This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Norethisterone oral high strength


Tablets containing norethisterone 5 mg

Drugs List

  • norethisterone 5mg tablets
  • PRIMOLUT N 5mg tablets
  • UTOVLAN 5mg tablets
  • Therapeutic Indications


    Disseminated carcinoma of breast
    Dysfunctional uterine bleeding
    Dysmenorrhoea (adjunctive treatment)
    Menstruation - postponement of
    Metropathia haemorrhagica
    Premenstrual syndrome

    Unlicensed Uses

    Sexual maturation in females: induction and maintenance of



    Dysfunctional uterine bleeding (menorrhagia and polymenorrhoea)
    5mg three times daily for ten days.
    5mg twice daily from 19th to the 26th day of each subsequent cycle to prevent recurrence.

    Metropathia haemorrhagica
    5mg three times daily for ten days. Bleeding usually stops within one to three days. A withdrawal bleed resembling normal menstruation occurs within two to four days after discontinuing treatment.

    Premenstrual syndrome (including premenstrual mastalgia)
    5mg daily from days 16 to 25 of the cycle to relieve symptoms such as headache, migraine, breast discomfort, water retention, tachycardia and psychological disturbances. Treatment should be repeated for several cycles.
    When treatment is stopped, the patient may remain asymptomatic for a number of months.

    Postponement of menstruation
    In special circumstances (e.g. surgical treatment, travel, sports) or in cases of too frequent menstrual bleeding, 5mg three times daily starting three days before the expected onset of menstruation will postpone onset. A normal period should occur two to three days after the patient has stopped taking the tablets.

    Endometriosis (pseudo-pregnancy treatment)
    Treatment should begin between the 1st and 5th day of the cycle with 5mg three times daily. In the event of 'spotting' bleeding, the dose is increased to 10mg twice daily. If bleeding ceases, dose reduction to the initial dose should be considered. Continue treatment for four to six months continuously or longer, if necessary. With uninterrupted daily intake, ovulation and menstruation do not usually occur.

    High dose treatment of disseminated carcinoma of the breast
    40mg per day increasing to 60mg if no regression is noted.


    Induction and maintenance of sexual maturation in females (unlicensed)
    5mg once daily for the last seven days of a 28-day cycle. Give with an oestrogen, after receiving twelve to eighteen months of oestrogen therapy.

    Postponement of menstruation (unlicensed)
    Three days before expected onset of menstruation, give 5mg three times daily.


    Breast neoplasms - unless for treatment
    Deep vein thrombosis
    Diabetes mellitus with vascular involvement
    Endometrial hyperplasia
    Familial conjugated hyperbilirubinaemias
    Female genital neoplasms - unless for treatment
    Focal migraine
    Hepatic neoplasm
    History of cholestatic jaundice during pregnancy
    History of hepatic neoplasm
    History of herpes gestationis
    History of pruritus during pregnancy
    History of severe arterial disorder
    History of venous thromboembolism
    Pulmonary embolism
    Severe arterial disorder
    Severe hepatic impairment
    Thromboembolic disorder
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Body mass index above 30kg per square metre
    Family history of venous thromboembolism
    History of recurrent spontaneous abortion
    Major surgery
    Prolonged immobilisation
    Severe trauma
    Cardiac impairment
    Diabetes mellitus
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    History of chloasma
    History of depression
    History of thromboembolic disorder without anticoagulant therapy
    Lactose intolerance
    Renal impairment
    Sickle cell disease

    Not all available brands are licensed for all indications
    If intra-abdominal haemorrhage consider liver tumour
    If upper abdominal complaints/liver enlargement consider liver tumour
    Monitor blood glucose closely in patients with diabetes mellitus
    Increased risk of VTE during travel involving >5hr immobilisation
    May induce or enhance hepatic tumour development
    Discontinue 4 - 6 weeks before major surgery
    Advise patient to seek advice at first indications of pregnancy
    Discontinue at first signs of jaundice, hepatitis or whole body itching
    Discontinue at first signs of thrombophlebitis or thromboembolism
    Discontinue if epilepsy is exacerbated
    Discontinue if pain or tightness in chest
    Discontinue if significant rise in blood pressure occurs
    Discontinue if sudden occurrence of visual/hearing/perceptual disorders
    Discontinue-first occurrence/worsening migraine/severe or frequent headache
    Advise patient not to take St John's wort concurrently
    Changes in menstrual bleeding patterns should be expected

    Norethisterone is partly metabolised to ethinylestradiol after oral administration or norethisterone or norethisterone acetate in humans. This conversion results in an equivalent dose of about of about 4 to 6 micrograms ethinylestradiol per 1 mg orally administered norethisterone or norethisterone acetate.

    Pregnancy and Lactation


    Use during pregnancy is contraindicated.

    Virilisation in females and hypospadias in males has been reported in the offspring of mothers who have received norethisterone 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 during lactation should be avoided as norethisterone is present in breast milk.

    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

    "Spotting" bleeding
    Abdominal pain
    Allergic skin reactions
    Altered serum lipid profile
    Anaphylactoid-like reaction
    Benign hepatic adenomata
    Breakthrough bleeding
    Breast discomfort
    Breast enlargement
    Breast tenderness
    Cerebral dysfunction
    Cervical erosion
    Changes in cervical secretion
    Changes in libido
    Cholestatic liver changes
    Concentration difficulties
    Congestive cardiac failure
    Cushing's syndrome
    Decreased glucose tolerance
    Diabetic cataract
    Disturbances of appetite
    Dry mouth
    Exacerbation of diabetes
    Exacerbation of epilepsy
    Fine tremor (usually hands)
    Fluid retention
    Hypersensitivity reactions
    Increased fasting blood glucose
    Intolerance to contact lenses
    Liver function disturbances
    Menstrual disturbances
    Myocardial infarction
    Ovarian cysts
    Premenstrual symptoms
    Prolonged anovulation
    Pulmonary embolism
    Retinal vascular thrombosis
    Visual disturbances
    Weight gain

    Further Information

    Last Full Review Date: June 2013

    Reference Sources

    Summary of product characteristics: Norethisterone tablets. Wockhardt UK Ltd. Revised February 2017.
    Summary of Product Characteristics: Primolut N. Bayer plc. Revised May 2017.
    Summary of Product Characteristics: Utovlan Tablets. Pharmacia Limited. Revised February 2018.

    NICE Evidence Services Available at: Last accessed: 13 September 2017

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

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

    FDB Logo

    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.