PAINSTOP NIGHT-TIME PAIN RELIEVER oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 1 mg/mL; paracetamol, Quantity: 24 mg/mL; promethazine hydrochloride, Quantity: 1.3 mg/mL

Available from:

Care Pharmaceuticals Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: purified water; sodium metabisulfite; sorbitol solution (70 per cent) (non-crystallising); propylene glycol; sucrose; disodium edetate; saccharin sodium; brilliant blue FCF; amaranth; phosphoric acid; ethanol; 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 and sedation is considered beneficial in patients over the age of 12 years ( see also CONTRAINDICATIONS and Paediatric Use)

Product summary:

Visual Identification: Clear mauve solution; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-15

Patient Information leaflet

Painstop Day-Time Pain Reliever

1
PAINSTOP NIGHT-TIME PAIN
RELIEVER®
_Paracetamol, codeine phosphate hemihydrate, promethazine
hydrochloride_
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Painstop Night-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 Night-
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 NIGHT-
TIME PAIN RELIEVER® IS
USED FOR
Painstop Night-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 and sedation is
required.
It contains paracetamol, codeine
phosphate hemihydrate and
promethazine hydrochloride.
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to reduce
fever.
Codeine phosphate hemihydrate is an
opioid pain reliever.
Promethazine hydrochloride is
antihistamine which in this instance is
used for its sedative properties.
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 on a doctor’s
prescription.
BEFORE YOU TAKE/GIVE
PAINSTOP NIGHT-TIME
PAIN RELIEVER®
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PAINSTOP NIGHT-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 NIGHT-TIME
PAIN RELIEVER® IF YOU HAVE AN
ALLERGY TO:
•
any medicine

Summary of Product characteristics

Page 1
AUSTRALIAN PRODUCT INFORMATION, PAINSTOP NIGHT-TIME PAIN
RELIEVER (PARACETAMOL 120MG IN 5ML, CODEINE PHOSPHATE
HEMIHYDRATE 5MG IN 5ML AND PROMETHAZINE HYDROCHLORIDE
6.5MG IN 5ML)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Painstop
Night-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 Night-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 Night-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 Night-Time Pain
Reliever.
Page 2
1.
NAME OF THE MEDICINE
Paracetamol, codeine phosphate hemihydrate and promethazine
hydrochloride.
2.
QUALITAT