CODASIG paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 15 mg; paracetamol, Quantity: 500 mg

Available from:

Sigma Company Limited

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; povidone; ethanol; purified water; potato starch; docusate sodium

Administration route:

Oral

Units in package:

20, 40

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the temporary relief of acute moderate pain in patients over the age of 12 years (see also CONTRAINDICATIONS and Paediatric Use).

Product summary:

Visual Identification: White to off white capsule shaped uncoated tablets plain on one side and breakline on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-07-28

Patient Information leaflet

Consumer Medicine Information (CMI)
CODASIG
CMI‐0621 v04
1
CONSUMER MEDICINE INFORMATION (CMI)
CODASIG (AUST R 226290)
Please read this information before you start taking this medicine
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Codasig
tablets 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 _
Codasig tablets 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 Codasig
tablets. 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 Codasig tablets.
Consumer Medicine Information (CMI)
CODASIG
CMI‐0621 v04
2
WHAT IS IN THIS LEAFLET?
This leaflet answers some
IF YOU WANT MORE INFORMATION,
ASK YOUR DOCTOR.
Do not take CODASIG tablets
during labou

Summary of Product characteristics

Product Information
CODASIG
PI0321 v04
1
AUSTRALIAN PRODUCT INFORMATION
CODASIG paracetamol 500 mg and codeine phosphate hemihydrate 15 mg
tablets blister pack (AUST R 226290)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Codasig
tablets 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 _
Codasig tablets 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
Codasig tablets. 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 Codasig tablets.
Product Information
CODASIG
PI0321 v04
2
1.
NAME OF THE MEDICINE
CODASIG paracetamol 500 mg and codeine phosphate hemihydrate 15 mg
tablets blister pack
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVES:
Each