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Active substance(s): ASPIRIN

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Leaflet mockup for submission purpose only
Package leaflet: Information for the user
Aspirin 300mg Soluble Tablets
(Referred to as Aspirin Tablets
throughout the rest of this leaflet)

Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking
Aspirin Tablets
• if you have asthma, or suffer from allergies;
• if you have problems with your heart, kidneys or liver;
• if you are dehydrated;
• if you have nasal polyps (inflamed swellings inside the nose);
• if you suffer from indigestion (dyspepsia);
• if you have an infection;
• if you have high blood pressure;
• if you have a lack of glucose 6-phosphate
dehydrogenase (G6PD);
• if you are elderly;
• if you are diabetic.
You should let your doctor know you are taking aspirin
tablets, particularly if you are going to have an operation,
as you may need to stop taking your tablets several days
before the operation.

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, pharmacist or nurse have 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,
pharmacist or nurse. 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 if
you feel worse after 3 days.
What is in this leaflet
1. What Aspirin Tablets are and what they are used for
2. What you need to know before you take Aspirin Tablets
3. How to take Aspirin Tablets
4. Possible side effects
5. How to store Aspirin Tablets
6. Contents of the pack and other information
1. What Aspirin Tablets are and what they are used for
The name of your medicine is Aspirin Tablets. The active
ingredient in your medicine is Aspirin. Aspirin belongs to a
group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). Aspirin works by preventing the release in
the body of substances which cause pain, inflammation
and fever.
Aspirin Tablets are used for the symptomatic relief of mild
to moderate pain, including migraine, toothache, neuralgia,
headache, sore throat, period pains, aches and pains
(including muscle pains and backache). For the symptomatic
relief of influenza, feverishness and feverish colds. For the
symptomatic relief of sprains, strains, rheumatic pain,
sciatica, lumbago, fibrositis, joint swelling and stiffness.
2. What you need to know before you take Aspirin Tablets
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 Aspirin Tablets 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 this
medicine (listed in section 6). Symptoms may include
rhinitis (runny nose), swollen face, mouth or tongue,
itchy rash or asthma attack;
• have or have had a stomach ulcer;
• have a condition where your blood does not clot properly
(e.g. haemophilia);
• are taking medicines to thin your blood such as warfarin;
• have or have had gout;
• are in the last 3 months of pregnancy or are breast-feeding.
Children and adolescents
Do not give this medicine to children under 16 years unless
on the advice of a doctor.

Your blood, kidney and liver should be monitored during
prolonged use of aspirin as blood, kidney and liver
disorders may develop.
Other Medicines and Aspirin Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. The
following medicines can affect or be affected by Aspirin:
• Mifepristone (used to terminate pregnancy). You should
not take aspirin until eight to twelve days after
mifepristone. If taken with aspirin this medicine may not
be as effective.
• Non-steroidal anti-inflammatory (NSAIDs) e.g.
ibuprofen or diclofenac sodium (used for pain relief and
to treat inflammation) or Corticosteroids e.g.
prednisolone and betamethasone (used to treat allergy
or inflammation): if taken with aspirin you may have
more severe side effects e.g. increased risk of bleeding
or ulcers in the stomach. If you suddenly stop taking
corticosteroids you may develop aspirin poisoning.
• Metoclopramide (used to treat nausea and vomiting): it
may increase the effect of aspirin.
• Adsorbents e.g. kaolin (for diarrhoea) and Antacids 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.
• Coumarins e.g. warfarin, phenindone or heparins (blood
thinning medicines), streptokinase.
• Clopidogrel and ticlopidine (used to prevent strokes and
heart attacks).
• Calcium channel blockers such as verapamil, used to
treat high blood pressure.
• 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.
• Antidepressants (used to treat depression) e.g. Selective
Serotonin Re-uptake Inhibitors (SSRIs) (such as
venlafaxine): if taken with aspirin you may increase the
likelihood of bleeding.
• Medicines to control epilepsy e.g. phenytoin and
valproate: aspirin may increase the effect of these
medicines. If you take sodium valproate with aspirin you
may increase the likelihood of bleeding
• Zafirlukast (used to prevent or treat asthma).
• Spironolactone (diuretic) water tablets, Probenicid or
Sulfinpyrazone (used to treat gout): if taken with aspirin
these medicines may not be as effective.
Phenylbutazone may reduce the effect of aspirin.
• Methotrexate (used in the treatment of arthritis, Crohn’s
disease and cancer). or Carbonic anhydrase inhibitors
e.g. acetazolamide (used in the treatment of glaucoma,
epilepsy and excess water retention): if taken with
aspirin the side effects of these medicines may become
more severe.
• Steroids such as cortisone and hydrocortisone, used to
treat allergic conditions.
• Thiopental (used as an anaesthetic).
• Gold compounds (used to treat rheumatoid arthritis).

