MEDCO Paracetamol 500 and Codeine Phosphate 15 paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablets blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

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

Commercializzato da:

Soul Pattinson Manufacturing Pty Ltd

Forma farmaceutica:

Tablet, uncoated

Composizione:

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

Via di somministrazione:

Oral

Confezione:

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

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

For temporary relief of acute moderate pain.

Dettagli prodotto:

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

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2019-05-30

Scheda tecnica

Product Information
Medco Paracetamol 500 & Codeine Phosphate 15
V1220
1
AUSTRALIAN PRODUCT INFORMATION -
MEDCO PARACETAMOL 500 & CODEINE PHOSPHATE 15
(PARACETAMOL & CODEINE PHOSPHATE HEMIHYDRATE)
1.
NAME OF THE MEDICINE
Paracetamol 500mg and Codeine phosphate hemihydrate 15mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVES: Each tablet contains Paracetamol 500mg and Codeine Phosphate
15mg
EXCIPIENTS: Potato starch, Lactose monohydrate, Povidone, Docusate
Sodium, Silica
Colloidal anhydrous, Magnesium Stearate.
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Medco
Paracetamol 500 &
Codeine Phosphate 15 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 15 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 15. 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