AMCAL STRONG PAIN RELIEF EXTRA paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
02-07-2021
Summary of Product characteristics
(SPC)
14-09-2021
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 15 mg
Available from:
Sigma Company Limited
INN (International Name):
codeine phosphate hemihydrate,Paracetamol
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: potato starch; purified water; povidone; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; docusate sodium; ethanol
Administration route:
Oral
Units in package:
24, 12, 10, 40, 36, 30, 20
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:
2013-04-18
Patient Information leaflet
Consumer Medicine Information (CMI)
Amcal Strong Pain Relief Extra Tablets
CMI0621 v02
1
CONSUMER MEDICINE INFORMATION (CMI)
AMCAL STRONG PAIN RELIEF EXTRA TABLETS
(AUST R 208319)
Please read this information before you start taking this medicine
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Amcal Strong
Pain Relief Extra
Paracetamol 500 mg and Codeine Phosphate hemihydrate 15 mg 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 _
Amcal Strong Pain Relief Extra Paracetamol 500 mg and Codeine
Phosphate hemihydrate 15
mg 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 Amcal Strong
Pain Relief Extra Paracetamol 500 mg and Codeine Phosphate hemihydrate
15 mg 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
Read the complete document
Summary of Product characteristics
PRODUCT INFORMATION
AMCAL STRONG PAIN RELIEF EXTRA Paracetamol 500 mg and
Codeine Phosphate hemihydrate 15 mg Tablets
PI0321v05
1
AUSTRALIAN PRODUCT INFORMATION
AMCAL STRONG PAIN RELIEF EXTRA
Paracetamol 500 mg and
Codeine Phosphate hemihydrate 15 mg
Tablets (AUST R 208319)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Amcal Strong
Pain Relief Extra
Paracetamol 500 mg and Codeine Phosphate hemihydrate 15 mg 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 _
Amcal Strong Pain Relief Extra Paracetamol 500 mg and Codeine
Phosphate
hemihydrate 15 mg 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 Amcal
Strong Pain Relief Extra Paracetamol 500 mg and Codeine Phosphate
hemihydrate 15 mg
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
patien
Read the complete document
