Diclofenac Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diclofenac sodium 50mg;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Diclofenac sodium 50 mg

Dosage:

50 mg

Pharmaceutical form:

Enteric coated tablet

Composition:

Active: Diclofenac sodium 50mg   Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Methacrylic acid copolymer Microcrystalline cellulose Purified talc Sodium starch glycolate Titanium dioxide Triethyl citrate

Units in package:

Blister pack, PVDC/PVC aluminium foil blister containing, 50 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Amoli Organics Limited

Therapeutic indications:

Treatment of: inflammatory and degenerative forms of rheumatism - rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism; acute attacks of gout; post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery; painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis; as an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.

Product summary:

Package - Contents - Shelf Life: Blister pack, Polypropylene/Aluminium or PVDC/PVC Aluminium - 50 tablets - 18 months from date of manufacture stored at or below 25°C

Authorization date:

2009-06-08

Patient Information leaflet

DICLOFENAC SANDOZ
®
1
DICLOFENAC SANDOZ
®
_diclofenac sodium enteric-coated tablets _
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

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 19
1 PRODUCT NAME
DICLOFENAC SANDOZ
25 mg enteric coated tablet
50 mg enteric coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Diclofenac Sandoz 25 mg tablet contains Diclofenac Sodium 25 mg
Each Diclofenac Sandoz 50 mg tablet contains Diclofenac Sodium 50 mg
_Excipients with known effect:_
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
25 MG
Brown-yellow gastro-resistant film coated tablets, round, biconvex
faced with a plain rim.
Approximate tablet dimensions: diameter 6.1 to 6.3 mm; thickness 2.9
to 3.2 mm. Each tablet
contains Diclofenac Sodium Ph Eur 25 mg.
50 MG
Brown-yellow gastro-resistant film coated tablets, round, biconvex
faced with a banded rim.
Approximate tablet dimensions: diameter 8.0 to 8.3 mm; thickness 3.5
to 3.8 mm. Each tablet
contains Diclofenac Sodium Ph Eur 50 mg.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
Inflammatory and degenerative forms of rheumatism - rheumatoid
arthritis, juvenile
rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and
spondylarthritis, painful
syndromes of the vertebral column, non-articular rheumatism;
•
Acute attacks of gout;
•
Post-traumatic and post-operative pain, inflammation, and swelling,
e.g. following dental
or orthopaedic surgery;
•
Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or
adnexitis;
NEW ZEALAND DATA SHEET
Page 2 of 19
•
As an adjuvant in severe painful inflammatory infections of the ear,
nose, or throat, e.g.
pharyngotonsillitis, otitis. In keeping with general therapeutic
principles, the underlying
disease should be treated with basic therapy, as appropriate. Fever
alone is not an
indication.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
Diclofenac Sandoz should only be prescribed when the benefits are
considered to outweigh the
potential risks. After assessing the risk/benefit ratio in each
individual patient, the lowest
effective dose for the shortest po