ASPIRIN 300 UNIMED TABLET

Երկիր: Հարավաֆրիկյան Հանրապետություն

Լեզու: անգլերեն

Աղբյուրը: South African Health Products Regulatory Authority (SAHPRA)

Հասանելի է:

Unimed Healthcare (Pty) Ltd

Դոզան:

See ingredients

Դեղագործական ձեւ:

TABLET

Կազմը:

EACH TABLET CONTAINS ASPIRIN 300 mg

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

1975-07-06

Տեղեկատվական թերթիկ

APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Aspirin 300 Unimed
DOSAGE FORM AND STRENGTH: Each tablet contains 300 mg Aspirin
20.04.2023
(v1)
Page 1 of 10
Initial:
PATIENT INFORMATION LEAFLET (PIL)
FOR MEDICINES FOR HUMAN USE
ASPIRIN 300 UNIMED (TABLETS)
SCHEDULING STATUS: S0
ASPIRIN 300 UNIMED TABLET
ASPIRIN
CONTAINS SUGAR: SUCROSE 2,94 MG PER TABLET
CONTAINS A PRESERVATIVE: BENZOIC ACID 0,0014 % _W/W_
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
ASPIRIN 300 UNIMED is available without a doctor’s prescription, for
you to treat a mild
illness. Nevertheless, you still need to use ASPIRIN 300 UNIMED
carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share ASPIRIN 300 UNIMED with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
10 days.
WHAT IS IN THIS LEAFLET:
1. What ASPIRIN 300 UNIMED is and what it is used for
2. What you need to know before you take ASPIRIN 300 UNIMED
3. How to take ASPIRIN 300 UNIMED
4. Possible side effects
5. How to store ASPIRIN 300 UNIMED
6. Contents of the pack and other information
APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Aspirin 300 Unimed
DOSAGE FORM AND STRENGTH: Each tablet contains 300 mg Aspirin
20.04.2023
(v1)
Page 2 of 10
Initial:
1. WHAT ASPIRIN 300 UNIMED IS AND WHAT IT IS USED FOR
The active ingredient aspirin has analgesic (reduces pain),
antipyretic (reduces fever) and
anti-inflammatory (reduces inflammation) actions.
ASPIRIN 300 UNIMED is indicated for the relief of mild to moderate
pain and fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN 300 UNIMED
DO NOT TAKE ASPIRIN 300 UNIMED
•
if you have stomach ulcers,
•
if you have a bleeding disorder such as haemophilia,
•
if you suffer from severe kidney impairment,
•
if you are taking oral anti-coagulant medicines (medicines that
prevent the blood from
clotting),
•

Ապրանքի հատկությունները

APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Aspirin 300 Unimed
DOSAGE FORM AND STRENGTH: Each tablet contains 300 mg Aspirin
20.04.2023
(v1)
Page 1 of 12
Initial:
PROFESSIONAL INFORMATION (PI)
FOR MEDICINES FOR HUMAN USE
ASPIRIN 300 UNIMED (TABLETS)
SCHEDULING STATUS
S0
1.
NAME OF THE MEDICINE
ASPIRIN 300 UNIMED tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Aspirin 300 mg.
EXCIPIENTS WITH KNOWN EFFECT:
Contains sugar: Sucrose 2,94 mg per tablet.
Contains a preservative: Benzoic acid 0,0014 % _w/w_.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Round, white, biconvex tablet with a break line on one side, 9,5 mm in
diameter. Odourless or
having a faintly acidic odour.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASPIRIN 300 UNIMED is indicated for the relief of mild to moderate
pain and fever.
APPLICANT: Unimed Healthcare (Pty) Ltd.
PRODUCT NAME: Aspirin 300 Unimed
DOSAGE FORM AND STRENGTH: Each tablet contains 300 mg Aspirin
20.04.2023
(v1)
Page 2 of 12
Initial:
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use the lowest effective dose for the shortest possible duration of
treatment.
Adults: One to two tablets every four hours with water.
Do not use continuously for longer than ten (10) days without
consulting your doctor.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS
•
Patients with peptic ulcers, haemophilia, severe renal impairment and
patients receiving oral
anti-coagulant therapy.
•
Patients with an intolerance (hypersensitivity) to aspirin, or
hypersensitivity to any of the
excipients in ASPIRIN 300 UNIMED.
•
Heart failure.
•
History of gastrointestinal perforation, ulceration or bleeding (PUBs)
related to previous
NSAIDs, including ASPIRIN 300 UNIMED.
•
Active or history of recurrent ulcer, haemorrhage or perforations.
•
Pregnancy and lactation (see section 4.6).
•
Not to be used in children under the age of 12 years (see section
4.4).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do