PANAMAX CO paracetamol 500 mg and codeine phosphate hemihydrate 8 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 8 mg; paracetamol, Quantity: 500 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

40 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the relief of acute moderate pain

Product summary:

Visual Identification: Flat white bevelled tablet, marked 'Panamax Co' on one side.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-12-15

Patient Information leaflet

PANAMAX CO
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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 USING PANAMAX CO?
Panamax Co contains the active ingredients paracetamol and codeine
phosphate hemihydrate. Panamax Co is used to relieve
moderate pain. For more information, see Section 1. Why am I using
Panamax Co? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PANAMAX CO?
Do not use if you have ever had an allergic reaction to Panamax Co 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
Panamax Co? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Panamax Co 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 PANAMAX CO?
The usual dose for Adults is 1 to 2 tablets. This dosage may be
repeated every 4 to 6 hours of necessary
More instructions can be found in Section 4. How do I use Panamax Co?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PANAMAX CO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Panamax Co.
•
Talk to your doctor about pain control if the medicine is not helping.
•
Tell your doctor if you become pregnant while taking Panamax Co.
THINGS YOU
SHOULD NOT DO
•
Do not take more than the recommended dose unless your doctor tells
you to.
•
Do not take more than 8 tablets a day.
•
Do not give Panamax Co to children under 12.
•
Do not take high doses of the medicine for long periods of time unless
you doctor tells you to.
•
Do not give this medicine to anyon

Summary of Product characteristics

panco-ccdsv5-piv20-03dec21
Page 1
AUSTRALIAN PRODUCT INFORMATION – PANAMAX CO
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE)
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, PANAMAX CO
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
PANAMAX CO 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 PANAMAX CO. 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 PANAMAX CO.
panco-ccdsv5-piv20-03dec21
Page 2
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Paracetamol 500 mg, codeine phosphate
hemihydrate 8 mg.
Excipients with known effect: potassium sorbate
For the full list of exci