Consumer medicine information

Panamax Co

Paracetamol; Codeine phosphate hemihydrate

BRAND INFORMATION

Brand name

Panamax Co

Active ingredient

Paracetamol; Codeine phosphate hemihydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Panamax Co.

SUMMARY CMI

Panamax Co

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 Panamax Co?

Panamax Co contains the active ingredients paracetamol and codeine phosphate hemihydrate. Panamax Co is used to relieve moderate pain. For more information, see Section 1. Why am I using Panamax Co? in the full CMI.

2. What should I know before I use Panamax Co?

Do not use if you have ever had an allergic reaction to Panamax Co 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 Panamax Co? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Panamax Co 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 Panamax Co?

The usual dose for Adults is 1 to 2 tablets. This dosage may be repeated every 4 to 6 hours if necessary

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

5. What should I know while using Panamax Co?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Panamax Co.
  • Talk to your doctor about pain control if the medicine is not helping.
  • Tell your doctor if you become pregnant while taking Panamax Co.
Things you should not do
  • Do not take more than the recommended dose unless your doctor tells you to.
  • Do not take more than 8 tablets a day.
  • Do not give Panamax Co to children under 12.
  • Do not take high doses of the medicine for long periods of time unless your doctor tells you to.
  • Do not give this medicine to anyone else.
Driving or using machines
  • Be careful driving or operating machinery until you know how this medicine affects you.
  • This medicine may cause dizziness or light-headedness in some people.
Drinking alcohol
  • Do not drink alcohol while taking Panamax Co.
Looking after your medicine
  • Store below 25°C.
  • Store in a cool, dry place away from young children.

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

6. Are there any side effects?

  • Tell your doctor or pharmacist immediately if you notice any of the following side effects shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, rash, itching or hives on the skin. They may be the signs of an allergic reaction.
  • Tell your doctor or pharmacist if you notice any of the following and they worry you: nausea or vomiting; drowsiness or dizziness; constipation; stomach pain; skin rashes; sweating. These are the more common side effects of your medicine. They are usually mild.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

WARNING:

Limitations of use

Panamax Co should only be used if your doctor decides other treatment options are not able to effectively manage your pain or you cannot tolerate them.

Hazardous and harmful use

Panamax Co contains codeine which may be habit forming. Panamax Co poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will assess your risks and monitor you regularly during treatment.

Life threatening respiratory depression

Serious, life-threatening, or fatal respiratory depression (shallow or difficulty breathing) may occur with the use of Panamax Co even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Panamax Co 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 Panamax Co

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



FULL CMI

Panamax Co

Active ingredient(s): paracetamol and codeine phosphate hemihydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Panamax Co. 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 Panamax Co.

Where to find information in this leaflet:

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

1. Why am I using Panamax Co?

Panamax Co contains the active ingredients paracetamol and codeine phosphate hemihydrate.

Paracetamol and codeine work together to stop the pain messages from getting through to the brain. Your doctor may have prescribed this medicine for another use.

Panamax Co is a type of analgesic intended for short term use to relieve moderate pain.

2. What should I know before I use Panamax Co?

Warnings

Do not use Panamax Co if:

  • you are allergic to paracetamol or codeine phosphate hemihydrate, 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 severe and/or acute respiratory diseases
  • you have acute breathing difficulties such as bronchitis, unstable asthma, emphysema (serious lung disease), respiratory depression (shallow breathing) or respiratory insufficiency (difficulty breathing).
  • you have Glucose-6-phosphatedehydrogenase deficiency (an enzyme deficiency)
  • you are an ultra-rapid metaboliser of CYP 2D6
  • you have diarrhoea caused by antibiotics or poisoning
  • you have chronic constipation
  • you have liver failure

Do not take codeine if you have a history of drug dependence, including alcohol dependence.

Do not give Panamax Co to children under 12 years.

Do not give Panamax Co to children aged between 12-18 years who have undergone tonsillectomy and/or adenoidectomy to treat sleep apnoea.

