Consumer medicine information

Actacode Linctus

Codeine phosphate hemihydrate

BRAND INFORMATION

Brand name

Actacode

Active ingredient

Codeine phosphate hemihydrate

Schedule

SUMMARY CMI

Actacode linctus (oral liquid)

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 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

More instructions can be found in Section 4. How do I use Actacode? in the full CMI.

5. What should I know while using Actacode?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using Actacode Take exactly as directed by your doctor
Things you should not do	Do not take any other medicines while taking Actacode without first telling your doctor
Driving or using machines	May cause dizziness in some people. DO not drive or operate machinery until you know how it affects you.
Drinking alcohol	Be careful drinking alcohol while taking Actacode. It may make some of the unwanted side effects of Actacode worse. Advise not to drink alcohol while taking alcohol
Looking after your medicine	Store below 30°C in a cool dry place, away from light.

For more information, see Section 5. What should I know while using Actacode? in the full CMI.

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.

WARNING:

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

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

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.

FULL CMI

Actacode linctus (oral liquid)

Active ingredient(s): codeine phosphate hemihydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Actacode. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about Actacode.

Where to find information in this leaflet:

1. Why am I using Actacode?
2. What should I know before I use Actacode?
3. What if I am taking other medicines?
4. How do I use Actacode?
5. What should I know while using Actacode?
6. Are there any side effects?
7. Product details

1. Why am I using Actacode?

Actacode contains the active ingredient codeine phosphate hemihydrate. Actacode is a cough suppressant.

Actacode is used to relieve unproductive, dry and intractable coughs associated with colds and flu.

2. What should I know before I use Actacode?

Warnings

Do not use Actacode if:

you are allergic to codeine phosphate, or any of the ingredients listed at the end of this leaflet.
You have ever had an allergic reaction to codeine, morphine, oxycodone
Symptoms of an allergic reaction may include red, itchy skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness
Always check the ingredients to make sure you can use this medicine.
you are experiencing breathing difficulties such as asthma, bronchitis, emphysema or other severe/acute respiratory diseases.
you are suffering from diarrhoea caused by poisoning or antibiotics.
you have recently ingested a large amount of alcoholic beverages.
you have had recent biliary tract surgery.
you recently have had a head injury or conditions that raise the pressure within your head.
you have been taking monoamine oxidase inhibitors (medicines for treating depression or mood swings, such as phenelzine, tranylcypromide or moclobemide) within the last 10 days.
You are a child under 12 years of age
You are aged between 12 to 18 years and have had your tonsils or adenoids removed to treat sleep apnoea

Check with your doctor if you:

Tell your doctor if you have or have had any medical conditions, especially the following:

a breathing disorder
heart disease
a history of asthma
lung disease or a history of asthma
liver disease, hepatitis
kidney disease or difficulty urinating
diarrhoea
recent urinary tract surgery
a prostate disorder
Addison's disease (low activity of the adrenal gland)
an underactive thyroid gland
a history of drug dependence, including alcohol dependence
you are a heavy drinker
you have had a recent head injury or brain tumour
you have had recent biliary tract surgery
if you about to have surgery under a general anaesthetic
if you are under 18 and have undergone adenoidectomy and/or tonsillectomy
if you know you are a CYP2D6 ultra-rapid metaboliser.
take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed. This medicine passes into breast milk and may affect the baby. If you require ACTACODE therapy, breastfeeding should be stopped and alternative arrangements should be made for feeding the baby during the treatment period.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Actacode and affect how it works.

CNS depressants such as tranquillisers, sedatives, pain killers, barbiturates, medicines to help you sleep or relieve anxiety
quinidine (a medicine to treat abnormal or irregular heart beat)
cimetidine (a medicine to treat reflux or stomach ulcer)
monoamine oxidase inhibitors (medicines for treating depression or mood swings, such as phenelzine, tranylcypromine or moclobemide) taken within the last 10 days
antihistamines (medicines for the treatment of allergies such as hay fever, insect bites and some cold remedies).

The above medicines may either reduce the effectiveness of ACTACODE, reduce their own effectiveness and/or react with it resulting in untoward or sometimes dangerous side effects.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ACTACODE.

Use in the elderly

Elderly patients may be more sensitive to the effects or side effects of this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Actacode.

4. How do I use Actacode?

How much to take / use

Your doctor will tell you the dose you need to take. This will depend on your age and other pre-existing health conditions. The usual recommended dose of ACTACODE for adults is 5 mL every four to six hours.
Follow the instructions provided and use Actacode until your doctor tells you to stop. If symptoms persist, see your doctor

If you forget to use Actacode

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted effect

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints

If you use too much Actacode

If you think that you have used too much Actacode, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Also report any other medicine or alcohol (including any barbiturates or narcotics) which has been taken.

