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.

SUMMARY CMI

Gold Cross Codeine Linctus

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

1. Why am I using Gold Cross Codeine Linctus?

Gold Cross Codeine Linctus contains the active ingredient codeine phosphate hemihydrate. Gold Cross Codeine Linctus is used to relieve unproductive, dry coughs associated with colds and flu.

For more information, see Section 1. Why am I using Gold Cross Codeine Linctus? in the full CMI.

2. What should I know before I use Gold Cross Codeine Linctus?

Do not use if you have ever had an allergic reaction to Gold Cross Codeine Linctus or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Gold Cross Codeine Linctus? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Gold Cross Codeine Linctus and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Gold Cross Codeine Linctus?

  • Adults: take 5 mL every 4 hours.

More instructions can be found in Section 4. How do I use Gold Cross Codeine Linctus? in the full CMI.

5. What should I know while using Gold Cross Codeine Linctus?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Gold Cross Codeine Linctus.
  • Tell your doctor if you become pregnant while taking Gold Cross Codeine Linctus.
Things you should not do
  • Do not take more than the recommended dose unless your doctor tells you to.
  • Do not use Gold Cross Codeine Linctus if you are breastfeeding.
  • Do not use Gold Cross Codeine Linctus if you have asthma or other breathing difficulties.
Driving or using machines
  • Do not drive or operate machinery until you know how Gold Cross Codeine Linctus affects you.
Drinking alcohol
  • Do not drink alcohol while using Gold Cross Codeine Linctus.
Looking after your medicine
  • Store below 30°C in a cool, dry place where children cannot reach it.

For more information, see Section 5. What should I know while using Gold Cross Codeine Linctus? in the full CMI.

6. Are there any side effects?

Some people may experience headaches, constipation, nausea or vomiting while taking Gold Cross Codeine Linctus. Call your doctor immediately or go straight to the Emergency Department at your nearest hospital if you experience confusion, blurred vision, rapid heartbeat, breathlessness or swelling of the face, lips, tongue, or other parts of the body, rash, itching or hives on the skin while taking Gold Cross Codeine Linctus.

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.

WARNINGS

Limitations of use

Gold Cross Codeine Linctus should only be used when your doctor decides that other treatment options are not able to effectively manage your cough or you cannot tolerate them.

Hazardous and harmful use

Gold Cross Codeine Linctus poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment.

Life threatening respiratory depression

Gold Cross Codeine Linctus can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Gold Cross Codeine Linctus and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate.

Use of other medicines while using Gold Cross Codeine Linctus

Using Gold Cross Codeine Linctus with other medicines that can make you feel drowsy such as sleeping tablets (e.g., benzodiazepines), pain relievers, antihistamines, antidepressants, antipsychotics, gabapentanoids (e.g., gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Gold Cross Codeine Linctus.



FULL CMI

Gold Cross Codeine Linctus

Active ingredient: Codeine phosphate hemihydrate


Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I using Gold Cross Codeine Linctus?

Gold Cross Codeine Linctus contains the active ingredient codeine phosphate hemihydrate. Gold Cross Codeine Linctus is a cough suppressant.

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

2. What should I know before I use Gold Cross Codeine Linctus?

Warnings

  • Do not give Gold Cross Codeine Linctus to children under the age of 12 years.
  • Do not give Gold Cross Codeine Linctus to children 12 to 18 years who have recently had surgery on their adenoids or tonsils to treat sleep apnoea.

Do not use Gold Cross Codeine Linctus if:

  • You are allergic to codeine, morphine, oxycodone or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • You have breathing difficulties such as asthma, bronchitis or emphysema.
  • You are suffering from diarrhoea caused by poisoning or antibiotics.
  • You are known to be an ultra-rapid metaboliser of codeine.
  • You are taking a monoamine oxidase inhibitor antidepressant or within 10 days of stopping such treatment
  • You have a serious head injury
  • You have been drinking alcohol
  • You are breastfeeding
  • If the packaging shows signs of tampering.

Check with your doctor if you have or have had any of the following medical conditions:

  • Breathing disorders, asthma or lung disease
  • Lung, heart, liver or kidney problems, including difficulty urinating
  • A history of drug dependence, including alcohol dependence
  • Addison's disease (Low adrenal gland function)
  • An underactive thyroid gland
  • Are a heavy drinker
  • A recent head injury or brain tumour
  • Have had recent biliary tract (gall bladder) surgery
  • Are about to have surgery under a general anaesthetic
  • Know you are a CYP2D6 ultra-rapid metaboliser of codeine
  • Take any medicines for any other condition
  • Are pregnant or intending to become pregnant.

Pregnancy and breastfeeding

Do not take Gold Cross Codeine Linctus during the third trimester of pregnancy or during labour, especially if the baby is premature.

This medicine can cause breathing problems and signs of withdrawal in the baby.

Opioid analgesics cross the placenta. Regular use during pregnancy may cause physical dependence in the foetus, leading to withdrawal symptoms in the newborn.

Do not take 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.