Do not take Panamax Co during the third trimester of pregnancy.

Do not take codeine during labour, especially if the baby is premature.

Do not take it if you are breastfeeding or planning to breastfeed.

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

If you take it after the expiry has passed, it may not work as well.

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

If it has expired or is damaged, return it to your pharmacist for disposal.

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

  • difficulty breathing, wheezing, chronic cough, asthma, or other chronic breathing conditions
  • compromised respiratory function (due to emphysema, kyphoscoliosis or obesity)
  • known analgesic intolerance
  • a history of drug dependence, including alcohol dependence
  • pre-existing opioid dependence
  • chronic alcohol use including recent cessation of alcohol intake
  • low glutathione reserves
  • Gilbert's syndrome
  • recent surgery on the stomach, intestine or urinary tract
  • chronic constipation
  • head injury or trauma
  • prostate problems
  • heart, liver or kidney problems
  • urinary, bowel or gallbladder conditions
  • Addison's disease
  • Multiple sclerosis
  • low blood pressure
  • underactive thyroid
  • convulsions, fits or seizures

Tell your doctor or pharmacist if you have allergies to aspirin, other NSAIDs, any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you plan to have surgery.

Tell your doctor or pharmacist if you take sedatives (medicines used to help you relax or sleep).

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

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

Pregnancy and breastfeeding

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Do not take Panamax Co during the third trimester of pregnancy.

Do not take codeine during labour, especially if the baby is premature.

This medicine may produce withdrawal effects in the newborn baby.

Do not take it if you are breastfeeding or planning to breastfeed.

Panamax Co passes into breast milk and there is a possibility your baby may be affected.

If you have not told your doctor or pharmacist about any of the above, tell them before start taking Panamax Co.

Addiction

You can become addicted to Panamax Co even if you take it exactly as prescribed. Panamax Co may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence

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

Tolerance

Tolerance to Panamax Co may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

Withdrawal

Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and 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.

Panamax Co given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

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 and Panamax Co may interfere with each other. These include:

  • medicines used to help you relax, sleep or relieve anxiety, such as barbiturates, sedatives, tranquillisers, hypnotics, gabapentinoids, cannabis and centrally-active anti-emetics
  • benzodiazepines (medicines used as sedatives or to treat anxiety)
  • medicines containing alcohol (ethanol), e.g. some cough syrups
  • antihistamines (medicines used to treat allergies)
  • medicines which thin the blood
  • medicines to treat epilepsy or fits
  • metoclopramide or domperidone, medicines used to control nausea and vomiting
  • propantheline, a drug used to relieve stomach cramps or spasms
  • medicines used to prevent travel sickness and to treat Parkinson's disease
  • medicines used to treat high blood pressure
  • medicines for diarrhoea, such as kaolin, pectin, and loperamide
  • medicines used to treat depression
  • monoamine oxidase inhibitors, medicines used to treat depression, taken within the last 14 days
  • other opioid analgesics used to treat pain
  • quinidine, a medicine used to treat abnormal or irregular heartbeat
  • phenothiazines and antipsychotic agents, medicines used to treat mental disorders
  • chloramphenicol, an antibiotic used to treat ear and eye infections
  • flucloxacillin, zidovudine or rifampicin, drugs used to treat infections
  • chelating resin
  • medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine or methadone)
  • medicines used to control electrolytes levels in kidney disease

These medicines may be affected by Panamax Co or may affect how well Panamax Co works. You may need different amounts of your medicines, or you may need to take different medicines.

If you have not told your doctor or pharmacist about any of these things, tell him/her before you take any Panamax Co.

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

4. How do I use Panamax Co?

How much to take

  • The label on your pack of Panamax Co will tell you how to take your medicine and how often.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

  • The usual dose of Panamax Co is:
    Adults:
    - 1 to 2 tablets.
    - This dosage may be repeated every 4 - 6 hours if necessary.

You should not take more than 8 tablets in 24 hours.

Do not take more than the recommended dose.

