MOVALIS meloxicam 7.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meloxicam

Available from:

Arrow Pharma Pty Ltd

Authorization status:

Registered

Patient Information leaflet

MOVALIS
®
- Consumer Medicine Information
Page 1 of 4
MOVALIS
® TABLETS
meloxicam
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOVALIS.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking MOVALIS against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read
it again.
WHAT MOVALIS IS USED
FOR
MOVALIS is used to treat the
symptoms of osteoarthritis. This
disease mainly affect the joints
causing pain and swelling.
Although it can relieve symptoms
such as pain and inflammation, it
will not cure your condition.
MOVALIS belongs to a family of
medicines called Non-Steroidal Anti-
inflammatory Drugs (NSAIDs).
These medicines work by relieving
pain and inflammation.
It is available only with a doctor's
prescription.
Your doctor may have prescribed
MOVALIS for another reason. Ask
your doctor if you have any
questions about why MOVALIS has
been prescribed for you.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE MOVALIS IF YOU ARE
ALLERGIC TO:
•
MELOXICAM
•
ASPIRIN OR OTHER NSAIDS
•
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET (THIS
INCLUDES LACTOSE).
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips, tongue or other parts
of the body, shortness of breath,
wheezing or troubled breathing.
DO NOT TAKE MOVALIS IF:
•
you are about to undergo
coronary artery bypass graft
surgery
•
you have a disease of the heart
with shortness of breath, and
swelling of the feet or lips due to
fluid build-up
•
you experience bleeding from the
stomach, gut or any other
bleeding
•
you have had a stroke resulting
from a bleed in the brain or you
have a bleeding disorder
•
you have a galactose intolera

Summary of Product characteristics

MOVALIS TABLETS- Product Information
1
MOVALIS
® TABLETS
(MELOXICAM)
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient:
Meloxicam
Chemical Names:
4-hydroxy-2-methyl-
N
-(5-methyl-2-thiazolyl)-2
H
-1,2-benzothiazine-3-
carboxamide-1,1-dioxide
2
H
-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 number is 71125-38-7
Structural formula:
DESCRIPTION
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.
MOVALIS is available as tablets containing 7.5 mg and 15 mg of
meloxicam. The excipients are
sodium citrate dihydrate, lactose monohydrate, microcrystalline
cellulose, povidone, crospovidone,
colloidal anhydrous silica, magnesium stearate.
MOVALIS TABLETS- Product Information
2
PHARMACOLOGY
MOVALIS 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
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.
Selective inhibition of the cyclooxygenase-2 (COX-2) isoenzyme,
relative to COX-1, by meloxicam
has been demonstr