Consumer medicine information

Trust Analgesic Calmative

Paracetamol + Codeine phosphate hemihydrate + Doxylamine succinate

BRAND INFORMATION

Brand name

Trust Analgesic Calmative

Active ingredient

Paracetamol + Codeine phosphate hemihydrate + Doxylamine succinate

Schedule

What is in this CMI

This leaflet answers some common questions about Trust Analgesic Calmative.

It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor.

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

What is Trust Analgesic Calmative used for

The name of your medicine is Trust Analgesic Calmative.

It contains the active ingredients paracetamol, codeine phosphate hemihydrate and doxylamine succinate.

Paracetamol, an analgesic with antipyretic action also reduces fever.

Doxylamine succinate is an antihistamine with pronounced sedative effects.

Codeine phosphate hemihydrate is an analgesic, and in combination with paracetamol and doxylamine produces greater analgesia than any of these drugs alone and avoids the side effects associated with large doses of these components.

Trust Analgesic Calmative is used to provide temporary relief of acute moderate pain and fever associated with

neck and back pain,
headache
tension headache,
toothache,
backache,
migraine headache,
muscle pain,
nerve pain,
arthritis,
rheumatics,
osteoarthritis
period pain,
symptoms of
- cold,
- sore throat,
- flu
trauma
surgery
dental procedures
and other pain

where a combined calmative and analgesic action is required.

It also reduces fever.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take Trust Analgesic Calmative

When you must not take it

Do not take this medicine if you have an allergy to:

any medicine containing paracetamol, codeine, doxylamine or other antihistamines or
any of the inactive ingredients listed at the end of this leaflet.

Signs of an allergic reaction may include:

rash,
itching of the skin,
shortness of breath and
swelling of the tongue or face.

Do not take this medicine if you have or have had any of the following medical conditions:

respiratory depression
liver failure
glaucoma (high pressure in the eyes)
stomach or duodenal ulcer, or other stomach problems
prostate problems
bladder problems
acute breathing difficulties such as bronchitis, unstable asthma or emphysema
chronic constipation
diarrhoea caused by antibiotics or poisoning
If you are a Ultra rapid metaboliser of CYP2D6
If you are aged below 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea.

Do not take this medicine if you have alcohol dependence.

Do not give this medicine to a child under 12 years.

Do not take this medicine during the third trimester of pregnancy.

Do not take this medicine during labour, especially if the baby is premature. The medicine may produce withdrawal effects in the newborn baby.

Do not take this medicine if you are also taking monoamine oxidase inhibitors, a type of medicine used to treat depression.

Do not take this medicine if you are breastfeeding or plan to breastfeed. It passes into the breast milk and there is a possibility that the baby may be affected.

Do not use this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

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

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

Before you start to take it

Tell your doctor if you have allergies to:

any of the ingredients listed at the end of this leaflet
any other medicines,
aspirin or any other NSAID medicine
any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant, intend to become pregnant. Like most medicines of this kind, Trust Analgesic Calmative is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are pregnant.

Do not take Trust Analgesic Calmative during labour, especially if the baby is premature.

This medicine may produce withdrawal effects in the newborn baby.

Your doctor will discuss the possible risks and benefits of using this medicine during pregnancy and breastfeeding.

Do not use Trust Analgesic Calmative if you are breastfeeding or planning to breastfeed. This medicine passes into breast milk and may affect the baby.

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

kidney or liver problems
heart problems
difficulty breathing, wheezing, chronic cough, asthma or other chronic breathing conditions
compromised respiratory function (due to emphysema, kyphoscoliosis or obesity)
known analgesic intolerance
you are a CYP 2D6 ultra-rapid metaboliser
glaucoma
chronic alcohol use including recent cessation of alcohol intake
low glutathione reserves
Gilbert's syndrome
prostate problems
thyroid problems
Multiple sclerosis
urinary, bowel or gallbladder conditions
have problems with the adrenal glands
convulsions, fits or seizures
pre-existing opioid dependence
chronic constipation
head injury or trauma
a history of drug dependence, alcohol dependence
- Caution is particularly recommended for use in adolescents and young adults with a history of drug and/or alcohol abuse.
recent surgery on the stomach or intestines
prostate problems
low blood pressure
underactive thyroid

Tell your doctor if you plan to have surgery. If you have not told your doctor about any of the above, tell them before you use this medicine.

