BRUFEN PLUS 200/12.8 Ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

15, 24, 20, 30, 12, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the temporary relief of acute moderate pain and inflammation

Product summary:

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

Authorization status:

Registered

Authorization date:

2018-03-28

Patient Information leaflet

BRUFEN
® PLUS
200/12.8
_ibuprofen and codeine phosphate hemihydrate_
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
BRUFEN PLUS 200/12.8 should only be used when your doctor decides that
other treatment options are not able to effec-
tively manage your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
BRUFEN PLUS 200/12.8 poses risks of abuse, misuse and addiction which
can lead to overdose and death. Your doctor will
monitor you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
BRUFEN PLUS 200/12.8 can cause life-threatening or fatal breathing
problems (slow, shallow, unusual or no breathing),
even when used as recommended. These problems can occur at any time
during use, but the risk is higher when first starting
BRUFEN PLUS 200/12.8 and after a dose increase, if you are older, or
have an existing problem with your lungs. Your
doctor will monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING BRUFEN PLUS 200/12.8
USING BRUFEN PLUS 200/12.8 WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL
DROWSY SUCH AS SLEEPING TABLETS (E.G.
BENZODIAZEPINES), OTHER PAIN RELIEVERS, ANTIHISTAMINES,
ANTIDEPRESSANTS, ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPEN-
TIN AND PREGABALIN), CANNABIS AND ALCOHOL MAY RESULT IN SEVERE
DROWSINESS, DECREASED AWARENESS, BREATHING PROBLEMS,
COMA AND DEATH. YOUR DOCTOR WILL MINIMISE THE DOSE AND DURATION OF
USE; AND MONITOR YOU FOR SIGNS AND SYMPTOMS OF
BREATHING DIFFICULTIES AND SEDATION. YOU MUST NOT DRINK ALCOHOL WHILE
USING BRUFEN PLUS 200/12.8.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BRUFEN PLUS
200/12.8. 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 BRUFEN
PLUS 200/12.8 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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BRUFEN
® PLUS 200/12.8
_Ibuprofen 200 mg/codeine phosphate hemihydrate 12.8 mg tablet _
_ _
1
NAME OF THE MEDICINE
ibuprofen and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Brufen Plus 200/12.8 tablet contains 200 mg of ibuprofen and 12.8
mg of codeine phosphate hemihydrate
as the active ingredients.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Brufen Plus 200/12.8: white to off-white capsule-shaped, biconvex,
film-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of acute moderate pain and inflammation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary
to control symptoms (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Brufen Plus
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 _
Brufen Plus 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 Brufen Plus 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 NERVO