FENAC EC diclofenac sodium 25 mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diclofenac sodium, Quantity: 25 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Diclofenac sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type A; magnesium stearate; iron oxide yellow; purified talc; PEG-40 hydrogenated castor oil; methacrylic acid - ethyl acrylate copolymer (1:1); lactose monohydrate; maize starch; triethyl citrate; povidone; hypromellose; titanium dioxide

Administration route:

Oral

Units in package:

20, 50

Prescription type:

(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: Round, pale yellow, enteric coated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-04-04

Patient Information leaflet

FENAC
® EC
_diclofenac sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FENAC EC.
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 EC
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 EC IS
USED FOR
FENAC EC 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).
FENAC EC 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 FENAC EC
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
FENAC EC is only available with a
doctor's prescription. It is not
addictive.
There is not enough information to
recommend the use of FENAC EC
tablets in children.
BEFORE YOU TAKE
FENAC EC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FENAC EC IF YOU ARE
ALLERGIC (HYPERSENSITIVE) TO:
•
diclofenac (the active ingredient
in FENAC EC) or any of the
other ingredients listed at the end
of this leaflet
•
other medicines containing
diclofenac
•
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
these medicines may include:
•
shortness of breath
•
wheezin

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FENAC
® EC
_(diclofenac sodium) enteric coated tablet _
1
NAME OF THE MEDICINE
Diclofenac sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains 25 mg or 50 mg of diclofenac
sodium as the active ingredient.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
FENAC EC 25 mg tablet: pale yellow, round, enteric coated tablets
plain on both sides.
FENAC EC 50 mg tablet: pale yellow, round, enteric coated tablets
plain on both sides.
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
FENAC EC enteric coated tablets are intended for oral 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.
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be divided or
chewed.
ADULTS
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 sy