ARTHROTEC 50 Diclofenac sodium 50mg and Misoprostol 200 microgram tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Diclofenac sodium,Misoprostol

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Diclofenac sodium,Misoprostol

Patient Information leaflet

ARTHROTEC
® 50
(ARTH-ROW-TECH)
_Diclofenac Sodium/Misoprostol (dic-low-fen-ack me-so-pros-tal)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Arthrotec 50.
It does not contain all the available
information. It does not 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 Arthrotec 50
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ARTHROTEC 50 IS
USED FOR
_WHAT ARTHROTEC 50 DOES_
This medicine is used to relieve joint
pain, tenderness, swelling and
stiffness that may occur in
osteoarthritis and rheumatoid
arthritis, whilst protecting your
stomach.
Although this medicine can relieve
the symptoms of pain and
inflammation, it will not cure your
condition.
_HOW ARTHROTEC 50 WORKS_
This medicine contains two active
ingredients: diclofenac sodium and
misoprostol.
Diclofenac sodium belongs to a
family of medicines called non-
steroidal anti-inflammatory drugs
(NSAIDs). These medicines work by
relieving pain and inflammation.
However, this kind of arthritis
medicine can sometimes irritate the
stomach or cause ulcers because it
reduces the amount of natural
protective substances (called
prostaglandins) in the stomach lining.
Misoprostol is very similar to these
natural prostaglandins and can help
protect the stomach. Arthrotec 50
therefore helps protect your stomach
while you continue to receive the
benefit from the anti-arthritis
medicine.
_TAKING ARTHROTEC 50_
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children under the age of 18 years.
BEFORE YOU TAKE
ARTHROT

Summary of Product characteristics

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PRODUCT INFORMATION
ARTHROTEC
® 50 (DICLOFENAC SODIUM/MISOPROSTOL)
NAME OF THE MEDICINE
ARTHROTEC 50 Diclofenac sodium 50 mg/Misoprostol 200 µg tablets.
DICLOFENAC SODIUM
The structural formula of diclofenac sodium is shown below:
Chemical name:
sodium [0-(2,6-dicloroanilino)phenyl] acetate
Molecular formula:
C
14
H
10
CI
2
NO
2
Na
Molecular weight:
318.1
CAS registry number:
15307-86-5.
MISOPROSTOL
The structural formulae of the two diastereomers of misoprostol are
shown below:
Chemical name:
(±)-methyl(13E)-11,16-dihydroxy-16-methyl-9-oxoprost-13-enoate
Molecular formula:
C
22
H
38
O
5
Molecular weight:
382.5
CAS registry number:
59122-46-2.
DESCRIPTION
Diclofenac sodium is a white to off-white, virtually odourless,
crystalline powder.
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Misoprostol is a water-soluble, viscous liquid and is a racemic
compound containing approximately
equal amounts of the two diastereomers.
ARTHROTEC 50 tablets consist of a diclofenac sodium core and a
misoprostol mantle. The tablets
also
contain
castor
oil-hydrogenated,
starch-maize,
cellulose-microcrystalline,
crospovidone,
talc-purified,
hypromellose
lactose,
magnesium
stearate,
povidone,
silica-colloidal
anhydrous,
methacrylic acid copolymer, sodium hydroxide and triethyl citrate.
PHARMACOLOGY
PHARMACODYNAMICS
ARTHROTEC 50 is effective in treating the signs and symptoms of
rheumatoid arthritis and
osteoarthritis. This activity is due to the presence of diclofenac
which has been shown to have
anti-inflammatory and analgesic properties. As with other
non-steroidal anti-inflammatory drugs
(NSAIDs), the exact mechanism of action of diclofenac is not known.
However, it may be related to
the ability of diclofenac to inhibit prostaglandin synthetase.
_ANTIARTHRITIC EFFECTS _
Diclofenac sodium (75-150 mg daily) has equivalent or superior
efficacy to aspirin (3-5 g daily), and
indomethacin (75-100 mg daily), and a variety of other NSAIDs in
treating rheumatoid