MELOXICAM-DP meloxicam 15mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

meloxicam, Quantity: 15 mg

Disponível em:

Medis Pharma Pty Ltd

DCI (Denominação Comum Internacional):

Meloxicam

Forma farmacêutica:

Tablet, uncoated

Composição:

Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; lactose monohydrate; maize starch; sodium citrate dihydrate; colloidal anhydrous silica; magnesium stearate

Via de administração:

Oral

Unidades em pacote:

30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Meloxicam-DP is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Resumo do produto:

Visual Identification: Pale yellow coloured, circular, flat beveled uncoated tablet, with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2007-06-05

Folheto informativo - Bula

MELOXICAM-DP TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
you
take
MELOXICAM-DP
tablets.
This leaflet answers some common
questions about MELOXICAM-DP. It
does
not
contain
all
available
information,
nor
does
it
take
the
place
of
talking
to
you
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
MELOXICAM-DP
against
the
benefits this medicine is expected to
have for you.
You
should
ask
your
doctor
or
pharmacist
if
you
have
any
questions about MELOXICAM-DP or
if
you
have
any
trouble
before,
during or after taking MELOXICAM-
DP.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE. You may need to read it
again later.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
WHAT MELOXICAM-DP IS USED FOR
MELOXICAM-DP
contains
the
active ingredient meloxicam and is
used
to
treat
the
symptoms
of
rheumatoid
arthritis
and
osteoarthritis,
which
affects
the
joints causing pain and swelling.
MELOXICAM-DP
belongs
to
a
family
of
medicines
called
Non-
Steroidal
Anti-inflammatory
Drugs
(NSAIDs). These medicines work by
relieving pain and inflammation.
Although
MELOXICAM-DP
can
relieve symptoms such as pain and
inflammation, it
will not cure
your
condition.
Your
doctor
may
have
prescribed
MELOXICAM-DP
for
another
reason.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
MELOXICAM-DP
HAS
BEEN
PRESCRIBED TO YOU.
This medicine is only available with
a doctor’s prescription.
There
is
no
evidence
that
MELOXICAM-DP is addictive.
BEFORE YOU TAKE MELOXICAM-DP
_WHEN _
_YOU _
_MUST _
_NOT _
_TAKE _
_MELOXICAM-DP_
DO
NOT
TAKE
MELOXICAM-DP
IF
YOU HAVE AN ALLERGY TO:
• The active ingredient, meloxicam,
or any of the other ingredients in
MELOXICAM-DP. This includes rare
inherited conditions of galactose
intolerance.
• aspirin or any other NSAID
medicine.
If you are not sure if you have these
allergies,
you
should
raise
those
concerns
with
your
doctor
or
pharmacist.
Some of the symptoms of an allergic
reaction m

Características técnicas

100621 Meloxicam-DP PI
Page 1 of 17
PRODUCT INFORMATION
MELOXICAM-DP TABLETS
NAME OF MEDICINE
: Meloxicam
DESCRIPTION:
The chemical name of meloxicam is
4-hydroxy-2-methyl-_N_-(5-methyl-1,3-thiazol-2-yl)-2_H_-
1,2-benzothiazine-3-carboxamide
1,1-dioxide.
The
molecular
formula
of
meloxicam
is
C
14
H
13
N
3
O
4
S
2
, the molecular weight is 351.4 and the CAS number is 71125-38-7.
Meloxicam is a pastel yellow solid with pKa values of 1.09 and 4.18
and a melting point of
about 256°C. The substance is practically insoluble in water, soluble
in dimethylformamide,
slightly soluble in chloroform and acetone, and very slightly soluble
in methanol. There are
no chiral centres and no polymorphs are formed under normal
conditions.
Meloxicam-DP is available as tablets containing 7.5 mg and 15 mg of
meloxicam.
Meloxicam-DP
tablets
also
contain
the
following
excipients:
maize
starch,
lactose,
microcrystalline cellulose, pregelatinised maize starch, sodium
citrate, colloidal anhydrous
silica and magnesium stearate.
PHARMACOLOGY:
Meloxicam-DP is a non-steroidal anti-inflammatory drug (NSAID) of the
enolic acid class,
which
has
shown
anti-inflammatory,
analgesic
and
antipyretic
properties
in
animals.
Meloxicam showed anti-inflammatory activity in all standard models of
inflammation. A
common mechanism for the above effects may exist in the ability of
meloxicam to inhibit the
biosynthesis
of
prostaglandins,
known
mediators
of
inflammation,
by
inhibition
of
cyclooxygenase (COX).
Comparison of the ulcerogenic dose and the anti-inflammatory effective
dose in rat adjuvant
arthritis model confirmed a greater therapeutic margin in animals over
other NSAIDs
(piroxicam, diclofenac, naproxen, flurbiprofen). In rats, meloxicam
showed greater inhibitory
effect on prostaglandin biosynthesis at the site of inflammation than
in the gastric mucosa or
the kidney.
100621 Meloxicam-DP PI
Page 2 of 17
_Selective inhibition of the cyclooxygenase-2 (COX-2) isoenzyme,
relative to COX-1, by _
_meloxicam _
_has _
_been _
_demonstrated _
_in _
_vitro _
_o