Codalgin

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Codeine phosphate hemihydrate 8mg; Paracetamol 500mg (As 521mg paracetamol DC)

Disponible depuis:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

DCI (Dénomination commune internationale):

Codeine phosphate hemihydrate 8 mg

Dosage:

500mg/8mg

forme pharmaceutique:

Tablet

Composition:

Active: Codeine phosphate hemihydrate 8mg Paracetamol 500mg (As 521mg paracetamol DC) Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Purified talc Wheat starch

Unités en paquet:

Blister pack, PVC/Al, 20 tablets

classe:

Restricted

Type d'ordonnance:

Restricted

Fabriqué par:

GlaxoSmithKline Australia Pty Ltd

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 20 tablets - 24 months from date of manufacture stored at or below 30°C

Date de l'autorisation:

2002-09-24

Résumé des caractéristiques du produit

Page 1/11
NEW ZEALAND DATA SHEET
1 PRODUCT NAME CODALGIN TABLETS
PARACETAMOL 500 MG, CODEINE PHOSPHATE 8 MG
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Codalgin tablets contain the following Active ingredients –
Paracetamol 500 mg, codeine phosphate hemihydrate 8 mg.
It also contains the following Inactives - gelatin, magnesium
stearate, microcrystalline
cellulose, purified talc, wheat starch
3 PHARMACEUTICAL FORM
Tablet - 12.7mm round, flat bevelled edge, white, with a break-bar on
one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the temporary relief of pain and discomfort associated with
migraine,
earache, period pain and rheumatic pain. Reduces fever.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS:
One to two tablets to be taken every
four to six hours as necessary. The maximum dosage of tablets in 24
hours is
8 tablets._ _
CHILDREN 7 - 12 YEARS:_ _Half to one tablet to be taken every four to
six hours
as necessary. The maximum dosage of tablets in 24 hours is 4 doses.
Codalgin should not be given to children under 7 years of age.
4.3 CONTRAINDICATIONS

Paracetamol should not be used in patients with active alcoholism as
chronic
excessive
alcohol
ingestion
predisposes
patients
to
paracetamol hepatotoxicity.

Paracetamol
should
not
be
used
in
patients
with
a
history
of
intolerance to the drug.
Page 2/11

Codeine should not be used in cases of acute respiratory depression
(eg
acute
asthma,
acute
exacerbations
of
chronic
obstructive
pulmonary disease) since codeine may exacerbate the condition.

Codalgin should not be used in patients with a past history of
allergic
reactions to codeine.

Hypersensitivity to any of the tablet excipients.

Due to codeine’s structural similarity to morphine and oxycodone,
patients experiencing systemic allergy (generalised rash, shortness of
breath) to these drugs should not receive codeine.

Codeine is contraindicated in patients with diarrhoea caused by
poisoning, until the toxic substance has been eliminated from th