MEDREICH Paracetamol 500 mg and codeine phosphate hemihydrate 15 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Medreich Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Paracetamol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: purified water; povidone; potato starch; ethanol; docusate sodium; magnesium stearate; lactose monohydrate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

24, 12, 20, 36, 30, 40, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For temporary relief of acute moderate pain.

Product summary:

Visual Identification: White to off white capsule shaped uncoated tablets plain on one side and breakline on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-08-23

Summary of Product characteristics

Product Information
Medreich Paracetamol 500 mg and Codeine Phosphate hemihydrate 15 mg
Tablets
V1217
1
PRODUCT INFORMATION
Medreich Paracetamol 500 mg and Codeine Phosphate hemihydrate 15 mg
Tablets
NAME OF THE MEDICINE
Medreich Paracetamol 500mg and Codeine Phosphate hemihydrate 15mg.
PARACETAMOL:
Molecular Formula : C
8
H
9
NO
2
Relative Molecular Mass : 151.2
CAS
: 103-90-2
CODEINE PHOSPHATE HEMIHYDRATE:
STRUCTURE
MOLECULAR FORMULA:
C
18
H
21
NO
3
, H
3
PO
4
,½H
2
O
MOLECULAR WEIGHT: 406.4
CAS: 41444-62-6
DESCRIPTION
Codeine phosphate hemihydrate is a white or almost white, crystalline
powder or small,
colourless crystals. It is freely soluble in water, slightly soluble
or very slightly soluble in
ethanol (96%). Codeine phosphate is a cough suppressant and an
analgesic.
Product Information
Medreich Paracetamol 500 mg and Codeine Phosphate hemihydrate 15 mg
Tablets
V1217
2
Paracetamol is a white or almost white crystalline powder. It is
sparingly soluble in
water, freely soluble in alcohol, very slightly soluble in methylene
chloride. Paracetamol
is an analgesic and antipyretic.
ACTIVES
: Each tablet contains Paracetamol 500mg and Codeine Phosphate 15mg
EXCIPIENTS
: Starch — Potato, Lactose, Povidone, Docusate Sodium, Silica
Colloidal
anhydrous, Magnesium Stearate.
PHARMACOLOGY
Paracetamol’s analgesic mechanism of action has not been fully
elucidated, but may
involve blocking impulse generation at the bradykinin sensitive
chemoreceptors that
evoke pain.
The antipyretic effect of paracetamol rises from its ability to block
the action of
prostaglandin synthetase and so prevent the synthesis of
prostaglandins in response to the
pyrogen stimulus in the region of the anterior hypothalamus.
Codeine acts centrally. It produces analgesia by dulling the response
to painful stimuli at
several loci in the central nervous system. This causes an alteration
in the sensation and
affective response of pain.
There is evidence to suggest that a combination of paracetamol with
codeine is superior
in analgesic action to eith