PARACETAMOL/CODEINE GH 500/30 paracetamol 500 mg and codeine phosphate hemihydrate 30 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 30 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: potassium sorbate; maize starch; povidone; purified talc; stearic acid; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch

Administration route:

Oral

Units in package:

10 tablets, 20 tablets, 4 tablets, 50 tablets, 2 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Paracetamol/Codeine GH 500/30 is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: White to off-white, capsule shaped tablets, marked "P" and "F" either side of a scoreline on one side and plain on the other. Dimensions: 17.46 x 7.14 x 6.05mm.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-10-22

Patient Information leaflet

PARACETAMOL/CODEINE GH 500/30
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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 TAKING PARACETAMOL/CODEINE GH 500/30?
Paracetamol/Codeine GH 500/30 contains the active ingredients
paracetamol and codeine phosphate hemihydrate. Paracetamol/
Codeine GH 500/30 is used to relieve severe pain.
For more information, see Section 1. Why am I taking
Paracetamol/Codeine GH 500/30? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE PARACETAMOL/CODEINE GH 500/30?
Do not use if you have ever had an allergic reaction to
Paracetamol/Codeine GH 500/30 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. You may develop addiction,
dependence and tolerance.
For more information, see Section 2. What should I know before I use
Paracetamol/Codeine GH 500/30? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Paracetamol/Codeine GH 500/30 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 TAKE PARACETAMOL/CODEINE GH 500/30?
The standard dose for adults is 1 or 2 tablets for severe pain, taken
every 4 to 6 hours if necessary. More instructions can be found
in Section 4. How do I use Paracetamol/Codeine GH 500/30? in the full
CMI.
5.
WHAT SHOULD I KNOW WHILE USING PARACETAMOL/CODEINE GH 500/30?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Paracetamol/Codeine GH 500/30.
•
Talk to your doctor about pain control if the medicine is not helping.
•
Tell your doctor if you become pregnant while taking
Para

Summary of Product characteristics

Paracetamol-codeine-gh-ccdsv5-piv12-03dec21
1
AUSTRALIAN PRODUCT INFORMATION –
PARACETAMOL/CODEINE GH 500/30 (PARACETAMOL, CODEINE
PHOSPHATE HEMIHYDRATE)
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS,
PARACETAMOL/CODEINE
GH 500/30 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 500/30 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 500/30. 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 500/30.
Paracetamol-codeine-gh-ccdsv5-piv12-03dec21
2
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule-shaped tablet cont