Drugs List

Therapeutic Indications

Uses

Moderate pain: acute treatment
Pyrexia (adjunctive treatment)

Contraindications

Acute alcohol intoxication
Children under 12 years
Risk of paralytic ileus
Acute asthma
Acute ulcerative colitis
Coma
CYP2D6 ultra-rapid metaboliser genotype
Enterocolitis
Gastrointestinal obstruction
Head trauma
Obstructive pulmonary disease
Paralytic ileus
Raised intracranial pressure
Respiratory depression
Respiratory impairment
Severe hepatic impairment

Precautions and Warnings

Debilitation
Elderly
Predisposition to seizures
Restricted sodium intake
Shock
Suicidal ideation
Within 2 weeks of discontinuing MAOIs
Adrenal insufficiency
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
Cardiac arrhythmias
CYP2D6 poor metaboliser genotype
Drug misuse
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Inflammatory bowel disease
Lactose intolerance
Myasthenia gravis
Non-cirrhotic alcoholic liver disease
Phaeochromocytoma
Pregnancy
Psychiatric disorder
Pulmonary oedema
Recent gastrointestinal surgery
Recent surgery of the urinary tract
Renal impairment
Urethral stricture

Children under 18 years: Increased risk of rare and severe adverse effects
Reduce dose in hypothyroidism
Sodium content of effervescent preparation may be significant
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Tolerance and dependence may occur: risk is low with short-term use
Excessive use may increase frequency of headache, may require withdrawal
Potential for withdrawal symptoms
Prolonged use and excessive doses may cause hepatic necrosis
Seek urgent medical advice in event of overdose, even if patient feels well
Avoid prolonged use
Advise patient not to take paracetamol during treatment
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose

Ultra-rapid metabolisers (CYP2D6 genotype) quickly convert codeine into morphine, its active metabolite, resulting in higher than expected serum morphine levels. Even at labelled dosage regimens, there is an increased risk of developing side effects of opioid toxicity.

Codeine is not recommended for post-operative use in children who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome, due to an increased risk of life-threatening adverse reactions.

Codeine is not recommended for use in children who might have compromised respiratory function including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.

Pregnancy and Lactation

Pregnancy

Use co-codamol with caution during pregnancy.

The manufacturer advises caution if co-codamol is used during pregnancy. Short term use may be considered with caution where weaker analgesics have failed to provide adequate pain control. Risk benefit must be considered with the use of co-codamol as it is known to cross the placenta.

Known effects of paracetamol during pregnancy
At the time of writing there have been no detrimental effects shown from the use of paracetamol in pregnancy. Paracetamol is commonly used during all stages of pregnancy. There does not appear to be a risk to the embryo or foetus from the maternal use of therapeutic doses. Paracetamol crosses the placenta easily and does not inhibit prostaglandin synthesis.

Known effects of codeine during pregnancy
At the time of writing there is limited published information regarding the use of codeine during pregnancy. Briggs (2015), states that codeine should be avoided in pregnancy due to a small absolute risk of congenital birth defects. Drug dependency in the foetus and withdrawal symptoms in the foetus may occur in prolonged treatment of the mother during pregnancy.

Lactation

Use co-codamol with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking co-codamol.

The amount of paracetamol excreted in human milk is much less than the doses usually given to infants and adverse effects in infants are rarely observed. Paracetamol as a single agent is the analgesic and antipyretic of choice during breastfeeding.

Codeine and its active metabolites may be present in breast milk at low doses which are unlikely to have adverse effects. Ultra rapid metabolisers of CYP2D6 may produce larger amounts of the active metabolite morphine which puts the infant at risk of opioid toxicity and can be fatal. LactMed (2020) recommends to control pain during breastfeeding with non-opioid analgesics and limit maternal oral intake of codeine to 2 to 4 days at a low dosage with close infant monitoring. Numerous professional organisations and regulatory agencies advise the use of other agents over codeine or to completely avoid it during breastfeeding; however, other opioid alternatives have been studied less and may be not safer (LactMed, 2020).

