Drugs List

Therapeutic Indications

Uses

Short term relief of moderate acute pain

Short term treatment of acute moderate pain such as headache, migraine, dysmenorrhoea, post-operative analgesia, when not relieved by paracetamol, ibuprofen or aspirin alone.

Contraindications

Children under 12 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Acute respiratory depression
Alcoholism
Breastfeeding
Chronic obstructive pulmonary disease
Galactosaemia
Head trauma
Pregnancy
Raised intracranial pressure

Precautions and Warnings

Children aged 12 to 18 years
Debilitation
Elderly
Predisposition to narrow angle glaucoma
Shock
Adrenal insufficiency
Benign prostatic hyperplasia
Biliary tract disorder
Cholelithiasis
CYP2D6 ultra-rapid metaboliser genotype
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of cardiac arrhythmias
History of drug misuse
History of seizures
Hypertension
Hypothyroidism
Lactose intolerance
Myasthenia gravis
Non-cirrhotic alcoholic liver disease
Peptic ulcer
Recent gastrointestinal surgery
Renal impairment
Sleep apnoea
Urinary retention

Advise patient ability to drive or operate machinery may be impaired
Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Avoid within 2 weeks of discontinuing a MAOI
Contains lactose
Contains sunset yellow (E110) - may cause allergic reaction
Some brands contain Quinoline Yellow (E104) : May cause allergic reactions
Can cause addiction
May cause respiratory depression
Monitor patient for signs and symptoms of respiratory depression
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Excessive use may increase frequency of headache, may require withdrawal
Neonate exposed in labour: Risk of respiratory depression
Overdosage causes liver damage
Seek urgent medical advice in event of overdose, even if patient feels well
May affect results of some laboratory tests
Maintain treatment for the shortest possible duration
Advise patient not to take paracetamol during treatment
Advise patient to avoid alcohol during treatment
Advise that alcohol increases the chances of liver damage with paracetamol
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose

Codeine should not be used in paediatric patients who are undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to the increased risk of adverse reactions.

Codeine is not recommended for use in children in whom respiratory function might be compromised (for example in neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures). These factors may worsen symptoms of morphine toxicity.

The long term use of codeine phosphate should be assessed regularly, considering the risks and benefits.

Patients with the CYP2D6 ultra-rapid metaboliser genotype may have an increased risk of developing side effects of opioid toxicity at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

Pregnancy and Lactation

Pregnancy

Paracetamol with codeine phosphate, doxylamine and caffeine is contraindicated during pregnancy.

The manufacturer does not recommend using paracetamol with codeine phosphate, doxylamine and caffeine during pregnancy and during labour.

Paracetamol is the analgesic of choice during pregnancy. It crosses the placenta, but in therapeutic doses appears safe for short term use. Prolonged exposure should be avoided. Caffeine crosses the placenta with foetal blood and tissue levels that are similar to maternal concentrations. When used in moderation, no association with congenital malformations, spontaneous abortions, preterm birth and low birth weight has been proven.

Codeine crosses the placenta along with it's active metabolites (which includes morphine). Codeine has been linked to congenital defects including respiratory malformations following first trimester exposure. Regular opioid use during pregnancy may cause physical dependence in the foetus, consequently leading to withdrawal symptoms in the neonate. Neonates exposed to codeine phosphate during labour may experience respiratory depression. additional caution should be exercised during the first and third trimester. Maternal tolerability should also be monitored as CYP2D6 ultra-rapid metabolisers could experience higher levels of active metabolites of codeine and consequently higher levels of foetal exposure.

Lactation

Paracetamol with codeine phosphate, doxylamine and caffeine is contraindicated during breastfeeding.

The manufacturer does not recommend using paracetamol with codeine phosphate, doxylamine and caffeine during breastfeeding.

Whilst available data indicates that paracetamol expressed in human breast milk, the quantity is not considered to be sufficient to cause adverse effects in the breastfeed infant.

