DICLOFENAC ARROW diclofenac sodium 25 mg modified release tablet bottle

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

diclofenac sodium

Prieinama:

Arrow Pharma Pty Ltd

INN (Tarptautinis Pavadinimas):

Diclofenac sodium

Autorizacija statusas:

Registered

Pakuotės lapelis

CLONAC- Consumer Medicine Information
Page 1 of 5
CLONAC
_diclofenac sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLONAC.
It does not contain all of 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.
Those updates may contain important
information about the medicine and its
use of which you should be aware.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you taking CLONAC against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT CLONAC IS USED
FOR
CLONAC belongs to a group of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs), which
are used to treat pain and reduce
inflammation (swelling and redness)
CLONAC is used to treat:
•
different types of arthritis including
rheumatoid arthritis and osteoarthritis
•
other painful conditions where
swelling is a problem such as back
pain, rheumatism, muscle strains,
sprains and tendonitis (e.g. tennis
elbow)
•
menstrual cramps (period pain).
It can relieve the symptoms of pain and
inflammation but it will not cure your
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
CLONAC is available only with a
doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of CLONAC in
children.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CLONAC IF YOU ARE
ALLERGIC (HYPERSENSITIVE) TO:
•
diclofenac sodium (the active
ingredient in CLONAC) or any of

Prekės savybės

_Product Information _
_Clonac 25mg/50mg, enteric-coated tablets _
_05/2017_
_ _
_Page 1 _
_Sandoz Pty Ltd _
_ _
_ Version 01_
_ _
PRODUCT INFORMATION
CLONAC
® 25MG AND 50MG ENTERIC-COATED TABLETS
NAME OF THE MEDICINE
Diclofenac sodium
CAS – 15307-79-6
Empirical formula: C
14
H
10
Cl
2
NNaO
2
Chemical Structure:
DESCRIPTION
The active ingredient of Clonac tablets is sodium
2-[(2,6-dichlorophenyl)-amino] phenyl]-
acetate (=diclofenac sodium), a phenylacetic acid derivative,
structurally similar to both the
phenylalkanoic acid and the anthranilic acid series of compounds.
Diclofenac sodium is an
odourless, yellowish-white, crystalline powder sparingly soluble in
water.
Clonac tablets are enteric coated and contain either 25 mg or 50 mg of
diclofenac sodium. The
excipients include: lactose, calcium hydrogen phosphate dihydrate,
microcrystalline cellulose,
maize starch, sodium starch
glycollate, magnesium stearate, colloidal anhydrous silica,
methacrylic acid copolymer, triethyl citrate, talc, titanium dioxide
and iron oxide yellow CI
77492.
PHARMACOLOGY
Pharmacodynamics
Diclofenac sodium, a non-steroidal compound, exhibits pronounced
antirheumatic, anti-
inflammatory, analgesic, and antipyretic properties.
CH
2
NH
C
O
O
Cl
Cl
Diclofenac Sodium
Na
+
-
_Product Information _
_Clonac 25mg/50mg, enteric-coated tablets _
_05/2017_
_ _
_Page 2 _
_Sandoz Pty Ltd _
_ _
_ Version 01_
_ _
As with other NSAIDs, its mode of action is not known; however, its
ability to inhibit
prostaglandin synthesis may be involved in the anti-inflammatory
effect.
In rheumatic diseases, the anti-inflammatory and analgesic properties
of diclofenac elicit a
clinical response characterised by relief from signs and symptoms such
as pain at rest, pain on
movement, morning stiffness, and swelling of the joints, as well as by
an improvement in
function.
In addition, clinical studies have revealed that in primary
dysmenorrhoea diclofenac is capable
of relieving the pain and reducing the extent of bleeding. Low
concentrations of diclofenac
sodium inh