CODAPANE FORTE 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, 4 tablets, 20 tablets, 50 tablets, 2 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Codapane Forte 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:

Registered

Authorization date:

2017-06-06

Patient Information leaflet

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

Summary of Product characteristics

Copadane-forte-ccdsv5-piv7-03dec21
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AUSTRALIAN PRODUCT INFORMATION – CODAPANE FORTE
500/30 (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, CODAPANE
FORTE 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
CODAPANE FORTE 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 CODAPANE FORTE. 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 CODAPANE FORTE.
Copadane-forte-ccdsv5-piv7-03dec21
2
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule-shaped tablet contains paracetamol 500 mg, codeine
phosphate hemihydrate
30 mg.
Excipients with known eff