AMCAL IBUPROFEN PLUS CODEINE 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:

Cipla Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Ibuprofen

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; purified water; maize starch; glyceryl behenate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMCAL IBUPROFEN PLUS CODEINE is used for temporary relief of acute moderate pain and inflammation in patients over the age of 12 years.

Product summary:

Visual Identification: White to off-white capsule shaped, biconvex, film coated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-09-01

Patient Information leaflet

AMCAL IBUPROFEN PLUS CODEINE
1
AMCAL IBUPROFEN PLUS CODEINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING AMCAL IBUPROFEN PLUS CODEINE?
AMCAL IBUPROFEN PLUS CODEINE contains the active ingredients Ibuprofen
and Codeine phosphate. AMCAL IBUPROFEN
PLUS CODEINE is used to relieve pain, inflammation (swelling, redness,
soreness) and fever when other analgesics have proven
not to be effective.
For more information, see Section 1. Why am I using AMCAL IBUPROFEN
PLUS CODEINE? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AMCAL IBUPROFEN PLUS CODEINE?
Do not use if you have ever had an allergic reaction to AMCAL
IBUPROFEN PLUS CODEINE or any of the ingredients listed at the
end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. Do not use at all during
the last three months of pregnancy,
For more information, see Section 2. What should I know before I use
AMCAL IBUPROFEN PLUS CODEINE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AMCAL IBUPROFEN PLUS CODEINE and
affect how it works. A list of these medicines is in
Section 3. What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE AMCAL IBUPROFEN PLUS CODEINE?
The usual dose of AMCAL IBUPROFEN PLUS CODEINE for adults and children
over 12 years of age is 2 tablets followed by, if
necessary 1 or 2 tablets every 4 hours. Do not take more AMCAL
IBUPROFEN PLUS CODEINE than 6 tablets in 24 hours. More
instructions can be found in Section 4. How do I use AMCAL IBUPROFEN
PLUS CODEINE? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AMCAL IBUPROFEN PLUS CODEINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - AMCAL IBUPROFEN PLUS CODEINE
(IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE) TABLET
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, AMCAL
IBUPROFEN PLUS CODEINE
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 _
AMCAL IBUPROFEN PLUS CODEINE 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 AMCAL
IBUPROFEN PLUS CODEINE. 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, cannabis 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 AMCAL
IBUPROFEN PLUS CODEINE.
1
NAME OF THE MEDICINE
Ibuprofen and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200 mg, codeine phosphate 12.8 mg.
AMCAL IBUPROFEN PLUS CODEINE tablets do not