APO-IBUPROFEN/CODEINE 200/12.8 film-coated tablet, blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ibuprofen, Quantity: 200 mg; codeine phosphate hemihydrate, Quantity: 12.8 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Ibuprofen

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

30, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also section CONTRAINDICATIONS and SPECIAL WARNINGS AND PRECUATIONS FOR USE - Paediatric Use)

Product summary:

Visual Identification: white to off-white capsule-shaped, biconvex, film-coated tablet; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-09-11

Patient Information leaflet

APO-IBUPROFEN/CODEINE 200/12.8 FILM-COATED TABLETS
1
APO-IBUPROFEN/
CODEINE 200/12.8
FILM-COATED TABLET
_Contains the active ingredient ibuprofen and codeine phosphate
hemihydrate _
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.
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 THIS MEDICINE IS
USED FOR
These tablets contain the active
ingredients ibuprofen and codeine
phosphate. Ibuprofen belongs to a
family of medicines called non-
steroidal anti-inflammatory drugs
(NSAIDS). This group of medicines
work by relieving pain, inflammation
(swelling, redness, soreness) and
fever.
Codeine phosphate hemihydrate is an
opioid analgesic that works in the
brain and spinal cord to relieve pain.
They work to provide:
•
temporary relief of acute
moderate pain and inflammation
in patients over the age of 12
years.
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 may be addictive if
taken for more than a few days at a
time.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
This medicine should not be used in
children under 12 years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
ibuprofen, codeine phosphate
hemihydrate or other opioid
analgesics such as morphine or
pethidine
•
aspirin, any other NSAID or other
anti-inflammatory medicines
•
any of the ingredients listed at the
end of this leaflet.
Many m

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
APO-IBUPROFEN/CODEINE 200/12.8
(IBUPROFEN/CODEINE PHOSPHATE HEMIHYDRATE)
TABLETS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids,
APO-IBUPROFEN/CODEINE
200/12.8 should only be used in patients for whom other treatment
options, including non-
opioid
analgesics,
are
ineffective,
not
tolerated
or
otherwise
inadequate
to
provide
appropriate management of pain (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE).
HAZARDOUS AND HARMFUL USE
APO-IBUPROFEN/CODEINE 200/12.8 poses risks of hazardous and harmful
use which
can lead to overdose and death. Assess the patient’s risk of
hazardous and harmful use
before prescribing and monitor the patient regularly during treatment
(see section 4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of APO-
IBUPROFEN/CODEINE 200/12.8. Be aware of situations which increase the
risk of
respiratory depression, modify dosing in patients at risk and monitor
patients closely,
especially on initiation or following a dose increase (see SECTION 4.4
SPECIAL WARNINGS
AND PRECAUTIONS FOR USE).
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants,
antipsychotics,
canabis
or
other
central
nervous
system
(CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Limit dosages and durations to the minimum required;
and monitor
patients for signs and symptoms of respiratory depression and
sedation. Caution patients
not to drink alcohol while taking APO-IBUPROFEN/CODEINE 200/12.8.
1 NAME OF THE MEDICINE
Ibuprofen and Codeine phosphate hemihydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg.
For the full list of excipients see section 6.1 LIST OF EXC