Talk to your doctor or pharmacist about pain control if Panamax Co is not helping.

If your body cannot metabolise codeine properly, you may be getting reduced benefit from the medicine.

If you are over 65 years of age, talk to your doctor or pharmacist about how much to take.

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

How to take Panamax Co

  • Swallow tablets with a little water or other liquid.

How long to take it

Adults:

Only take Panamax Co for a few days at a time unless your doctor tells you to take it longer.

Children:

Only give Panamax Co to children for up to 48 hours unless a doctor has told you to give it longer.

If you take too much Panamax Co

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 Panamax Co 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 taken too much Panamax Co, 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.

If you take too many tablets you may feel nauseous, experience stomach pain, sweating, anxiety, lightheaded, dizzy or drowsy for example.

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 Panamax Co as recommended by your doctor. If overdose symptoms occur, seek immediate medical advice.

5. What should I know while using Panamax Co?

Things you should do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Panamax Co.

Talk to your doctor or pharmacist if your symptoms don't improve.

Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Panamax Co.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

Things you should not do

  • Children: Do not give Panamax Co for more than 48 hours unless a doctor has told you to.
  • Adults: Do not take for more than a few days at a time unless your doctor tells you to.
  • Do not take more than the recommended dose unless your doctor tells you to.
  • Do not take Panamax Co to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful if you are elderly, unwell or taking other medicines.

Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

Driving or using machines

Be careful driving or operating machinery until you know how this medicine affects you.

This medicine may cause dizziness or light-headedness in some people

Children should be supervised while bike riding or engaging in other potentially hazardous activities to avoid potential harm.

Drinking alcohol

Do not drink alcohol while taking Panamax Co.

Drinking alcohol while taking paracetamol (which is contained in Panamax Co) may increase the risk of liver side effects.

Looking after your medicine

  • Store below 25°C.

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

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

  • in the bathroom or near a sink, or
  • in the car or on windowsills.

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

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
Gastrointestinal related:
  • nausea or vomiting
  • indigestion
  • constipation
  • stomach pain
Head and neurology related:
  • dizziness
  • drowsiness or sleepiness
  • headache
  • dry mouth
Allergy related:
  • skin rashes
  • sweating
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
Allergy related:
  • shallow breathing, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin
  • flushing of the face
Heart related:
  • fast heartbeat
Skin related:
  • severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
  • painful red areas with blisters and peeling layers of skin which may be accompanied by fever and/or chills
  • hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine, yellowing of the skin and eyes)
Head and neurology related:
  • dizziness, light-headedness
  • unusual or extreme mood swings
  • confusion
Eyes related:
  • blurred vision.
Metabolism Related
  • Symptoms of rapid breathing, rapid heart rate and changes in consciousness caused by pyroglutamic acidosis (an accumulation of pyroglutamic acid due to low levels of a protein called glutathione).
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 Panamax Co contains

Active ingredients
(main ingredient)		Paracetamol and codeine phosphate hemihydrate.
Other ingredients
(inactive ingredients)		Maize starch, povidone, potassium sorbate, microcrystalline cellulose, stearic acid, magnesium stearate, purified talc and pregelatinised maize starch.

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

What Panamax Co looks like

Panamax Co is available as white tablets marked ‘PANAMAX CO’ (Aust R 62661).

Panamax Co is available in packs of 10 or 40 tablets.

*Not all pack sizes may be marketed

Who distributes Panamax Co

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
AUSTRALIA
Toll Free Number (medical information): 1800 818 806
Email: [email protected]

This leaflet was prepared in December 2021.

panamax-co-ccdsv5-cmiv17-03dec21

Published by MIMS February 2022

BRAND INFORMATION

Brand name

Panamax Co

Active ingredient

Paracetamol; Codeine phosphate hemihydrate

Schedule

S4

 

1 Name of Medicine

Paracetamol and codeine phosphate hemihydrate.

2 Qualitative and Quantitative Composition

Each tablet contains: paracetamol 500 mg, codeine phosphate hemihydrate 8 mg.

