APO-PARACETAMOL/CODEINE 500/30 paracetamol / codeine phosphate hemihydrate 500mg / 30mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 30 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: magnesium stearate; stearic acid; povidone; pregelatinised maize starch

Administration route:

Oral

Units in package:

50, 20, 4, 2, 10, 12

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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: White, round tablets, engraved with 'PC' on one side and score line on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-03-13

Patient Information leaflet

APO-PARACETAMOL/CODEINE 500/30
TABLETS
1
APO-PARACETAMOL/CODEINE 500/30
TABLETS
_Paracetamol and codeine phosphate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-
Paracetamol/Codeine 500/30
tablets. 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 APO-
Paracetamol/Codeine 500/30
against the benefits this medicine is
expected to have for you.
KEEP THIS INFORMATION WITH THE
TABLETS.
You may need to read it again.
WHAT IS APO-
PARACETAMOL/CODEINE
500/30 USED FOR
APO-Paracetamol/Codeine 500/30
is used to relieve moderate to
severe pain and fever.
APO-Paracetamol/Codeine 500/30
contains paracetamol and codeine.
Paracetamol and codeine work
together to stop the pain messages
from getting through to the brain.
Paracetamol also acts in the brain
to reduce fever.
Your doctor may have prescribed
this medicine for another use.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THE MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
BEFORE YOU TAKE APO-
PARACETAMOL/CODEINE
500/30
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE APO-
PARACETAMOL/CODEINE 500/30 IF
YOU ARE ALLERGIC TO PARACETAMOL
OR CODEINE OR ANY OF THE
INGREDIENTS LISTED UNDER "PRODUCT
DESCRIPTION" AT THE END OF THIS
LEAFLET.
THE
SYMPTOMS
OF
AN
ALLERGIC
REACTION
MAY
INCLUDE
A
RASH,
ASTHMA
ATTACK OR HAY FEVER.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
Acute
breathing
difficulties
such
as
bronchitis,
unstable
asthma or emphysema
•
Glucose-6-phosphate
dehydrogenase deficiency
(an enzyme deficiency)
•
Diarrhoea caused by poisoning
or antibiotics
•
CYP 2D6 ultra-rapid
metaboliser
DO NOT TAKE APO-
PARACETAMOL/CODEINE 500/30 IF
YOU HAVE ALCOHOL DEPENDENCE.
DO
NOT
TAKE
APO-
PARACETAMOL/CODEINE
500/30
DURING
THE
THIRD
TRIMESTER OF PREGNANCY.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - APO-PARACETAMOL/CODEINE
500/30 (Paracetamol & Codeine phosphate hemihydrate) tablet
1
NAME OF THE MEDICINE
Paracetamol and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Codeine phosphate
hemihydrate 30 mg.
Excipients of known effect: None.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-Paracetamol/Codeine 500/30 tablet is available as white, round,
engraved with “PC” on one side
and score line on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Relief of moderate to severe pain, and fever.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_Adults_
The initial dose is 1 tablet, repeated every 4 to 6 hours if necessary
for mild to moderate pain.
The
initial dose is 2 tablets repeated every 4 to 6 hours if necessary
(maximum 8 tablets per day)
for
severe pain.
_ _
APO-Paracetamol/Codeine 500/30 is contraindicated for use in patients
who are:
•
younger than 12 years.
•
aged between 12-18 years in whom respiratory function might be
compromised, including
post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea.
(See also section
4.3 Contraindications and section 4.4 Special Warnings and Precautions
for use, _Paediatric _
_Use_).
Tablets to be taken with water.
4.3
C
ONTRAINDICATIONS
APO-Paracetamol/Codeine 500/30 must not be used in patients with known
hypersensitivity to
paracetamol, codeine
or any of the excipients used in this product. It must not be used in
patients
with known glucose-6-
phosphate-dehydrogenase deficiency or pre-existing respiratory
depression,
for example acute
asthma, acute exacerbations of chronic obstructive pulmonary disease
since
codeine may
exacerbate the condition.
Paracetamol should not be used in patients with a history of
intolerance to the drug.
Paracetamol should not be used in patients with severe hepatocellular
insufficiency.
Due to codeine’s structural similarity to morphine and oxycodone,
patients experien