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Mesalazine oral enteric coated

Updated 2 Feb 2023 | Aminosalicylates


Enteric coated tablets of mesalazine.

Drugs List

  • mesalazine 1g gastro-resistant tablets
  • mesalazine 250mg gastro-resistant tablets
  • mesalazine 500mg gastro-resistant tablets
  • SALCROZINE 1g gastro-resistant tablets
  • SALCROZINE 500mg gastro-resistant tablets
  • SALOFALK 1g gastro-resistant tablets
  • SALOFALK 250mg gastro-resistant tablets
  • SALOFALK 500mg gastro-resistant tablets
  • Therapeutic Indications


    Crohn's disease - maintenance of remission
    Ulcerative colitis: induction of remission
    Ulcerative colitis: maintenance of remission


    The release characteristics of enteric-coated preparations of mesalazine vary and should not be considered interchangeable.

    Dosage should be individually determined on the clinical requirements of the patient.

    Dosage recommendations vary according to brand: consult product literature for more information.


    Ulcerative colitis
    Acute attack
    1.5g to 4g once daily or in divided doses.

    When using the highest dose (4g), the effect of the treatment should be evaluated at eight weeks.

    Maintenance of remission
    1.5g to 3g once daily or in divided doses.


    Children aged 6 to 18 years
    Ulcerative colitis
    Active disease: 30 to 50mg/kg/day in divided doses with a maximum dose of 75mg/kg/day. The total dose should not exceed 3g/day.
    Maintenance treatment: 15 to 30mg/kg/day in divided doses. The total dose should not exceed 1.5g/day.
    It is suggested that half the adult dose may be given to children up to a body weight of 40kg; and a normal adult dose to those above 40kg.

    In children below 40kg, it is preferable to use mesalazine preparations of lower strength.

    The following alternative dosing schedules may be suitable:

    Ulcerative colitis
    Acute attack in children aged 5 to 18 years and body-weight over 40kg: 0.5g to 1g three times daily.
    Acute attack in children aged 5 to 18 years and body-weight under 40kg: 10mg/kg to 20mg/kg three times daily.

    Maintenance of remission in children aged 5 to 18 years and body-weight over 40kg: 500mg three times daily.
    Maintenance of remission in children aged 5 to 18 years and body-weight under 40kg: 7.5mg/kg to 15mg/kg twice a day. Total dose may alternatively be given in 3 divided doses.


    Children under 5 years
    Haemorrhagic diathesis
    Renal impairment - glomerular filtration rate below 20ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Children aged 5 to 18 years
    Restricted sodium intake
    Duodenal ulcer
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of myocarditis
    History of pericarditis
    Lactose intolerance
    Peptic ulcer
    Pulmonary disease
    Renal impairment - glomerular filtration rate 20-50ml/minute

    Some formulations contain aspartame - caution in phenylketonuria
    Some formulations contain more than 1mmol (23mg) sodium per dose
    Not all available brands are licensed for all indications
    Not all available brands/formulations are licensed for use in children
    Restore electrolyte & fluid balance in case of dehydration
    Some formulations contain lactose
    Some formulations contain sucrose
    Delivery characteristics of e-c preps may vary and are not interchangeable
    Ensure patient has adequate fluid intake
    Blood counts should be performed before and periodically during treatment
    Monitor hepatic function before treatment and regularly during treatment
    Monitor renal function prior to initiating treatment
    Elderly: Monitor renal function and consider dose modification
    Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
    Monitor patients with bronchial asthma
    Monitor renal function especially during the initial phase of treatment
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Drug-induced cardiac hypersensitivity[myocarditis & pericarditis] may occur
    Suspect drug-induced nephrotoxicity if renal impairment occurs with therapy
    May affect results of some laboratory tests
    Discontinue if myocarditis or pericarditis occurs
    Discontinue if renal function deteriorates
    Discontinue if severe hypersensitivity reactions occur
    Discontinue if severe skin reaction occurs
    Discontinue immediately if suspicion of a blood dyscrasia
    Avoid concurrent use of lactulose
    Advise patients that empty tablet/capsule may be observed in stools

    Haematological investigations are generally recommended within 14 days of initiation of therapy and with 2 to 3 repeat tests at intervals of 4 weeks. If the results are normal, tests are recommended quarterly.

