ASPALGIN aspirin 300 mg codeine phosphate hemihydrate 8 mg dispersible tablet blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

codeine phosphate hemihydrate, Quantity: 8 mg; aspirin, Quantity: 300 mg

थमां उपलब्ध:

Viatris Pty Ltd

फार्मास्यूटिकल फॉर्म:

Tablet, dispersible

रचना:

Excipient Ingredients: citric acid; wheat starch; purified talc; saccharin sodium; calcium carbonate; disodium edetate; sodium lauryl sulfate

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

20 tablets, 40 tablets

वर्ग:

Medicine Registered

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

For the temporary relief of acute moderate pain, inflammation and fever

उत्पाद समीक्षा:

Visual Identification: A round white tablet flat with bevelled edges one face plain one engraved FM having a diameter of 17/32".; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

1991-08-30

सूचना पत्रक

ASPALGIN
_aspirin and codeine phosphate hemihydrate_
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
ASPALGIN 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
ASPALGIN 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
ASPALGIN 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 ASPALGIN 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 ASPALGIN
USING ASPALGIN WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH
AS SLEEPING TABLETS (E.G. BENZODIAZE-
PINES), OTHER PAIN RELIEVERS, ANTIHISTAMINES, ANTIDEPRESSANTS,
ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPENTIN AND PRE-
GABALIN), 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 ASPALGIN.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASPALGIN. 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 has weighed
the risks of you taking ASPALGIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ASPALGIN IS
USED FOR
This medicine is used for the
temporary relief of acute moderate
p

उत्पाद विशेषताएं

AUSTRALIAN PRODUCT INFORMATION
ASPALGIN
_aspirin and codeine phosphate hemihydrate dispersible tablets _
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, ASPALGIN
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 _
ASPALGIN 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 ASPALGIN. 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 ASPALGIN.
1
NAME OF THE MEDICINE
Aspirin and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ASPALGIN dispersible tablet contains 300 mg aspirin and 8 mg
codeine phosphate hemihydrate as the
active ingredients.
Excipients of known effect: gluten, saccharin.
For the full list of excipients,