Excipients with known effect.

Potassium sorbate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets (white, scored, marked PANAMAX CO).

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of acute moderate pain.

4.2 Dose and Method of Administration

Adults and children 12 years of age and older.

1 to 2 tablets (maximum 8 tablets per day).
To be taken with water; repeat every 4-6 hours if necessary.
Use in children under 12 years is contraindicated.

4.3 Contraindications

Panamax Co must not be used in patients with known hypersensitivity to paracetamol, codeine or any of the excipients used in this product. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency, patients with severe hepatocellular insufficiency, or severe respiratory disease, acute respiratory disease and respiratory depression, for example acute asthma, acute exacerbations of chronic obstructive pulmonary disease since codeine may exacerbate the condition.
Panamax Co 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 tonsillectomy and/or adenoidectomy to treat 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);
breast-feeding (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).
Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth.

4.4 Special Warnings and Precautions for Use

Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction.

To avoid the risk of overdose.

Check that paracetamol is absent from the composition of other medicinal products taken concomitantly.
Caution is advised in patients with underlying sensitivity to aspirin and/or to nonsteroidal anti-inflammatory drugs (NSAIDs).

Severe cutaneous adverse reactions (SCARs).

Life threatening cutaneous reactions Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) have been reported with the use of paracetamol. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If symptoms or signs of SJS and TEN (e.g. progressive skin rash often with blisters or mucosal lesions) occur, patients should stop paracetamol treatment immediately and seek medical advice.

Paracetamol should be used upon medical advice in patients with the following.

Mild to moderate hepatocellular insufficiency (see Section 4.4 Special Warnings and Precautions for Use, Use in hepatic impairment); severe renal insufficiency (see Section 4.4 Special Warnings and Precautions for Use, Use in renal impairment); chronic alcohol use including recent cessation of alcohol intake; low glutathione reserves; Gilbert's syndrome.
Codeine must be administered with caution in certain patients such as those who present with impaired cardiac, hepatic or renal function, hypotension, benign prostatic hyperplasia, urethral stenosis, adrenal insufficiency (Addison's disease), hypothyroidism, multiple sclerosis, chronic colitis ulcerative, gallbladder conditions and diseases that present with reduced respiratory capacity such as emphysema, kyphoscoliosis and severe obesity.
Patients who have had a cholecystectomy should be treated with caution. The contraction of the sphincter of Oddi can cause symptoms resembling those of myocardial infarction or intensify the symptoms in patients with pancreatitis.
Codeine should be used with caution in patients with convulsive disorders.
Extensive use of analgesics to relieve headaches or migraines, especially at high doses, may induce headaches that must not be treated with increased doses of the drug. In such cases, the analgesic should not continue to be taken without medical advice.
Monitoring after prolonged use should include blood count, liver function and renal function.
Codeine should only be used after careful risk-benefit assessment in case of:
Opioid dependence.
Chronic constipation.
Conditions with elevated intracranial pressure and head trauma. Codeine can increase the pressure of cerebrospinal fluid and may increase the respiratory depressant effect. Like other narcotics, it causes adverse reactions that can obscure the clinical course of patients with head injury.
Impaired consciousness.
Compromised respiratory function (due to emphysema, kyphoscoliosis, severe obesity) and chronic obstructive airway disease.
Codeine should be used with caution in patients with CNS depression or decreased respiratory reserve.
Patients with known analgesic intolerance or known bronchial asthma must only use Panamax Co after having consulted a physician (hypersensitivity reactions including bronchospasm possible).

CYP2D6 metabolism.

Panamax Co 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 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 CYP 2D6 in children is not known, but is assumed to be similar to that reported in adults. The prevalence of ultra-rapid metabolisers differs according to racial and ethnic group. It 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.)

Hazardous and harmful use.

