Codeine Phosphate Tablets (Noumed)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Codeine phosphate hemihydrate 30mg;  ;  ;  ;  

Available from:

Noumed Pharmaceuticals Limited

INN (International Name):

Codeine phosphate hemihydrate 30 mg

Dosage:

30 mg

Pharmaceutical form:

Tablet

Composition:

Active: Codeine phosphate hemihydrate 30mg         Excipient: Acacia Lactose monohydrate Magnesium stearate Maize starch Purified talc

Units in package:

Bottle, glass, 100 tablets

Class:

Class C2 Controlled Drug

Prescription type:

Class C2 Controlled Drug

Manufactured by:

Vistin Pharma AS

Therapeutic indications:

Codeine phosphate is indicated for: The relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain and headache), The relief of symptoms of diarrhoea (except diarrhoea caused by poisoning),

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, glass, - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-30

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
CODEINE
PHOSPHATE
TABLETS
(NOUMED)
_Codeine Phosphate Hemihydrate BP _
_ _
Tablet, uncoated 15 mg, 30 mg & 60 mg
WARNINGS
LIMITATIONS OF USE
Codeine Phosphate Tablets (Noumed) should only be used when your
doctor
decides that other treatment options are not able to effectively
manage your pain, or
you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
Codeine Phosphate Tablets (Noumed) poses risks of abuse, misuse and
addiction
which can lead to overdose and death. Your doctor will monitor you
regularly during
treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
Codeine Phosphate Tablets (Noumed) can cause life-threatening or fatal
breathing
problems (slow, shallow, unusual or no breathing), even when used as
recommended. These problems can occur at any time during use, but the
risk is
higher when first starting Codeine Phosphate Tablets (Noumed) and
after a dose
increase, if you are older, or have an existing problem with your
lungs. Your doctor
will monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING CODEINE PHOSPHATE TABLETS (NOUMED)
Codeine Phosphate Tablets (Noumed) with other medicines that can make
you feel
drowsy such as sleeping tablets (e.g. benzodiazepines), other pain
relievers,
antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g.
gabapentin and
pregabalin), cannabis and alcohol may result in severe drowsiness,
decreased
awareness, breathing problems, coma and death. Your doctor will
minimise the dose
and duration of use; and monitor you for signs and symptoms of
breathing difficulties
and sedation. You must not drink alcohol while using Codeine Phosphate
Tablets
(Noumed).
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Codeine
Phosphate Tablets
(Noumed).
This leaflet answers some common questions about Codeine Phosphate
Tablets
(Noumed).
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
2
It does not contain all the available information. It does not take
the place of talking to
your docto

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 14
1.
PRODUCT
NAME
Codeine Phosphate Tablets (Noumed) 15 mg, 30 mg & 60 mg tablets
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Name and strength of the active substance
Codeine Phosphate Hemihydrate BP 15 mg
Codeine Phosphate Hemihydrate BP 30 mg
Codeine Phosphate Hemihydrate BP 60 mg
Codeine phosphate hemihydrate is obtained from opium or made by
methylating
morphine. It occurs as odourless colourless crystals or white
crystalline powder.
The molecular formula of codeine phosphate is C
18
H
21
NO
3
,H
3
PO
4
.½H
2
O and the
molecular weight 406.4.
Excipient(s) with known effect
Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral – tablet, uncoated
Presentation
Codeine Phosphate Tablets (Noumed) are white to cream, biconvex
circular tablets.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic indications
Codeine phosphate is indicated for:
•
the relief of mild to moderate pain (including pain associated with
terminal
illness, post-operative pain, headache),
•
the relief of symptoms of diarrhoea (except diarrhoea caused by
poisoning).
4.2
Dose and method of administration
_Adults _
Codeine phosphate may be given orally in doses of 15 mg – 60 mg
every 4 – 6 hours
as needed.
If these doses fail to relieve pain, larger doses rarely succeed and
may give rise to
restlessness and excitement.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 14
The maximum daily dose in adults should not exceed 300 mg.
_Paediatric _
Do not use in children aged less than 12 years (see sections 4.3 and
4.4).
The usual paediatric dose is 0.5 mg per kg of body weight, every 4 to
6 hours as needed.
The total dose should not exceed 240 mg in 24 hours. The duration of
treatment should
not normally exceed 3 days.
4.3
Contraindications
Codeine phosphate is contraindicated in:
•
Known hypersensitivity to codeine, other opioids, or any component of
the tablets
•
Acute respiratory depression, especially in the presence of cyanosis
a