Aspirin 300mg caplets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aspirin

Available from:

The Boots Company Plc

ATC code:

N02BA01

INN (International Name):

Aspirin

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPIRIN 300MG CAPLETS
Aspirin
(Referred to as Aspirin Caplets throughout the rest
of this leaflet)
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 Caplets are and what they are used for
2. What you need to know before you take Aspirin Caplets
3. How to take Aspirin Caplets
4. Possible side effects
5. How to store Aspirin Caplets
6. Contents of the pack and other information
1. WHAT ASPIRIN CAPLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Aspirin Caplets. 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 Caplets 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 CAPLETS
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 AGE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Caplets _ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin 300mg
3
PHARMACEUTICAL FORM
Tablet
White capsule shaped tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of mild to moderate pain, for example,
migraine,
toothache, neuralgia, headache, sore throat, dysmenorrhoea or period
pain.
For the relief of the symptoms of minor inflammatory conditions such
as
rheumatic pain, aches and pains, sciatica, lumbago, fibrositis,
muscular pains,
joint swelling, sprains and strains and stiffness.
To reduce feverishness , feverish cold and aches and pains of cold and
flu (not
in children under 16).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral.
ADULTS AND CHILDREN OVER 16 YEARS: 1 to 3 caplets to be swallowed with
water. The dose should not be taken more frequently than every 4 hours
and
not more than 4 times in any 24 hour period.
MAXIMUM DOSE: 12 caplets (3.6g) every 24 hours in divided doses.
THE ELDERLY: A total reduction in the daily dose may be advisable.
DO NOT GIVE TO CHILDREN AGED UNDER 16 YEARS, UNLESS SPECIFICALLY
INDICATED
(E.G. FOR KAWASAKI’S DISEASE).
Gastro-intestinal irritation may be reduced by taking aspirin with or
immediately after food.
4.3
CONTRAINDICATIONS
i)
Children under 16 years unless specifically indicated (e.g for
Kawasaki’s disease)
ii)
Active peptic ulceration or a history of peptic ulceration
iii)
Haemophilia, other coagulopathies or concurrent anticoagulant therapy.
iv)
Hypersensitivity to aspirin or any of the excipients (see section 6.1)
In
patients with a history of hypersensitivity to aspirin (or any of the
excipients) or any other NSAIDs and in patients in whom attacks of
asthma, angioedema, urticaria or rhinitis have been precipitated by
aspirin
or other NSAIDs.
v)
Gout.
vi)
Doses > 100mg/day during the third trimester of pregnancy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised in patients with asthma, allergi