Taking other medicines

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

Do not take with other medicines containing paracetamol, unless your doctor says you can.

Some medicines may interact with this medicine.

These include:

antihistamines
sleeping tablets or sedatives
tranquillisers (medicines used for anxiety or nerves
benzodiazepines (medicines used as sedatives or to treat anxiety)
medicines containing alcohol (ethanol), e.g. some cough syrups
any medicine which thins the blood
other opioid analgesics used to treat pain
monoamine oxidase inhibitors, medicine used to treat depression, taken within the last 14 days
antihypertensives (medicines used to help lower blood pressure)
medicines to treat epilepsy
metoclopramide or domperidone, medicines used to control nausea and vomiting
propantheline, a medicine used to treat stomach ulcers
chloramphenicol (antibiotic used to treat ear and eye infections)
flucloxacillin, zidovudine or rifampicin, medicines used to treat infections
antidepressants
antipsychotics (medicines used to treat mental illnesses)
chelating resin
medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine or methadone)
CYP 2D6 inhibitors such as quindine, fluoxetine, paroxetine, bupropion, cinacalcet, methadone
CYP 3A4 inducers such as rifampin.

These medicines may be affected by Trust Analgesic Calmative or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

How to take Trust Analgesic Calmative

Follow all directions given to you by your doctor carefully and keep to the recommended dose. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor for help.

How much to take

The usual dose for adults and children over 12 years of age is one to two tablets every 4 to 6 hours, as needed for relief.

Do not take more than 8 tablets in a 24 hour period.

Do not give this medicine to a child under 12 years.

How to take it

Swallow the tablets with a full glass of water.

When to take it

It does not matter if you take this medicine before or after food.

How long to take it

This medicine is for short term use only.

Adults and children over 12 years: The usual dose is one to two tablets to be taken every four to six hours, as needed for pain relief, up to four times daily. Do not exceed 8 tablets in 24 hours period. Keep to the recommended dose.

Adults (over 18 years): Do not take this medicine for longer than a few days at a time unless advised by a doctor.

Adolescents (12-17 years): Do not take this medicine for longer than 48 hours at a time unless advised by a doctor.

If pain persists for more than three days, please see your doctor.

If you forget to take it

There is no need to take extra doses if the pain has gone away.

If the pain is still present, take your next dose if required.

Do not double a dose to make up for the dose you have missed.

If you are not sure what to do, ask your doctor.

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

If you take too much (Overdose)

Immediately telephone your doctor or the Poisons Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning because of the risk of delayed, serious liver damage. You may need urgent medical attention. Large amounts of paracetamol can cause liver damage.

If children take too many Trust Analgesic Calmative they can suffer from nightmares, hallucinations, fitting or have difficulty sleeping.

While you are taking Trust Analgesic Calmative

Things you must do

Tell all doctors and dentists who are treating you that you are taking this medicine.

If you are about to be started on any new medicine, tell your doctor that you are taking this medicine.

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

Tell your doctor if:

you develop a skin rash or hives while taking this medicine
you become pregnant while taking this medicine

Things you must NOT do

Do not take more than the recommended dose unless your doctor or pharmacist tells you to.

Do not give this medicine to anyone else, even if they have the same symptoms as you.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Things to be careful of

This medicine may cause drowsiness or lightheadedness in some people especially after the first dose.

Do not drive a car, operate machinery, or do anything else that could be dangerous if you feel dizzy.

