Aspirin 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aspirin

Available from:

Aspar Pharmaceuticals Ltd

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; GTIN: 5024071220124 5024071220056

Patient Information leaflet

1. W
HAT THESE TABLETS DO
These tablets contain Aspirin which is a type of painkiller. It is
used to relieve pain,
swelling and high temperature. It can be used to treat headaches,
migraine, neuralgia,
toothache, sore throat, period pains and for the relief of sprains,
strains, rheumatic pain, sciatica,
lumbago, muscle aches, fibrositis, joint swelling and stiffness.
2. C
HECK BEFORE YOU TAKE
DO NOT TAKE THESE TABLETS IF YOU:
·
Are allergic to Aspirin, NSAIDs which includes those when in attacks
of asthma,
angioedema, uticaria or rhinitis have been precipitated by aspirin or
any other NSAID or any of
the other ingredients listed in section 6
·
Have a stomach ulcer or have had problems with ulcers in the past.
·
Suffer from haemophilia or any other bleeding condition.
·
Suffer from gout or had in the past.
·
Are in the last 3 months of pregnancy or are breast feeding.
IMPORTANT WARNING:
Do not give this medicine to children under the age of 16 unless your
doctor tells you.
This is because 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.
TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF YOU:
·
Are intolerant to some sugars as these tablets contain lactose
·
Have asthma or have ever had it in the past
·
Have dehydration
·
Have been told you are deficient in glucose-6-phosphate dehydrogenase
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE ALREADY TAKING ANY OF THE
FOLLOWING MEDICINES,
AS THEIR EFFECTIVENESS MAY BE INFLUENCED BY ASPIRIN IF THEY ARE TAKEN
AT THE SAME TIME.
·
Metoclopramide (for sickness and digestive disorders)
·
Blood thinning medicines such as Heparin, Warfarin or nicoumalone
·
Corticosteroids e.g. hydrocortisone (which can be used for arthritis,
asthma and inflammatory
conditions)
·
Anti-inflammatory medicines or steroids for pain and inflammation e.g.
ibuprofen
·
High blood pressure medicines e.g diuretic/water tablets, Angio-II
receptor antagonists or ACE
inhibitors
·
Epilepsy medicines e.g.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Aspirin 300mg.
For excipients see Section 6.1
3
PHARMACEUTICAL FORM
Tablet
White circular with break line on one face
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anti-inflammatory indications:
Symptomatic relief of sprains, strains, rheumatic pain, sciatica,
lumbago, muscular
aches, fibrositis, joint swelling and stiffness.
Analgesic and antipyretic indications:
Mild to moderate pain including headache, migraine, neuralgia,
toothache, sore
throat, period pains, aches and pains, symptomatic relief of influenza
and feverish
colds. For rheumatoid arthritis, osteothritis and acute chronic
rheumatic conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults & children over 16 years: 1 - 3 tablets every four hours, or as
directed by a
doctor.
Not more than 4 doses in 24 hours.
Do not give to children aged under 16 years, unless Aspirin has been
specifically
prescribed for that child (e.g. for Kawasaki’s disease).
Elderly: A lower dose is recommended.
The tablets to be taken orally with water.
4.3
CONTRAINDICATIONS
Aspirin is contraindicated in patients with;
•
active peptic ulceration or a history of peptic ulceration.
•
Haemophilia, haemorrhagic disease or a history of bleeding disorders.
•
Gout or a history of gout.
•
Hypersensitivity to aspirin (e.g. asthma, rhinitis, angioedema or
urticaria), other NSAIDs or other tablet excipients
•
During the third trimester of pregnancy
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is a possible association between aspirin and Reye’s syndrome
when
given to children. Reye’s syndrome is a very rare disease, which
affects the
brain and liver and can be fatal. For this reason aspirin should not
be given to
children under 16 years unless specifically indicated (e.g. for
Kawasaki’s
disease).
Patients with rare hereditary problems of galactose intolerance, the
Lapp
lactose deficiency or glucose- galactos