Consumer medicine information

Gold Cross Codeine Linctus

Codeine phosphate hemihydrate

BRAND INFORMATION

Brand name

Gold Cross Codeine Linctus

Active ingredient

Codeine phosphate hemihydrate

Schedule

S8

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Gold Cross Codeine Linctus.

WHAT IS THIS LEAFLET

This leaflet answers some common questions about Gold Cross Codeine Linctus.

It does not contain all of the available information about Gold Cross Codeine Linctus.

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 Gold Cross Codeine Linctus against the benefits he/she expects it will have.

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 IS Gold Cross Codeine Linctus

The name of your medicine is Gold Cross Codeine Linctus.

The active ingredient is called codeine phosphate hemihydrate.

Gold Cross Codeine Linctus belongs to a group of medicines called cough suppressants.

WHAT Gold Cross Codeine Linctus IS USED FOR

Gold Cross Codeine Linctus is used for the relief of unproductive, dry coughs associated with colds and flu.

Ask your doctor if you have any questions about why Gold Cross Codeine Linctus has been prescribed for you.

If you have any concerns, you should discuss with your doctor.

Gold Cross Codeine Linctus is available only with a doctor’s prescription.

BEFORE YOU TAKE Gold Cross Codeine Linctus

When you must not take it

Do not take Gold Cross Codeine Linctus if you are allergic to:

  • Codeine or any of the ingredients listed at the end of this leaflet
  • Morphine
  • Oxycodone

Some of the symptoms of an allergic reaction to Gold Cross may include red, itchy skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.

Gold Cross Codeine Linctus should not be taken if you are experiencing breathing difficulties such as asthma, bronchitis or emphysema.

Do not use Gold Cross Codeine Linctus if you are suffering from diarrhoea caused by poisoning or antibiotics.

Do not use Gold Cross Codeine Linctus after the expiry date (EXP.) printed on the pack. If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not purchase or use Gold Cross Codeine Linctus if the packaging shows signs of tampering.

Do not use Gold Cross Codeine Linctus if you are known to be an ultra-rapid metaboliser of codeine.

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

Do not give it to children aged 12 to 18 years of age who have recently had surgery to remove their tonsils or adenoids to treat sleep apnoea.

Like all medicines, Gold Cross Codeine Linctus should not be used during pregnancy without first consulting your doctor.

Do not use Gold Cross Codeine Linctus if you are breastfeeding or planning to breastfeed. This medicine passes into breast milk and may affect the baby. If you require Gold Cross Codeine Linctus, breastfeeding should be stopped and alternative arrangements should be made for feeding the baby during the treatment period.

Elderly patients are more likely to have less effective kidney function due to age. This may increase the risk of side effects.

You should discuss how much Gold Cross Codeine Linctus to take with your doctor or pharmacist.

Before you start to take it

You must tell your doctor if you are:

  1. Allergic to any other medicines or any foods, dyes or preservatives.
  2. You have any other medical conditions/health problems, including:
    a. A breathing disorder
    b. heart disease
    c. a history of asthma
    d. lung disease
    e. liver disease, hepatitis
    f. kidney disease or difficulty urinating
    g. Addison’s disease (Low activity of the adrenal gland)
    h. an underactive thyroid gland
  3. You are a heavy drinker
  4. You have had a recent head injury or brain tumour
  5. You have had recent biliary tract surgery
  6. If you are about to have surgery under a general anaesthetic
  7. If you are under 18 and have undergone adenoidectomy and/or tonsillectomy
  8. If you know you are a CYP2D6 ultra-rapid metaboliser of codeine

If you have not told your doctor about any of the above, tell them before you start taking Gold Cross Codeine Linctus.

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 Gold Cross Codeine Linctus.

These include:

  • CNS depressants such as tranquilisers, 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 Gold Cross Codeine Linctus, reduce their own effectiveness and/or react with Gold Cross Codeine Linctus 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 Gold Cross Codeine Linctus.

HOW TO TAKE Gold Cross Codeine Linctus

a) How much to take

The recommended doses of Gold Cross Codeine Linctus is:

Adults: 5mL every four hours.

b) How to take it

The linctus should be swallowed neat followed by a glass of water.

c) How long to take it

Continue taking Gold Cross Codeine Linctus as long as your doctor recommends it. If symptoms persist, see your doctor.

d) 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.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time. 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 phone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken an overdose of Gold Cross Codeine Linctus. 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.

Keep telephone numbers for these places handy.

If you take too much Gold Cross Codeine Linctus you may have symptoms of weakness, dizziness, lethargy, nausea, vomiting, sweating, mental confusion and hypotension.

WHILE YOU ARE USING Gold Cross Codeine Linctus

Things you must do:

Use Gold Cross Codeine Linctus exactly as directed or as your doctor has prescribed.

Tell your doctor if you feel Gold Cross Codeine Linctus is not helping your condition.

Your doctor needs to check your progress and see whether you need to keep taking Gold Cross Codeine Linctus.

Always discuss with your doctor any problems or difficulties or after taking Gold Cross Codeine Linctus.

Things you must not do:

Do not take any other medicines while you are taking Gold Cross Codeine Linctus without first telling your doctor.

Do not drive or operate machinery until you know how Gold Cross Codeine Linctus affects you.

Gold Cross Codeine Linctus may cause dizziness in some people and may affect alertness.

