VOREN ENTERIC MICROENCAPSULATED CAPSULE 50MG

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

DICLOFENAC SODIUM PELLET

Dostupné z:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (Medzinárodný Name):

DICLOFENAC SODIUM PELLET

Počet v balení:

10Capsule Capsules

Výrobca:

Y.S.P. INDUSTRIES (M) SDN BHD

Súhrn charakteristických

Manufacturer and Product Registration Holder:
Y.S.P. INDUSTRIES (M) SDN. BHD.
(192593 U)
Lot 3, 5 & 7, Jalan P/7, Section 13,
Kawasan Perindustrian Bandar Baru Bangi,
43000 Kajang, Selangor Darul Ehsan, Malaysia.
Ordering Line: 1 800 88 3027
Product Info: 1 800 88 3679
R
Date of Revision: 20 Nov 15
6.
NSAIDs may very rarely cause serious cutaneous adverse events such as
exfoliative dermatitis,
toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS),
which can be fatal and
occur without warning. These serious adverse events are idiosyncratic
and are independent of
dose or duration of use. Patients should be advised of the signs and
symptoms of serious skin
reaction and to consult their doctor at the first appearance of a
skin rash or any other sign of
hypersensitivity.
7.
It should not be used in conjunction with anti-inflammatory drugs or
other non-steroidal
anti-inflammatory drugs including aspirin. Diclofenac Sodium in
common with other NSAIDs, can
reversibly inhibit platelet aggregation.
8.
Safe condition for its use in pregnant women have not been
established. Diclofenac Sodium is
not recommended for nursing mothers because it will be excreted in the
milk.
9.
Observational studies have indicated that non-selective NSAIDs may be
associated with an
increased risk of serious cardiovascular events, principally
myocardial infarction, which may
increase with dose or duration of use. Patients with cardiovascular
disease or cardiovascular risk
of
an
adverse
cardiovascular
event
in
patient
taking
NSAID,
especially
in
those
with
cardiovascular risk factors, the lowest effective dose should be used
for the shortest possible
duration.
10.
There is no consistent evidence that the concurrent use of aspirin
mitigates the possible
increased risk of serious cardiovascular thrombotic events associated
with NSAID use.
11.
NSAIDs may lead to the onset of new hypertension or worsening the
pre-existing hypertension
and patients taking anti-hypertensive with NSAIDs may have an impaired
anti-hypertensive
response. Cau