Oruvail SR

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ketoprofen

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Listed (Export Only)

Patient Information leaflet

ORUVAIL
®
 SR

_Ketoprofen_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Oruvail SR.
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 this medicine
against the benefits they expect it
will 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 ORUVAIL SR IS
USED FOR
Oruvail SR relieves pain and reduces
inflammation (swelling, redness and
soreness) that may occur in
rheumatoid arthritis or osteoarthritis.
Oruvail SR is used to treat the
symptoms of rheumatoid arthritis and
osteoarthritis. Although Oruvail SR
can relieve the symptoms of pain and
inflammation, it will not cure your
condition.
Oruvail SR belongs to a family of
medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs).
These medicines work by relieving
pain and inflammation.
Your doctor, however, may prescribe
Oruvail SR for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Oruvail SR is not recommended for
use in children as there have been no
studies of its effects in children.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ORUVAIL SR IF YOU
HAVE:
•
a peptic ulcer (eg a stomach
ulcer), a recent history of one, or
have had peptic ulcers before
•
problems with your heart
•
severe kidney or liver disease
DO NOT TAKE ORUVAIL SR IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE ORUVAIL SR IF YOU ARE
IN YOUR THIRD TRIMESTER OF
PREGNANCY.
DO NOT TAKE ORUVAIL SR IF YOU ARE
ALLERGIC TO ASPIRIN OR ANY OTHER
ANTI-INFLAMMATORY MEDICINES.
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin o

Summary of Product characteristics

 
_Oruvail-ccdsv4-pi10-d1-30may11 _
_ _
_ _
_Page _1_ _

PRODUCT INFORMATION 
ORUVAIL

 SR CAPSULES 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Ketoprofen 
CHEMICAL STRUCTURE 

CAS NUMBER 
22071-15-4 
DESCRIPTION 
Ketoprofen  is  DL-2-(3-benzoylphenyl)  propionic  acid.    It  is  a  white  or  off-white  powder  with  melting 
point  of about 93°C.   MW: 254.3.  Ketoprofen is very slightly soluble in water at 20°C, 2% soluble in 
dimethylformide  and  readily  soluble  in  benzene,  ethanol,  chloroform,  acetone  and  ethyl  acetate  at 
20°C. 
PHARMACOLOGY 
Animal  pharmacological  studies  have  shown  that  ketoprofen  has  anti-inflammatory,  analgesic  and 
antipyretic  properties.    It  also  inhibits  prostaglandin  synthetase.    Ketoprofen  has  been  shown  to 
possess  antibradykinin  activity  in  guinea  pigs  and  mice.    Inhibition  of  platelet  aggregation  has  been 
demonstrated in rabbits. 
Ketoprofen  reduces  joint  pain  and  inflammation  and  facilitates  increase  in  mobility  and  functional 
independence.  As with other NSAIDs, it does
not cure the underlying disease. 
PHARMACOKINETICS 
The sustained release form of ketoprofen is based upon a multiple pellet system, each pellet acting as 
an individual delivery system  bounded by a pH sensitive dialysing membrane which prevents release 
of ketoprofen in the stomach.  About 100
pellets are needed to deliver each 100 mg of ketoprofen. 
Owing to gradual release of ketoprofen, maximum plasma concentrations occur around 6 hours after 
administration  of  a  single  dose  of  200  mg  of  ketoprofen.    These  are  considerably  lower  (3.5  +  1 
microgram/mL)  than  those  after  a  single  dose  of  100