    The enteric coated tablet may be excreted undissolved in the stool in patients who have undergone bowel resection/bowel surgery in the ileocoecal region with removal of the ileocoecal valve, due to the excessively rapid intestinal passage.

    Pregnancy and Lactation


    Use mesalazine with caution during pregnancy.

    The manufacturers recommends mesalazine is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. One manufacturer states that blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in neonates of mothers being treated with mesalazine and recommends use with caution.

    Although mesalazine acts within the gastrointestinal tract, systemic absorption occurs with up to 50% of the dose being absorbed after oral administration.

    In inflammatory bowel disease, symptoms and activity are linked to pregnancy outcomes, active disease being associated with low birth weights, higher rates of spontaneous abortion, prematurity and perinatal complications. Most authors conclude that mesalazine does not further increase the risk of adverse pregnancy outcomes. There is one report of renal insufficiency in an infant exposed after long term use of a high dose (2g to 4g, orally) of mesalazine.

    Schaefer states that mesalazine is the drug of choice for chronic inflammatory bowel disease during pregnancy. Inflammatory markers and haematology should be monitored regularly. Dosage should be as required for optimal disease control.


    Use mesalazine with caution during breastfeeding.

    The manufacturer advises that mesalazine is excreted in breast milk in small quantities while its metabolite N-acetyl-5-aminosalicyclic acid is excreted in larger amounts. There have been a number of reported cases of diarrhoea in the nursing infant which were considered to be due to a possible hypersensitivity reaction. The manufacturer recommends that if the infant develops diarrhoea, breast feeding should be discontinued.

    Side Effects

    Abdominal distension
    Abdominal pain
    Abnormal liver function tests
    Allergic alveolitis
    Allergic lung reactions
    Aplastic anaemia
    Back pain
    Benign intracranial hypertension
    Bone marrow depression
    Bullous reactions
    Cholestatic hepatitis
    Discolouration of urine
    Drug fever
    Ear pain
    Elevated amylase levels
    Eosinophilic pneumonia
    Erythema multiforme
    Erythematous rash
    Exacerbation of colitis
    Facial oedema
    Fibrosing alveolitis
    Hepatic failure
    Hepatic impairment
    Hypersensitivity reactions
    Increase of liver transaminases
    Influenza-like syndrome
    Interstitial nephritis
    Interstitial pneumonia
    Lupus erythematosus-like syndrome
    Nephrotic syndrome
    Oligospermia (reversible)
    Peripheral neuropathy
    Pharyngolaryngeal pain
    Pulmonary eosinophilia
    Pulmonary infiltration
    Quincke's oedema
    Rectal disorders
    Renal failure
    Renal impairment
    Respiratory tract infection
    Serum bilirubin increased
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis


    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 2018

    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: Salcrozine 500mg gastro-resistant tablets. Faes Farma, S.A. Revised April 2022.
    Summary of Product Characteristics: Salcrozine 1000mg gastro-resistant tablets. Faes Farma, S.A. Revised March 2022.

    Summary of Product Characteristics: Salofalk 250mg tablets. Dr. Falk Pharma UK Ltd. Revised October 2017.
    Summary of Product Characteristics: Salofalk 500mg gastro-resistant tablets. Dr. Falk Pharma UK Ltd. Revised October 2017.
    Summary of Product Characteristics: Salofalk 1g gastro-resistant tablets. Dr Falk Pharma UK Ltd. Revised June 2018.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    NICE Evidence Services Available at: Last accessed: 7 October 2022.

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