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Paracetamol with ibuprofen oral

Updated 2 Feb 2023 | NSAIDs Paracetamol


Oral formulations of ibuprofen with paracetamol

Drugs List

  • NUROMOL 200mg + 500mg tablets
  • paracetamol 500mg and ibuprofen 200mg tablets
  • Therapeutic Indications


    Pain - mild to moderate



    One tablet to be taken up to three times a day. At least six hours should be left between doses.

    If one tablet does not control symptoms, a maximum of two tablets may be taken up to three times a day. At least six hours should be left between doses.

    No more than six tablets should be taken in any 24 hour period.


    One tablet to be taken up to three times a day. At least six hours should be left between doses.

    If one tablet does not control symptoms, a maximum of two tablets may be taken up to three times a day. At least six hours should be left between doses.

    No more than six tablets should be taken in any 24 hour period.


    Children under 18 years
    Predisposition to haemorrhage
    Gastrointestinal ulcer
    History of gastrointestinal haemorrhage secondary to NSAID
    History of gastrointestinal ulceration
    Severe cardiac failure
    Severe hepatic impairment
    Severe renal impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Allergic disposition
    Fluid retention
    Patients over 65 years
    Cardiac impairment
    Cerebrovascular disorder
    Congestive cardiac failure
    Connective tissue disorder
    Crohn's disease
    First trimester of pregnancy
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of asthma
    History of cardiac failure
    History of gastrointestinal disorder
    Ischaemic heart disease
    Lactose intolerance
    Left ventricular dysfunction
    Non-cirrhotic alcoholic liver disease
    Renal impairment
    Second trimester of pregnancy
    Systemic lupus erythematosus
    Ulcerative colitis

    NSAIDs may provoke or exacerbate asthma
    Advise ability to drive/operate machinery may be affected by side effects
    Some formulations contain lactose
    Discontinue if signs of gastro-intestinal bleeding occur
    Elderly - monitor for gastro-intestinal bleeding over initial 4 weeks
    If visual disturbances occur, perform ophthalmic evaluation
    May inhibit platelet aggregation - observe for signs of bleeding
    Monitor blood pressure in hypertensive patients
    Monitor patients with cardiovascular conditions
    Monitor renal function in patients with risk factors for renal impairment
    Advise patients to report signs or symptoms of gastro-intestinal ulcer
    Discontinue if signs of gastro-intestinal ulceration occur
    May prolong bleeding time
    Overdosage causes liver damage
    Seek urgent medical advice in event of overdose, even if patient feels well
    Discontinue treatment if skin rash or other allergic reaction occurs
    Maintain treatment at the lowest effective dose
    Start treatment at lowest recommended dose
    Maintain treatment for the shortest possible duration
    Only recommended for short term use
    May cause impaired fertility
    Advise patients to report skin rash
    Consult doctor if symptoms persist or treatment is required for > 3 days

    Pregnancy and Lactation


    Paracetamol with ibuprofen is contraindicated in the third trimester of pregnancy and should be used with caution in the first and second trimester.

    At the time of writing there is limited published information regarding the use of paracetamol with ibuprofen in humans during pregnancy.

    Schaefer (2015) states that paracetamol does cross the placenta, however due to the drugs analgesic and antipyretic properties, it is the preferred drug of choice to use in pregnancy. Briggs (2015) states teratogenic potential in humans was initially suspected, along with an association with gastroschisis, reduction in proportion of preterm birth, possible causative factor for asthma and elevated IgE levels but subsequent investigations have indicated no developmental risk. Commonly used in all stages of pregnancy therapeutic doses in short-term is deemed safe, while routine use should be avoided

    NSAIDs have been associated with spontaneous abortions and congenital abnormalities, although no teratogenic effects have been demonstrated in animal experiments (Briggs et al, 2015). Schaefer (2015) states that therapeutic doses of NSAIDs within the third trimester of pregnancy are associated with a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension as well as delaying the onset of labour but increasing the duration with an increased bleeding tendency in both mother and child.

