CODALGIN FORTE codeine phosphate hemihydrate 30 mg and paracetamol 500 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Viatris Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; maize starch; povidone; crospovidone; stearic acid; colloidal anhydrous silica

Administration route:

Oral

Units in package:

10, 4 tablets (physician's sample pack), 12, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CODALGIN FORTE 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: A 16.8mm x 7.7mm white, capsule shaped tablet, plain on one side and with a breakbar on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-11-03

Patient Information leaflet

CODALGIN 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 USING CODALGIN FORTE?
CODALGIN FORTE contains the active ingredients paracetamol and codeine
phosphate hemihydrate. CODALGIN FORTE is used
for the short-term management of severe pain when all other pain
management options have not worked. For more information, see
Section 1. Why am I using CODALGIN FORTE? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CODALGIN FORTE?
Do not use if you have ever had an allergic reaction to CODALGIN 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
CODALGIN FORTE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CODALGIN 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 USE CODALGIN 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 CODALGIN FORTE? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CODALGIN FORTE?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
CODALGIN FORTE. Talk to your
doctor about pain control if the medicine is not helping. Tell your
doctor if you become pregnant while taking
CODALGIN 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 COD

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CODALGIN FORTE
_Paracetamol & codeine phosphate hemihydrate tablet _
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, CODALGIN
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 _
CODALGIN 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 CODALGIN 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 CODALGIN FORTE.
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CODALGIN FORTE tablet contains 500 mg of paracetamol and 30 mg of
codeine phosphate
hemihydrate as the active ingredients.
codeine phosphate hemihydrate
For the full list of e