MEDCO PARACETAMOL 500 CODEINE PHOSPHATE 10 AND DOXYLAMINE SUCCINATE 5.1 tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 10 mg; doxylamine succinate, Quantity: 5.1 mg

Beschikbaar vanaf:

Soul Pattinson Manufacturing Pty Ltd

farmaceutische vorm:

Tablet, uncoated

Samenstelling:

Excipient Ingredients: stearic acid; magnesium stearate; ethanol; microcrystalline cellulose; lactose monohydrate; maize starch; povidone; crospovidone

Toedieningsweg:

Oral

Eenheden in pakket:

20, 24, 12, 36, 10, 30, 40

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

For the temporary relief of acute moderate pain and fever.

Product samenvatting:

Visual Identification: White capsule shaped, biconvex, bevel edged, uncoated tablet with breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2019-05-23

Productkenmerken

Product Information
Medco Paracetamol 500, Codeine Phosphate 10 & Doxylamine Succinate 5.1
V1220
1
AUSTRALIAN PRODUCT INFORMATION -
MEDCO PARACETAMOL 500, CODEINE PHOSPHATE 10 &
DOXYLAMINE SUCCINATE 5.1
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE & DOXYLAMINE
SUCCINATE)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Medco
Paracetamol 500, Codeine
Phosphate 10 & Doxylamine Succinate 5.1 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 _
Medco Paracetamol 500, Codeine Phosphate 10 & Doxylamine Succinate 5.1
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 Medco
Paracetamol 500, Codeine Phosphate 10 & Doxylamine Succinate 5.1. 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 depre