The presence of doxylamine is human breast milk is unknown.

Caffeine is present in human breast milk, effects on the exposed infant are unknown.

Codeine phosphate is present in human breast milk at low doses and is unlikely to cause adverse effects in the breastfeed infant. However, if the mother has a CYP2D6 ultra-rapid metaboliser genotype, higher levels of the active metabolite of codeine, morphine, may be present in breast milk which may result in symptoms of opioid toxicity in the infant.

Side Effects

Addiction
Agranulocytosis
Anaphylactic shock
Angioedema
Anorexia
Arrhythmias
Blood disorders
Blurred vision
Bradycardia
Confusion
Constipation
Convulsions
Depression
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Dysuria
Extrapyramidal effects
Facial flushing
Facial oedema
Gastro-intestinal disturbances
Hallucinations
Headache
Hypersensitivity reactions
Hypotension
Increased frequency of micturition
Intestinal cramp
Involuntary muscle contractions
Irritability
Itching
Liver function disturbances
Malaise
Muscle rigidity
Nightmares
Palpitations
Pancreatitis
Paradoxical reactions
Psychomotor impairment
Rash
Respiratory depression
Restlessness
Sleep disturbances
Stomach cramp
Sweating
Thickening of bronchial secretions
Thrombocytopenia
Tiredness
Tremor
Urinary retention
Vertigo
Vomiting

Presentation

Oral formulation of paracetamol with codeine phosphate, doxylamine and caffeine.

Drugs List

Therapeutic Indications

Uses

Short term relief of moderate acute pain

Short term treatment of acute moderate pain such as headache, migraine, dysmenorrhoea, post-operative analgesia, when not relieved by paracetamol, ibuprofen or aspirin alone.

Dosage

Duration of treatment should be limited to 3 days.

Adults

Children

Contraindications

Children under 12 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Acute respiratory depression
Alcoholism
Breastfeeding
Chronic obstructive pulmonary disease
Galactosaemia
Head trauma
Pregnancy
Raised intracranial pressure

Precautions and Warnings

Children aged 12 to 18 years
Debilitation
Elderly
Predisposition to narrow angle glaucoma
Shock
Adrenal insufficiency
Benign prostatic hyperplasia
Biliary tract disorder
Cholelithiasis
CYP2D6 ultra-rapid metaboliser genotype
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of cardiac arrhythmias
History of drug misuse
History of seizures
Hypertension
Hypothyroidism
Lactose intolerance
Myasthenia gravis
Non-cirrhotic alcoholic liver disease
Peptic ulcer
Recent gastrointestinal surgery
Renal impairment
Sleep apnoea
Urinary retention

Advise patient ability to drive or operate machinery may be impaired
Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Avoid within 2 weeks of discontinuing a MAOI
Contains lactose
Contains sunset yellow (E110) - may cause allergic reaction
Some brands contain Quinoline Yellow (E104) : May cause allergic reactions
Can cause addiction
May cause respiratory depression
Monitor patient for signs and symptoms of respiratory depression
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Excessive use may increase frequency of headache, may require withdrawal
Neonate exposed in labour: Risk of respiratory depression
Overdosage causes liver damage
Seek urgent medical advice in event of overdose, even if patient feels well
May affect results of some laboratory tests
Maintain treatment for the shortest possible duration
Advise patient not to take paracetamol during treatment
Advise patient to avoid alcohol during treatment
Advise that alcohol increases the chances of liver damage with paracetamol
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose

Codeine should not be used in paediatric patients who are undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to the increased risk of adverse reactions.

Codeine is not recommended for use in children in whom respiratory function might be compromised (for example in neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures). These factors may worsen symptoms of morphine toxicity.

The long term use of codeine phosphate should be assessed regularly, considering the risks and benefits.

