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Dienogest oral

Updated 2 Feb 2023 | Progestogens


Oral formulations of dienogest.

Drugs List

  • dienogest 2mg tablets
  • DIMETRUM 2mg tablets
  • ZALKYA 2mg tablets
  • Therapeutic Indications


    Treatment of endometriosis

    Treatment of endometriosis post menarche



    One tablet to be taken daily at the same time each day. Tablet taking is continuous without regard to vaginal bleeding.

    Dienogest can be started on any day of the menstrual cycle.

    Each subsequent pack is to be started the day after the last tablet of the previous pack.

    There is no experience in treatment with dienogest after 15 months in patients with endometriosis.


    Dienogest is not indicated in children prior to menarche.

    Additional Dosage Information

    Missed tablets
    If the patient misses one or more tablets, a tablet should be taken immediately and continue the next dose on the next day at the usual time.

    If vomiting or diarrhoea occurs within 3 to 4 hours of taking a tablet, another tablet should be taken immediately and continue the next dose on the next day at the usual time.


    Abnormal liver function test
    Cardiovascular disorder
    Diabetes mellitus with vascular involvement
    Hepatic neoplasm
    History of hepatic neoplasm
    History of severe arterial disorder
    Hormone dependent neoplasm
    Severe arterial disorder
    Severe hepatic disorder
    Undiagnosed uterine bleeding
    Venous thromboembolism

    Precautions and Warnings

    Children under 18 years
    History of ectopic pregnancy
    Predisposition to thromboembolic disease
    Prolonged immobilisation
    Recent surgery
    Recent trauma
    Risk of uterine bleeding
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    History of chloasma
    History of cholestatic jaundice during pregnancy
    History of severe depression
    Lactose intolerance
    Post partum
    Severe depression
    Uterine bleeding

    May decrease glucose tolerance in patients with diabetes mellitus
    Assess family medical history prior to commencing treatment
    Discontinue hormonal contraception before treatment initiation
    Exclude oestrogen dependent neoplasm before treatment
    Some formulations contain lactose
    Measure bone density in at risk patients prior to therapy
    Perform a complete physical and gynaecological examination before therapy
    Abnormal and/or irregular bleeding should be investigated
    If intra-abdominal haemorrhage consider liver tumour
    If pregnancy occurs possibility of ectopic pregnancy should be considered
    If upper abdominal complaints/liver enlargement consider liver tumour
    May induce insulin resistance
    Monitor patient for signs and symptoms of depression
    Advise patient of thromboembolic symptoms and to report them if they occur
    Advise patient to report any new or worsening depression/suicidal ideation
    Vomiting or severe diarrhoea may impair efficacy
    May affect results of some laboratory tests
    Discontinue prior to surgery: increased risk of thrombosis
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if cholestatic jaundice occurs
    Discontinue if depression worsens or recurs
    Discontinue if hypertension develops
    Discontinue if thromboembolism occurs
    Advise patient not to take St John's wort concurrently
    Female: Not for contraception.Use non-hormonal contraception, if required
    Changes in menstrual bleeding patterns should be expected
    Women with a history of chloasma should avoid exposure to sun/UV light

    For long term immobilisation, discontinuing the use of dienogest is advisable. For elective surgery, discontinuation of dienogest should be at least four weeks in advance. Restarting treatment after two weeks of complete remobilisation.

    Serious uterine bleeding
    Uterine bleeding may be aggravated when taking dienogest, for example, in women with adenomyosis uteri or uterine leiomyomata. Heavy, continuous bleeding may lead to severe anaemia in some case. Discontinuation of dienogest should be considered in the event of anaemia.

    Cholestatic jaundice and/or pruritus
    Discontinue dienogest upon recurrence of cholestatic jaundice and/or pruritus, which occurred first during pregnancy or previous use of sex steroids.

    Persistent ovarian follicles
    Persistent ovarian follicles may occur during treatment with dienogest. Most follicles are asymptomatic, however, some follicles may be accompanied by pelvic pain.

    Use of dienogest in children aged 12 to 18 years old over a treatment period of 12 months was associated with decreased bone mineral density. Patients who are at an increased risk of osteoporosis should have a risk-benefit assessment performed before starting dienogest.

    Pregnancy and Lactation


    Dienogest is contraindicated during pregnancy.

    Manufacturer advises there is no need to treat endometriosis during pregnancy. There is no indication in animal studies that dienogest has direct or indirect harmful effects with respect to reproductive toxicity.


    Dienogest is contraindicated during breastfeeding.

    Manufacturer advises that a decision on whether to discontinue breastfeeding or to abstain from dienogest treatment should be made. This should take into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. Animal data reports dienogest is excreted in breast milk however presence in human breast milk is unknown.

    Side Effects

    "Spotting" bleeding
    Abdominal discomfort
    Abdominal distension
    Abdominal pain
    Alteration of autonomic nervous system
    Altered sensation in extremities
    Attention disturbances
    Back pain
    Bone pain
    Breast changes
    Breast discomfort
    Breast mass
    Changes in mood
    Circulatory disturbances
    Decrease in bone mineral density
    Depressed mood
    Dry eyes
    Dry skin
    Fibrocystic breast changes
    Gastro-intestinal symptoms
    Hair growth abnormal
    Hot flushes
    Increased appetite
    Irregular uterine bleeding
    Loss of libido
    Menstrual disturbances
    Muscle spasm
    Ovarian cysts
    Painful extremities
    Pelvic pain
    Seborrhoeic dermatitis
    Skin photosensitivity
    Skin pigmentation changes
    Sleep disorders
    Urinary tract infections
    Uterine bleeding
    Vaginal bleeding
    Vaginal candidiasis
    Vaginal discharge
    Vaginal dryness
    Weight gain
    Weight loss

    Effects on Laboratory Tests

    Progestogens may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function; plasma levels of carrier proteins; parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.

    These changes generally remain within normal laboratory ranges.


    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: March 2020

    Reference Sources

    Summary of Product Characteristics: Dimetrum 2mg tablets. Besins healthcare (UK) Ltd. Revised October 2021.

    Summary of Product Characteristics: Zalkya 2mg film-coated tablets. Stragen UK Ltd. Revised September 2019.

    NICE Evidence Services Available at: Last accessed: 16 September 2022

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