Aspirin 75mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aspirin

Available from:

Medreich Plc

ATC code:

B01AC06

INN (International Name):

Aspirin

Dosage:

75mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02090000; GTIN: 05060292741871

Patient Information leaflet

WIN\\192.168.1.33\pdc\Artworks\Medreich\UK Products\Key
Pharmaceuticals\Aspirin\Tablets\75 mg\PIL\Aspirin Tablets - 75 mg -
S/L - English - PIL_17.07.20.ai
V-1
SIDE EFFECTS WITH UNKNOWN FREQUENCY
•
Ringing in your ears (tinnitus) or reduced hearing ability
•
Headache
•
Vertigo
•
Ulcers in stomach or small intestine and perforation
•
Diarrhoea
•
Prolonged bleeding time
•
Impaired kidney function
•
Salt and water retention
•
Impaired liver function
•
High level of uric acid in the blood
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:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store.
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.
The
medicinal
product
does
not
require
any
special
storage
conditions.
Do not use after the expiry date which is stated on the packaging.
The expiry date refers to the last day of the month.
Do not throw away medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT ASPIRIN TABLETS CONTAIN
The active substance is acetylsalicyclic acid (aspirin) 75 mg.
The other ingredients are lactose monohydrate, maize starch and
purified talc.
WHAT ASPIRIN TABLETS LOOK LIKE AND CONTENTS OF THE PACK
6.8 mm to 7.2mm white coloured, circular flat beveled edge,
uncoated tablets scored on one side and plain on the other side.
Aspirin tablets are supplied in Alu- PVC/ PVDC blister packs of 28
tablets.
NOT ALL PACK SIZES MAY BE MARKETED.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER:
Key Pharmaceuticals Ltd.
Galen House, 83 High Street,
Somersham, Cambridgeshire,
PE28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 75mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Acetylsalicylic acid (Aspirin) 75.0 mg.
Excipients with known effect
Also contains 50.2 mg lactose monohydrate and 0.2 mg sunset yellow
Lake
(E-110)
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Orange colored, circular flat beveled edge, uncoated tablet,
approximate
diameter 7.0mm, scored on one side and plain on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the secondary prevention of thrombotic cerebrovascular or
cardiovascular
disease and following by-pass surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For the management of cardiovascular or cerebrovascular disease:
The advice of a doctor should be sought before commencing therapy for
the
first time. The usual dosage, for long term use, is 75-150 mg once
daily. In
some Circumstances a higher dose may be appropriate, especially in the
short
term, and up to 300 mg a day may be used on the advice of a doctor. In
general, acetylsalicylic acids should be used with caution in elderly
patients
who are more prone to adverse events. 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.
These tablets should be taken orally with a drink of water.
Children: Aspirin 75mg tablets are not indicated for use in children
and young
people less than 16 years of age (see ‘Special Warnings and
Precautions for
Use’).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to salicylic acid compounds or prostaglandin
synthetase
inhibitors (e.g. certain asthma patients who may suffer an attack or
faint
and certain patients who may suffer from bronchospasm, rhinitis and
urticaria) and to any of the excipients;
•
Active,
or
history
of
recurrent
peptic
ulcer
and/or
gastri