PARACETAMOL/CODEINE GH 500/15 tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Generic Health Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the relief of acute moderate pain and fever.

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: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2012-01-31

Patient Information leaflet

Paracetamol/Codeine GH 500/15 v2.1
1
PARACETAMOL/CODEINE GH 500/15
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING PARACETAMOL/CODEINE GH 500/15?
Paracetamol/Codeine GH 500/15 contains the active ingredients
paracetamol and codeine phosphate hemihydrate.
Paracetamol/Codeine GH 500/15 is used to relieve acute moderate pain
and fever. For more information, see Section 1. Why
am I using Paracetamol/Codeine GH 500/15? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PARACETAMOL/CODEINE GH 500/15?
Do not take if you have ever had an allergic reaction to
Paracetamol/Codeine GH 500/15 or any of the ingredients listed at the
end of the CMI. Talk to your doctor if you have any other medical
conditions, take any other medicines, or are pregnant or
plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Paracetamol/Codeine GH 500/15? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Paracetamol/Codeine GH 500/15 and
affect how it works. A list of these medicines is in
Section 3. What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE PARACETAMOL/CODEINE GH 500/15?
The standard dose for adults and children aged 12 years and over for
this medicine is 2 caplets, taken every 4 to 6 hours if
necessary. More instructions can be found in Section 4. How do I use
Paracetamol/Codeine GH 500/15? in the full CMI..
5.
WHAT SHOULD I KNOW WHILE USING PARACETAMOL/CODEINE GH 500/15?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
PARACETAMOL/CODEINE GH
500/15.
•
TALK TO YOUR DOCTOR ABOUT PAIN CONTROL IF THE MEDICINE IS NOT HELPING.
•
TELL YOUR DOCTOR IF YOU BECOME PREGNANT WHILE TAKING
PARACETAMOL/CODEINE GH 500/15.
T

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PARACETAMOL/CODEINE GH
500/15
(PARACETAMOL AND CODEINE PHOSPHATE HEMIHYDRATE) UNCOATED TABLET
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids,
Paracetamol/Codeine GH 500/15 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
Paracetamol/Codeine GH 500/15 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 Paracetamol/Codeine
GH 500/15. 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 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 Paracetamol/Codeine GH
500/15.
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg and codeine phosphate
hemihydrate 15 mg.
List of excipients with