CALPOL TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GlaxoSmithKline Consumer Healthcare SA (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET COPNTAINS PARACETAMOL 500,0 mg

Authorization status:

Registered

Authorization date:

2018-11-11

Patient Information leaflet

GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD
CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG)
APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S0 for packs containing 6, 10, 12, 16 or 24 film-coated tablets
S1 for packs containing 48, 96 or 100 film-coated tablets
PROPRIETARY NAME AND DOSAGE FORM:
CALPOL TABLETS
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
CALPOL TABLETS is available without a doctor’s prescription, for you
to treat a mild illness.
Nevertheless, you still need to use CALPOL TABLETS carefully to get
the best results from it.

Keep this leaflet. You may need to read it again.

Do not share CALPOL TABLETS 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
10 days.
COMPOSITION:
WHAT CALPOL TABLETS CONTAIN:
Each film-coated tablet contains 500 mg paracetamol.
GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD
CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG)
APPROVED PATIENT INFORMATION LEAFLET
The other ingredients are: maize starch, calcium carbonate, alginic
acid, crospovidone, povidone
(K-25), magnesium stearate, colloidal anhydrous silica, titanium
dioxide, hypromellose 3cP,
hypromellose 6cP, macrogol, polysorbate 80, carnauba wax.
Sugar Free.
APPROVED INDICATIONS AND USE
WHAT CALPOL TABLETS IS USED FOR:
CALPOL TABLETS is fast absorbed and is indicated for the symptomatic
relief of mild to
moderate
pain and fever such as headache, migraine, backache, muscle pains,
sore
throat, toothache, pain and fever associated with colds and flu.
INSTRUCTIONS BEFORE TAKING CALPOL TABLETS.
DO NOT TAKE CALPOL TABLETS:

If you are allergic to paracetamol or any of the ingredients in the
tablet.

If
you have severe liver problems.
TAKE SPECIAL CARE WITH CALPOL TABLETS:

DO NOT EXCEED THE RECOMMENDED DAILY DOSE, AS IT MAY CAUSE SERIOUS HARM
TO YOUR
LIVER.

Do not use Calpol tablets if you are taking any other p

Summary of Product characteristics

GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD
CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG)
APPROVED PROFESSIONAL INFORMATION
Page 1 of 11
GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD
CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG)
APPROVED PROFESSIONAL INFORMATION
Page 2 of 11
SCHEDULING STATUS:
S0 for packs containing 6, 10, 12, 16 or 24 film-coated tablets
S1 for packs containing 48, 96 or 100 film-coated tablets
PROPRIETARY NAME AND DOSAGE FORM:
CALPOL TABLETS (film-coated tablet)
COMPOSITION:
Each film-coated tablet contains 500 mg paracetamol.
Excipients:
As
preservative:
Nipasept
sodium
0,199
%
m/m
(containing
sodium
methyl
parahydroxybenzoate,
sodium
ethyl
parahydroxybenzoate;
sodium
propyl
parahydroxybenzoate)
The other ingredients are: maize starch, calcium carbonate, alginic
acid, crospovidone,
povidone (K-25), magnesium stearate, colloidal anhydrous silica,
titanium dioxide,
hypromellose 3cP, hypromellose 6cP, macrogol, polysorbate 80, carnauba
wax.
Sugar Free.
PHARMACOLOGICAL CLASSIFICATION:
A 2.7. Antipyretic or Antipyretic and anti-inflammatory analgesics
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES
Paracetamol is an antipyretic and analgesic.
GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD
CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG)
APPROVED PROFESSIONAL INFORMATION
Page 3 of 11
Its mechanism of action is believed to include inhibition of
prostaglandin synthesis,
primarily within the central nervous system_. _
_ _
_ _
Clinical Efficacy
The perception of analgesia occurred from a median time of 15 minutes
post dosing in
adult patients after surgical removal of third molars with a Calpol
dose of 1 gram. The
1 gram dose demonstrated superior analgesia compared to the Calpol
500mg dose and
placebo. Both Calpol doses provided analgesia superior to placebo.
PHARMACOKINETIC PROPERTIES
Paracetamol tablets contain disintegrant excipient(s) which
accelerates/improves the
rate of disintegration/dissolution and absorption from the
ga