Aspirin 300mg dispersible tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-12-2019
Summary of Product characteristics
(SPC)
19-12-2019
Active ingredient:
Aspirin
Available from:
Waymade Healthcare Plc
ATC code:
N02BA01
INN (International Name):
Aspirin
Dosage:
300mg
Pharmaceutical form:
Dispersible tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070100
Patient Information leaflet
DISPERSIBLE ASPIRIN 300MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need 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.
INDEX
1
1.
WHAT DISPERSIBLE ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU TAKE
3.
HOW TO TAKE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE
6.
FURTHER INFORMATION
1
1.
WHAT DISPERSIBLE ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR
Dispersible Aspirin tablets belong to a group of medicines which have
analgesic (pain
relieving), anti-inflammatory (inflammation reducing) and anti-pyretic
(temperature reducing)
properties.
These tablets may be used for the relief of:
•
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 and pains.
2.
BEFORE YOU TAKE
DO NOT TAKE
Dispersible Aspirin tablets and
TELL
your doctor if you have:
•
an
ALLERGY
(hypersensitivity) to aspirin, salicylates or non-steroidal
anti-inflammatory
drugs (NSAIDs) or other ingredients in the product. You may have
developed difficulty
breathing, a runny nose, itchy skin or swelling after taking aspirin
or a NSAID previously
(see section 6)
•
a
STOMACH ULCER
or a history of ulcers or
INDIGESTION
•
BLEEDING
in the
STOMACH
and/or
INTESTINES
, or other kinds of bleeding such as
BLEEDING
from the
BLOOD VESSELS OF THE BRAIN
•
NASAL POLYPS
associated with
ASTHMA
•
HAEMOPHILIA
or other
BLOOD CLOTTING
disorder or are taking medicines to thin the blood.
•
SEVERE
liver, kidney or heart failure
•
are in the
THIRD
trimester of pregnancy
•
taking
METHOTREXATE
(more than 15mg a week)
•
a child
UNDER 16
years old.
IMPORTANT WARNING:
There is a possible association between asp
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets 300mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Aspirin
3
PHARMACEUTICAL FORM
White uncoated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aspirin has analgesic, antipyretic and anti-inflammatory actions. It
is indicated
for:
1)
The
relief
of
headache,
toothache,
migraine,
neuralgia,
sore
throat,
dysmenorrhoea.
2)
The
symptomatic
relief
of
influenza,
feverishness,
rheumatic
pains,
sciatica, lumbago, fibrositis, muscular aches and pains.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be dispersed in water before administration.
ADULTS INCLUDING ELDERLY: _ _1-2 tablets at intervals of not less than
4 hours, to a
maximum of four doses in 24 hours.
CHILDREN: Do not give to children aged under 16 years, unless
specifically
indicated (e.g. for Kawasaki’s disease).
To be dispersed in water for oral use.
4.3
CONTRAINDICATIONS
Aspirin should not be taken by patients with the following conditions:
•
Known hypersensitivity to aspirin, other ingredients in the product,
other
salicylates or non-steroidal anti-inflammatory drugs (a patient may
have developed
anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by
aspirin or other
NSAIDs).
•
Nasal polyps associated with asthma (high risk of severe sensitivity
reactions).
•
Active, or history of recurrent peptic ulcer, dyspepsia and/or
gastric/intestinal
haemorrhage, or other kinds of bleeding such as cerebrovascular
haemorrhages.
•
Haemorrhagic diathesis; coagulation disorders such as haemophilia and
thrombocytopenia.
•
Concurrent anticoagulant therapy should be avoided.
•
Severe hepatic impairment
•
Severe renal impairment
•
Severe cardiac failure
•
Doses >100 mg/day during the third trimester of pregnancy (see section
4.6);
•
Methotrexate used at doses >15mg/week (see section 4.5).
•
children under 16 years old, unless specifically indicated (e.g.
Kawasaki’s
disease).
4.4
SPECIAL WARNINGS AND
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