Children should not ride bicycles if affected and should be supervised to avoid potential harm.

Be careful if you are over 65 and 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.

Drinking alcohol increases the likelihood of becoming drowsy while taking this medicine. Drinking alcohol and taking paracetamol at the same time can cause liver damage. It is not recommended that you drink alcohol while taking this medicine.

Trust Analgesic Calmative may be habit forming if taken at high doses for extended periods of time. Ask your doctor or pharmacist if you are concerned about this.

Side Effects

Tell your doctor as soon as possible if you do not feel well while you are taking this medicine.

This medicine helps most people with pain, but may have unwanted side effects in a few people.

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

Ask your doctor any questions you may have.

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

drowsiness
dizziness
nausea
vomitting
stomach pain
constipation
skin rashes
sweating
diarrhoea
dry mouth
indigestion
ringing in the ear
headache
loss of appetite, weight loss
depression

Tell your doctor as soon as possible if you notice any of the following:

painful red areas with blisters and peeling layers of skin which may be accompanied by fever and/or chills
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine)
difficulty breathing
flushing of the face
unusual or extreme mood swings
feeling confused
dizziness, light-headedness
fast heartbeat

If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing
hives
fainting
yellowing of the skin and eyes (jaundice)

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Trust Analgesic Calmative. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

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

After taking Trust Analgesic Calmative

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.

Keep your medicine in a cool, dry place where it stays below 30°C.

Do not store it, or any other medicine, in the bathroom or near a sink.

Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.

Keep this medicine 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.

Disposal

Return any unused medicines to your pharmacist.

Product Description

What it looks like

Tablets are white capsule shaped, biconvex, bevel edged, uncoated tablets with break line on one side and plain on other side.

It is available in packs of 10 tablets, 12 tablets, 20 tablets, 24 tablets, 30 tablets, 36 tablets and 40 tablets.

Active ingredients:

Each tablet contains:
Paracetamol 500mg
Codeine phosphate hemihydrate 10mg
Doxylamine Succinate 5.1mg

Other ingredients:

Lactose monohydrate, Starch-Maize, Povidone, Ethanol, Crospovidone, Cellulose-microcrystalline, Stearic Acid, Magnesium Stearate.

Name and Address of the sponsor

Trust Analgesic Calmative tablets are supplied in Australia by:

Pharmacor Pty. Ltd.
Suite 803, Tower A, The Zenith,
821 Pacific Highway,
Chatswood NSW 2067
Australia
Web: www.pharmacor.com.au
Phone: 1300 138 805

Australian Register Number

AUST R 217762

This leaflet was prepared in October 2020.

Published by MIMS February 2021

BRAND INFORMATION

Brand name

Trust Analgesic Calmative

Active ingredient

Paracetamol + Codeine phosphate hemihydrate + Doxylamine succinate

Schedule

1 Name of Medicine

Paracetamol, codeine phosphate hemihydrate, and doxylamine succinate.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg, codeine phosphate hemihydrate 10 mg, and doxylamine succinate 5.1 mg.

Excipients with known effect.

Contains sugars (as lactose monohydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Trust Analgesic Calmative are white capsule shaped, biconvex, bevel edged, uncoated tablets with break line on one side and plain on other side.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of acute moderate pain and fever.

4.2 Dose and Method of Administration

Adults and children over 12 years.

One or two tablets every four to six hours as needed for relief. Do not exceed eight tablets in a 24 hour period. For short-term use only. This product is not recommended for use over long periods.
Use in children under 12 years is contraindicated.

