SANDOZ IBUPROFEN PLUS CODEINE film coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
29-01-2021
Summary of Product characteristics
(SPC)
19-08-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg
Available from:
Sandoz Pty Ltd
INN (International Name):
codeine phosphate hemihydrate,Ibuprofen
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400
Administration route:
Oral
Units in package:
10, 30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also Contraindications and Paediatric Use)
Product summary:
Visual Identification: white to off white coloured, caplet shaped film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-06-27
Patient Information leaflet
Sandoz® Ibuprofen Plus Codeine
1
SANDOZ® IBUPROFEN PLUS CODEINE TABLETS
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 SANDOZ IBUPROFEN PLUS CODEINE?
Sandoz Ibuprofen Plus Codeine contains the active ingredient ibuprofen
and codeine phosphate. Sandoz Ibuprofen Plus
Codeine is used to provide temporary relief of acute moderate pain and
inflammation.
For more information, see Section 1. Why am I using Sandoz Ibuprofen
Plus Codeine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SANDOZ IBUPROFEN PLUS CODEINE?
Do not use if you have ever had an allergic reaction to Sandoz
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. You may develop
addiction, dependence and tolerance.
For more information, see Section 2. What should I know before I use
Sandoz Ibuprofen Plus Codeine?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sandoz 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 SANDOZ IBUPROFEN PLUS CODEINE?
•
The usual dose of Sandoz Ibuprofen Plus Codeine is 2 tablets then, if
necessary 1 or 2 tablets every 4 to 6 hours.
More instructions can be found in Section 4. How do I use Sandoz
Ibuprofen Plus Codeine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SANDOZ IBUPROFEN PLUS CODEINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sandoz Ibuprofen Plus Codeine.
•
Talk to your doctor about pain control if Sandoz Ibuprofen Plus
Codeine is not helping.
•
Tell your docto
Read the complete document
Summary of Product characteristics
210810-sandoz-ibuprofen-plus-codeine-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
SANDOZ
® IBUPROFEN PLUS CODEINE (IBUPROFEN/CODEINE PHOSPHATE
HEMIIHYDRATE) FILM COATED TABLETS
1.
NAME OF THE MEDICINE
Ibuprofen and Codeine phosphate hemihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sandoz
®
Ibuprofen plus Codeine film coated tablet contains 200 mg ibuprofen
and 12.8
mg codeine phosphate hemihydrate.
For the full list of excipients, see Section 6.1 List of excipients.
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, Sandoz
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_
Sandoz 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 Sandoz
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 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
patien
Read the complete document