Side Effects

Abdominal pain
Addiction
Agranulocytosis
Allergic reaction
Anaphylaxis
Angioedema
Anorexia
Biliary spasm
Blood dyscrasias
Bradycardia
Bronchospasm
Confusion
Constipation
Convulsions
Decreased appetite
Dependence
Depression
Difficulty in micturition
Diminution of potency
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dysphoria
Euphoria
Facial flushing
Fasciculation
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hypersensitivity reactions
Hypotension
Hypothermia
Leucopenia
Light-headedness
Liver damage
Malaise
Methaemoglobinaemia
Miosis
Mood changes
Myocarditis
Nausea
Neutropenia
Nightmares
Oedema
Palpitations
Pancreatitis
Papillary necrosis
Paralytic ileus
Postural hypotension
Pruritus
Raised intracranial pressure
Rash
Respiratory depression
Sedation
Seizures
Shortness of breath
Sleep disturbances
Stevens-Johnson syndrome
Sweating
Tachycardia
Thrombocytopenia
Tolerance
Toxic epidermal necrolysis
Toxic megacolon
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting
Withdrawal symptoms

Presentation

Oral formulations of low strength codeine and paracetamol (containing less than 15mg of codeine phosphate).

Drugs List

Therapeutic Indications

Uses

Moderate pain: acute treatment
Pyrexia (adjunctive treatment)

Dosage

Where possible, treatment duration should be limited to 3 days.

Adults

Children

Contraindications

Acute alcohol intoxication
Children under 12 years
Risk of paralytic ileus
Acute asthma
Acute ulcerative colitis
Coma
CYP2D6 ultra-rapid metaboliser genotype
Enterocolitis
Gastrointestinal obstruction
Head trauma
Obstructive pulmonary disease
Paralytic ileus
Raised intracranial pressure
Respiratory depression
Respiratory impairment
Severe hepatic impairment

Precautions and Warnings

Debilitation
Elderly
Predisposition to seizures
Restricted sodium intake
Shock
Suicidal ideation
Within 2 weeks of discontinuing MAOIs
Adrenal insufficiency
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
Cardiac arrhythmias
CYP2D6 poor metaboliser genotype
Drug misuse
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Inflammatory bowel disease
Lactose intolerance
Myasthenia gravis
Non-cirrhotic alcoholic liver disease
Phaeochromocytoma
Pregnancy
Psychiatric disorder
Pulmonary oedema
Recent gastrointestinal surgery
Recent surgery of the urinary tract
Renal impairment
Urethral stricture

Children under 18 years: Increased risk of rare and severe adverse effects
Reduce dose in hypothyroidism
Sodium content of effervescent preparation may be significant
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Tolerance and dependence may occur: risk is low with short-term use
Excessive use may increase frequency of headache, may require withdrawal
Potential for withdrawal symptoms
Prolonged use and excessive doses may cause hepatic necrosis
Seek urgent medical advice in event of overdose, even if patient feels well
Avoid prolonged use
Advise patient not to take paracetamol during treatment
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose

Ultra-rapid metabolisers (CYP2D6 genotype) quickly convert codeine into morphine, its active metabolite, resulting in higher than expected serum morphine levels. Even at labelled dosage regimens, there is an increased risk of developing side effects of opioid toxicity.

Codeine is not recommended for post-operative use in children who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome, due to an increased risk of life-threatening adverse reactions.

Codeine is not recommended for use in children who might have compromised respiratory function including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.

Pregnancy and Lactation

Pregnancy

Use co-codamol with caution during pregnancy.

The manufacturer advises caution if co-codamol is used during pregnancy. Short term use may be considered with caution where weaker analgesics have failed to provide adequate pain control. Risk benefit must be considered with the use of co-codamol as it is known to cross the placenta.

Known effects of paracetamol during pregnancy
At the time of writing there have been no detrimental effects shown from the use of paracetamol in pregnancy. Paracetamol is commonly used during all stages of pregnancy. There does not appear to be a risk to the embryo or foetus from the maternal use of therapeutic doses. Paracetamol crosses the placenta easily and does not inhibit prostaglandin synthesis.

Known effects of codeine during pregnancy
At the time of writing there is limited published information regarding the use of codeine during pregnancy. Briggs (2015), states that codeine should be avoided in pregnancy due to a small absolute risk of congenital birth defects. Drug dependency in the foetus and withdrawal symptoms in the foetus may occur in prolonged treatment of the mother during pregnancy.

Lactation

Use co-codamol with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking co-codamol.

The amount of paracetamol excreted in human milk is much less than the doses usually given to infants and adverse effects in infants are rarely observed. Paracetamol as a single agent is the analgesic and antipyretic of choice during breastfeeding.

