Consumer medicine information

1. Why am I using Actacode?

Actacode contains the active ingredient codeine phosphate. Actacode is used for relief of unproductive, dry and intractable coughs associated with colds and flu.
For more information, see Section 1. Why am I using Actacode? in the full CMI.

2. What should I know before I use Actacode?

Do not use if you have ever had an allergic reaction to codeine phosphate 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 Actacode? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Actacode 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 Actacode?

• Usual adult recommended dose is 5 mL every 4-6 hours

5. What should I know while using Actacode?

6. Are there any side effects?

The more common side effect are constipation, nausea (feeling sick), vomiting, dizziness, drowsiness, skin rashes.
Serious side effects include breathing difficulties.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Hazardous and harmful use. Actacode 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 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of Actacode. 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 minimum required and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Actacode.

1 Name of Medicine

Codeine phosphate hemihydrate.

2 Qualitative and Quantitative Composition

Actacode oral liquid contains codeine phosphate hemihydrate 5 mg/mL.
Excipients with known effect. Sucrose, potassium sorbate, hydroxybenzoic acid esters (present in Nipastat ARTG No 10363).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The oral liquid is a clear, almost colourless syrup, almost odourless and free from visible contamination.

4 Clinical Particulars

4.9 Overdose

Symptoms. Symptoms of codeine overdosage include vomiting, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis, miosis and coma.
Treatment. Treatment of overdose involves the following measures.
Support respiratory and cardiovascular function. Assisted ventilation may be necessary.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
If clinically significant respiratory or cardiac depression is present, give naloxone. The usual adult dose is 0.4-2.0 mg intravenously (or subcutaneously), repeated every 2 to 3 minutes if necessary. The use of naloxone in physically dependent patients may precipitate withdrawal symptoms.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No significant effects have been reported.
Carcinogenicity. No significant effects have been reported.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Codeine phosphate hemihydrate is a small, colourless, odourless crystal or a white, odourless crystalline powder. Codeine phosphate hemihydrate is soluble in 4 parts of water, slightly soluble in ethanol (96%), practically insoluble in chloroform and ether.
Chemical structure. Codeine phosphate hemihydrate is (5R,6S)-7,8-didehydro-4,5-epoxy-3-methoxy-N-methylmorphinan-6-ol dihydrogen orthophosphate hemihydrate. It has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCOPHHE.gif The molecular formula is C₁₈H₂₁NO₃.H₃PO₄.1/2H₂O. The molecular weight is 406.4.
CAS number. 41444-62-6.

7 Medicine Schedule (Poisons Standard)

Controlled Drug - Schedule 8.

Summary Table of Changes

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