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Lydisilka is a brand name for Estetrol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral contraception. The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Verbatim from this product's EMA label. Tap a section to expand.
e. the first day of her menstrual bleeding, and when doing so, no additional contraceptive measures are necessary. If the first tablet is taken on days 2 to 5 of the woman’s menstruation, this medicinal product will not be effective until after the first 7 consecutive days of pink active tablet-taking.
A reliable barrier method of contraception such as a condom must therefore be used additionally during these first 7 days. The possibility of pregnancy should be considered before starting Lydisilka. 3 • Changing from a CHC (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start with Lydisilka preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
In case a vaginal ring or transdermal patch has been used the woman should start using Lydisilka preferably on the day of removal, but at the latest when the next application would have been due. • Changing from a progestogen-only-method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases be advised to additionally use a barrier method for the first 7 consecutive days of tablet-taking.
• Following first-trimester abortion The woman may start immediately. When doing so, she needs not take additional contraceptive measures. • Following delivery or second-trimester abortion Women should be advised to start between day 21 and 28 after delivery or second-trimester abortion.
When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of CHC use or the woman has to wait for her first menstrual period.
6. Missed or delayed doses White placebo tablets from the last row of the blister can be disregarded. However, they should be discarded to avoid unintentionally prolonging the placebo tablet phase.
The following advice only refers to missed pink active tablets:
4%). Tabulated list of adverse reactions Adverse reactions that have been identified are listed below (see table 3). Adverse reactions are listed according to the MedDRA system organ class and ranked under frequency groupings using the following convention: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and rare (≥ 1/10 000 to < 1/1000).
4. 4 Special warning and precautions for use: - Venous thromboembolic disorders; - Arterial thromboembolic disorders; - Hypertension; - Liver tumours; - Occurrence or deterioration of conditions for which association with CHC use is not conclusive: Crohn’s disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus 17 erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; - Chloasma; - Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal; - Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema.
The frequency of diagnosis of breast cancer is very slightly increased among CHC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with CHC use is unknown.
4. 5). Paediatric population In a phase 3 study including 105 adolescents aged 12 to 17 years, Lydisilka was well-tolerated for 6 cycles of use and no safety concerns were raised during the study. 9%). Other adverse reactions were reported in ≤ 1% of the study population.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. […]
If any of the conditions or risk factors mentioned below is present, the suitability of Lydisilka should be discussed with the woman before she decides to start using it. In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Lydisilka should be discontinued.
All data presented below are based upon epidemiological data obtained with CHCs containing ethinylestradiol. It contains estetrol. As no epidemiological data are yet available with estetrol containing-CHCs, the warnings are considered applicable to the use of Lydisilka.
In case of suspected or confirmed VTE or ATE, CHC use must be discontinued. In case anticoagulant therapy is started, adequate alternative non-hormonal contraception should be initiated because of the teratogenicity of anticoagulant therapy (coumarins).
Circulatory disorders Risk of VTE The use of any CHC increases the risk of VTE compared with no use. Products that contain low dose ethinylestradiol (< 50 mcg ethinylestradiol) combined with levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
It is not yet known how the risk with Lydisilka compares with these lower risk products. The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant about 2 out of 10 000 will develop a VTE over the period of one year.
However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). 7 Epidemiological studies in women who use low dose (< 50 mcg ethinylestradiol) combined hormonal contraceptives have found that out of 10 000 women between about 6 and 12 will develop a VTE in one year.
1. As no epidemiological data are yet available for estetrol-containing CHCs, the contraindications for ethinylestradiol-containing CHCs are considered applicable to the use of Lydisilka. CHCs should not be used in the following conditions.
Should any of the conditions appear for the first time during Lydisilka use, the medicinal product should be stopped immediately. g. deep venous thrombosis [DVT] or pulmonary embolism [PE]). - Known hereditary or acquired predisposition for venous thromboembolism, such as activated protein C (APC)-resistance (including factor V Leiden), antithrombin-III- deficiency, protein C deficiency, protein S deficiency.
4). 4). g. g. angina pectoris). g. transient ischaemic attack [TIA]). - Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
- History of migraine with focal neurological symptoms. 4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms; - severe hypertension; - severe dyslipoproteinaemia. - Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- Severe renal insufficiency or acute renal failure. - Presence or history of liver tumours (benign or malignant). g. of the genital organs or the breasts). - Undiagnosed vaginal bleeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estetrol in European Union.
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If the user is less than 24 hours late in taking any pink active tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as possible and should take further tablets at the usual time. If she is more than 24 hours late in taking any pink active tablet, contraceptive protection may be reduced.
The management of missed tablets can be guided by the following two basic rules: 1. The recommended hormone-free tablet interval is 4 days, tablet-taking must never be discontinued for longer than 4 days. 2. Seven days of uninterrupted pink active tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.
Accordingly, the following advice can be given in daily practice:
Day 1-7 The user should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used until she has completed 7 days of uninterrupted pink active tablet-taking.
If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the placebo tablet phase, the higher the risk of a pregnancy. 4 Day 8-17 The user should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time.
She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if she has missed more than 1 tablet, the woman should be advised to use extra precautions until she has completed 7 days of uninterrupted pink active tablet- taking.
Day 18-24 The risk of reduced reliability is imminent because of the forthcoming placebo tablet phase. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly.
If this is not the case, she should follow the first of these two options and use extra precautions until she has completed 7 days of uninterrupted pink active tablet-taking as well. 1. The user should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time.
She then continues to take tablets at her usual time until the pink active tablets are used up. The 4 white placebo tablets from the last row must be discarded. The next blister pack must be started right away. The user is unlikely to have a withdrawal bleed until the end of the pink active tablets section of the second pack, but she may experience spotting or breakthrough bleeding on pink active tablet-taking days.
2. The woman may also be advised to discontinue pink active tablet-taking from the current blister pack. She should then take white placebo tablets from the last row for up to 4 days, including the days she missed tablets, and subsequently continue with the next blister pack.
If the woman missed tablets and subsequently has no withdrawal bleeding in the placebo tablet phase, the possibility of a pregnancy should be considered. Advice in case of gastrointestinal disturbances In case […]
It is estimated1 that out of 10 000 women who use a CHC containing ethinylestradiol and drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 62 in 10 000 women who use a levonorgestrel-containing CHC.
It is not yet known how the risk of VTE with CHC containing estetrol and drospirenone compares with the risk with low dose levonorgestrel-containing CHCs. The number of VTEs per year with low-dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.
VTE may be fatal in 1-2% of cases. g. hepatic, mesenteric, renal or retinal veins and arteries. Risk factors for VTE The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table 1).
3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk of VTE should be considered. 3).
Table 1:
Risk factors for VTE Risk factor Comment Obesity (body mass index [BMI] over 30 kg/m²). Risk increases substantially as BMI rises. Particularly important to consider if other risk factors also present. Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma.
Note: temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors. In these situations, it is advisable to discontinue use of the pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
Another method of contraception should be used to avoid unintentional pregnancy. Antithrombotic treatment should be considered if Lydisilka has not been discontinued in advance. 1These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different medicinal products compared with levonorgestrel-containing CHCs.
g. before 50 years). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use. Other medical conditions associated with VTE. Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease.
Increasing age. Particularly above 35 years. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis. 6). Symptoms of VTE (DVT and PE) In the event of symptoms, women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Symptoms of DVT can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking; - increased warmth in the affected leg; red or discoloured skin on the leg.
Symptoms of PE can […]