CIPLA PAIN RELIEF PARACETAMOL and CODEINE PHOSPHATE HEMIHYDRATE 8 tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 8 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: erythrosine aluminium lake; lactose monohydrate; magnesium stearate; potato starch; povidone; docusate sodium; colloidal anhydrous silica

Administration route:

Oral

Units in package:

10, 36, 20, 12, 40, 24, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the temporary relief of acute moderate pain in patients over the age of 12 years

Product summary:

Visual Identification: Pink, circular, flat beveled tablets with central break line on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-11-04

Patient Information leaflet

Cipla pain relief paracetamol and codeine phosphate hemihydrate 8
tablets
1
CIPLA PAIN RELIEF PARACETAMOL AND CODEINE
PHOSPHATE HEMIHYDRATE 8 TABLETS
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 AND CODEINE PHOSPHATE
HEMIHYDRATE 8
TABLETS?
Cipla Pain Relief Paracetamol and Codeine Phosphate Hemihydrate 8
tablets contains the active ingredient Paracetamol and
Codeine Phosphate. Cipla Pain Relief Paracetamol and Codeine Phosphate
Hemihydrate 8 tablets is used to temporarily relieve
acute moderate pain fever when other analgesics have proven not to be
effective.. For more information, see Section 1. Why
am I using Cipla Pain Relief Paracetamol and Codeine Phosphate
Hemihydrate 8 tablets? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA PAIN RELIEF PARACETAMOL AND
CODEINE PHOSPHATE
HEMIHYDRATE 8 TABLETS?
Do not use if you have ever had an allergic reaction to paracetamol
and codeine phosphate 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 and Codeine Phosphate Hemihydrate 8 tablets?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Pain Relief Paracetamol and
Codeine Phosphate Hemihydrate 8 tablets 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 AND CODEINE PHOSPHATE
HEMIHYDRATE 8 TABLETS?
•
For adults and adolescents over 12 years take one to two tablets to be
taken every four to six hours, when

Summary of Product characteristics

Product Information
Cipla Pain Relief Paracetamol and Codeine 8 Tablets
V002-20210222
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AUSTRALIAN PRODUCT INFORMATION
CIPLA PAIN RELIEF
PARACETAMOL AND CODEINE 8 (PARACETAMOL AND CODEINE
PHOSPHATE HEMIHYDRATE) TABLETS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Cipla Pain
Relief Paracetamol
and Codeine 8 tablets 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 _
Cipla Pain Relief Paracetamol and Codeine 8 tablets 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 Cipla
Pain Relief Paracetamol and Codeine 8 tablets. 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 Cipla Pain Relief
Paracetamol and
Codeine 8 tablets.
1.
NAME