4.3 Contraindications

Trust Analgesic Calmative is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol, codeine, doxylamine succinate or substances of similar chemical structure or other opiates or other antihistamines of the ethanolamine class (or any of other ingredients in the product excipients listed, see Section 6.1 List of Excipients).
Trust Analgesic Calmative is also contraindicated for use in patients with:
severe respiratory disease, acute respiratory disease and respiratory depression;
severe hepatocellular insufficiency;
glucose-6-phosphate-dehydrogenase deficiency;
chronic constipation;
during labour or when delivery of a premature infant is anticipated as it may produce codeine withdrawal symptoms in the neonate;
active alcoholism;
diarrhoea caused by pseudomembranous colitis or poisoning (until the causative organism or toxin has been eliminated from the gastrointestinal tract, since codeine may slow down the elimination, thereby prolonging the diarrhoea);
narrow-angle glaucoma;
stenosing peptic ulcer;
symptomatic prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction.
Trust Analgesic Calmative is contraindicated for use in:
patients taking monoamine oxidase inhibitors (MAOIs) or have stopped treatment within the last 14 days (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions);
patients who are CYP2D6 ultra rapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism);
children younger than 12 years of age (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
patients aged between 12-18 years of age in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, obesity and pulmonary disease due to an increased risk of developing serious 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).

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.
Avoid alcohol.
Patients should be cautioned against the concomitant ingestion of alcohol and antihistamines.
This medication may be dangerous when used in large amounts or for long periods. Hepatotoxicity may develop following a dose of paracetamol 10 g and hepatic failure is known to occur occasionally with the long-term use of paracetamol.
Patients with known analgesic intolerance or known bronchial asthma must only use Trust Analgesic Calmative after having consulted a physician (hypersensitivity reactions including bronchospasm are possible).
Caution is advised in patients with underlying sensitivity to aspirin and/or to non-steroidal 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. If symptoms or signs of SJS and TEN (e.g. progressive skin rash often with blisters or mucosal lesions) occur, patients should stop immediately paracetamol treatment and seek medical advice.
Paracetamol should be used upon medical advice in patients with:
mild to moderate hepatocellular insufficiency;
severe renal insufficiency;
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, 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 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.
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).
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.
Doxylamine must be administered with caution in patients with:
urinary retention;
susceptibility to angle closure glaucoma.

CYP2D6 metabolism.

Trust Analgesic Calmative 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 in infants of rapid metaboliser mothers who take codeine.
The prevalence of codeine ultra-metabolism by CYP2D6 in children is not known, but it 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).
Codeine is not recommended for use in children in whom respiratory function might be compromised.
Codeine present in this medicine may obscure the diagnosis or the course of gastrointestinal diseases. Codeine present in this medicine may produce physical and psychological dependence, if used for a prolonged period.

Hazardous and harmful use.

Trust Analgesic Calmative contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Trust Analgesic Calmative 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 Trust Analgesic Calmative.
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 Trust Analgesic Calmative 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 Trust Analgesic Calmative 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).
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, (see Section 4.2 Dose and Method of Administration), 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 Trust Analgesic Calmative 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 Trust Analgesic Calmative 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 Trust Analgesic Calmative.

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 nonpharmacological 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 Trust Analgesic Calmative 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; see Section 4.2 Dose and Method of Administration).

Accidental ingestion/exposure.

Accidental ingestion or exposure of Trust Analgesic Calmative, 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 Trust Analgesic Calmative (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 (see Section 4.2 Dose and Method of Administration). 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.

Trust Analgesic Calmative should be used with caution in patients with impaired liver function. Trust Analgesic Calmative is contraindicated in patients with severe hepatocellular insufficiency.

Use in renal impairment.

Trust Analgesic Calmative should be used with caution in patients with renal dysfunction.

Use in the elderly.

Elderly people may be more sensitive to the effects of this medicinal product, especially respiratory depression. 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.

Trust Analgesic Calmative 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-metabolisers of codeine due to 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

The following interactions have been noted:

Interactions with paracetamol.

Coumarins.

Paracetamol may increase the risk of bleeding in patients taking warfarin and other antivitamin K. Patients taking paracetamol and antivitamin K should be monitored for appropriate coagulation and bleeding complications.

Chloramphenicol.

