Gold Cross Codeine Linctus codeine phosphate hemihydrate 5 mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate, Quantity: 5 mg/mL

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: glycerol; propylene glycol; purified water; sucrose; methyl hydroxybenzoate

Administration route:

Oral

Units in package:

100 mL

Class:

Medicine Registered

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Relief of unproductive, dry and intractable coughs associated with colds and flu Relief of unproductive, dry and intractable coughs associated with colds and flu.

Product summary:

Visual Identification: Clear, almost colourless liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-11-11

Patient Information leaflet

GOLD CROSS CODEINE LINCTUS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING GOLD CROSS CODEINE LINCTUS?
Gold Cross Codeine Linctus contains the active ingredient codeine
phosphate hemihydrate. Gold Cross Codeine Linctus is used to
relieve unproductive, dry coughs associated with colds and flu.
For more information, see Section 1. Why am I using Gold Cross Codeine
Linctus? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GOLD CROSS CODEINE LINCTUS?
Do not use if you have ever had an allergic reaction to Gold Cross
Codeine Linctus or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Gold Cross Codeine Linctus? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Gold Cross Codeine Linctus and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE GOLD CROSS CODEINE LINCTUS?
•
Adults: take 5 mL every 4 hours.
More instructions can be found in Section 4. How do I use Gold Cross
Codeine Linctus? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GOLD CROSS CODEINE LINCTUS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Gold Cross Codeine Linctus.
•
Tell your doctor if you become pregnant while taking Gold Cross
Codeine Linctus.
THINGS YOU
SHOULD NOT DO
•
Do not take more than the recommended dose unless your doctor tells
you to.
•
Do not use Gold Cross Codeine Linctus if you are breastfeeding.
•
Do not use Gold Cross Cod

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GOLD CROSS CODEINE
(CODEINE PHOSPHATE HEMIHYDRATE) LINCTUS
1
NAME OF THE MEDICINE
Codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine phosphate hemihydrate 5 mg/mL
Excipients with known effects: sucrose and methyl hydroxybenzoate. For
the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Gold Cross Codeine Linctus is a clear, almost colourless, oral liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Relief of unproductive, dry and intractable coughs associated with
colds and flu.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults: 5 mL every four to six hours.
(See also 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Paediatric
Use.)
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Gold Cross Codeine Linctus contains codeine and poses risks of
hazardous and harmful use which can
lead to overdose and death. Assess the patient’s risk of hazardous
and harmful use before prescribing
and monitor the patient regularly during treatment (see section
4.4SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of Gold Cross Codeine
Linctus. Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose increase (see
section 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Limit
dosages and durations to the minimuthem required; and monitor patients
for signs and symptoms of
respiratory depression and sedation. Caution patient