Codeine and its active metabolites may be present in breast milk at low doses which are unlikely to have adverse effects. Ultra rapid metabolisers of CYP2D6 may produce larger amounts of the active metabolite morphine which puts the infant at risk of opioid toxicity and can be fatal. LactMed (2020) recommends to control pain during breastfeeding with non-opioid analgesics and limit maternal oral intake of codeine to 2 to 4 days at a low dosage with close infant monitoring. Numerous professional organisations and regulatory agencies advise the use of other agents over codeine or to completely avoid it during breastfeeding; however, other opioid alternatives have been studied less and may be not safer (LactMed, 2020).

Effects on Ability to Drive and Operate Machinery

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.

Counselling

Warn patient not to take any other products containing paracetamol or opiate derivatives.

Advise patient that regular use of codeine for a prolonged period of time can lead to addiction.

Advise patient that dizziness or sedation may occur which may affect their ability to drive or operate machinery. Alcohol may worsen these effects.

Patients should be advised to consult their doctor if no relief from symptoms after 3 days.

Patient should be advised that prolonged use of a painkiller for headaches may make them worse.

Advise patients to seek urgent medical advice in the event of an overdose, even if they feel well due to the risk of delayed serious liver damage.

Advise patients not to take for longer than directed and not to exceed the recommended dose or frequency of administration.

Advise patient not to take alcohol during treatment.

Advise patient not to take St. John's Wort concurrently with this medication.

Side Effects

Abdominal pain
Addiction
Agranulocytosis
Allergic reaction
Anaphylaxis
Angioedema
Anorexia
Biliary spasm
Blood dyscrasias
Bradycardia
Bronchospasm
Confusion
Constipation
Convulsions
Decreased appetite
Dependence
Depression
Difficulty in micturition
Diminution of potency
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dysphoria
Euphoria
Facial flushing
Fasciculation
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hypersensitivity reactions
Hypotension
Hypothermia
Leucopenia
Light-headedness
Liver damage
Malaise
Methaemoglobinaemia
Miosis
Mood changes
Myocarditis
Nausea
Neutropenia
Nightmares
Oedema
Palpitations
Pancreatitis
Papillary necrosis
Paralytic ileus
Postural hypotension
Pruritus
Raised intracranial pressure
Rash
Respiratory depression
Sedation
Seizures
Shortness of breath
Sleep disturbances
Stevens-Johnson syndrome
Sweating
Tachycardia
Thrombocytopenia
Tolerance
Toxic epidermal necrolysis
Toxic megacolon
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting
Withdrawal symptoms

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Co-codamol 8/500mg Effervescent tablets. Accord Ltd. Revised May 2020.

Summary of Product Characteristics: Co-codamol 8/500mg capsules, tablets. Actavis Ltd. Revised September 2017.

Summary of Product Characteristics: Co-codamol 8/500mg capsules. Custom Healthcare Ltd. Revised November 2016.

Summary of Product Characteristics: Co-codamol 8/500mg effervescent tablets. Teva Ltd. Revised August 2017.

Summary of Product Characteristics: Co-codamol 8/500mg tablets. Teva Ltd. Revised August 2017.

Summary of Product Characteristics: Co-codamol 8/500mg tablets. Wockhardt Ltd. Revised February 2017.

Summary of Product Characteristics: Migraleve Yellow tablets. McNeil Products Ltd. Revised December 2017.

Summary of Product Characteristics: Panadol Ultra. GlaxoSmithKline Consumer Healthcare Ltd. Revised August 2017.

Summary of Product Characteristics: Paracodol tablets. Bayer plc. Revised August 2017.

Summary of Product Characteristics: Solpadeine max tablets. Omega Pharma Ltd. Revised January 2018.

Summary of Product Characteristics: Zipamol Plus 8mg/500mg effervescent tablets. Accord-UK Ltd. Revised July 2021.

MHRA Drug Safety Update: Volume 3, Issue 2, September 2009. Over-the-counter painkillers containing codeine or dihydrocodeine.
https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON057141
Last accessed 26 February 2018 (via archive site).

MHRA 2nd September 2009. Updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC).
https://www.mhra.gov.uk/SafetyInformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON057118
Last accessed 26 February 2018 (via archive site).

MHRA 16th October 2009. Guidance on the development of artwork in relation to medicines containing codeine and dihydrocodeine.
https://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON059982
Last accessed 26 February 2018 (via archive site).

Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: Advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk/ Last accessed: 26 February 2018.
New drug driving offence implications for medicines packaging. Medicines Regulatory News. 24 July 2013. Available at: https://www.mhra.gov.uk Last accessed: 26 February 2018.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Acetaminophen. Last revised: 31 October 2018.
Last accessed: 20 July 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Codeine. Last revised: 15 June 2020.
Last accessed: 20 July 2020.