CHEMISTS' OWN STRONG PAIN EXTRA paracetamol 500mg + codeine 15mg tablets blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 15 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

codeine phosphate hemihydrate,Paracetamol

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: stearic acid; sodium lauryl sulfate; maize starch; colloidal anhydrous silica; pregelatinised maize starch; purified talc; hyprolose; magnesium stearate; povidone

Vía de administración:

Oral

Unidades en paquete:

24, 40, 10, 12

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the temporary relief of acute moderate pain

Resumen del producto:

Visual Identification: Paracetamol & codeine tablets are white to off white, capsule shaped biconvex, uncoated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2013-04-17

Información para el usuario

Chemists’ Own Strong Pain Extra CMI
1
CHEMISTS’ OWN STRONG PAIN EXTRA_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Chemists’ Own
®
Strong Pain Extra 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 or
pharmacist has weighed the risks
of you taking Chemists’ Own
Strong Pain Extra 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 CHEMISTS’ OWN STRONG PAIN
EXTRA USED FOR
Chemists’ Own Strong Pain Extra is
used to relieve moderate to severe
pain.
Chemists’ Own Strong Pain Extra
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.
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 CHEMISTS’
OWN STRONG PAIN EXTRA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE _CHEMISTS’ OWN _
_STRONG PAIN EXTRA _IF:
1.
YOU HAVE AN ALLERGY TO:
•
Paracetamol or Codeine
Phosphate hemihydrate, 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.
_2. _
_DO NOT TAKE THIS _
_MEDICINE IF_
_ _
_YOU HAVE _
_ANY OF THE FOLLOWING_
_ _
_CONDITIONS: _
•
Acute breathing
difficulties
such as
bronchitis,
unstable
asthma or
emphysema
•
Glucose-6-phosphate-
dehydrogenase
deficiency (an enzyme
deficiency)
•
Ultra-rapid
metaboliser of CYP
2D6
•
Liver failure
•
chronic constipation
•
Diarrhoea caused
by
antibiotics or
poisoning

_DO NOT TAKE THIS _
_MEDICINE IF YOU_
_ HAVE _
_A HISTORY OF

Ficha técnica

Page 1 of 14
CHEMISTS’ OWN STRONG PAIN EXTRA PRODUCT INFORMATION (PI)
NAME OF THE MEDICINE : CHEMISTS’ OWN STRONG PAIN EXTRA
AUSTRALIAN APPROVED NAME
Paracetamol and Codeine phosphate hemihydrate
CHEMICAL STRUCTURE
_Paracetamol. _Chemical name: N-( 4-hydroxyphenyl)acetamide.
Molecular formula: C
8
H
9
NO
2
MW: 151.2.
_Codeine _
_phosphate _
_hemihydrate_.
Chemical
name:
(5R,6S)-7,
8-didehydro-4,5-
epoxy-3-methoxy-N-
methylmorphinan-6-ol
dihydrogen
orthophospate
hemihydrate.
Molecular formula: C
18
H
21
NO
3
.H
3
PO
4
.½H
2
O.
MW: 406.4
DESCRIPTION:
COMPOSITION _ACTIVE_. Each capsule-shaped tablet contains Paracetamol
500 mg and codeine
phosphate hemihydrate 15 mg._ _
_INACTIVE_.Starch – maize, Hydroxypropylcellulose,
Starch-Pregelantinised maize, Sodium lauryl
sulphate, Talc-purified, Silica colloidal anhydrous, Magnesium sterate
Page 2 of 14
Paracetamol is a white or almost white, crystalline powder. It is
sparingly soluble in water, freely
soluble in alcohol and very slightly soluble in methylene chloride. It
has a melting point between
168°C and 172°C.
Codeine phosphate hemihydrate is a white or almost white, crystalline
powder or small,
colourless crystals. It is freely soluble in water and slightly
soluble or vey slightly soluble in
ethanol (96 percent).
ACTIONS
Analgesic and antipyretic.
PHARMACOLOGY:
PARACETAMOL: Paracetamol is a p-aminophenol derivative that exhibits
analgesic and antipyretic
activity. It does not possess anti-inflammatory activity. Paracetamol
is thought to produce
analgesia through a central inhibition of prostaglandin synthesis.
CODEINE: Codeine acts centrally. It has an analgesic effect, which is
thought to be due mainly to
its partial metabolic conversion to morphine. Codeine has about
one-sixth the analgesic activity
of morphine.
There is evidence to suggest that a combination of paracetamol with
codeine is superior in
analgesic action to either drug administered alone.
PHARMACOKINETICS:
PARACETAMOL: Paracetamol is readily absorbed from the gastrointestinal
tract with peak