POM: Prescription only medicine
This information is intended for use by health professionals
Excipients with known effect:Lactose monohydrate 55.07 mg, soybean oil (maximum 0.026 mg).For the full list of excipients, see section 6.1.
How to take DesogestrelTablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one.
How to start Desogestrel
No preceding hormonal contraceptive use [in the past month]Tablet taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding).Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.
Following first-trimester abortion:After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.
Following delivery or second-trimester abortion:Contraceptive treatment with Desogestrel after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed pregnancy ought to be ruled out and an additional method of contraception should be used for the first week.For additional information for breastfeeding women see section 4.6.
How to start Desogestrel when changing from other contraceptive methods
Changing from a combined oral contraceptive (combined hormonal contraceptive (COC), vaginal ring or transdermal patch)The woman should start with Desogestrel preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries.The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.
Changing from a progestogen-only method (minipill, injection, implant or from a progestogen-releasing intrauterine system (IUS))The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due).
Management of missed tabletsContraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.
Advice in case of gastrointestinal disturbancesIn case of severe gastrointestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet taking absorption may not be complete. In such an event, the advice concerning missed tablets is applicable.
Treatment surveillanceBefore prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease (see section 4.4), the control examinations should be timed accordingly.Despite the fact that Desogestrel is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out.Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.The treatment should be stopped if a pregnancy occurs.Women should be advised that Desogestrel does not protect against HIV (AIDS) and other sexually transmitted diseases.
Paediatric populationThe safety and efficacy of desogestrel in children below 18 years has not yet been established. No data are available.Method of administrationOral use
|Age group||Expected cases COC-users||Expected cases non-users|
InteractionsInteractions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only contraceptives).Hepatic metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones (such as, hydantoins, (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, and possibly also for oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum))Maximal enzyme induction is not seen for 2-3 weeks, but may then be sustained for at least 4 weeks after cessation of drug therapy. Women on treatment with any of these medicinal products should temporarily use a barrier method in addition to Desogestrel. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. For women on long-term treatment with hepatic enzyme inducers a non-hormonal method of contraception should be considered.During treatment with medical charcoal, the absorption of the steroid in the tablet may be reduced and thereby the contraceptive efficacy. Under these circumstances, the advice as given for missed pills in section 4.2 is applicable.Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin) or decrease.Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Laboratory testsData obtained with COCs have been shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.
PregnancyDesogestrel is not indicated during pregnancy. If pregnancy occurs during treatment with Desogestrel, further intake should be stopped.Animal studies have shown that very high doses of progestagenic substances might cause masculinisation of female foetuses.Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. Pharmacovigilance data collected with various desogestrel-containing combined COCs also do not indicate an increased risk.
BreastfeedingDesogestrel does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 - 0.05 microgram etonogestrel per kg body weight per day might be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day).Limited long-term follow up data are available on children, whose mothers started using Desogestrel during the 4th to 8th weeks post-partum. They were breast-fed for 7 months and followed up to 1.5 years (n = 32) or to 2.5 years (n = 14) of age. Evaluation of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants, whose mother used a copper IUD. Based on the available data Desogestrel may be used during lactation. The development and growth of a nursing infant, whose mother uses Desogestrel, should however, be carefully observed.
|System Organ Class (MedDRA)*||Frequency of adverse reactions|
|Infections and infestations||Vaginal infection|
|Psychiatric disorders||Mood altered, Depressed mood, Libido decreased|
|Nervous system disorders||Headache|
|Eye disorders||Contact lens intolerance|
|Skin and subcutaneous tissue disorders||Acne||Alopecia||Rash, Urticaria, Erythema nodosum|
|Reproductive system and breast disorders||Breast pain, Menstruation irregular, Amenorrhoea||Dysmenorrhoea, Ovarian cyst|
|General disorders and administration site condition||Fatigue|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard
AbsorptionAfter oral dosing of Desogestrel, desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.
DistributionENG is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to SHBG.BiotransformationDSG is metabolised via hydroxylation and dehydrogenation to the active metabolite ENG. ENG is metabolised via sulphate and glucuronide conjugation.
EliminationENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing. Steady-state levels in plasma are reached after 4-5 days. The serum clearance after IV administration of ENG is approximately 10 l per hour. Excretion of ENG and its metabolites either as free steroid or as conjugates, is with urine and faeces (ratio 1.5:1). In lactating women, ENG is excreted in breast milk with a milk/serum ratio of 0.37-0.55. Based on these data and an estimated milk intake of 150 ml/kg/day, 0.01 - 0.05 microgram etonogestrel may be ingested by the infant.
Tablet core:Lactose monohydrate Maize starchPovidone K30 (E1201)d-α-Tocopherol (E307)Soybean oilSilical, colloidal hydrated (E551)Silica, colloidal anhydrous (E551)Stearic acid (E570)
Coating:Hypromellose 2910 (E464)Polyethylene GlycolTitanium Dioxide (E 171)