Paracetamol may considerably slow down the excretion of chloramphenicol, entailing the risk of increased toxicity.
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.

Floxacillin.

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.

Barbiturates and antiepileptic medications.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as barbiturates and other antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol. The induced metabolism results in an elevated production of the hepatotoxic oxidative metabolite of paracetamol. Hepatotoxicity will occur if this metabolite exceeds the normal glutathione binding capacity.

Probenecid.

Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Concomitant use of paracetamol and isoniazid, phenytoin, sulfinpyrazone has been reported to result in hepatotoxicity. Therefore, patients receiving isoniazid, phenytoin, or sulfinpyrazone therapy should avoid large and/or chronic doses of paracetamol.

Zidovudine.

When used concurrently with zidovudine, an increased tendency for neutropenia may develop. Combination of Trust Analgesic Calmative and zidovudine should be avoided.
Concurrent intake of drugs, which delay gastric emptying, such as propantheline, may slow down the uptake of paracetamol, thereby retarding its onset of action. Conversely, drugs, which accelerate gastric emptying, such as metoclopramide or domperidone, may accelerate the absorption rate of paracetamol and its onset of action.

Interactions with codeine.

Antitussives and antihistamines.

Concomitant use of codeine with antitussives and/or antihistamines may exhibit an additive CNS depression (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

Anticholinergics.

Concomitant use of codeine and anticholinergic agents may increase the risk of severe constipation and/or urinary retention.

Neuromuscular blocking agents.

Codeine may enhance the effects of neuromuscular blocking agents resulting in increased respiratory depression.

Antihypertensives.

Hypotensive effects may be potentiated when used concurrently with codeine and lead to orthostatic hypotension.

Antiperistaltic antidiarrhoeals (e.g. kaolin, pectin and loperamide).

Concomitant use of codeine with antiperistaltic antidiarrhoeal drugs can increase the risk of severe constipation and CNS depression.

Alcohol.

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

Metoclopramide.

Codeine may antagonise the effects of metoclopramide on gastrointestinal motility.

Monoamine oxidase inhibitors (MAOIs).

Concomitant administration of MAOIs can potentiate the central nervous effects and other side effects of unpredictable severity. Codeine should not be used within 14 days after the discontinuation of MAOI treatment.

Opioid analgesics.

Concurrent use of codeine and other opioid receptor antagonists or partial agonists is usually inappropriate as additive CNS depression, respiratory depression and hypotensive effects may occur or it can precipitate or delay codeine effects (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

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, phenothiazines and antipsychotic agents, 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.

CNS depressants.

Patients receiving other narcotic analgesics, benzodiazepines or other CNS depressants e.g. gabapentinoids, cannabis, antipsychotics, centrally-active anti-emetics, general anaesthetics, antianxiety, hypnotics, sedatives, tranquillisers, tricyclic antidepressants, antihistamines, concomitantly may exhibit an additive CNS depression and increases the risk of sedation, respiratory depression, coma and death (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).

Interactions with doxylamine succinate.

Monoamine oxidase inhibitors (MAOIs).

Concurrent administration or use within 14 days of ceasing MAOIs may enhance or prolong the anticholinergic and CNS depressive effects of doxylamine succinate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Paracetamol, codeine phosphate hemihydrate and doxylamine succinate have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed. 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 Trust Analgesic Calmative should be avoided during the third trimester of pregnancy and during labour. Trust Analgesic Calmative should only be used during pregnancy under medical supervision if the potential benefit justifies the potential risk to the foetus. If administered during pregnancy, morphinomimetic properties of codeine should be taken into account.
Trust Analgesic Calmative is contraindicated during breastfeeding (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.
There are no data available on the use of Trust Analgesic Calmative during lactation. Paracetamol, doxylamine and codeine are excreted into human breast milk. Analgesic doses excreted in breast milk are generally low. However, infants of breastfeeding mothers taking codeine may have increased risk of morphine overdose if the mother is an ultrarapid metaboliser of codeine. Codeine is excreted into human breast milk. Codeine partially metabolised 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 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, Trust Analgesic Calmative 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.
Breast feeding mothers should be told how to recognize 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

