DICLOFENAC SODIUM VIATRIS diclofenac sodium 50 mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diclofenac sodium, Quantity: 50 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Diclofenac sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

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

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: round brown tablet; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-01-11

Patient Information leaflet

FENAC
_contains the active ingredient diclofenac sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FENAC.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking FENAC against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FENAC IS USED
FOR
FENAC belongs to a group of
medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs).
These medicines work by relieving
pain and inflammation (swelling and
redness).
FENAC is used to treat the
symptoms of:
•
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).
Although FENAC can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Your doctor may have prescribed
FENAC for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FENAC HAS
BEEN PRESCRIBED FOR YOU.
FENAC is not recommended for use
in children as its safety and
effectiveness in children has not been
established.
There is no evidence that FENAC is
addictive.
FENAC is available only with a
doctor's prescription.
BEFORE YOU TAKE
FENAC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FENAC IF YOU ARE
ALLERGIC (HYPERSENSITIVE) TO:
•
diclofenac (the active ingredient
in this medicine) any of the other
ingredients listed at the end of
this leaflet other medicines
containing diclofenac (e.g
Voltaren Rapid tablets, Voltaren
Emulgel)
•
aspirin
•
ibuprofen
•
any other NSAID
IF YOU ARE NOT SURE IF YOU ARE
TAKING ANY OF THE ABOVE MEDICINES,
ASK YOUR DOCTOR OR PHARMACIST.
Symptoms of an allergic reaction to

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FENAC
_Diclofenac sodium enteric coated tablets _
1
NAME OF THE MEDICINE
Diclofenac sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FENAC tablets are enteric coated and contain either 25 mg or 50 mg of
diclofenac sodium.
Excipients with known effect: Contains sugars as lactose and trace
amounts of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
FENAC 25 mg is available as a round brown coloured enteric-coated
tablet.
FENAC 50 mg is available as a round brown coloured enteric-coated
tablet.
4
CLINICAL PARTICULARS
4.1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
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.
DOSE
Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100
mg daily is usually sufficient.
The daily dosage should generally be prescribed in 2 or 3 divided
doses.
In primary dysmenorrhoea the daily dosage, which should be
individually adapted, is generally 50 to 150 mg.
Initially a dose of 50 to 100 mg should be given and, if necessary,
raised in the course of several menstrual
cycles up to a maximum of 200 mg/day. Treatment should be started upon
appearance of the first symptoms
and, depending on the symptomatology, continued for a few days.
METHOD OF ADMINISTRATION
The tablets should be swallowed whole with liquid, preferably before
meals, and must not b