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Paracetamol with codeine and caffeine oral


Oral formulations containing paracetamol, codeine phosphate and caffeine.

Drugs List

  • CODASOLVE 8mg + 500mg + 30mg effervescent tablet
  • SOLPADEINE MAX soluble tablet
  • SOLPADEINE PLUS capsules
  • SOLPADEINE PLUS soluble tablet
  • ULTRAMOL soluble tablet
  • VEGANIN tablets
  • Therapeutic Indications


    Moderate pain: acute treatment

    Short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.


    The quantity of paracetamol, codeine and/or caffeine in each tablet/capsule/effervescent tablet is not consistent for all brands.
    The recommended dose schedule remains the same for all products. As such, switching between different brands may cause changes in analgesic effect and/or the occurrence side effects. Where this cannot be avoided, adjust the dose according to response.


    One or two tablets/capsules/effervescent tablets every 4 to 6 hours, if required.
    Maximum of eight tablets/capsules/effervescent tablets in 24 hours.
    Maximum treatment duration of 3 days.


    Children aged 12 to 18 years
    One or two tablets/capsules/effervescent tablets every 6 hours if required.
    Maximum of eight tablets/capsules/effervescent tablets in 24 hours.
    Maximum treatment duration of 3 days.

    Alternative dose schedules
    Some manufacturers recommend a dose frequency of every 4 to 6 hours.
    Due to reports of toxicity following the use of codeine in children the MHRA (2013) recommend a minimum dose interval of 6 hours.

    Children aged 12 to 16 years:
    Some manufacturers recommend a reduced dose schedule in this patient group of:
    One tablet/capsule/effervescent tablet every 6 hours if required.
    Maximum of four tablets/capsules/effervescent tablets in 24 hours.
    Maximum treatment duration of 3 days.


    Acute alcohol intoxication
    Children under 12 years
    Risk of paralytic ileus
    Acute asthma
    Chronic obstructive pulmonary disease
    CYP2D6 ultra-rapid metaboliser genotype
    Head trauma
    Raised intracranial pressure
    Respiratory depression

    Precautions and Warnings

    Acute abdomen
    Restricted sodium intake
    Within 2 weeks of discontinuing MAOIs
    Adrenal insufficiency
    Benign prostatic hyperplasia
    Biliary tract disorder
    Cardiac arrhythmias
    Cardiogenic shock
    CYP2D6 poor metaboliser genotype
    Gall bladder disorder
    Gastrointestinal obstruction
    Hepatic impairment
    Hereditary fructose intolerance
    History of drug misuse
    Inflammatory bowel disease
    Myasthenia gravis
    Non-cirrhotic alcoholic liver disease
    Renal impairment
    Respiratory impairment

    Children under 18 years: Increased risk of rare and severe adverse effects
    Sodium content of effervescent preparation may be significant
    Some formulations contain aspartame - caution in phenylketonuria
    Advise ability to drive/operate machinery may be affected by side effects
    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
    Can cause addiction
    Tolerance and dependence may occur
    Excessive use may increase frequency of headache, may require withdrawal
    Overdosage causes liver damage
    Seek urgent medical advice in event of overdose, even if patient feels well
    Withdraw gradually after long-term use
    Avoid prolonged use
    For three days use only
    Avoid excessive intake of tea, coffee or other stimulants
    Consult doctor if symptoms persist or treatment is required for > 3 days
    Patients should not exceed recommended dose

    Products containing codeine must not be used in children under 18 years who are undergoing the removal of tonsils or adenoids for obstructive sleep apnoea syndrome due to an increased risk of life-threatening adverse events including death.

    Products containing codeine are not recommended in children whose breathing may be compromised (including neuromuscular disorders, severe cardiac or respiratory conditions, respiratory infections, multiple trauma or extensive surgical procedures). These factors may worsen symptoms of opiate toxicity.

    Pregnancy and Lactation


    Use paracetamol with codeine and caffeine with caution during pregnancy.

    The manufacturer recommends that paracetamol with codeine and caffeine should be avoided during pregnancy.