Panamax Co contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Panamax Co 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 Panamax Co.
There have been reports of drug abuse with codeine, including cases in children and adolescents. Caution is particularly recommended for use in children, adolescents, young adults and in patients with a history of drug and/or alcohol abuse. See Section 4.4 Special Warnings and Precautions for Use, Paediatric use.
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 Panamax Co 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 Panamax Co 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 hepatic and renal impairment (see Use in hepatic impairment and Use in renal 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. The use of opioids is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression (see Section 4.3 Contraindications).
The risk of respiratory depression is greater with the use of high doses of opioids, especially high potency and modified release formulations, and in opioid naïve patients. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief. Careful calculation of equianalgesic doses is required when changing opioids or switching from immediate release to modified release formulations, together with consideration of pharmacological differences between opioids. Consider starting the new opioid at a reduced dose to account for individual variation in response.

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 Panamax Co 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 Panamax Co 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 Panamax Co.

Use of opioids in chronic (long-term) non-cancer pain (CNCP).

Opioid analgesics have an established role in the treatment of acute pain, cancer pain and palliative and end-of-life care. Current evidence does not generally support opioid analgesics in improving pain and function for most patients with chronic non-cancer pain. The development of tolerance and physical dependence and risks of adverse effects, including hazardous and harmful use, increase with the length of time a patient takes an opioid. The use of opioids for long-term treatment of CNCP is not recommended.
The use of an opioid to treat CNCP should only be considered after maximised non-pharmacological and non-opioid treatments have been tried and found ineffective, not tolerated or otherwise inadequate to provide sufficient management of pain. Opioids should only be prescribed as a component of comprehensive multidisciplinary and multimodal pain management.
Opioid therapy for CNCP should be initiated as a trial in accordance with clinical guidelines and after a comprehensive biopsychosocial assessment has established a cause for the pain and the appropriateness of opioid therapy for the patient (see Hazardous and harmful use, above). The expected outcome of therapy (pain reduction rather than complete abolition of pain, improved function and quality of life) should be discussed with the patient before commencing opioid treatment, with agreement to discontinue treatment if these objectives are not met.
Owing to the varied response to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose and titrated to achieve an adequate level of analgesia and functional improvement with minimum adverse reactions. Immediate-release products should not be used to treat chronic pain, but may be used for a short period in opioid-naïve patients to develop a level of tolerance before switching to a modified-release formulation. Careful and regular assessment and monitoring is required to establish the clinical need for ongoing treatment. Discontinue opioid therapy if there is no improvement of pain and/or function during the trial period or if there is any evidence of misuse or abuse. Treatment should only continue if the trial has demonstrated that the pain is opioid responsive and there has been functional improvement. The patient's condition should be reviewed regularly and the dose tapered off slowly if opioid treatment is no longer appropriate (see Ceasing opioids).

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 Panamax Co in a person who may be physically-dependent, the drug should not be ceased abruptly but withdrawn by tapering the dose gradually (see Ceasing opioids).

Accidental ingestion/exposure.

Accidental ingestion or exposure of Panamax Co, 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 Panamax Co (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal).

Hyperalgesia.

Hyperalgesia may occur with the use of opioids, particularly at high doses. Hyperalgesia may manifest as an unexplained increase in pain, increased levels of pain with increasing opioid dosages or diffuse sensitivity not associated with the original pain. Hyperalgesia should not be confused with tolerance (see Tolerance, dependence and withdrawal). If opioid induced hyperalgesia is suspected, the dose should be reduced and tapered off if possible. A change to a different opioid may be required.

Ceasing opioids.

Abrupt discontinuation or rapid decreasing of the dose in a person physically dependent on an opioid may result in serious withdrawal symptoms and uncontrolled pain (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, the type of pain being treated and the physical and psychological attributes of the patient. A multimodal approach to pain management should be in place before initiating an opioid analgesic taper. During tapering, patients require regular review and support to manage any increase in pain, 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. If the patient is experiencing increased pain or 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.

Use in hepatic impairment.

Panamax Co should be administered with caution to patients with hepatic dysfunction.

Use in renal impairment.

