PRODEINE paracetamol 500 mg and codeine phosphate hemihydrate 9.6 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 9.6 mg; paracetamol, Quantity: 500 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; purified talc; stearic acid; povidone; pregelatinised maize starch; crospovidone

Administration route:

Oral

Units in package:

36, 40, 2, 12, 24, 12 caplets purse pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the relief of acute moderate pain and fever

Product summary:

Visual Identification: A white capsule shaped tablet plain on one side and breakline on the other.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-09-04

Patient Information leaflet

PRODEINE
®
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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 PRODEINE?
Prodeine contains the active ingredients paracetamol and codeine
phosphate hemihydrate. Prodeine is used to relieve acute
moderate pain and fever.
For more information, see Section 1. Why am I using Prodeine? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PRODEINE?
Do not use if you have ever had an allergic reaction to Prodeine 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
Prodeine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Prodeine 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 PRODEINE?
Adults and children 12 years or over:
One or two tablets every 3 to 4 hours as needed for relief. Do not
take more than 8 caplets in 24 hour period
More instructions can be found in Section 4. How do I use Prodeine? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PRODEINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Prodeine.
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to help you relax,
anything that contains alcohol (like cough syrup) or other medicines
that treat pain.
THINGS YOU
SHOULD NOT DO
•
Do not take more than the recommended dose unless your doctor tells
you to.
•
Do not give this medicine to children under 12 years of age.
•
Do not take Prodeine during the third trimester of pregnancy or if you
are in la

Summary of Product characteristics

prodeine-ccdsv5-piv18-03dec21
Page 1
AUSTRALIAN PRODUCT INFORMATION – PRODEINE
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE)
UNCOATED TABLET
WARNINGS
LIMITATIONS OF USE
BECAUSE OF THE RISKS ASSOCIATED WITH THE USE OF OPIOIDS, PRODEINE
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
PRODEINE 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 PRODEINE. 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 PRODEINE.
prodeine-ccdsv5-piv18-03dec21
Page 2
1
NAME OF THE MEDICINE
Paracetamol, codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prodeine contains paracetamol 500 mg and codeine phosphate hemihydrate
9.6 mg.
Prodeine is aspirin-free.
For the full list of excipients, see