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Dispersible Aspirin Tablets Bp 300mg

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DISPERSIBLE ASPIRIN 300MG TABLETS


PATIENT INFORMATION LEAFLET


Read this leaflet carefully because it contains important information for you.

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

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

•    You must contact a doctor or pharmacist if your symptoms worsen or do not improve.


IN THIS LEAFLET:


1.    What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

[] WHAT THIS MEDICINE IS FOR

Dispersible Aspirin 300mg Tablets contain aspirin, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature.

This medicine is used to relieve:

•    sprains, strains, rheumatic pain, muscular aches and pains, sciatica and lumbago (lower back pain)

•    fibrositis, joint swelling and stiffness

•    neuralgia (nerve pain)

•    headache and migraine

•    dental pain, period pain

•    sore throat and fever (high temperature)

•    the symptoms of colds and flu.

VX BEFORE YOU TAKE THE MEDICINE

Do not take Dispersible Aspirin 300mg Tablets if you:

•    have or have ever had a stomach ulcer, perforation or bleeding

•    are allergic to aspirin, to any of the ingredients (listed in section 6), or to ibuprofen or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)

•    have severe kidney or liver disease

•    suffer from a bleeding disorder (e.g. haemophilia), asthma or gout

•    are taking other NSAID painkillers

•    are taking medicines for thinning the blood (anticoagulants)

•    are in the last 3 months of pregnancy or are breastfeeding


Talk to your doctor or pharmacist before taking Dispersible Aspirin 300mg Tablets if you:

•    have asthma or have suffered from asthma

•    have liver or kidney problems

•    have stomach or bowel disorders

•    suffer from dehydration

•    suffer from glucose-6-phosphate dehydrogenase deficiency

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 under 16 years, unless on the advice of a doctor.

If you are taking other medicines

You must not take these tablets if you are taking certain other medicines - see section 2 ‘Do not take Dispersible Aspirin 300mg Tablets if.

Talk to your pharmacist or doctor before you take the tablets if you are taking any regular medication, especially:

•    medicines for high blood pressure and water tablets (diuretics)

•    corticosteroids

•    methotrexate (a medicine for cancer)

•    probenecid and sulfinpyrazone (medicines for gout)

•    acetazolamide (a medicine for the eye disorder glaucoma, epilepsy and water retention)

•    metoclopramide and domperidone (medicines used to treat the feeling of sickness and being sick)

•    phenytoin and sodium valproate (medicines for epilepsy)

•    antacids (medicines for acid indigestion)

•    mifepristone (a medicine used to terminate a pregnancy)

•    cilostazol (a medicine used to treat heart disease)

•    sibutramine, SSRI's and venlafaxine (medicines used to treat depression)

•    zafrilukast (a medicine used to treat asthma)

Pregnancy and Breastfeeding

Do not take Dispersible Aspirin 300mg Tablets if you are in the last 3 months of pregnancy or are breastfeeding. Talk to your doctor or pharmacist before taking Dispersible Aspirin 300mg Tablets if you are in the first 6 months of pregnancy.

Important information about some of the ingredients of this medicine.

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

Further information overleaf.


El HOW TO TAKE THE MEDICINE


The tablets must be dispersed in water immediately before use.


Age

Dose and how often to take

Adults, the elderly and children over 16 years

Take 1 to 3 tablets up to 4 times a day, as required. Disperse the tablets in water before taking them.

Do not take more often than every 4 hours.

Do not exceed 12 tablets in 24 hours.

The tablets are intended for short-term use only. Use them for the shortest time needed to relieve symptoms. Always use the lowest dose that relieves your symptoms. Do not take Dispersible Aspirin 300mg Tablets for longer than 10 days unless your doctor tells you to.

Do not give to children under 16 years.


Talk to a doctor or pharmacist if you do not get better or get worse, or if new symptoms occur.


If you take too many tablets: Talk to a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you.

n POSSIBLE SIDE EFFECTS

Most people take Dispersible Aspirin 300mg Tablets without any problems, but it can have side effects, like all medicines.

To reduce the chance of side effects, especially if you are elderly, use the lowest effective dose for the shortest possible time.

STOP TAKING the tablets and contact your doctor immediately if you develop any of the following symptoms at any time while taking your medicine:

Allergic reactions:

The following reactions may mean you are having an allergic reaction to this medicine:

•    asthma, worsening of asthma, unexplained wheezing or shortness of breath

•    swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)

•    rapid heart rate, low blood pressure, collapse.

•    Also, there may be skin reaction (including hives, rash and itching) - very rarely these can be severe with blistering and peeling skin


Stomach and bowel problems including:

•    stomach discomfort or pain, nausea, indigestion or heartburn, stomach ulcer

•    vomit with blood or dark particles (like coffee grounds)

•    black tarry stools or blood passed in your stools

•    worsening of bowel problems (ulcerative colitis or Crohn's disease)

Blood disorders which can cause:

•    unexplained or unusual bruising or bleeding

•    sore throat or mouth ulcers

•    fever (high temperature)

•    extreme paleness or weakness and exhaustion Other side effects that may occur include those listed below. If you experience any of these symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking the tablets and see your doctor.

Other stomach and intestine effects including diarrhoea, flatulence, constipation and vomiting. Nervous system problems including hearing disorders (such as tinnitus), vertigo and mental confusion.

El STORING THE MEDICINE

Do not use after the expiry date shown on the pack. Store below 25°C in a dry place and protect from light. Keep all medicines out of the reach and sight of children.

El FURTHER INFORMATION

What is in this medicine:

The active ingredient is:

Aspirin 300mg per dispersible tablet.

The other ingredients are:

Starch, Sodium Saccharin, Lactose, Anhydrous Citric Acid, Calcium Carbonate, Talc, Sodium Lauryl Sulphate.

What this medicine looks like and contents of the pack

Dispersible Aspirin 300mg Tablets are round white tablets which must be dispersed in water immediately before use. This pack contains 8, 10, 12, 16, 24 or 32 tablets (not all packs may be marketed and packs of 24 and 32 tablets are only available from your pharmacist).

Marketing Authorisation Holder: Galpharm Healthcare Ltd, Upper Cliffe Road, Dodworth Business Park, Dodworth, South Yorkshire S75 3SP

Manufacturer: Galpharm International Ltd, Upper Cliffe Road, Dodworth Business Park, Dodworth, South Yorkshire S75 3SP

4001630

Date of approval: 04/20 0 9    464405 ddbgllooagagb