Paracetamol + Codeine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Codeine phosphate hemihydrate 8mg equivalent to 5.92 mg codeine; Paracetamol 500mg;  

Available from:

Viatris Limited

INN (International Name):

Codeine phosphate hemihydrate 8 mg (= 5.92 mg codeine)

Pharmaceutical form:

Tablet

Composition:

Active: Codeine phosphate hemihydrate 8mg equivalent to 5.92 mg codeine Paracetamol 500mg   Excipient: Maize starch Potassium sorbate Povidone Purified talc Starch Stearic acid

Units in package:

Blister pack, PVC/Al, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sun Pharmaceuticals Industries (Australia) Pty Ltd

Therapeutic indications:

For adults and children aged 12 years and above for effective, temporary relief of pain and discomfort associated with: · headache · migraine headache · tension headache · period pain · back pain · muscle pain · arthritis · toothache · dental procedures · neuralgia · cold and flu symptoms in adults only (18 years and older) · sore throat Paracetamol + Codeine tablets also help reduce fever. Paracetamol + Codeine is suitable for asthmatics sensitive to aspirin and NSAIDs.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 1000 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2008-07-04

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
PARACETAMOL + CODEINE
_PARACETAMOL 500 MG, CODEINE PHOSPHATE 8 MG TABLETS_
WARNINGS
_LIMITATIONS OF USE_
Paracetamol + Codeine should only be used when your doctor decides
that other treatment options are not able to
effectively manage your pain, or you cannot tolerate them.
_HAZARDOUS AND HARMFUL USE_
Paracetamol + Codeine poses risks of abuse, misuse and addiction which
can lead to overdose and death. Your
doctor will monitor you regularly during treatment
_LIFE THREATENING RESPIRATORY DEPRESSION_
Paracetamol + Codeine can cause life-threatening or fatal breathing
difficulties (slow, shallow, unusual or no
breathing) even when used as recommended. These problems can occur at
any time during use but the risk is
higher when first starting Paracetamol + Codeine and after a dose
increase, if you are older, or have an existing
problem with your lungs. Your doctor will monitor you and change the
dose as appropriate.
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING _
_ALCOHOL_
Using Paracetamol + Codeine with other medicines that can make you
feel drowsy such as sleeping tablets (e.g.
benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g.
gabapentin and pregabalin), cannabis and alcohol may result in severe
drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will minimise the dose
and duration of use; and monitor you for
signs and symptoms of breathing difficulties and sedation. You must
not drink alcohol while using Paracetamol +
Codeine.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Paracetamol +
Codeine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
Paracetamol + Codeine against the
benefits he/she expects it will have
for you.
IF YOU HAVE AN

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
PARACETAMOL + CODEINE
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, Paracetamol +
Codeine 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 (refer to _section 4.4 _
_Special Warnings and Precautions for Use_).
_HAZARDOUS AND HARMFUL USE_
Paracetamol + Codeine 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 (refer to _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 Paracetamol +
Codeine. 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
(refer to _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 Paracetamol
+ Codeine.
1. PRODUCT NAME
Paracetamol + Codeine, 500 mg + 8 mg, tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Paracetamol + Codeine contains 500 mg of paracetamol and 8 mg of
codeine phosphate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Paracetamol + Code