PAINSTOP DAY-TIME PAIN RELIEVER oral liquid bottle (reformulation)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 24 mg/mL; codeine phosphate hemihydrate, Quantity: 1 mg/mL

Available from:

Care Pharmaceuticals Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: macrogol 400; purified water; saccharin sodium; methyl hydroxybenzoate; glycerol; citric acid monohydrate; sodium citrate dihydrate; propyl hydroxybenzoate; sodium chloride; Flavour

Administration route:

Oral

Units in package:

200ml, 100ml

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the temporary relief of acute moderate pain when paracetamol alone is not sufficient in patients over the age of 12 years (see also CONTRAINDICATIONS and Paediatric use).

Product summary:

Visual Identification: Clear colourless to pale brownish solution; Container Type: Bottle; Container Material: Plastic; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-09-26

Patient Information leaflet

Painstop Day-Time Pain Reliever

1
PAINSTOP DAY-TIME PAIN RELIEVER®
_Paracetamol, codeine phosphate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Painstop Day-Time
Pain Reliever®.
It does not contain all the available
information. It does not take the place
of talking to your pharmacist or doctor.
All medicines have risks and benefits.
Your pharmacist or doctor has weighed
the risks of you taking Painstop Day-
Time Pain Reliever® against the
benefits they expect it will have for
you.
If you have any concerns about taking
this medicine, ask your pharmacist or
doctor.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT PAINSTOP DAY-
TIME PAIN RELIEVER® IS
USED FOR
Painstop Day-Time Pain Reliever® is
an analgesic (pain reliever). It works to
temporarily relieve acute moderate
pain when paracetamol alone is not
sufficient in adults and children 12
years and older.
It contains paracetamol and codeine
phosphate.
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to reduce
fever.
Codeine phosphate is an opioid pain
reliever.
Ask your pharmacist or doctor if you
have any questions about this
medicine.
THIS MEDICINE MAY BE ADDICTIVE IF
TAKEN FOR MORE THAN A FEW DAYS AT A
TIME.
It is only available from your
pharmacist.
BEFORE YOU TAKE/GIVE
PAINSTOP DAY-TIME
PAIN RELIEVER®
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PAINSTOP DAY-TIME PAIN
RELIEVER® IF YOU:

ARE UNDER 12 YEARS OF AGE

ARE BREASTFEEDING

ARE AGED 18 YEARS OR YOUNGER AND
HAVE HAD RECENT SURGERY ON YOUR
TONSILS OR ADENOIDS

ARE KNOWN TO BE AN ULTRA-RAPID
METABOLISER OF CODEINE.
DO NOT TAKE PAINSTOP DAY-TIME PAIN
RELIEVER® IF YOU HAVE AN ALLERGY TO:

any medicine containing
paracetamol

any medicine containing codeine

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swel

Summary of Product characteristics

Page 1
AUSTRALIAN PRODUCT INFORMATION, PAINSTOP DAY-TIME PAIN
RELIEVER (PARACETAMOL 120MG IN 5ML AND CODEINE PHOSPHATE
HEMIHYDRATE 5MG IN 5ML)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Painstop
Day-Time Pain Reliever 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 _
Painstop Day-Time Pain Reliever 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 Painstop Day-
Time Pain Reliever. 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 Painstop Day-Time Pain Reliever.
Page 2
1.
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Painstop Day-Time Pain Reliever contains the fol