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Naldemedine tablets

Drugs List

  • naldemedine 200microgram tablets
  • RIZMOIC 200microgram tablets
  • Therapeutic Indications


    Treatment of opioid-induced constipation

    Treatment of opioid-induced constipation (OIC) in patients who have been previously been treated with a laxative.



    200 micrograms daily.

    Take at the same time each day. Naldemedine must be discontinued if treatment with the opioid pain medicinal product is discontinued.


    Children under 18 years
    Predisposition to gastrointestinal perforation
    Suspected gastrointestinal obstruction
    Gastrointestinal obstruction
    Gastrointestinal perforation
    Severe hepatic impairment

    Precautions and Warnings

    Patients over 75 years
    Advanced Alzheimer's disease
    Brain neoplasm
    Central nervous system metastasis
    Crohn's disease
    Gastrointestinal malignancy
    Multiple sclerosis
    Ogilvie's syndrome
    Peptic ulcer
    Severe renal impairment
    Within 3 months of a cerebrovascular accident
    Within 3 months of a myocardial infarction

    Advise patient to stop and contact Dr if severe/persistent abdominal pain
    Discontinue if severe abdominal symptoms develop
    If opioid withdrawal occurs, discontinue treatment and contact physician
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid grapefruit products

    Patients that experience blood-brain barrier disruptions may be at increased risk of opioid withdrawal or reduced analgesia. A risk assessment prior to treatment and close monitoring should be considered in these patients.

    Pregnancy and Lactation


    Use naldemedine with caution during pregnancy.

    The manufacturer does not recommend using naldemedine during pregnancy unless the clinical condition of the woman requires treatment. At the time of writing there is limited published information regarding the use of naldemedine during pregnancy. The use of naldemedine during pregnancy may cause opiod withdrawal in the foetus due to the immature foetal blood brain barrier. Potential risks are unknown.


    Naldemedine is contraindicated during breastfeeding.

    Use of naldemedine when breastfeeding is contraindicated by the manufacturer. It is unknown whether naldemedine or its metabolites are excreted in human milk. Animal data reports significant levels of naldemedine in the breast milk. The effects on exposed infants are unknown.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Gastro-intestinal perforation
    Hot flushes
    Hypersensitivity reactions
    Increased lacrimation
    Opioid withdrawal syndrome
    Sensation of cold


    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: June 2021

    Reference Sources

    Summary of Product Characteristics: Rizmoic 200micrograms film-coated tablets. Shionogi. Revised January 2020.

    NICE Evidence Services Available at: Last accessed: 23 June 2021

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.