MEDCO IBUPROFEN 200 and CODEINE PHOSPHATE 12.8 ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 12.8 mg; ibuprofen, Quantity: 200 mg

Available from:

Soul Pattinson Manufacturing Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

24, 30, 15, 20, 10, 12

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the temporary relief of acute moderate pain and inflammation

Product summary:

Visual Identification: White to off white coloured, caplet shaped film coated tablets plain on both sides.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-05-30

Summary of Product characteristics

Product Information
Medco Ibuprofen 200 & Codeine phosphate 12.8
V1220
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION –
MEDCO IBUPROFEN 200 & CODEINE PHOSPHATE 12.8
(IBUPROFEN & CODEINE PHOSPHATE HEMIHYDRATE)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Medco
Ibuprofen 200 & Codeine
Phosphate 12.8 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 Ibuprofen 200 & Codeine Phosphate 12.8 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
Ibuprofen 200 & Codeine Phosphate 12.8. 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 Medco Ibuprofen 200 & Codeine
Phosphate 12.8.
1.
NAME OF THE MEDICINE
Ibuprofen 200mg/Codeine phosphate 12.8m