Consumer medicine information

Actacode Linctus

Codeine phosphate hemihydrate

BRAND INFORMATION

Brand name

Actacode

Active ingredient

Codeine phosphate hemihydrate

Schedule

S8

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Actacode Linctus.

What is in this leaflet

This leaflet answers some common questions about ACTACODE. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ACTACODE against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ACTACODE is used for

ACTACODE contains codeine phosphate as the active ingredient. It belongs to a group of medicines called cough suppressants.

ACTACODE is used for the relief of unproductive, dry and intractable coughs associated with colds and flu.

Ask your doctor if you have any questions about why ACTACODE has been prescribed for you. Your doctor may have prescribed it for another purpose.

ACTACODE is available only with a doctor’s prescription.

Before you take it

When you must not take it

Do not take ACTACODE if you have ever had an allergic reaction to:

  • codeine
  • morphine
  • oxycodone
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include red, itchy skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.

Do not take ACTACODE if you are experiencing breathing difficulties such as asthma, bronchitis, emphysema or other severe/acute respiratory diseases.

Do not take it if you are suffering from diarrhoea caused by poisoning or antibiotics.

Do not take ACTACODE if you have recently ingested a large amount of alcoholic beverages.

Do not take ACTACODE if you have had recent biliary tract surgery.

Do not take ACTACODE if you recently have had a head injury or conditions that raise the pressure within your head.

Do not take ACTACODE if 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.

Do not take ACTACODE after the expiry date (EXP) printed on the pack.

Do not take it if the packaging is torn or shows signs of tampering.

Do not give it to children under the age of 12 years.

Do not take it if you are aged between 12 to 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea.

Do not take it if you are pregnant without first consulting with your doctor.

Do not take it if you are breast feeding or planning 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.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

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.

Taking other medicines

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

Some medicines may interfere with ACTACODE. These include:

  • 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.

How to take it

How much to take

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.

How long to take it

Continue taking ACTACODE as long as your doctor recommends it.

If symptoms persist, see your doctor.

If you forget to take it

Take your dose as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that 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 take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much ACTACODE. 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.

While you are taking it

Things you must 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.

You should tell any other doctors or dentists treating you that you are taking ACTACODE.

Things you must not do

Do not take any other medicines while you are taking ACTACODE without first telling your doctor.

Do not drive or operate machinery until you know how it affects you.

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

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Be careful drinking alcohol while taking ACTACODE.

If you drink alcohol, it could make some of the unwanted side effects of ACTACODE worse.

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

Some people may experience side effects such as nausea, vomiting, constipation, drowsiness, and dizziness, which may further affect the risk when driving or using dangerous machinery.

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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ACTACODE.

ACTACODE helps most people, but it may have unwanted side effects in some people, especially in elderly patients or those with underlying disorders.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • constipation
  • nausea (feeling sick)
  • vomiting
  • dizziness
  • drowsiness
  • skin rashes.

These side effects are common.

Tell your doctor immediately if you notice any of the following side effects:

  • breathing difficulties
  • fast or irregular heart beat
  • difficulty in urinating (passing water)
  • blurred or double vision
  • itchy, raised or red skin rash.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell, even if you do think the problems are not connected with this medicine or are not listed in this leaflet. Some people may get other side effects while taking ACTACODE.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

Keep ACTACODE in a cool dry place, protected from light, where the temperature stays below 30°C.

Do not store it or any other medicines in a bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep your medicine in the bottle it was provided in until it is time to take it.

Store ACTACODE where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medication or it has passed its expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

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

Available in 100 mL glass bottles.

Ingredients

Active ingredient:

Each one mL contains 5 mg codeine phosphate.

Inactive ingredients:

  • propylene glycol
  • hydroxybenzoic acid esters (present in Nipastat)
  • potassium sorbate
  • sucrose
  • glycerol
  • hydrochloric acid
  • sodium hydroxide
  • water – purified.

ACTACODE linctus does not contain glucose, lactose, tartrazine or any other azo dyes.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia

Australian Registration Number: AUST R 124245.

This leaflet was updated in June 2023.

Published by MIMS August 2023

BRAND INFORMATION

Brand name

Actacode

Active ingredient

Codeine phosphate hemihydrate

Schedule

S8

 

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.

Summary Table of Changes