    The manufacturer recommends paracetamol with ibuprofen should be avoided in the first six months of pregnancy, unless the potential benefit to the patient outweighs the potential risk to the foetus, and contraindicated in the last three months of pregnancy due to insufficient data regarding the safety of ibuprofen during pregnancy.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use paracetamol with ibuprofen with caution in breastfeeding.

    At the time of writing there is limited published information regarding the use of ibuprofen during breast feeding. Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breast fed infant adversely. Because of its extremely low levels in breast milk and short half life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers.

    Paracetamol is excreted into human breast milk in low concentrations that it is not considered harmful, it belongs to the group of analgesic drugs of choice during breastfeeding.

    Hale (2014) and Schaefer (2015) state that paracetamol and ibuprofen are the drugs of choice when treating pain and requires no limitation of breastfeeding, but continuous treatment should be avoided. Adverse effects in breastfed infants appear to be rare (Briggs et al, 2015). The manufacturer recommends that it is not necessary to interrupt breastfeeding for short term treatment at the recommended dose.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Abnormal liver function
    Allergic reaction
    Altered liver function tests
    Aplastic anaemia
    Aseptic meningitis
    Cardiac failure
    Erythema multiforme
    Exacerbation of colitis
    Exacerbation of Crohn's disease
    Exfoliative dermatitis
    Facial swelling
    Fluid retention
    Gamma glutamyl transferase (GGT) increased
    Gastric discomfort
    Gastro-intestinal haemorrhage
    Gastro-intestinal perforation
    Haemolytic anaemia
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increase in blood urea or creatinine
    Increased platelet count
    Interstitial nephritis
    Myocardial infarction
    Nephrotic syndrome
    Optic neuritis
    Peptic ulceration
    Pulmonary eosinophilia
    Renal failure
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Ulcerative stomatitis
    Visual disturbances


    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 represented below:

    Liver damage is possible in patients who have taken 75mg/kg or more of paracetamol in less than an hour, and these patients should be referred to hospital. To avoid underestimating the potentially toxic paracetamol dose ingested by obese patients who weigh more than 110kg, a bodyweight of 110kg (rather than the actual bodyweight) should be used to calculate the total dose of paracetamol ingested in mg/kg.

    Signs and Symptoms

    Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.


    Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

    Treatment with activated charcoal should be considered if the overdose in excess of 150mg/kg has been taken within 1 hour. Treatment with acetylcysteine is used up to, and possibly beyond, 24 hours of ingesting paracetamol. It is most effective if given within 8 hours of ingestion, after which effectiveness declines. If required, the patient should be given intravenous acetylcysteine, in line with the established dosage schedule. Giving acetylcysteine by mouth (unlicensed route) is an alternative if intravenous access is not possible. Acetylcysteine can be given irrespective of the plasma paracetamol concentration:
    in circumstances where the overdose is staggered or there is doubt over the time of paracetamol ingestion; or
    in overdose with a timed plasma paracetamol concentration on or above a single treatment line joining points of 100mg/L at 4 hours and 15mg/L at 15 hours nomogram (, regardless of risk factors of hepatotoxicity.

    Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentration are unreliable). If vomiting is not a problem, and overdose has been taken within 10-12 hours, oral methionine may be a suitable alternative for remote areas outside hospital. Management of patients who present beyond 24 hours from ingestion or with serious hepatic dysfunction should be discussed with the NPIS ( or a liver unit.

    Further Information

    Last Full Review Date: November 2016

    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.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 10 November 2016.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Nuromol 200 mg/500 mg tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised November 2011.

    Summary of Product Characteristics: Combogesic 500 mg/125 mg film coated tablets. Thornton & Ross Ltd. Revised November 2014.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Last revised: 04 February 2016
    Last accessed: 10 November 2016

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Last revised: 04 February 2016
    Last accessed: 10 November 2016

    MHRA 10th September 2012
    Last accessed: September 20, 2012

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