APO-DICLOFENAC Diclofenac sodium 50mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

diclofenac sodium, Quantity: 50 mg

Διαθέσιμο από:

Apotex Pty Ltd

INN (Διεθνής Όνομα):

Diclofenac sodium

Φαρμακοτεχνική μορφή:

Tablet, enteric coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

50 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Visual Identification: Brown yellow film coated tablet, biconvex with facet on both sides, 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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2009-05-06

Φύλλο οδηγιών χρήσης

APO-DICLOFENAC
1
APO-DICLOFENAC
_Diclofenac sodium _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using 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 THIS MEDICINE IS
USED FOR
APO-Diclofenac 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).
APO-Diclofenac 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)
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.
This medicine is available only with
a doctor's prescription. It is not
addictive.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU USE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE THIS MEDICINE IF YOU ARE
ALLERGIC (HYPERSENSITIVE) TO:
•
diclofenac
•
or any of the other ingredients
listed at the end of this leaflet
•
aspirin
•
ibuprofen
•
any other NSAID
•
lactose, or are lactose intolerant -
these tablets contain a small
amount of l

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION
APO-DICLOFENAC ENTERIC COATED TABLETS
(DICLOFENAC SODIUM)
1
NAME OF THE MEDICINE
Diclofenac sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg or 50 mg of diclofenac sodium as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
25 MG TABLETS (AUST R 160729)
Brown yellow film-coated tablet, biconvex with an intact surface and
uniform colour.
50 MG TABLETS (AUST R 160730)
Brown yellow film-coated tablet, biconvex with facet on both sides,
intact surface and
uniform colour.
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
APO- Diclofenac enteric coated tablets are intended for oral
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
minimised by using
the lowest effective dose for the shortest duration necessary to
control symptoms (see 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.
Initial dosage is 75 to 150 mg daily. For long-term therapy, 75 to 100
mg daily is usually
sufficient.
2
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 to 100 mg should be
given