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Ibuprofen and codeine tablets

Updated 2 Feb 2023 | Opioid analgesics NSAIDs


Oral formulations of ibuprofen and codeine phosphate.

Drugs List

  • ibuprofen 200mg and codeine 12.8mg tablets
  • NUROFEN PLUS tablets
  • Therapeutic Indications


    Pain - mild to moderate

    Symptomatic relief of mild to moderate pain in such conditions as:
    Soft tissue injuries
    Musculo-tendinous conditions
    Non-serious arthritic and rheumatic conditions

    Also for the relief of mild to moderate pain in:
    Dental pain

    The MHRA advises that these products should only be used for the short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.


    Advise patients not to take treatment for more than 3 days continuously without medical review.
    The minimum effective dose should be used for the shortest time necessary to relieve symptoms.


    1 or 2 tablets every four to six hours.
    Not more than 6 tablets should be taken in 24 hours.


    Children 12 years and over:
    1 or 2 tablets every four to six hours.
    Not more than 6 tablets should be taken in 24 hours.


    Children under 12 years
    Risk of paralytic ileus
    Acute asthma
    Chronic constipation
    Chronic obstructive pulmonary disease
    CYP2D6 ultra-rapid metaboliser genotype
    Head trauma
    History of gastrointestinal haemorrhage secondary to NSAID
    History of peptic ulcer
    Peptic ulcer
    Raised intracranial pressure
    Severe cardiac failure
    Severe hepatic impairment
    Severe renal impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Acute abdomen
    Within 2 weeks of discontinuing MAOIs
    Adrenal insufficiency
    Benign prostatic hyperplasia
    Biliary tract disorder
    Cardiac arrhythmias
    Cardiac impairment
    Connective tissue disorder
    CYP2D6 poor metaboliser genotype
    First trimester of pregnancy
    Gastrointestinal disorder
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    History of asthma
    History of cardiac failure
    History of drug misuse
    History of gastrointestinal disorder
    Inflammatory bowel disease
    Lactose intolerance
    Myasthenia gravis
    Renal impairment
    Respiratory impairment
    Second trimester of pregnancy
    Systemic lupus erythematosus

    Children under 18 years: Increased risk of rare and severe adverse effects
    May precipitate bronchospasm in patients with asthma or allergy
    NSAIDs may provoke or exacerbate asthma
    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
    Determine CYP2D6 metaboliser status before initiation of treatment
    Some formulations contain lactose
    Can cause addiction
    Discontinue if signs of gastro-intestinal bleeding occur
    Monitor patients receiving concurrent anticoagulants
    Monitor renal function in patients with renal impairment
    Advise patient to report any abdominal or pelvic pain
    Discontinue if signs of gastro-intestinal ulceration occur
    Excessive use may increase frequency of headache, may require withdrawal
    May cause dependence
    Withdrawal symptoms after long-term normal use on abrupt cessation
    Discontinue treatment if gastrointestinal perforation occurs
    Discontinue treatment if skin rash or other allergic reaction occurs
    Maintain treatment at the lowest effective dose
    Reduce dose in elderly
    For three days use only
    May cause impaired fertility
    Discontinue and consult a doctor if there is no improvement within 3 days

    History of gastrointestinal toxicity, particularly in elderly patients - advise patients to report any unusual abdominal symptoms, particularly in initial stages of treatment.

    Gastro-intestinal bleeding, ulceration or perforation, possibly fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. If gastro-intestinal bleeding or ulceration occurs, treatment should be withdrawn.

    Anticoagulant therapy - prothrombin time should be monitored daily for the first few days of combined treatment.

    Use with caution in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

    Ultra-rapid metabolisers (CYP2D6 genotype), convert codeine into its active metabolite, morphine, more rapidly and completely than other people, resulting in higher than expected serum morphine levels. Even at labelled dosage regimens, overdose symptoms such as extreme sleepiness, confusion or shallow breathing can occur.

