take the unused and leftover tablets to the pharmacist for safe disposal. Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment. This medicine has been prescribed for you. Do not give it to anyone else even if their symptoms appear to be the same as yours, since it may be harmful to them.

6. Further information

♦ What Soluble Aspirin tablets contain:

•    The active substance (the ingredient that makes the tablets work) is 300mg of aspirin.

•    The other ingredients are: Citric Acid, Saccharin sodium, Lactose, maize starch, Sodium lauryl sulphate and purified talc.

♦ What Soluble Aspirin tablets look like and the contents of the pack:

•    White, flat circular tablets with beveled edge and a breakline on one face.

•    Soluble Aspirin 300mg tablets are available in pack sizes of “12, 16, 24, 25, 32, 50, 100, 500and 1000 tablets”.

•    Larger packs containing more than 16 tablets are only available from a pharmacist.

The Marketing Authorization Holder and company responsible for manufacture:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.

Telephone: 02089975444 Fax:    02089975433

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

PL 04556 / 0014

Reference: 00140912

The last leaflet revised: Sep 2012.