MELOXICAM AN meloxicam 7.5 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meloxicam

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Meloxicam

Authorization status:

Registered

Patient Information leaflet

_Meloxicam AN – Consumer Medicine Information _
_ _
MELOXICAM AN TABLETS
_meloxicam _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MELOXICAM AN. It does not
contain all available information,
nor does it take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
MELOXICAM AN against the
benefits they expect it will have for
you.
KEEP THIS INFORMATION.
You may need to read it again
later.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT MELOXICAM
AN IS USED FOR
MELOXICAM AN is used to treat
the symptoms of:
•
osteoarthritis
•
rheumatoid arthritis
Both diseases mainly affect the
joints causing pain and swelling.
Although MELOXICAM AN can
relieve symptoms such as pain
and inflammation, it will not cure
your condition.
MELOXICAM AN belongs to a
family of medicines called Non-
Steroidal Anti-inflammatory Drugs
(NSAIDs). These medicines work
by relieving pain and inflammation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
MELOXICAM AN HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
MELOXICAM AN for another
reason.
BEFORE YOU TAKE
MELOXICAM AN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MELOXICAM AN IF
YOU HAVE AN ALLERGY TO:
•
the active ingredient,
meloxicam, or any of the other
ingredients in MELOXICAM AN
(all of these ingredients are
listed at the end of this leaflet).
This includes rare inherited
conditions of galactose
intolerance.
•
aspirin or any other NSAID
medicine
Some of the symptoms of an
allergic reaction may include:
•
rash, itching or hives on the skin
•
swelling of the face, lips, tongue
or other parts of the body
•
shortness of breath, wheezing or
troubled breathing.
ASK YOUR DOCTOR IF YOU ARE
UNSURE IF YOU ARE ALLERGIC TO
THESE INGREDIENTS.
DO NOT TAKE MELOXICAM AN IF:
•
you are about to undergo
coronary artery bypass graft
surgery
•
you have a disease of the heart
with shortness of brea

Summary of Product characteristics

_Meloxicam AN Tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd_
_ _
MELOXICAM AN
_(MELOXICAM TABLETS_
_)_
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is Meloxicam
O
O
S
CH
3
N
H
N
N
OH
O
S
CH
3
CHEMICAL NAMES:
4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-
carboxamide-1,1-dioxide and
2H-1,2-benzothiazine-3-carboxamide,4-hydroxy-2-methy-N-(5-
methyl-2-thiazolyl)-,1,1-dioxide.
MOLECULAR FORMULA:
C
14
H
13
N
3
O
4
S
2
Molecular Weight:
351.4
CAS REGISTRY NUMBER: _[71125-38-7]_
DESCRIPTION
A pale yellow powder 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 AN is available as tablets containing 7.5 mg and 15 mg of
meloxicam.
_MELOXICAM AN 7.5MG_
Light yellow, round, uncoated tablet with score line between ‘F’
and ‘1’ debossed on one side
and plain on the other side.
_MELOXICAM AN 15MG_
Light yellow, round, uncoated tablet with score line between ‘F’
and ‘2’ debossed on one side
Meloxicam AN PI v2.0
Page 1 of 19
_Meloxicam AN Tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd_
_ _
and plain on the other side.
INACTIVE:
Sodium citrate, lactose, microcrystalline cellulose, povidone,
crospovidone, colloidal
anhydrous silica, magnesium stearate.
PHARMACOLOGY
Meloxicam 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-inflammator