CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15, paracetamol 500mg + codeine phosphate hemihydrate 15mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 15 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: pregelatinised maize starch; maize starch; sodium lauryl sulfate; povidone; purified talc; magnesium stearate; colloidal anhydrous silica; hyprolose; stearic acid

Administration route:

Oral

Units in package:

40, 24, 12

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Temporary relief of acute moderate pain.

Product summary:

Visual Identification: Paracetamol & codeine tablets are white to off white, capsule shaped biconvex, uncoated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-09-06

Patient Information leaflet

CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15
1
CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15
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 CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15?
CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15 contains the active
ingredient Paracetamol and Codeine phosphate. CIPLA
PAIN RELIEF PARACETAMOL + CODEINE 15 is used to relieve pain , when
other analgesics have proven not to be effective.
For more information, see Section 1. Why am I using CIPLA PAIN RELIEF
PARACETAMOL + CODEINE 15? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA PAIN RELIEF PARACETAMOL +
CODEINE 15?
Do not use if you have ever had an allergic reaction to CIPLA PAIN
RELIEF PARACETAMOL + CODEINE 15 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 CIPLA PAIN RELIEF
PARACETAMOL + CODEINE 15? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CIPLA PAIN RELIEF PARACETAMOL +
CODEINE 15 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 CIPLA PAIN RELIEF PARACETAMOL + CODEINE 15?
The usual dose for adults and children over 12 years of age is one to
two tablets every 4 to 6 hours with water as needed for
relief of pain. Do not exceed 8 tablets in a 24 hour period. The usual
dose for children 12 years is one tablet every 4 to 6 hours
with water as needed up to a maximum of 4 tablets in 24 hours. CIPLA
PAIN RELIEF PARACETAMOL + CODEINE 15 is not
recommended for children under 12 years of age. More instructions can
be