Voltaren Ophtha

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Diclofenac sodium

Tillgänglig från:

Alcon Laboratories Australia Pty Ltd

Klass:

Medicine Registered

Bipacksedel

VOLTAREN(R) OPHTHA
1
VOLTAREN(R) OPHTHA
_diclofenac sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Voltaren Ophtha
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine. You can also
download the most up to date leaflet
from www.novartis.com.au. Those
updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Voltaren
Ophtha against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOLTAREN OPHTHA
IS USED FOR
This medicine is used to treat
inflammation of the eye e.g.
inflammation which occurs as a
result of surgery.
It belongs to a group of medicines
called non-steroidal
anti-inflammatory drugs (NSAIDs).
NSAIDs relieve pain and reduce
inflammation (i.e. swelling, redness
and throbbing).
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 not addictive.
It is available only with a doctor's
prescription.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU USE
VOLTAREN OPHTHA
_WHEN YOU MUST NOT USE IT_
DO NOT USE VOLTAREN OPHTHA IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
OR ATTACK OF ASTHMA AFTER TAKING OR
USING:
*
any medicine containing
diclofenac sodium, including
Voltaren tablets or supposit

Produktens egenskaper

1 
VOLTAREN
®
 OPHTHA 
(DICLOFENAC SODIUM)

NAME OF THE DRUG 

Active ingredient: 
diclofenac sodium 
Chemical name: 
sodium [2-(2,6-dichloroanilino)phenyl] acetate, a phenylacetic 
acid derivative 
Molecular formula: 
C
14
H
10
Cl
2
NNaO
2
CAS 
number: 
  15307-79-6 
Molecular weight: 

318.1 
Structural formula: 

N
Cl
H
Cl
CH
2
COONa

DESCRIPTION 

Diclofenac sodium is a yellowish-white, odourless, crystalline powder
sparingly soluble in 
water. 

Excipients: 
Multidose bottle: Benzalkonium chloride 50µg/mL as preservative,
disodium edetate, 
hydroxypropyl gamma cyclodextrin, hydrochloric acid, propylene
glycol, trometamol, 
tyloxapol and water for injections. 

Single dose units: PEG-35 castor oil, boric acid, trometamol and water
for injections. 

PHARMACOLOGY 

PHARMACODYNAMICS 
Pharmacotherapeutic group: anti-inflammatory agents, ATC code:
S01BC03 

Voltaren Ophtha contains diclofenac sodium, a non-steroidal compound
with anti-
inflammatory and analgesic properties. 

Inhibition of prostaglandin biosynthesis, which has been demonstrated
experimentally, is 
regarded as having an important bearing on its mechanism of action.
Prostaglandins play a 
major role in the causation of inflammation and pain. 

2 
In clinical trials Voltaren Ophtha has been found to inhibit miosis
during cataract surgery and 
to reduce inflammation following surgical interventions. 

The effective daily dose after ocular application of Voltaren Ophtha
eye drops (approx. 0.25-
0.5 mg diclofenac sodium) corresponds less than 1% of the daily dose
recommended for 
Voltaren in rheumatic indications. 

The benzalkonium chloride containing formulation of Voltaren Ophtha
multidose bottle 
contains a cyclodextrin, hydroxypropyl gamma cyclodextrin.
Cyclodextrins (CDs) increase 
the aqueous solubility of some lipophilic water-soluble drugs. It is
believed that CDs act as 
true carriers by keeping hydrophobic drug molecules in solution and
delivering th