ASPEN CODEINE codeine phosphate hemihydrate 30mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 30 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate

Administration route:

Oral

Units in package:

100 tablets, 10, 20 tablets

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Aspen Codeine tablets are 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: Plain white round biconvex tablet of diameter 7/32"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-08-31

Patient Information leaflet

1
ASPEN CODEINE TABLETS
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
Aspen Codeine tablets 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
Aspen Codeine tablets 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
Aspen Codeine tablets can cause life-threatening or fatal breathing
problems (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 Aspen Codeine
tablets 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.
USE OF OTHER MEDICINES WHILE USING ASPEN CODEINE TABLETS
Using Aspen Codeine tablets 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 Aspen Codeine
tablets.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Aspen Codeine tablets.
It does not contain all of
the available information
about Aspen Codeine
tablets.
It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks
and benefits. Your doctor
has weighed the risks of
you taking Aspen Codeine
tablets against the benefits
he/she expect it will have.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS
MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need
t

Summary of Product characteristics

Aspen Codeine tablets - July 2020
1
AUSTRALIAN PRODUCT INFORMATION
ASPEN CODEINE (CODEINE PHOSPHATE HEMIHYDRATE) TABLETS
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Aspen Codeine
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
Aspen Codeine 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 Aspen
Codeine 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 Aspen Codeine tablets.
1
NAME OF THE MEDICINE
Codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipient with known effect: Contains sugar as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Plain white rou