BAYER ASPIRIN ORIGINAL FLAVOUR TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH CHEW TABLET CONTAINS ASPIRIN 500,0 mg

Authorization status:

Registered

Authorization date:

1999-03-05

Patient Information leaflet

Applicant/ PHCR:
BAYER (PTY) LTD
MODULE
1.3.2
Product Name:
BAYER ASPIRIN
Dosage form and strength
300 MG ACETYLSALICYLIC ACID PER TABLET
PATIENT INFORMATION LEAFLET
BAY167 CCDSv6.0&7.0/ZA-v2/122020
Page 1 of 9
SCHEDULING STATUS:
BAYER ASPIRIN 300 MG TABLETS
ACETYLSALICYLIC ACID
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Bayer
Aspirin
is
available
without
a
doctor’s
prescription,
for
you
to
treat
a
mild
illness.
Nevertheless, you still need to use Bayer Aspirin carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share Bayer Aspirin with any other person.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
5 days.
WHAT IS IN THIS LEAFLET
1.
What Bayer Aspirin is and what it is used for
2.
What you need to know before you take Bayer Aspirin
3.
How to take Bayer Aspirin
4.
Possible side effects
5.
How to store Bayer Aspirin
6.
Contents of the pack and other information
S0
Applicant/ PHCR:
BAYER (PTY) LTD
MODULE
1.3.2
Product Name:
BAYER ASPIRIN
Dosage form and strength
300 MG ACETYLSALICYLIC ACID PER TABLET
PATIENT INFORMATION LEAFLET
BAY167 CCDSv6.0&7.0/ZA-v2/122020
Page 2 of 9
1.
WHAT BAYER ASPIRIN IS AND WHAT IT IS USED FOR
Bayer Aspirin is an antipyretic (reduces fever) and anti-inflammatory
analgesic indicated
for short-term use in the relief of mild to moderate pain (headache,
toothache,
menstrual
cramps,
nerve
pain,
muscular
and
joint
pain,
back
pain
and
pain
associated with colds) and fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BAYER ASPIRIN
DO NOT TAKE BAYER ASPIRIN:
•
If you are hypersensitive (allergic) to acetylsalicylic acid or other
salicylates or to any
other ingredients of Bayer Aspirin
•
If you are suffering from acute gastrointestinal ulcers
•
If you are suffering from blood clotting disorder, a low blood
platelet count or other
bleeding tendencies
•
If you have liver, kidney or heart failure
•
If you

Summary of Product characteristics

Applicant/ PHCR:
BAYER (PTY) LTD
MODULE
1.3.1
Product Name:
BAYER ASPIRIN
Dosage form and strength
300 MG ACETYLSALICYLIC ACID PER TABLET
PROFESSIONAL INFORMATION
BAY167 CCDSv6.0&7.0/ZA-v2/122020
Page 1 of 15
SCHEDULING STATUS
S0
1.
NAME OF THE MEDICINE
BAYER ASPIRIN 300 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
300 mg acetylsalicylic acid per tablet.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
A round white biconvex tablet with the Bayer cross on one side and
Aspirin 0.3 on the other.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Bayer Aspirin is indicated for short-term use in the relief of mild to
moderate pain and fever.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Bayer Aspirin must not be taken for more than 3 – 5 days without
consulting a doctor.
Adults and children 12 years and over:
300 – 1000 mg as a single dose, to be repeated as needed after a
minimum period of 4 hours.
A maximum daily dose of 4000 mg must not be exceeded.
Use the lowest effective dose for the shortest possible duration of
treatment.
Applicant/ PHCR:
BAYER (PTY) LTD
MODULE
1.3.1
Product Name:
BAYER ASPIRIN
Dosage form and strength
300 MG ACETYLSALICYLIC ACID PER TABLET
PROFESSIONAL INFORMATION
BAY167 CCDSv6.0&7.0/ZA-v2/122020
Page 2 of 15
SPECIAL POPULATIONS
•
PATIENTS WITH HEPATIC IMPAIRMENT
Bayer Aspirin should be used with caution in patients with abnormal
hepatic function (See
section 4.4).
•
PATIENTS WITH RENAL IMPAIRMENT
Bayer Aspirin should be used with caution in patients with abnormal
renal function (See
section 4.4).
PAEDIATRIC POPULATION
Bayer Aspirin is recommended for children below 12 years only under
physician’s supervision. In
general, the daily dose of Bayer Aspirin in children is about 60
mg/kg, given as 4 to 6 divided doses,
i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours. In case
of accidental administration
or use in children, see section “Special warnings and precautions
for use”.
METHOD OF ADMINISTRATION
For oral use.
The table