TRUST ANALGESIC CALMATIVE paracetamol 500mg + codeine phosphate hemihydrate 10mg + doxylamine succinate 5.1mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
14-12-2020
Summary of Product characteristics
(SPC)
14-12-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 10 mg; doxylamine succinate, Quantity: 5.1 mg
Available from:
Pharmacor Pty Ltd
INN (International Name):
codeine phosphate hemihydrate,doxylamine succinate,Paracetamol
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: crospovidone; lactose monohydrate; stearic acid; magnesium stearate; maize starch; ethanol; povidone; microcrystalline cellulose
Administration route:
Oral
Units in package:
10, 36, 24, 12, 40, 30, 20
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the temporary relief of acute moderate pain and fever.
Product summary:
Visual Identification: White capsule shaped, biconvex, bevel edged, uncoated tablet with break line on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-11-26
Patient Information leaflet
Trust Analgesic Calmative (V – 05)
1
TRUST ANALGESIC CALMATIVE
_Paracetamol 500mg, codeine phosphate 10mg and doxylamine succinate
5.1mg_
CONSUMER MEDICINE INFORMATION (CMI)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, TRUST
ANALGESIC CALMATIVE 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
_HAZARDOUS AND HARMFUL USE _
TRUST ANALGESIC CALMATIVE 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
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of TRUST ANALGESIC
CALMATIVE. 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
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 TRUST ANALGESIC CALMATIVE.
Please read this information before you start taking this medicine.
WHAT IS IN THIS CMI
This leaflet answers some
common questions about Trust
Analgesic Calmative.
It does not contain all the available
information. It does not take the
place of talking to your doctor. All
medicines have risks and benefits.
Your doctor has weighed the risks of
taking this m
Read the complete document
Summary of Product characteristics
Trust Analgesic Calmative (V – 06)
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION –
TRUST ANALGESIC CALMATIVE (PARACETAMOL, CODEINE
PHOSPHATE HEMIHYDRATE, DOXYLAMINE SUCCINATE) TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, TRUST
ANALGESIC
CALMATIVE 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 _
TRUST ANALGESIC CALMATIVE 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 TRUST ANALGESIC CALMATIVE. 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 TRUST ANALGESIC CALMATIVE.
1
NAME OF THE MEDICINE
Paracetamol, codeine phosphate hemihydrate, and doxylamine succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
para
Read the complete document