Addiction

You can become addicted to Gold Cross Codeine Linctus even if you take it exactly as prescribed. Gold Cross Codeine Linctus may become habit forming causing mental and physical dependence. If abused, it may become less able to relieve your cough.

Dependence

As with all other opioid containing products, your body may become used to you taking Gold Cross Codeine Linctus. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Gold Cross Codeine Linctus suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to Gold Cross Codeine Linctus may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

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?

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 Gold Cross Codeine Linctus and affect how it works.

  • Central nervous system (CNS) depressants such as tranquillisers, sedatives, opioid pain killers, barbiturates, or medicines to help you sleep or relieve anxiety
  • Quinidine (a medicine to treat abnormal or irregular heartbeat)
  • Cimetidine (a medicine to treat reflux or stomach ulcers)
  • Monoamine oxidase inhibitors (MAOIs) (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)
  • Medicines used to treat nausea or vomiting.

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.

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

4. How do I use Gold Cross Codeine Linctus?

How much to take

The recommended dose of Gold Cross Codeine Linctus for adults is 5 mL.

The directions given to you by your doctor may be different from the information in this leaflet. If you are unsure what dose to take, ask your doctor or pharmacist.

When to take Gold Cross Codeine Linctus

Take every 4 to 6 hours or as directed by your doctor. Ask your doctor if you are not sure how long to take this medicine for.

If you forget to take Gold Cross Codeine Linctus

  • 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.

If you use too much Gold Cross Codeine Linctus

If you or someone else receive too much (overdose), and experience one or more of the symptoms below, immediately call triple zero (000) for an ambulance. Keep the person awake by talking to them or gently shaking them every now and then. You should follow the above steps even if someone other than you have accidentally used Gold Cross Codeine Linctus that was prescribed for you. If someone takes an overdose, they may experience one or more of the following symptoms:

  • Slow, unusual, or difficult breathing
  • Drowsiness, dizziness, or unconsciousness
  • Slow or weak heartbeat
  • Nausea or vomiting
  • Convulsions or fits.

If you think that you have used too much Gold Cross Codeine Linctus, 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.

When seeking medical attention, take this leaflet and remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

Depending on your body's individual ability to break down codeine, you may experience signs of overdose even when you take Gold Cross Codeine Linctus as stated on the labelling. If overdose symptoms occur, seek immediate medical advice.

5. What should I know while using Gold Cross Codeine Linctus?

Things you should do

  • Take Gold Cross Codeine Linctus exactly as your doctor has prescribed.
  • Tell your doctor if you feel Gold Cross Codeine Linctus is not helping your condition.
  • Always keep any appointments with your doctor to check your progress. Your doctor will check whether you need to keep taking Gold Cross Codeine Linctus.
  • Tell your doctor if you become pregnant while you are using Gold Cross Codeine Linctus.

Things you should not do

  • Do not take any other medicines while you are taking Gold Cross Codeine Linctus without first telling your doctor.
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Driving or using machines

Do not drive or use any machines or tools until you know how Gold Cross Codeine Linctus affects you.

Gold Cross Codeine Linctus may cause dizziness, light-headedness, drowsiness and problems with vision in some people.

Drinking alcohol

Do not drink alcohol while using Gold Cross Codeine Linctus.

This includes medicines that contain alcohol.

Alcohol may make some of the unwanted side effects of Gold Cross Codeine Linctus worse.

Withdrawal

Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, you may experience some, or all, of the following withdrawal symptoms:

  • Nervousness, restlessness, agitation, trouble sleeping or anxiety
  • Body aches, weakness, or stomach cramps
  • Loss of appetite, nausea, vomiting or diarrhoea
  • Increased heart rate, breathing rate or pupil size
  • Watery eyes, runny nose, chills or yawning
  • Increased sweating.

Looking after your medicine

  • Store below 30°C.

Follow the instructions on the medicine label 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 windowsills.

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 effectsWhat to do
Digestive system:
  • Constipation
  • Dry mouth
  • Nausea or vomiting
Nervous system:
  • Drowsiness
  • Dizziness
  • Restlessness
  • Headache
Skin reaction:
  • Mild skin rashes
  • Itch
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Nervous system related:
  • Confusion
  • Mood swings
  • Seizures
Allergy related:
  • Skin rash, itching or hives on the skin
  • Flushing of the face
  • Shortness of breath,difficulty breathing
  • Swelling in the face or lips
Heart related
  • Rapid heartbeat
Urinary related
  • Problems passing urine
Eye related
  • Blurred or double vision
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 Gold Cross Codeine Linctus contains

Active ingredient
(main ingredient)
Codeine phosphate hemihydrate 5 mg/mL
Other ingredients
(inactive ingredients)
Sucrose (sugar)
Glycerol
Methyl hydroxybenzoate
Propylene glycol
Purified water.
Potential allergensContains the preservative methyl hydroxybenzoate.

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

What Gold Cross Codeine Linctus looks like

Gold Cross Codeine Linctus is a clear, almost colourless liquid

Registration number: AUST R 27219

Who distributes Gold Cross Codeine Linctus

iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel (toll free): 1800 630 056

This leaflet was updated in December 2021.

Published by MIMS March 2022

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