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

Things to be careful of:

Be careful drinking alcohol while taking Gold Cross Codeine Linctus.

If you drink alcohol, it could make some of the unwanted side effects of Gold Cross Codeine Linctus worse.

Your doctor may suggest that you avoid alcohol completely or reduce the amount of alcohol you drink while you are taking Gold Cross Codeine Linctus.

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.

Gold Cross Codeine Linctus may be habit forming if used for extended periods of time.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Gold Cross Codeine Linctus.

Gold Cross Codeine Linctus helps most people with the medical condition listed in the beginning of this leaflet, but it may have unwanted side effects in some people, especially in elderly patients or those with underlying disorders.

All medicines 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.

Common Side Effects:

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

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

Some side effects are potentially serious. Contact your doctor immediately if you notice any of the following side effects:

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

Some people may get other side effects of Gold Cross Codeine Linctus.

Check with your doctor as soon as possible if you have any problems while taking Gold Cross Codeine Linctus even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

AFTER USING Gold Cross Codeine Linctus

Storage

Keep Gold Cross Codeine Linctus 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.

Keep Gold Cross Codeine Linctus in a cool dry place where the temperature stays below 30°C and protect from light.

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. Do not take Gold Cross Codeine Linctus if it does not look quite right.

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

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

a) What it looks like

Gold Cross Codeine Linctus is a linctus and is supplied in a glass bottle containing 100mL.

b) Ingredients

Gold Cross Codeine Linctus codeine linctus contains codeine phosphate hemihydrate 5mg/mL.

Gold Cross Codeine Linctus also contains the following excipients:

  • propylene glycol
  • methylhydroxybenzoate
  • sucrose
  • glycerol
  • water-purified

The Australian Registration Number for Gold Cross Codeine Linctus is AUST R 27219.

SPONSOR

Biotech Pharmaceuticals Pty Ltd
83 Cherry Lane
Laverton North
Victoria 3026
AUSTRALIA
A.C.N 009701517
Telephone: 03 9278 7555.

This leaflet was updated in July 2016.


Published by MIMS July 2017

BRAND INFORMATION

Brand name

Gold Cross Codeine Linctus

Active ingredient

Codeine phosphate hemihydrate

Schedule

S8

 

1 Name of 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 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.
(Also see Section 4.4 Special Warnings and Precautions for Use, Paediatric use.)

4.3 Contraindications

Gold Cross Codeine Linctus is contraindicated for use in patients who are:
CYP2D6 ultra-rapid 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 tonsilllectomy 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 or conditions in which intracranial pressure is raised.
Severe respiratory disease, acute respiratory disease and respiratory depression.
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 who experience systemic allergic reactions (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.
Gold Cross Codeine Linctus is contraindicated in patients with a history of allergic reactions to codeine.

4.4 Special Warnings and Precautions for Use

Hazardous and harmful use.

Gold Cross Codeine Linctus contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Gold Cross Codeine Linctus 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 Gold Cross Codeine Linctus.
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 Gold Cross Codeine Linctus 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 Gold Cross Codeine Linctus, 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 Gold Cross Codeine Linctus 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 Gold Cross Codeine Linctus 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 Gold Cross Codeine Linctus.

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 Gold Cross Codeine Linctus 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 Gold Cross Codeine Linctus, especially by children, can result in a fatal overdose of codeine. Patients and their caregivers should be given information on safe storage and disposal of unused Gold Cross Codeine Linctus (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.

Identified precautions.

Codeine should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, 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.

CYP2D6 metabolism.

Gold Cross Codeine Linctus is contraindicated for use in patients who are CYP2D6 ultra-rapid 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 ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into 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 ultra-rapid metabolism by CYP2D6 in children is not known, but is assumed to be similar to that reported in adults. The prevalence of ultra-rapid 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.
(See Section 4.4 Special Warnings and Precautions for Use, Paediatric use; Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation.)

Use in hepatic impairment.

Codeine should be given with caution or in reduced doses to patients with impaired hepatic function.

Use in the elderly.

Codeine should be used with caution in elderly or debilitated patients because of the danger of respiratory or cardiac depression.
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.

Paediatric use.

Gold Cross Codeine Linctus 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 ultra-rapid 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, centrally-active anti-emetics and other CNS depressants, including alcohol, may potentiate the effects of CNS depressants and 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 non-selective 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.
 Gold Cross Codeine Linctus is contraindicated during breast-feeding (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 breast feeding mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultra-rapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine is partially metabolised by cytochrome P450 2D6 (CYPD26) into morphine, which is excreted into breast milk. If nursing mothers are CYP2D6 ultra-rapid 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, Gold Cross Codeine Linctus 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 sedation and 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.

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 of codeine overdosage include vomiting, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis, miosis and coma.
Treatment of overdose involves the following measures:
Support respiratory and cardiovascular function. Assisted ventilation may be necessary.
Activated charcoal may reduce absorption of the drug 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

Propylene glycol, sucrose, glycerol, methyl hydroxybenzoate, 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

Glass (Type III coloured) bottle, linctus containing codeine phosphate hemihydrate 5 mg/mL, 100 mL.

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.
The molecular formula is C18H21NO3,H3PO4,½H2O. The molecular weight is 406.4.

CAS number.

CAS - 41444-62-6.

7 Medicine Schedule (Poisons Standard)

Controlled Drug - Schedule 8.

Summary Table of Changes