You may need urgent medical attention.

Symptoms of overdose may include weakness, dizziness, lethargy, nausea, vomiting, sweating, mental confusion and hypotension

5. What should I know while using Actacode?

Things you should do

Take ACTACODE exactly as directed by your doctor.

Tell your doctor if you feel this medicine is not helping your condition. Your doctor needs to check your progress and see whether you need to keep taking it.

Always discuss with your doctor any problems or difficulties during or after taking ACTACODE

Remind any doctor, dentist or pharmacist you visit that you are using Actacode.

Things you should not do

take any other medicines while you are taking ACTACODE without first telling your doctor.
give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

ACTACODE may be habit forming if used for extended periods of time.
Depending on your body's individual ability to break down codeine, you may experience signs of overdose even when you take ACTACODE as recommended by your doctor. If symptoms such as slow or shallow breathing, confusion, sleepiness, small pupils or circulatory problems occur, seek immediate medical advice.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Actacode affects you.

ACTACODE may cause dizziness in some people and may affect alertness.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may make some of the unwanted side effects of ACTACODE worse.

Be careful drinking alcohol while taking ACTACODE.

Your doctor may suggest that you avoid alcohol completely or reduce the amount of alcohol you drink while you are taking this medicine

Looking after your medicine

Keep below 30°C
Keep your medicine in the bottle it was provided in until it is time to take it.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
constipation nausea (feeling sick) vomiting dizziness drowsiness skin rashes	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
breathing difficulties fast or irregular heart beat difficulty in urinating (passing water) blurred or double vision itchy, raised or red skin rash	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Actacode contains

Active ingredient (main ingredient)	Each one mL contains 5 mg codeine phosphate
Other ingredients (inactive ingredients)	propylene glycol hydroxybenzoic acid esters (present in Nipastat) potassium sorbate sucrose glycerol hydrochloric acid sodium hydroxide water – purified
Potential allergens	-

Do not take this medicine if you are allergic to any of these ingredients.

What Actacode looks like

Actacode is a thick, almost colourless and almost odourless syrup free from visible contamination.

Available in 100 mL glass bottles.

(Aust R 124245).

Who distributes Actacode

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia
www.arrotex.com.au

This leaflet was prepared in January 2025

Published by MIMS March 2025

BRAND INFORMATION

Brand name

Actacode

Active ingredient

Codeine phosphate hemihydrate

Schedule

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

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Adults.

5 mL every four to six hours.
Actacode is contraindicated for use in patients who are:
younger than 12 years;
aged between 12-18 years in whom respiratory function might be compromised, including post-tonsillectomy and/or adenoidectomy for obstructive sleep apnoea (also see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, Paediatric use).

4.3 Contraindications

Actacode is contraindicated for use in patients who are:
CYP2D6 ultrarapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).
Younger than 12 years (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Aged between 12-18 years in whom respiratory function might be compromised, including post-tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, due to an increased risk of developing serious and life threatening adverse reactions (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Breastfeeding (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).
After operations on the biliary tract as codeine may cause biliary contraction.
In the presence of acute alcohol intoxication, head injuries and conditions in which intracranial pressure is raised.
In heart failure secondary to chronic lung disease.
Codeine is contraindicated in patients taking MAOI's or within ten days of stopping such treatment.
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 the gastrointestinal tract, or diarrhoea associated with pseudomembranous colitis caused by antibiotic administration since codeine may slow the elimination of the toxic material or antibiotic.
Actacode is contraindicated in patients with a past history of allergic reactions to codeine.
Actacode is contraindicated in severe respiratory disease, acute respiratory disease and respiratory depression, including in the presence of cyanosis and excessive bronchial secretion.

4.4 Special Warnings and Precautions for Use

CYP2D6 metabolism.

Actacode is contraindicated for use in patients who are CYP2D6 ultrarapid metabolisers.
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. However, if the patient is an extensive or ultrarapid metaboliser there is an increased risk of developing side effects of opioid toxicity, even at commonly prescribed doses. These patients convert codeine to morphine rapidly, resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life threatening and very rarely fatal. Children are particularly susceptible due to their immature airway anatomy. Deaths have been reported in children with rapid metabolism who were given codeine for analgesia post adenotonsillectomy. Morphine can also be ingested by infants through breast milk, causing risk of respiratory depression to infants of rapid metaboliser mothers who take codeine.
The prevalence of codeine ultrarapid metabolism by CYP2D6 in children is not known, but is assumed to be similar to that reported in adults. The prevalence of ultrarapid metabolisers is estimated to be 1% in those of Chinese, Japanese and Hispanic descent, 3% in African Americans and 1%-10% in Caucasians. The highest prevalence (16%-28%) occurs in North African, Ethiopian and Arab populations.
(Also see Section 4.4 Special Warnings and Precautions for Use, Paediatric use; Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).

