DICLOTROY EC tablet 50mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

AIPHARMA HEALTHCARE SDN BHD

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

10x10tablet Tablets

Dikeluarkan oleh:

Troikaa Pharmaceuticals Ltd

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DICLOTROY EC TABLETS
Diclofenac Sodium BP 50 mg
WHAT IS IN THIS LEAFLET
1.
What Diclotroy EC tablets is used for
2.
How Diclotroy EC tablets works
3.
Before you use Diclotroy EC tablets
4.
How to use Diclotroy EC tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Diclotroy
EC tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT DICLOTROY EC TABLETS IS USED FOR
Diclotroy EC relieves pain, reduce
swelling and ease inflammation in
conditions affecting the joints, muscles,
tendons, teeth and minor surgery.
HOW DICLOTROY EC TABLETS WORKS
Diclotroy EC, is nonsteroidal anti-
inflammatory drugs (NSAIDs), works by
blocking a specific enzyme known as
cyclooxygenase (COX), inhibiting the
production
of
various
inflammatory
substances in the body. This action helps
to treat pain and inflammation.
BEFORE YOU USE DICLOTROY EC TABLETS
-
_When you must not use it_
Do not take Diclotroy EC tablets if:

If you think you may be allergic to
Diclofenac
Sodium,
Aspirin,
Ibuprofen or any other NSAID, or to
any
of
the
other
ingredients
of
Diclotroy EC.

Signs of a hypersensitivity reaction
include
swelling
of
the
face
and
mouth
(angioedema),
breathing
problems,
runny nose,
skin rash or
any other allergic type reaction.

If you have now, or have ever had, a
stomach
(gastric)
or
duodenal
(peptic)
ulcer,
or
bleeding
in
the
digestive tract (this can include blood
in vomit,
bleeding when emptying
bowels,
fresh
blood
in
faeces
or
black, tarry faeces).

If you have severe heart,
kidney or
liver failure.

If
you are
more
than six months
pregnant.
-
_Before you start use it_
Tell your pharmacist or doctor if you are
using any other painkillers.
Tell your doctor if you recently had or you
are going to have a surgery of the stomach
or
intestinal
tract
before
receiving
/
taking/
using Diclotroy EC tablets,
as
Diclotroy
EC Tablets
can
sometimes
worsen wound healing in your gut
after
surgery.
PREGNANCY AND LACT

Ciri produk

Prescribing Information
For the use of Registered Medical Practitioner,
Hospital or a Laboratory Only.
Diclofenac Tablets BP
Brown colored, round, biconvex, enteric coated tablet.
Metabolism : Roughly half of the active substance is metabolised
during its first
passage through the liver (first pass effect); consequently, the areas
under the
concentration curves (AUCs) after an oral dose are only about one-half
as large
as after a parenteral dose of the same size. The biotransformation of
diclofenac
involves partly-glucuronidation of the intact molecule but mainly
single and
multiple hydroxylation followed by glucuronidation. Approx. 60% of the
dose
administered is excreted in the urine than 1% as unchanged substance.
The
remainder of the dose is eliminated as metabolites through the bile in
the faeces.
No relevant age-dependent differences in the drug's absorption,
metabolism, or
excretion have been observed.
Elimination : The total systemic clearance of diclofenac in plasma is
263±56
mL/min (x ± SD). The terminal half-life in plasma is 1-2 hours.
Kinetics in special
clinical situations In patients suffering from renal impairment, no
accumulation of
the unchanged active substance can be inferred from the singled-ose
kinetics
when applying the usual dosage schedule. At a creatinine clearance of
less than
10 mL/ min, the theoretical steady-state plasma level of metabolites
is about four
Each enteric coated tablet contains :
ACTION AND CLINICAL PHARMACOLOGY :
DESCRIPTION :
PHARMACOKINETICS :
Although diclofenac sodium does not alter the course of the underlying
disease,
it has been found to relieve pain, reduce fever, swelling and
tenderness, and
increase mobility in patients with rheumatic disorders of the types
listed.
COMPOSITION :
Absorption : Diclofenac is rapidly and completely absorbed from the
coated
tablets. When the tablets are taken with a meal, the quantity of
active substance
absorbed is not diminished, although the speed of its absorption may
possibly
be reduced. Distribution Following ingestion of o