DICLOFENAC SANDOZ Diclofenac sodium 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diclofenac sodium, Quantity: 25 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: lactose monohydrate; sodium starch glycollate; microcrystalline cellulose; iron oxide yellow; purified talc; titanium dioxide; calcium hydrogen phosphate dihydrate; maize starch; colloidal anhydrous silica; magnesium stearate; triethyl citrate; methacrylic acid copolymer

Administration route:

Oral

Units in package:

50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Inflammatory and degenerative forms of rheumatism; rheumatoid arthritis; osteoarthritis. Relief of acute or chronic pain states in which there is an inflammatory component. Symptomatic treatment of primary dysmenorrhoea.

Product summary:

Visual Identification: Brown yellow film coated tablet, biconvex with an intact surface and uniform colour; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1998-03-30

Patient Information leaflet

DICLOFENAC SANDOZ
®
1
DICLOFENAC SANDOZ
®
_diclofenac sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Diclofenac Sandoz.
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.sandoz.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 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 DICLOFENAC
SANDOZ IS USED
FOR
This medicine is used to treat:
•
inflammatory and degenerative
forms of rheumatism, rheumatoid
arthritis and osteoarthritis
•
relief of acute or chronic pain
states in which there is an
inflammatory component
•
symptoms of menstrual pain
(period pain).
It contains the active ingredient
diclofenac sodium.
Diclofenac sodium belongs to a
group of medicines called non-
steroidal anti-inflammatory drugs
(NSAIDs).
It works by reducing pain and
inflammation (swelling and redness).
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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
There is not enough information to
recommend the use of Diclofenac
Sandoz tablets in children.
BEFORE YOU TAKE
DICLOFENAC
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE

Summary of Product characteristics

diclofenac-sandoz-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
DICLOFENAC SANDOZ
® (DICLOFENAC SODIUM)
1
NAME OF THE MEDICINE
Diclofenac sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Diclofenac Sandoz
®
25 mg film-coated tablets contains 25 mg diclofenac sodium.
Each Diclofenac Sandoz
®
50 mg film-coated tablets contains 50 mg diclofenac sodium.
Diclofenac sodium is an odourless, yellowish-white, crystalline powder
sparingly soluble in
water.
_List of excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Diclofenac Sandoz 25 mg enteric coated tablet: Brown yellow film
coated tablet, biconvex with
an intact surface and uniform colour.
Diclofenac Sandoz 50 mg enteric coated tablet: Brown yellow film
coated tablet, biconvex with
facet on both sides, intact surface and uniform colour.
_Not all strengths may be marketed in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Inflammatory
and
degenerative
forms
of
rheumatism;
rheumatoid
arthritis,
osteoarthritis.
•
Relief of acute or chronic pain states in which there is an
inflammatory component.
•
Symptomatic treatment of primary dysmenorrhoea.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for
the shortest possible duration should be used. Adverse effects may be
minimized by using the
lowest effective dose for the shortest duration necessary to control
symptoms (see Section 4.4
Special warnings and precautions for use). Patients on long-term
treatment should be reviewed
regularly with regards to efficacy, risk factors and ongoing need for
treatment.
Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100
mg daily is usually
sufficient. The daily dose should generally be prescribed in two or
three divided doses.
In primary dysmenorrhoea the daily dosage, which should be
individually adapted, is generally
50 to 150 mg. Initially, a dose of 50