    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). Human data is limited but animal studies have not shown any hazard. Codeine has been linked to congenital defects including respiratory malformations following first trimester exposure. Codeine has been suggested as an option for short term use where paracetamol alone is ineffective. Use during the later stages of pregnancy does pose a risk of respiratory depression and withdrawal symptoms so any use during this period should be at low doses for short periods. As such, the largest risk of using the combined preparations lies with the codeine component. The quantity of codeine contained within available preparations is small so with short term use (3 days) the risk is likely to be low. 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.


    Paracetamol with codeine and caffeine is contraindicated during breastfeeding.

    Use of paracetamol with codeine and caffeine is contraindicated by the manufacturer.

    At the time of writing there is limited published information regarding the use of paracetamol with codeine and caffeine during breastfeeding.

    Paracetamol passes into the breast milk but exposure is well tolerated (Lactmed, 2018).

    Data on individual components describes potential risks with exposure to codeine. Codeine itself is generally well tolerated but reports of CNS depression (including lethargy, apnoea and death) have raised concerns. In some of these cases, mothers have been identified as CYP2D6 ultra-rapid metabolisers. This condition results in higher maternal levels of active metabolites (including morphine) which pass into the breast milk and increase the infant's exposure. Following these reports, in 2013 the MHRA issued an alert advising against the use of codeine during breastfeeding.

    Caffeine passes into the breast milk in variable amounts but exposure at normal doses (up to 300mg) is well tolerated. Accumulation of caffeine can develop in exposed preterm or newborn infants due to immature hepatic metabolism pathways requiring additional caution. High caffeine exposure causes irritability, restlessness and disturbed sleep patterns.

    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.

    Side Effects

    Abdominal pain
    Allergic reaction
    Biliary spasm
    Blood dyscrasias
    Blurred vision
    Difficulty in micturition
    Double vision
    Dry mouth
    Facial flushing
    Facial oedema
    Fixed drug eruption
    Fluid and electrolyte disturbances
    Gastro-intestinal symptoms
    Hepatic damage
    Hypersensitivity reactions
    Mood changes
    Muscle rigidity
    Muscle twitch
    Postural hypotension
    Reduced libido
    Reduction of male potency
    Renal damage
    Respiratory depression
    Sexual dysfunction
    Stevens-Johnson syndrome
    Stomach pain
    Toxic epidermal necrolysis
    Ureteric spasm
    Urinary retention


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2020.

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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: Codasolve 8mg/500mg/30mg Effervescent Tablets. Kent Pharma UK Limited. Revised June 2020.
    Summary of Product Characteristics: Solpadeine Plus soluble tablets. Omega Pharma Ltd. Revised December 2016.
    Summary of Product Characteristics: Solpadeine Plus tablets. Omega Pharma Ltd. Revised July 2018.
    Summary of Product Characteristics: Solpadeine Plus capsules. Omega Pharma Ltd. Revised January 2017.
    Summary of Product Characteristics: Solpadeine Max Soluble Tablets. Omega Pharma Ltd. Revised December 2016.
    Summary of Product Characteristics: Syndol Headache Relief Tablets. Zebtiva. Revised February 2017.
    Summary of Product Characteristics: Ultramol soluble tablets. Sanofi. Revised May 2020.
    Summary of Product Characteristics: Veganin caplets. Omega Pharma Ltd. Revised July 2018.

    EMA 28th June 2013. Restrictions on the use of codeine for pain relief in children - CMDh endorses PRAC recommendation.
    Last accessed: 03 November 2017. 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: Last accessed: 15 June 2020.

    MHRA 2nd September 2009. Updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC).
    Archived site - content added on 05 December 2014.
    Last accessed: 03 November 2017.

    NICE Evidence Services. Available at: Last accessed: 15 June 2020.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Acetaminophen. Last revised: 31 October 2018.
    Caffeine. Last revised: 30 June 2019.
    Codeine. Last revised: 15 June 2020.
    Last accessed: 29 July 2020.

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