    Codeine should not be used in children under 18 years who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions including death.

    Use with caution in renal, hepatic or cardiac impairment. In patients with renal impairment, renal function should be monitored since it may deteriorate following the use of any NSAID.

    Patients should be advised to consult their doctor if the medicine is needed for longer periods in higher doses than recommended, and if stopping the medicine makes them feel unwell but they feel better when they start taking it again.

    May cause impairment of female fertility via an effect on ovulation, which is reversible upon withdrawal of treatment.

    Use of ibuprofen may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

    Serious and potential fatal skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs. Higher risk of these reactions appears to be early in the treatment, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen and codeine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

    Pregnancy and Lactation


    Ibuprofen and codeine is contraindicated during the third trimester of pregnancy but may be used with caution during the first and second trimester.

    The manufacturer does not recommend using ibuprofen and codeine during pregnancy. Ibuprofen is contraindicated during the third trimester as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. Labour onset may be delayed and its duration increased, with an increased bleeding tendency in both mother and child.

    Codeine has been associated with neonatal respiratory depression and withdrawal. There is also the risk of gastric stasis and inhalation pneumonia in the mother during labour.


    Use ibuprofen and codeine with caution during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking ibuprofen and codeine. Both ibuprofen and codeine are secreted in breast milk at a very low concentration that is unlikely to adversely affect the breast fed 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). 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.


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

    Patients should be advised to use the lowest effective dose for the shortest duration necessary to control symptoms.

    Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.

    Patients should be warned that taking codeine regularly for a long time can lead to addiction, and hence to feeling restless and irritable upon discontinuation.

    Patients should be warned that taking a painkiller for headaches too often or for too long can make them worse.

    Side Effects

    Abdominal pain
    Aggravation of existing asthma
    Allergic reaction
    Aseptic meningitis
    Biliary spasm
    Blood disorders
    Bullous reactions
    Cardiac failure
    Cough suppression
    Dry mouth
    Epidermal necrolysis
    Erythema multiforme
    Exacerbation of Crohn's disease
    Facial oedema
    Gastro-intestinal discomfort
    Gastrointestinal bleeding
    Hearing disturbances
    Hepatic damage
    Hepatic impairment
    Hypersensitivity reactions
    Laryngeal swelling
    Micturition disorders
    Mood changes
    Muscle rigidity
    Ocular changes
    Papillary necrosis
    Peptic ulceration
    Postural hypotension
    Pulmonary eosinophilia
    Renal failure
    Respiratory depression
    Sexual dysfunction
    Sleep disturbances
    Stevens-Johnson syndrome
    Tongue oedema
    Toxic epidermal necrolysis
    Ulcerative colitis
    Ulcerative stomatitis
    Ureteric spasm
    Urinary retention
    Visual disturbances
    Withdrawal symptoms


    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 ( ).

    The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is attached below for codeine :

    The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

    Signs and Symptoms

    Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.


    This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

    Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

    Further Information

    Last Full Review Date: August 2012

    Reference Sources

    Summary of Product Characteristics: Nurofen Plus. Reckitt Benckiser Healthcare (UK) Ltd. Revised January 2011.

    Summary of Product Characteristics: Solpadeine Migraine Ibuprofen & Codeine tablets. Solpaflex. Cuprofen PLUS. Omega Pharma Ltd. Revised December 2015. 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: 18 September 2020

    MHRA 22nd January 2007
    Last accessed: February 6, 2009

    MHRA Drug Safety Update: Volume 3, Issue 2, September 2009. Over-the-counter painkillers containing codeine or dihydrocodeine.
    Last accessed November 6, 2009

    MHRA 2nd September 2009. Updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC).
    Last accessed November 6, 2009

    MHRA 16th October 2009. Guidance on the development of artwork in relation to medicines containing codeine and dihydrocodeine.
    Last accessed November 6, 2009
    New drug driving offence: implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 18 September 2020.

    NICE Evidence Services Available at: Last accessed: 18 September 2020

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