Hazardous and harmful use.

Actacode contains the opioid codeine phosphate and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Actacode at recommended doses.
The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Actacode.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids are sought by people with addiction and may be subject to diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the safe storage and proper disposal of any unused drug (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal). Caution patients that abuse of oral or transdermal forms of opioids by parenteral administration can result in serious adverse events, which may be fatal.
Patients should be advised not to share Actacode with anyone else.

Respiratory depression.

Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even when used as recommended. It can occur at any time during the use of Actacode but the risk is greatest during initiation of therapy or following an increase in dose. Patients should be monitored closely for respiratory depression at these times.
The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated patients, in patients with renal and hepatic impairment, and in patients with existing impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma). Opioids should be used with caution and with close monitoring in these patients (see Section 4.2 Dose and Method of Administration). The use of opioids is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression (see Section 4.3 Contraindications).

Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Actacode with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible. If a decision is made to prescribe Actacode concomitantly with any of the medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. Patients and their caregivers should be made aware of these symptoms. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Actacode.

Tolerance, dependence and withdrawal.

Neuroadaptation of the opioid receptors to repeated administration of opioids can produce tolerance and physical dependence. Tolerance is the need for increasing doses to maintain analgesia. Tolerance may occur to both the desired and undesired effects of the opioid.
Physical dependence, which can occur after several days to weeks of continued opioid usage, results in withdrawal symptoms if the opioid is ceased abruptly or the dose is significantly reduced. Withdrawal symptoms can also occur following the administration of an opioid antagonist (e.g. naloxone) or partial agonist (e.g. buprenorphine). Withdrawal can result in some or all of the following symptoms: dysphoria, restlessness/agitation, lacrimation, rhinorrhoea, yawning, sweating, chills, myalgia, mydriasis, irritability, anxiety, increasing pain, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, increased blood pressure, increased respiratory rate and increased heart rate.
When discontinuing Actacode in a person who may be physically dependent, the drug should not be ceased abruptly but withdrawn by tapering the dose gradually.

Accidental ingestion/exposure.

Accidental ingestion or exposure of Actacode, especially by children, can result in a fatal overdose of codeine phosphate. Patients and their caregivers should be given information on safe storage and disposal of unused Actacode (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal).

Ceasing opioids.

Abrupt discontinuation or rapid decreasing of the dose in a person physically dependent on an opioid may result in serious withdrawal symptoms (see Tolerance, dependence and withdrawal). Such symptoms may lead the patient to seek other sources of licit or illicit opioids. Opioids should not be ceased abruptly in a patient who is physically dependent but withdrawn by tapering the dose slowly. Factors to take into account when deciding how to discontinue or decrease therapy include the dose and duration of the opioid the patient has been taking and the physical and psychological attributes of the patient. During tapering, patients require regular review and support to manage any psychological distress and withdrawal symptoms.
There are no standard tapering schedules suitable for all patients and an individualised plan is necessary. In general, tapering should involve a dose reduction of no more than 10 percent to 25 percent every 2 to 4 weeks (see Section 4.2 Dose and Method of Administration). If the patient is experiencing serious withdrawal symptoms, it may be necessary to go back to the previous dose until stable before proceeding with a more gradual taper.
When ceasing opioids in a patient who has a suspected opioid use disorder, the need for medication assisted treatment and/or referral to a specialist should be considered.

Other precautions.

Codeine should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired hepatic function, or shock.
Codeine should be administered with caution in patients with prostatic hypertrophy, urethral stricture or recent urinary tract surgery since codeine may cause urinary retention.

Use in the elderly.

The elderly are more likely to have age related renal impairment and may be more susceptible to the respiratory effects of opioid analgesics. Dose reduction may be required.
Codeine should be used with caution in elderly or debilitated patients because of the danger of respiratory or cardiac depression.

Paediatric use.

Actacode is contraindicated for use in children:
younger than 12 years;
aged between 12-18 years in whom respiratory function might be compromised, including post-tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Respiratory depression and death have occurred in some children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultrarapid metabolisers of codeine due to a CYP2D6 polymorphism (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).

Effects on laboratory tests.

Plasma amylase and lipase activity.

Codeine may cause increased biliary tract pressure, thus increasing plasma amylase and/or lipase concentrations.

Gastric emptying studies.

Gastric emptying is delayed by codeine so gastric emptying studies will not be valid.

4.5 Interactions with Other Medicines and Other Forms of Interactions

CNS depressants.

Concomitant use of opioids and other CNS depressant medicines such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tranquillisers, general anaesthetics, tricyclic antidepressants, antipsychotics, antihistamines, and centrally-active anti-emetics, including alcohol, may result in sedation, respiratory depression, coma and death (also see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

Antihistamines.

