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GEDAREL is a brand name for Ethinyl Estradiol (also known as Ethinylestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral contraception The decision to prescribe Gedarel should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Gedarel compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology How to take Gedarel Tablets must be taken in the order directed on the package every day at about the same time. One tablet is taken daily for 21 consecutive days. Each subsequent pack is started after a 7- day tablet-free interval; during which time a withdrawal bleed usually occurs.
This usually starts on day 2-3 day after the last tablet and may not have finished, before the next pack is started. e. on the first day on which the woman has a menstrual bleeding). Tablet intake is also allowed to start on day 2-5, but during the first cycle concurrent use of a barrier method for the first 7 days of tablet intake is advisable.
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), combined contraceptive vaginal ring or transdermal patch) The woman should start taking Gedarel on the day after the last active tablet (the last tablet containing the active substance) of her previous COC, but at the latest on the day following the usual tablet-free interval or following the last placebo tablet (tablet containing no active substance) of her previous COC.
In case a vaginal ring or a transdermal patch has been used, the woman should start using Gedarel preferably on the day of removal. The woman may also start using Gedarel on the day the new vaginal ring or a transdermal patch would have been due, but no later than this day.
If the woman has been using her previous contraception method regularly and correctly and if the woman is not pregnant she may also switch from her previous hormonal contraception on any day of the cycle. The hormone-free period from the previous contraception method must not be extended for longer than recommended.
Not all administration methods of hormonal contraception (transdermal patch, vaginal ring) is necessarily marketed in all EU countries. Changing from progestogen only products (progestogen-only-pills, injection, implant or a progestogen-releasing intrauterine system (IUS)) The woman can change from progestogen-only pills on any day (changing from implant or IUS on the day of its removal; changing from injection when the next injection should have been given) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.
After abortion in the 1st trimester Tablet intake should start immediately. In this case no further contraceptive measures are necessary. 6. The woman should be advised to start the pill on day 21-28 after delivery or abortion in the 2nd trimester.
In the first part of the treatment period a large part (10-30%) of women may expect to get side effects such as breast tenderness, malaise and spot bleeding. However, these side effects are usually temporary and disappear after 2-4 months.
4. Other side effects have been reported in women using combined hormonal contraceptives. 4. As with all CHCs, changes in vaginal bleeding patterns may occur, especially during the first months of use. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration.
Possibly related undesirable effects that have been reported in users of Gedarel and users of combined hormonal contraceptives in general are listed in the table below3. All ADRs are listed by system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (frequency cannot be estimated from the available data).
Systems Organ Class Very common >1/10 Common >1/100 to <1/10 Uncommon >1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Not known (frequency cannot be estimated from the available data) Immune system disorders Hypersensitivity reaction Exacerbation of symptoms of hereditary and acquired angioedema Metabolism and nutrition disorders Fluid retention Psychiatric disorders Depressed mood, Mood altered Nervousness Libido decreased Libido increased Nervous system disorders Headache, Dizziness Migraine Eye disorders Contact lens intolerance Ear and labyrinth disorders Otosclerosis Vascular disorders Hypertension Venous thromboembolism (VTE), Arterial thromboembolism (ATE) Gastrointestinal disorders Nausea, Abdominal pain Vomiting, Diarrhoea Skin and subcutaneous tissue disorders Acne Rash, Urticaria Erythema nodosum, Erythema multiforme, Chloasma Reproductive system and breast disorders Irregular bleeding Breast pain, Breast tenderness, Amenorrhea, Dysmenorrhea, Premenstrual syndrome Breast enlargement Vaginal secretion Breast secretion Investigations Weight increased Weight decreased 3 The most appropriate MedDRA term to describe a certain adverse reaction is listed.
Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Gedarel should be discussed with the woman. 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 Gedarel should be discontinued.
Circulatory disorders Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Other products such as Gedarel may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with Gedarel, 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). It is estimated1 that out of 10,000 women who use a CHC containing desogestrel between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.
In both cases, the number of VTEs per year is fewer than the number expected during pregnancy or in the postpartum period. VTE may be fatal in 1-2% of cases. 1 These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs.
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the condition appear for the first time while taking oral contraceptives, the use of oral contraceptives should be stopped immediately.
g. deep venous thrombosis [DVT] or pulmonary embolism [PE]). - Known hereditary or acquired predisposition for venous thromboembolism, such as 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).
4). 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.
- Presence or history of liver tumours (benign or malignant). g. of the genital organs or the breasts) - Endometrial hyperplasia. - Undiagnosed vaginal bleeding. - Known or suspected pregnancy. - Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethinyl Estradiol in United Kingdom.
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She should be advised to use a barrier method concurrently during the first 7 days of tablet intake if she starts the pill later. In case she has already had intercourse, pregnancy should be excluded or she should wait for her first menstrual bleeding before she starts taking Gedarel.
Missed tablets If the tablet intake is forgotten for less than 12 hours, contraceptive protection is not reduced. The woman should take the forgotten tablet as soon as she remembers, and the remaining tablets are taken as usual. If the tablet intake is forgotten for more than 12 hours, contraceptive protection may be reduced.
The following two basic rules should be considered in case of forgotten tablets: 1. Continuous tablet intake must not be interrupted for longer than a period of 7 days. 2. 7 days of uninterrupted tablet intake are required to achieve sufficient suppression of the hypothalamus-pituitary-ovarian-axis.
Thus, the following advice may be given for daily practice:
Week 1 The woman should take the last forgotten tablet as soon as she remembers, even if this means that she has to take 2 tablets at the same time. Then, she continues taking the tablets at the usual time of the day. g. a condom, for the next 7 days.
If intercourse has taken place during the preceding 7 days, the possibility of pregnancy should be considered. The more tablets are forgotten and the closer they are to the regular tablet-free period, the higher the risk of pregnancy is.
Week 2 The woman should take the last forgotten tablet as soon as she remembers, even if this means that she has to take 2 tablets at the same time. Then, she continues taking the tablets at the usual time of the day. Provided that the tablets have been taken in a correct manner during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive measures.
However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to use another contraceptive method for 7 days. Week 3 The risk of reduced contraceptive protection is imminent due to the forthcoming 7-day tablet- free period.
However, this risk may be prevented by adjusting tablet intake. Thus, it is not necessary to take further contraceptive measures if one of the two alternatives below is followed, provided that all tablets have been taken in a correct manner during the 7 days preceding the forgotten tablet.
If this is not the case, the woman should be advised to follow the first of the two alternatives and concurrently use another contraceptive method for the next 7 days. 1. The woman should take the last forgotten tablet as soon as she remembers even if it means that she has to take 2 tablets at the same time.
Then she continues taking the tablets at the usual time of the day. e. there is no break between the packs. It is not very likely that the woman will have her menstrual bleeding until the end of the second pack, but she may experience spotting or break-through bleeding on the days she is taking tablets.
2. The woman may also be advised to stop taking […]
Synonyms or related conditions are not listed, but should be taken into account as well. 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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6. 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).
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:
Risk factors for VTE Risk factor Comment Obesity (body mass index 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 patch/pill/ring (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 Gedarel has not been discontinued in advance. g. before 50). 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 (deep vein thrombosis and pulmonary embolism) 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 deep vein thrombosis (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 pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis; - sharp chest pain; - severe light headedness or dizziness; - rapid or irregular heartbeat.
g. g. respiratory tract infections). Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity. If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision.
Sometimes loss of vision can occur […]