- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of dienogest.
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
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
Diabetes mellitus with vascular involvement
History of hepatic neoplasm
History of severe arterial disorder
Hormone dependent neoplasm
Severe arterial disorder
Severe hepatic disorder
Undiagnosed uterine bleeding
Precautions and Warnings
Children under 18 years
History of ectopic pregnancy
Predisposition to thromboembolic disease
Risk of uterine bleeding
Glucose-galactose malabsorption syndrome
History of chloasma
History of cholestatic jaundice during pregnancy
History of severe depression
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.
Alteration of autonomic nervous system
Altered sensation in extremities
Changes in mood
Decrease in bone mineral density
Fibrocystic breast changes
Hair growth abnormal
Irregular uterine bleeding
Loss of libido
Skin pigmentation changes
Urinary tract infections
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: March 2020
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: www.nice.org.uk Last accessed: 16 September 2022
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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