Both doxylamine succinate and codeine phosphate hemihydrate may cause drowsiness in some patients; codeine may also cause disturbances of visuomotor coordination and visual acuity, and psychomotor impairment impacting the mental and or physical ability required for the performance of potentially dangerous tasks, therefore patients should not operate vehicles or machinery, or engage in activities that require them to be fully alert.

4.8 Adverse Effects (Undesirable Effects)

Side effects with Trust Analgesic Calmative are infrequent. However, among those reported are anorexia, drowsiness, depression, dizziness, sweating, anaphylactic shock, angioneurotic oedema, angioedema, difficulty in breathing, drop in blood pressure, gastrointestinal discomfort (e.g. nausea and diarrhoea), dry mouth and, on rare occasions, erythema, urticaria, rash.
Paracetamol may occasionally cause skin reactions, and isolated cases of agranulocytosis and thrombocytopenic purpura have been reported. Changes in blood picture (rarely thrombocytopenia, neutropenia, leukopenia, and, in isolated cases, pancytopenia) may occur.
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 and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported.
Doxylamine succinate may cause drowsiness in some individuals as well as paradoxical stimulation, psychomotor impairment, blurred vision, thickened respiratory secretions, gastrointestinal disorders and urinary retention. Constipation may occur in association with codeine.
Haemolytic anaemia, particularly in patients with underlying glucose 6-phosphate dehydrogenase deficiency has been reported. Kounis syndrome and bronchospasm have also been reported.
Side effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Overdosage with paracetamol, if left untreated, can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
The most common adverse effects associated with codeine are nausea, vomiting, drowsiness, dizziness and constipation.
Other side effects include: cough suppression, respiratory depression, euphoria, dysphoria, skin rashes, histamine release (hypotension, flushing of the face, tachycardia, breathlessness) and other allergic reactions, confusional state, dysphoria, euphoria, seizure, headache, somnolence, hypotension, sedation, miosis, tinnitus, respiratory depression, dry mouth, pruritus, urinary retention, and fatigue. Long-term use also entails the risk of drug dependence. Visuomotor coordination and visual acuity may be adversely affected in a dose-dependent manner at higher doses or in particularly sensitive patients.

Central nervous system (CNS) effects.

CNS depressive effects of doxylamine succinate include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night-time dose.
CNS stimulatory effects of doxylamine succinate may include anxiety, hallucinations, appetite stimulation, muscle dyskinesias and activation of epileptogenic foci.
High doses of doxylamine succinate may cause nervousness, tremor, insomnia, agitation, and irritability.

Anticholinergic effects.

Side effects of doxylamine succinate associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.

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

Paracetamol.

It has been reported that paracetamol may produce symptoms of acute toxicity in adults following the ingestion of more than 15 g. Hepatotoxicity may develop after the ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) and a dose of more than 25 g is potentially fatal. 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. Patients may be asymptomatic for several days following ingestion of large doses of paracetamol and laboratory evidence of hepatotoxicity may be delayed for up to one week. Nonfatal hepatic damage is usually reversible. The antidote, N-acetylcysteine, should be administered as early as possible.
Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
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.

Codeine.

In an evaluation of codeine intoxication in children, symptoms ranked by decreasing order of frequency included sedation, rash, miosis, vomiting, itching, ataxia and swelling of the skin. Respiratory failure may occur. Blood concentrations of codeine ranged from 1.4 to 5.6 microgram/mL in eight adults whose deaths were attributed primarily to codeine overdosage.
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.

