VOLTAREN 25 diclofenac disodium 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diclofenac sodium, Quantity: 25 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Diclofenac sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: macrogol 8000; iron oxide yellow; PEG-40 hydrogenated castor oil; acrylates copolymer; maize starch; sodium starch glycollate; purified talc; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; magnesium stearate; povidone; lactose monohydrate; titanium dioxide; simethicone; sorbic acid; steareth-2

Administration route:

Oral

Units in package:

20 tablets, 50 tablets

Prescription type:

(S3) Pharmacist Only Medicine, (S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: yellow, round, slightly biconvex tablets with bevelled edges. Debossed with BZ on one side and CG on reverse side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-12-17

Patient Information leaflet

VOLTAREN
® TABLETS &
SUPPOSITORIES
_diclofenac sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Voltaren tablets and
suppositories. 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 this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOLTAREN IS USED
FOR
Voltaren 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).
Voltaren 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)
•
relieve pain in children after they
have had an operation.
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 purpose.
Voltaren is only available with a
doctor's prescription. It is not
addictive.
Voltaren suppositories should not be
used in children under 12 months of
age. Because of their strength,
Voltaren

Summary of Product characteristics

1
AUSTRALIAN PI – VOLTAREN
®
(DICLOFENAC SODIUM)
TABLETS AND SUPPOSITORIES
1
NAME OF THE MEDICINE
Active ingredient: Diclofenac sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Voltaren Tablets are enteric coated and contain either 25 mg or 50 mg
of diclofenac sodium.
List of excipients with known effect: lactose monohydrate
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
Voltaren Suppositories contain either 12.5 mg, 25 mg, 50 mg or 100 mg
diclofenac sodium in a
triglyceride base.
3
PHARMACEUTICAL FORM
Enteric coated tablets
25 MG: yellow, round, slightly biconvex tablets with bevelled edges.
Debossed with BZ on one side
and CG on reverse side’.50 MG: light brown, round, slightly convex,
coated tablets. Imprinted with
CG on one side and GT on the other’.
Suppositories
12.5 MG, 25 MG AND 50 MG: white to yellowish torpedo-shaped with
smooth surfaces’
100 MG: yellowish white "torpedo shaped" suppository, rounded one end,
flat at other, being 30 mm
long 12 mm diameter at widest part tapering to 9 mm small end’
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tablets:
•
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis and
osteoarthritis.
•
Relief of acute or chronic pain states in which there is an
inflammatory component.
•
Symptomatic treatment of primary dysmenorrhoea.
Suppositories:
•
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis and
osteoarthritis.
•
Short term (up to three days) treatment of post-operative pain in
children.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Pregnancy: see Section 4.3 CONTRAINDICATIONS and Section 4.6
FERTILITY, PREGNANCY and
LACTATION.
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