Concomitant use of codeine and antihistamines with anticholinergic effects may result in an increased risk of severe constipation and/or urinary retention. Codeine may potentiate the CNS depressant effects of certain antihistamines.

Monoamine oxidase inhibitors.

Serious and sometimes fatal reactions have occurred in patients concurrently administered MAO inhibitors and pethidine. Codeine should not be given to patients taking nonselective MAO inhibitors or within 10 days of stopping such treatment. Caution is advised with the combination of codeine and selective MAO inhibitors (reversible inhibitors of monoamine oxidase A).

Quinidine.

Quinidine interferes with the metabolism of codeine to morphine lowering the analgesic effect of codeine.

Cimetidine.

Cimetidine may reduce the metabolism of codeine, enhancing the possibility of codeine toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No significant effects have been reported.
(Category A)
Opioid analgesics cross the placenta. Regular use during pregnancy may cause physical dependence in the foetus, leading to withdrawal symptoms in the neonate.
Actacode is contraindicated during breastfeeding (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism) due to risk of respiratory depression in the infant.
Analgesic doses excreted in breast milk are generally low. However, infants of breastfeeding mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultrarapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine is partially metabolised by cytochrome P450 2D6 (CYP2D6) into morphine, which is excreted into breast milk. If nursing mothers are CYP2D6 ultrarapid metabolisers, higher levels of morphine may be present in their breast milk. This may result in symptoms of opioid toxicity in both mother and the breastfed infant. Life threatening adverse events or neonatal death may occur even at therapeutic doses (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism).
Therefore, Actacode is contraindicated for use during breastfeeding. However, in circumstances where a breastfeeding mother requires codeine therapy, breastfeeding should be suspended and alternative arrangements should be made for feeding the infant for any period during codeine treatment.
Breastfeeding mothers should be told how to recognise signs of high morphine levels in themselves and their babies. For example, in a mother, symptoms include extreme sleepiness and trouble caring for the baby. In the baby, symptoms include signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Medical advice should be sought immediately.

4.7 Effects on Ability to Drive and Use Machines

Patients should be warned that codeine may cause drowsiness and may impair their ability to perform activities requiring mental alertness or physical coordination (e.g. operating machinery, driving a motor vehicle). Alcohol should be avoided.

4.8 Adverse Effects (Undesirable Effects)

Gastrointestinal.

Common: constipation.
Uncommon: nausea, vomiting, dry mouth.

Neurological.

Common: dizziness, drowsiness.
Uncommon: euphoria, dysphoria, nervousness, restlessness, paradoxical CNS stimulation (especially in children), confusion, headache, blurred or double vision.

Hypersensitive.

Uncommon: skin rashes and other allergic reactions (pruritus, urticaria), histamine release (hypotension, sweating, flushing of the face, tachycardia, breathlessness).

Genitourinary.

Uncommon: urinary retention or hesitance.

Withdrawal syndrome.

A withdrawal syndrome may be precipitated when chronic administration of codeine is discontinued or opioid antagonists administered. The following symptoms may be observed: body aches, diarrhoea, gooseflesh, loss of appetite, nervousness or restlessness, runny nose, sneezing, tremors, shivering, stomach cramps, nausea, sleep disturbance, increased sweating and yawning, weakness, tachycardia, fever, irritability, vomiting, mydriasis. Also see Section 4.4 Special Warnings and Precautions for Use, Tolerance, dependence and withdrawal.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Codeine causes suppression of the cough reflex by a direct effect on the cough centre in the medulla of the brain and appears to exert a drying effect on the respiratory tract mucosa and to increase viscosity of bronchial secretions.
On a weight basis, antitussive activity of codeine is less than that of morphine. Codeine also has mild analgesic and sedative effects.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Codeine is well absorbed after administration by mouth. It is metabolised in the liver to morphine and norcodeine, which with codeine are excreted in the urine, partly as conjugates with glucuronic acid. Patients who metabolise drugs poorly via CYP2D6 are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite. Most of the excretion products appear in the urine within 6 hours and excretion of up to 86% of the dose is almost complete in 24 hours. About 70% of the codeine is excreted free or conjugated, about 10% as free and conjugated morphine, and about 10% as free and conjugated norcodeine. Only traces are excreted in the faeces.

5.3 Preclinical Safety Data

Genotoxicity.

No significant effects have been reported.

Carcinogenicity.

No significant effects have been reported.

6 Pharmaceutical Particulars

6.1 List of Excipients

Actacode oral liquid contains the following excipients: Propylene glycol, sucrose, glycerol, hydroxybenzoic acid esters (present in Nipastat ARTG No 10363), potassium sorbate, hydrochloric acid, sodium hydroxide and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

100 mL solution in a glass bottle with a child resistant closure (polypropylene).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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:

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.

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Actacode Linctus

Codeine phosphate hemihydrate

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