NUROFEN TABLET 400MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ibuprofen

Available from:

RECKITT BENCKISER (SINGAPORE) PTE LTD

ATC code:

M01AE01

Dosage:

400mg

Pharmaceutical form:

TABLET, SUGAR COATED

Composition:

Ibuprofen 400mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED

Authorization status:

ACTIVE

Authorization date:

2014-08-13

Patient Information leaflet

NUROFEN COATED TABLET 400MG
IBUPROFEN 400MG
PRODUCT DESCRIPTION
A white to off-white, round, biconvex, sugar coated tablet printed
with an identifying logo in red on one face.
Also contains: Sodium laurilsulfate, silica colloidal anhydrous,
stearic acid, croscarmellose sodium, sodium citrate.
Coating: Macrogol 6000, acacia (spray dried), carmellose sodium,
titanium dioxide (E171), talcum, sucrose. Printing Ink: 
Shellac, Iron Oxide Red (E172), Propylene Glycol (E1520), Ammonium
Hydroxide (E527), Simethicone.
PHARMACODYNAMICS
Ibuprofen is a propionic acid derivative with analgesic,
anti-inflammatory and antipyretic properties. The drug, as a 
nonsteroidal anti-inflammatory agent acts by inhibition of
prostaglandin synthesis.
Experimental data suggests that ibuprofen may inhibit the effect of
low dose aspirin on platelet aggregation when they are
dosed concomitantly.
In one study, when a single dose of ibuprofen 400 mg was taken within
8 h before or within 30 min after immediate
release aspirin dosing (81 mg), a decreased effect of acetylsalicylic
acid on the formation of thromboxane or platelet
aggregation occurred. However, the limitations of these data and the
uncertainties regarding extrapolation of ex vivo data
to the clinical situation imply that no firm conclusions can be made
for regular ibuprofen use, and no clinically relevant
effect is considered to be likely for occasional ibuprofen use.
PHARMACOKINETICS
Ibuprofen is rapidly absorbed from the gastrointestinal tract. In case
of empty stomach peak serum concentration is 
achieved about 1-2 hours after taking coated tablets. If ibuprofen is
taken after meal, rate of absorption may be decreased. 
The elimination half-life is approximately 2 hours.
Ibuprofen is highly bound to plasma protein. It passes into the
synovial fluid.
Ibuprofen is metabolised in the liver to two major inactive
metabolites and these together with unchanged ibuprofen are 
excreted by the kidney either as such or as conjugates. Excretion by
the kidney is both rapid and com

Summary of Product characteristics

Nurofen Coated Tablet 400mg
Ibuprofen 400mg
Date of Text Revision: Aug 2021
PRODUCT DESCRIPTION
A white to off-white, biconvex, round, sugar coated tablet printed
with an identifying logo in red on one face.
PHARMACODYNAMICS
Ibuprofen is a propionic acid derivative NSAID that has demonstrated
its efficacy by inhibition of prostaglandin synthesis.
with analgesic, anti-inflammatory and antipyretic properties. The
drug, as a nonsteroidal anti-inflammatory agent acts
by inhibition of prostaglandin synthesis.
Experimental data suggest that ibuprofen may inhibit the effect of low
dose aspirin on platelet aggregation when they are
dosed concomitantly. In one study, when a single dose of ibuprofen
400mg was taken within 8 hours before or within 30
minutes after immediate release aspirin dosing (81mg), a decreased
effect of ASA on the formation of thromboxane or
platelet aggregation occurre
d. However, the limitations of these data and the uncertainties
regarding extrapolation of ex
vivo data to the clinical situation imply that no firm conclusions can
be made for regular ibuprofen use and no relevant
effects are considered to be likely for occasional ibuprofen use.
PHARMACOKINETICS
Ibuprofen is rapidly absorbed from the gastrointestinal tract. In case
of empty stomach peak serum concentration is achieved
about 1-2
hours after taking coated tablets. If ibuprofen is taken after meal,
rate of absorption may be decreased. The
elimination half-life is approximately 2 hours. Ibuprofen is highly
bound to plasma protein. It passes into the synovial fluid.
Ibuprofen is metabolised in the liver to two major inactive
metabolites and these together with unchanged ibuprofen are
excreted by the kidney either as such or as conjugates. Excretion by
the kidney is both rapid and complete. No significant
differences in pharmacokinetic profile are observed in the elderly.
INDICATIONS
Nurofen relieves pain such as headache, migraine, dental pain, period
pain, rheumatic pain, muscular pain and backache.
Nurofen relieves fever such as fever as