VOREN SUPPOSITORIES 50MG

Country: Malaysia

Language: English

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

Active ingredient:

DICLOFENAC SODIUM

Available from:

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

INN (International Name):

DICLOFENAC SODIUM

Units in package:

10Pieces Pieces

Manufactured by:

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

Patient Information leaflet

VOREN SUPPOSITORIES
Diclofenac sodium (12.5mg, 25mg, 50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What VOREN SUPPOSITORIES is
used fo
r
2.
How
VOREN
SUPPOSITORIS
works
3.
Be
fore
you
use
VORE
N
SU
PPOSITORIES
4.
How
to
use
VOREN
SUPPOSITORIES
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
VORE
N
SU
PPOSITORIES
8.
Product Description
9.
Manu
facturer and Produc
t
Registrati
o
n Holder
10.
Date of revision
WHAT
VOREN
SUPPOSITORIES
IS
USED FOR
VOREN SUPPOSITORIES is indicated for
chronic
rheumatic
arthritis
(systemic
inflammatory disorder that effects joints),
degenerative
osteoarthritis
(degenerative
joint
disease)
and
painful
post-operative
inflammation.
HOW
VOREN
SUPPOSITORIES
WORKS
VOREN
SUPPOSITORIES
contains
a
substance called Diclofenac. Diclofenac
is
a
non-steroidal
anti-inflammatory
drugs
(NSAIDs)
which
reduces
inflammation, pain and fever
Rectally
administered
Diclofenac
Sodium is rapidly and almost completely
absorbed and distributed to blood, liver
and kidneys.
BEFORE
YOU
USE
VOREN
SUPPOSITORIES
_-When you must not use it_
Do not use VOREN SUPPOSITORIES:
1.
If
you allergy or hypersensitivity to
Diclofenac
Sodium
or
any
ot
her
ingredients listed at the end of this
leaflet
2.
If
you
have
or
have
had
any
inflammatory lesions of the rectum or
anus
3.
If you are under 12 months of age
4.
If you have active or suspected stomach
ulcer
or
stomach
and
intestinal
bleeding.
5.
If
you
have
had
asthma,
rhinitis
(I
nflammation of the nasal mu
cous
m
embrane),
urticaria
(itching
or
hives)
and
the
symptoms
become
worsen
caused
by
Aspirin
or
NSAIDs.
_ _
_-Before you start to_
_ use it_
Please kindly inform your doctor:
1.
I
f you have blood disorder
2.
If you have heart disease or st
roke
3.
If you have hypertension
4.
If you have fluid retension or oedema
5.
If you have infection
6.
If you have liver, or kidney problem
7.
If you are elderly
8.
If you have or have had ulcerati
on,
bleeding
and
perforation
of
the
st
omach and intestinal
9.
If
you
suffering
from

Summary of Product characteristics

VOREN
®
SUPPOSITORIES
INGREDIENT(S):
Voren Suppositories 12.5mg:
Each supp. contains:
Diclofenac Sodium
..........................................................................................................................
12.5mg
Voren Suppositories 25mg:
Each supp. contains:
Diclofenac Sodium
.............................................................................................................................
25mg
Voren Suppositories 50mg:
Each supp. contains:
Diclofenac Sodium
.............................................................................................................................
50mg
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETICS):
1. Diclofenac is a potent non-steroidal anti-inflammatory (NSAID)
with analgesic and antipyretic
properties. It also has some uricosuric effect. Diclofenac inhibits
cyclo-oxygenase activity with a
reduction in the tissue production of prostaglandins such as
Prostaglandin F2a and Prostaglandin E2.
The anti-inflammatory effect, measured in the adjuvant-induced
arthritis model, is greater than that of
aspirin and similar to indomenthacin. Diclofenac causes gastric
erosions and prolongs the bleeding
time.
2. Although Diclofenac Sodium does not alter the cause of the
underlying disease, it has been found to
relieve pain, reduce fever, swelling, and tenderness, and increase
mobility in patients with rheumatic
of the types indicated.
3. The rectally administered Diclofenac Sodium is rapidly and almost
completely absorbed and
distributed to blood, liver and kidneys. The plasma concentration
shows a linear relationship to the
amount of drug administered.
4. The plasma AUC values for unchanged Diclofenac Sodium following
rectal administration are within
the same range as those of the oral doses of enteric coated tablets.
INDICATION(S):
Chronic rheumatic arthritis, degenerative osteoarthritis and painful
post-operative inflammation.
DOSAGE AND ADMINISTRATION:
Adult: 100mg, usually to be used at night. Maximum total daily dose is
150mg.
Childre