Aspirin 75mg dispersible tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
27-10-2022
Summary of Product characteristics
(SPC)
27-10-2022
Public Assessment Report
(PAR)
10-02-2006
Active ingredient:
Aspirin
Available from:
Accord-UK Ltd
ATC code:
B01AC06
INN (International Name):
Aspirin
Dosage:
75mg
Pharmaceutical form:
Dispersible tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02090000; GTIN: 5012617017116 5012617017147 5012617017154
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ASPIRIN 75MG DISPERSIBLE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
1.
WHAT ASPIRIN DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN DISPERSIBLE TABLETS
3.
HOW TO TAKE ASPIRIN DISPERSIBLE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ASPIRIN DISPERSIBLE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1
1.
WHAT ASPIRIN DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Aspirin Dispersible tablets belong to a group of medicines which have
analgesic (pain
relieving), anti-inflammatory (inflammation reducing) and anti-pyretic
(temperature reducing)
properties. Aspirin also acts on the blood, helping to prevent the
formation of blood clots.
These tablets may be used to help prevent heart attacks and stroke in
patients who have
previously suffered such events, in patients who have unstable angina
and following by-pass
surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN DISPERSIBLE TABLETS
DO NOT TAKE
ASPIRIN DISPERSIBLE TABLETS
if you:
•
are
ALLERGIC
to aspirin or any of the other ingredients of this medicine (listed in
section 6),
salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). You may
have developed
difficulty breathing, asthma attacks or fainting, a runny nose, itchy
skin or swelling after
taking aspirin or a NSAID previously (see section 6)
•
have a
STOMACH ULCER
or a history of ulcers or
INDIGESTION
•
have
BLEEDING
in the
STOMACH
and/or
INTESTINES
, or
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 75mg Dispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg Aspirin.
Excipients with known effect
Each Aspirin Dispersible tablet contains:
34.25mg of Lactose
0.75mg Saccharin sodium (0.084mg sodium)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Dispersible tablet. White, circular, flat, bevelled-edge, uncoated tablets impressed
“C” and the
identifying letters “AY” on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the secondary prevention of thrombotic cerebrovascular or
cardiovascular
disease, following by-pass surgery and in patients suffering from
unstable
angina.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The tablets should be dispersed in water before administration.
The advice of a doctor should be sought before commencing therapy for
the
first time.
_ _
The usual dosage for long term use is 1-2 tablets (75-150mg) once
daily. In
some circumstances a higher dose may be appropriate, especially in the
short-
term, and up to 4 tablets (300mg) a day may be used on the advice of a
doctor.
The usual adult dose is recommended in the absence of severe renal or
hepatic
insufficiency (see sections 4.3 and 4.4). Treatment should be reviewed
at
regular intervals.
_ _
_Paediatric population _
Do not give to children aged under 16 years, unless specifically
indicated (e.g.
for Kawasaki’s disease)(see section 4.4).
_ _
_Method of Administration _
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 the active substances or to any of the
excipients
listed in section 6.1, other salicylates or non-steroidal
anti-inflammatory
drugs (a patient may have developed anaphylaxis, angioedema, asthma
and
may suffer an attack or faint, certain patients may suffer from
bronchospasm, rhinitis or urticaria induced by aspirin or other
NSAIDs).
•
Nasal polyps as
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