Patients with the CYP2D6 ultra-rapid metaboliser genotype may have an increased risk of developing side effects of opioid toxicity at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

Pregnancy and Lactation

Pregnancy

Paracetamol with codeine phosphate, doxylamine and caffeine is contraindicated during pregnancy.

The manufacturer does not recommend using paracetamol with codeine phosphate, doxylamine and caffeine during pregnancy and during labour.

Paracetamol is the analgesic of choice during pregnancy. It crosses the placenta, but in therapeutic doses appears safe for short term use. Prolonged exposure should be avoided. Caffeine crosses the placenta with foetal blood and tissue levels that are similar to maternal concentrations. When used in moderation, no association with congenital malformations, spontaneous abortions, preterm birth and low birth weight has been proven.

Codeine crosses the placenta along with it's active metabolites (which includes morphine). Codeine has been linked to congenital defects including respiratory malformations following first trimester exposure. Regular opioid use during pregnancy may cause physical dependence in the foetus, consequently leading to withdrawal symptoms in the neonate. Neonates exposed to codeine phosphate during labour may experience respiratory depression. additional caution should be exercised during the first and third trimester. Maternal tolerability should also be monitored as CYP2D6 ultra-rapid metabolisers could experience higher levels of active metabolites of codeine and consequently higher levels of foetal exposure.

Lactation

Paracetamol with codeine phosphate, doxylamine and caffeine is contraindicated during breastfeeding.

The manufacturer does not recommend using paracetamol with codeine phosphate, doxylamine and caffeine during breastfeeding.

Whilst available data indicates that paracetamol expressed in human breast milk, the quantity is not considered to be sufficient to cause adverse effects in the breastfeed infant.

The presence of doxylamine is human breast milk is unknown.

Caffeine is present in human breast milk, effects on the exposed infant are unknown.

Codeine phosphate is present in human breast milk at low doses and is unlikely to cause adverse effects in the breastfeed infant. However, if the mother has a CYP2D6 ultra-rapid metaboliser genotype, higher levels of the active metabolite of codeine, morphine, may be present in breast milk which may result in symptoms of opioid toxicity in the infant.

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). This medicine may be subject to police testing and has specified maximum blood levels for driving.
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.

Side Effects

Addiction
Agranulocytosis
Anaphylactic shock
Angioedema
Anorexia
Arrhythmias
Blood disorders
Blurred vision
Bradycardia
Confusion
Constipation
Convulsions
Depression
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Dysuria
Extrapyramidal effects
Facial flushing
Facial oedema
Gastro-intestinal disturbances
Hallucinations
Headache
Hypersensitivity reactions
Hypotension
Increased frequency of micturition
Intestinal cramp
Involuntary muscle contractions
Irritability
Itching
Liver function disturbances
Malaise
Muscle rigidity
Nightmares
Palpitations
Pancreatitis
Paradoxical reactions
Psychomotor impairment
Rash
Respiratory depression
Restlessness
Sleep disturbances
Stomach cramp
Sweating
Thickening of bronchial secretions
Thrombocytopenia
Tiredness
Tremor
Urinary retention
Vertigo
Vomiting

Effects on Laboratory Tests

Opioids have been shown to interfere with a number of laboratory tests including plasma amylase, bilirubin, alanine aminotranferase, lipase, alkaline phosphatase, lactate dehydrogenase and aspartate aminotransferase.
In addition opioids may interfere with hepatobiliary imaging which use technetium Tc 99m disofenin, and may also interfere with gastric emptying studies.

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: January 2023

Reference Sources

Summary of Product Characteristics: Syndol Film-coated Tablets. SANOFI Consumer Healthcare. Revised November 2021

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: 17 January 2023

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: 21 March 2022
Last accessed: 29 November 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Caffeine Last revised: 20 June 2022
Last accessed: 29 November 2022

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: 19 September 2022
Last accessed: 29 November 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Doxylamine Last revised: 20 September 2021
Last accessed: 29 November 2022