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. Reactions associated with doxylamine overdosage may vary from CNS depression to stimulation.
Stimulation is particularly likely in children; insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions can occur. Atropine-like signs and symptoms such as dry mouth, fixed, dilated pupils, flushing and gastrointestinal symptoms may also occur.
Further measures will depend on the severity, nature and course of clinical symptoms of intoxication and should follow standard intensive care protocols.

Doxylamine.

Reactions associated with doxylamine overdosage may vary from CNS depression to stimulation. Stimulation is particularly likely in children. Insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions can occur. Atropine-like signs and symptoms (e.g. dry mouth, fixed and dilated pupils, flushing and gastrointestinal symptoms) may also occur.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or 0800 764 766 (New Zealand). In case of overdose, immediately contact the Poisons Information Centre or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage with paracetamol.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol is an effective and fast acting analgesic that relieves mild to moderate pain. It is rapidly absorbed from the gastrointestinal tract with peak plasma levels usually reached 30 to 60 minutes after oral administration. It also reduces fever by a direct effect on the heat regulating centres to increase dissipation of body heat.
Codeine phosphate hemihydrate is an effective oral analgesic that provides relief from mild to moderate pain. It is also well absorbed from the gastrointestinal tract after oral administration.
Doxylamine succinate belongs to the ethanolamine class of antihistamines with sedative properties.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Paracetamol.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.

Codeine.

Codeine and its salts are well absorbed from the gastrointestinal tract: peak plasma codeine concentrations occur at about one hour after ingestion of codeine phosphate. Codeine is metabolised by O- and N-demethylation in the liver (via the cytochrome P450 system) to morphine (about ten percent of a codeine dose is demethylated to morphine), norcodeine and other metabolites including normorphine and hydrocodone. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. Approximately 3% to 16% of a dose is eliminated unchanged in the urine.
About 8% of people metabolise drugs poorly via CYP2D6, and are likely to obtain reduced benefit from codeine due to reduced formation of the active metabolite, morphine. The plasma half-life of codeine has been reported to be between 3 and 4 hours after oral administration.

Doxylamine succinate.

Doxylamine succinate is readily absorbed from the gastrointestinal tract. Following oral administration, the mean peak plasma concentration occurs after 2-3 hours. It has an elimination half-life of about 10 hours in healthy adults. It is excreted in the urine as unchanged doxylamine (60%) and metabolites (nordoxylamine and dinordoxylamine).
The major metabolic site is the liver and major metabolic pathways are N-demethylation, N-oxidation, hydroxylation, N-acetylation, N-desalkylation and ether cleavage.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, maize starch, povidone, ethanol, crospovidone, microcrystalline cellulose, stearic acid, magnesium stearate.

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.

6.5 Nature and Contents of Container

The product is presented in blister pack sizes of 10 tablets, 12 tablets, 20 tablets, 24 tablets, 30 tablets, 36 tablets and 40 tablets.

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

Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Paracetamol is an analgesic and antipyretic.
Codeine phosphate hemihydrate is a white or almost white, crystalline powder or small, colourless crystals. It is freely soluble in water, slightly soluble or very slightly soluble in ethanol (96%). Codeine phosphate hemihydrate is a cough suppressant and an analgesic.
Doxylamine succinate is a white or creamy white powder with a characteristic odour.

Chemical structure.

Paracetamol.

Molecular formula: C₈H₉NO₂.
Molecular weight: 151.2.

Codeine phosphate hemihydrate.

Molecular formula: C₁₈H₂₁NO₃, H₃PO₄, ½ H₂O.
Molecular weight: 406.4.

Doxylamine succinate.

Molecular formula: C₁₇H₂₂N₂O0.C₄H₆O₄.
Relative molecular mass: 388.46.

CAS number.

Paracetamol.

103-90-2.

Codeine phosphate hemihydrate.

1444-62-6.

Doxylamine succinate.

562-10-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4: Prescription Only Medicine.

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Trust Analgesic Calmative

Paracetamol + Codeine phosphate hemihydrate + Doxylamine succinate

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