Panamax Co should be administered with caution to patients with renal dysfunction.

Use in the elderly.

Elderly people may be more sensitive to the effects of this medicinal product. The elderly are more likely to have hypertrophy, prostatic obstruction and age-related renal impairment and may be more susceptible to the undesirable effects due to opioid-induced urinary retention and the respiratory effects of opioid analgesics.

Paediatric use.

Panamax Co 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.

Uric acid and blood glucose.

Intake of paracetamol may affect the laboratory determination of uric acid by phosphotungstic acid and of blood glucose by glucose oxidase-peroxidase.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Paracetamol may increase the risk of bleeding in patients taking warfarin and other antivitamin K. Anticoagulant dosage may require reduction and patients should be monitored for appropriate coagulation and bleeding complications.
Paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide or domperidone, and decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, narcotic analgesics. Paracetamol may increase chloramphenicol concentrations. The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), hypnotics, rifampicin and alcohol.
When used concurrently with zidovudine, an increased tendency for neutropenia may develop. Combination of Panamax Co and zidovudine should be avoided.
Chelating resin can decrease the intestinal absorption of paracetamol and potentially decrease its efficacy if taken simultaneously. In general, there must be an interval of more than 2 hours between taking the resin and taking paracetamol, if possible.
Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.
Concurrent administration of sedatives or tranquillisers may enhance the potential respiratory depressant effects of codeine.
Patients receiving other narcotic analgesics, antitussives, antihypertensives, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol, gabapentinoids, cannabis, centrally-active anti-emetics) concomitantly with this codeine-containing drug may exhibit additive CNS depression. (See Section 4.4 Special Warnings and Precautions for Use.)
The concomitant use of benzodiazepines and opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids (see Section 4.4 Special Warnings and Precautions for Use).
The concomitant use of alcohol and opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. Concomitant use with alcohol is not recommended (see Section 4.4 Special Warnings and Precautions for Use).
A codeine-induced respiratory depression can be potentiated by tricyclic antidepressants.
Concomitant administration of monoamine oxidase inhibitors (MAOIs) can potentiate the central nervous effects and other side effects of unpredictable severity. Codeine should not be used within two weeks after the discontinuation of MAOI treatment.
Concomitant use of codeine with antiperistaltic antidiarrhoeal drugs can increase the risk of severe constipation and CNS depression.

Morphinic agonists-antagonists.

Concomitant use of codeine with a partial agonist (e.g. buprenorphine) or antagonist (e.g. naltrexone) can precipitate or delay codeine effects.

CYP2D6 inhibitors.

Codeine is metabolized by the liver enzyme CYP2D6 to its active metabolite morphine. Medicines that inhibit CYP2D6 activity may reduce the analgesic effect of codeine. Patients taking codeine and moderate to strong CYP2D6 inhibitors (such as quinidine, fluoxetine, paroxetine, bupropion, cinacalcet, methadone) should be adequately monitored for reduced efficacy and withdrawal signs and symptoms. If necessary, an adjustment of the treatment should be considered.

CYP3A4 inducers.

Medicines that induce CYP3A4 activity may reduce the analgesic effect of codeine. Patients taking codeine and CYP3A4 inducers (such as rifampin) should be adequately monitored for reduced efficacy and withdrawal signs and symptoms. If necessary, an adjustment of the treatment should be considered.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
There are no indications of a connection between the occurrences of malformations in newborn infants and the use of paracetamol within the recommended dose range during the first four months of pregnancy. During pregnancy, however, the patient is requested to use Panamax Co only after a thorough assessment of possible risks and benefits by the physician. If Panamax Co is administered during pregnancy, morphinomimetic properties of codeine should be taken into account. Codeine may cause respiratory depression and withdrawal syndrome in neonates born to mothers who use codeine during the third trimester of pregnancy. As a precautionary measure, use of Panamax Co should be avoided during the third trimester of pregnancy and during labour.
 Panamax Co is contraindicated during breast-feeding (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism) due to risk of respiratory depression in the infant. Paracetamol and codeine is excreted into human breast milk. 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 ultra-rapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine is partially metabolized by cytochrome P450 2D6 (CYP2D6) 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 breast-fed 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, Panamax Co 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