• Dummy codes are placed for layout purpose only.

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Aspirin 300mg Soluble Tablets - 32 Tabs
Wockhardt UK

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Aspirin Soluble
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• Insulin and other drugs used to treat diabetes.
• Sulphonamides, such as sulphamethoxazole, used to
treat infections.
• Vitamin C.
• Cilostazol (for leg pain that occurs when walking due to
poor circulation): the dose of aspirin should not be
greater than 80mg a day.
Aspirin may affect the results of thyroid function tests.
Aspirin Tablets with alcohol
Avoid drinking alcohol while taking Aspirin.
Pregnancy, breast-feeding and fertility
Do NOT take Aspirin Tablets if you are in the last 3 months
of your pregnancy or you are breast-feeding.
It is not recommended to take Aspirin Tablets during the
first six months of pregnancy unless you have been told to
do so by your doctor.
Taking this medicine may impair fertility in women, making
it more difficult to get pregnant. This effect is reversible on
stopping the medicine.
Aspirin Tablets 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.
3. How to take Aspirin Tablets
For oral use. Aspirin Soluble Tablets should be dispersed in
water before being taken.
Always take this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse have told
you. Check with your doctor, pharmacist or nurse if you are
not sure.
Adults (including the elderly and children over 16 years):
The recommended dose is one to three tablets, dispersed
in water.
The dose should not be taken more frequently than every four
hours and not more than four times in any 24 hour period.
Maximum daily dose: 12 tablets (3.6g) every 24 hours in
divided doses.
Take the tablets with or immediately after food to reduce
the risk of getting stomach and bowel irritation.
Do not exceed the stated dose.
If symptoms persist for more than three days, consult your
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 Aspirin Tablets than you should
If you take more Aspirin Tablets than you should contact
your nearest hospital casualty department or doctor
immediately. Take the medicine or this leaflet with you to
show the doctor.
Symptoms of an overdose include vomiting, dehydration,
tinnitus, vertigo, headache, nausea, dizziness,
restlessness, heart failure, breathing failure, deafness,
sweating, warm extremities with racing pulse, increased
breathing rate and hyperventilation.
If you forget to take Aspirin Tablets
• If you forget to take a dose, do not worry. Take the next
dose when it is due.
• 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, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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, skin rash, swelling of eyelids, face,
lips, mouth or tongue, 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.
Other possible side effects:
• stomach upset and feeling sick;
• an increased tendency to bleed;
• anaemia and
other blood
• mouth ulcers;
• slight blood
loss which
may result in
during long
term use;
• diarrhoea;
• blood in the
• Stevens-Johnson syndrome (fever, rash sore mouth and
eyes, joint and muscle aches);
• severe skin problem with shedding of the upper layer;
• you may succumb to infections more easily;
• you may bruise more easily.
Some patients have developed liver problems (particularly
with high doses).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the yellow card scheme at
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Aspirin Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label.
Do not store above 25°C. Store in the original container in
order to protect from moisture.
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 to
protect the environment.
6. Contents of the pack and other information
What Aspirin Tablets contain
The active substance is aspirin. Each soluble tablet
contains 300mg of aspirin.
The other ingredients are lactose, calcium carbonate,
maize starch, citric acid, talc, sodium saccharin and
sodium lauryl sulfate.
What Aspirin Tablets look like and contents of the pack
Soluble Aspirin Tablets are white, round tablets, which have
embossed on one face and a break line on the other.
Each pack of Aspirin Soluble Tablets contains 8, 10, 12, 16.
Not all pack sizes are marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Reference number

Aspirin 300mg Soluble Tablets


This leaflet was last revised in 06/2016


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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.