APX-PARACETAMOL/CODEINE 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

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:

20 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APX-Paracetamol/Codeine 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:

Registered

Authorization date:

2020-06-29

Patient Information leaflet

APX-PARACETAMOL/CODEINE
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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 APX-PARACETAMOL/CODEINE?
APX-Paracetamol/Codeine contains the active ingredients paracetamol
and codeine phosphate hemihydrate. APX-Paracetamol/
Codeine is used to relieve severe pain. For more information, see
Section 1. Why am I using APX-Paracetamol/Codeine? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE APX-PARACETAMOL/CODEINE?
Do not use if you have ever had an allergic reaction to
APX-Paracetamol/Codeine 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 APX-Paracetamol/Codeine? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APX-Paracetamol/Codeine 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 APX-PARACETAMOL/CODEINE?
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 APX-Paracetamol/Codeine? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING APX-PARACETAMOL/CODEINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
APX-Paracetamol/Codeine.
•
Talk to your doctor about pain control if the medicine is not helping.
•
Tell your doctor if you become pregnant while taking
APX-Paracetamol/Codeine.
THINGS YOU
SHOULD NOT DO
•
Do not take more than the recommende

Summary of Product characteristics

apx-para-cod-ccdsv5-piv3-03dec21
1
AUSTRALIAN PRODUCT INFORMATION – APX-
PARACETAMOL/CODEINE (PARACETAMOL, CODEINE
PHOSPHATE HEMIHYDRATE)
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, APX-
PARACETAMOL/CODEINE 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
APX-PARACETAMOL/CODEINE 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 APX-PARACETAMOL/CODEINE. 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 APX-PARACETAMOL/CODEINE.
apx-para-cod-ccdsv5-piv3-03dec21
2
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule-shaped tablet contains paracetamol 500 mg, codeine
phosphate hemihydr