Panamax Co may cause drowsiness, disturbances of visuomotor coordination and visual acuity. Due to the preparation's sedative action, impairment of the mental and/or physical abilities required for the performance of potentially hazardous activities may occur. Hence, children engaging in bike riding and other hazardous activities should be supervised to avoid potential harm.
Patients should not drive, operate machinery, or drink alcohol whilst taking this medication.

4.8 Adverse Effects (Undesirable Effects)

Paracetamol.

Reports of adverse reactions are rare. Although the following reactions have been reported, a causal relationship to the administration of paracetamol has been neither confirmed nor refuted: dyspepsia, sweating, erythema, urticaria, anaphylactic shock, angioneurotic oedema, difficulty breathing, drop in blood pressure, nausea, allergic reactions such as skin rashes, and haematological reactions, including thrombocytopenia, leukopenia, neutropenia, agranulocytosis and pancytopenia. Bronchospasm may be triggered in patients having a tendency of analgesic asthma. Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption (see Section 4.4 Special Warnings and Precautions for Use) and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported.
Haemolytic anaemia, particularly in patients with underlying glucose 6-phosphate-dehydrogenase deficiency has been reported. Kounis syndrome has been reported, as has pyroglutamic acidosis in patients with pre-disposing factors for glutathione depletion. Bronchospasm has also been reported.

Codeine.

Nausea and vomiting, constipation, dizziness and drowsiness have been reported at therapeutic doses. Very rarely, skin rashes may occur in patients hypersensitive to codeine. There have also been very rare reports of pancreatitis. Other adverse reactions reported to be associated with codeine include: confusional state, dysphoria, euphoria, seizure, headache, somnolence, fatigue, hypotension, sedation, respiratory depression, dry mouth, pruritus, miosis, tinnitus and urinary retention. Visuomotor coordination and visual acuity may be adverse affected in a dose-dependent manner at higher doses or in particularly sensitive patients. Long term use also entails the risk of drug dependence.

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

Elderly persons, small children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients concomitantly treated with enzyme-inducing drugs are at an increased risk of intoxication, including fatal outcome.

Symptoms.

Toxic symptoms include vomiting, abdominal pain, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis and coma. Nausea, vomiting, anorexia, pallor and abdominal pain generally appear during the first 24 hours of overdosage with paracetamol. Overdosage with paracetamol may cause hepatic cytolysis which can lead to hepatocellular insufficiency, gastrointestinal bleeding, metabolic acidosis, encephalopathy, disseminated intravascular coagulation, coma and death. Increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin with a reduction in prothrombin level can appear 12 to 48 hours after acute overdosage. It can also lead to pancreatitis, acute renal failure and pancytopenia. The most serious adverse effect of acute overdosage of paracetamol is a dose dependent, potentially fatal hepatic necrosis. In adults, hepatotoxicity may occur after ingestion of a single dose of 10 to 15 g (30 tablets) of paracetamol; a dose of 25 g (50 tablets) or more is potentially fatal. Symptoms during the first two days of acute poisoning by paracetamol do not reflect the potential seriousness of the intoxication. Major manifestations of liver failure such as jaundice, hypoglycaemia and metabolic acidosis may take at least three days to develop.
The ingestion of very high doses of codeine can cause initial excitation, anxiety, insomnia followed by drowsiness in certain cases, areflexia progressing to stupor or coma, headache, miosis, alterations in blood pressure, arrhythmias, dry mouth, hypersensitivity reactions, cold clammy skin, bradycardia, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting and respiratory depression.
Severe intoxication can lead to apnoea, circulatory collapse, cardiac arrest and death.

Treatment.

Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Consists primarily of management of paracetamol toxicity; naloxone is the treatment of choice for codeine intoxication.
Determinations of the plasma concentration of paracetamol are recommended.
Plasma concentration of paracetamol should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Where paracetamol intoxication is suspected, intravenous administration of SH group donators such as acetylcysteine within the first 10 hours after ingestion is indicated. Although acetylcysteine is most effective if initiated within this period, it can still offer some degree of protection if given as late as 48 hours after ingestion; in this case it is taken for longer.
In cases of overdosage, methods of reducing the absorption of ingested drug are important.
Prompt administration of 50 g activated charcoal and 500 mL iced mannitol 20% by mouth may reduce absorption.
If the history suggests that 15 g paracetamol or more has been ingested, administer one of the following antidotes:

Acetylcysteine 20% i.v.

Administer 20% acetylcysteine (Parvolex, David Bull) immediately without waiting for positive urine test or plasma level results: initial dose 150 mg/kg over 15 minutes, followed by continuous infusion of 50 mg/kg in 500 mL 5% glucose over 4 hours and 100 mg/kg in 1 L 5% glucose over 16 hours or;

Oral methionine.

2.5 g immediately followed by three further doses of 2.5 g at four hourly intervals. For a 3-year-old child, 1 g methionine 4-hourly for four doses has been used.
If more than ten hours have elapsed since the overdosage was taken, the antidote may be ineffective.

Relating to codeine component.

In general, treatment should be symptomatic: re-establish adequate respiratory exchange by ensuring a clear airway and using mechanical ventilation. When treatment for paracetamol toxicity has been initiated the opioid antagonist naloxone hydrochloride is an antidote to respiratory depression; naloxone 400 microgram may be administered SC, IM or IV; IV may be repeated at intervals of 2 to 3 minutes if necessary. Assisted respiration may be required.
Further measures will depend on the severity, nature and course of clinical symptoms of intoxication and should follow standard intensive care protocols.
For information on the management of overdose contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Analgesic and antipyretic.
There is evidence to suggest that a combination of paracetamol with codeine is superior in analgesic action to either drug administered alone.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

After oral administration, paracetamol is absorbed rapidly and completely from the small intestine; peak plasma levels occur 30 to 120 minutes after administration. Food intake delays paracetamol absorption. Codeine has about one-sixth of morphine's analgesic activity. It is well absorbed from the gastrointestinal tract and does not interfere with paracetamol absorption.

Distribution.

Paracetamol is uniformly distributed throughout most body fluids; the apparent volume of distribution is 1 to 1.2 L/kg. Paracetamol can cross the placenta and is excreted in milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

Metabolism.

Paracetamol is metabolised by the hepatic microsomal enzyme system. In adults at therapeutic doses, paracetamol is mainly conjugated with glucuronide (45-55%) or sulfate (20-30%). A minor proportion (less than 20%) is metabolised to catechol derivatives, and mercapturic acid compounds via oxidation. Paracetamol is metabolised differently by infants and children compared to adults, the sulfate conjugate being predominant. Patients who metabolise drugs poorly via CYP2D6 are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite.

Excretion.

Paracetamol is excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol with 85-90% of the administered dose eliminated in the urine within 24 hours of ingestion. The elimination half-life varies from 1 to 4 hours.
Codeine is metabolised in the liver to morphine and norcodeine, which with codeine, are excreted in the urine, partly as conjugates with glucuronic acid. Excretion is almost complete within 24 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Other ingredients are maize starch, povidone, potassium sorbate, microcrystalline cellulose, stearic acid, magnesium stearate, purified talc and pregelatinised maize starch.

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 25°C.

6.5 Nature and Contents of Container

Tablets, 10s and 40s. Not all pack sizes marketed.

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

Chemical structure.


Paracetamol MW: 151.17. Codeine phosphate hemihydrate MW: 406.37.

CAS number.

CAS: 103-90-2 (paracetamol). CAS: 41444-62-6 (codeine phosphate hemihydrate).

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (40s) (Schedule 4).

Summary Table of Changes