Loading…
RIGEVIDON 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 hormonal contraception. The decision to prescribe Rigevidon should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Rigevidon 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 use Rigevidon? Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary. One tablet is to be taken daily for 21 consecutive days. Every subsequent blister pack is started after a 7-day tablet-free interval during which time a withdrawal bleeding usually occurs.
This bleeding will usually start on the 2nd or 3rd day after the last tablet has been taken and it may not have stopped, before the next blister pack is started. How to start the use of Rigevidon No preceding hormonal contraceptive use in the past month.
Tablet-taking is started on day 1 of the woman's natural cycle (= the first day of her menstrual bleeding). Changing from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch): Take the first tablet the day after the dose of the last active tablet of the previous contraceptive or, at the latest, the day after the usual period of stopping the tablets.
In case of vaginal ring or transdermal patch, take the first tablet the day of removal or at the latest the day scheduled for application of the new device or ring. Changing from a progestogen-only method (mini pill, injection, implant or from a progestogen-releasing intrauterine system (IUS)) Switching from the mini pill can be performed at any time in the cycle and Rigevidon coated tablet should be commenced the day after stopping.
Switching from an implant or IUS should occur on the day of removal and for an injectable contraceptive on the day scheduled for the new injection. In all cases, using an additional method of contraception for the 7 first days of treatment is recommended.
After abortion in 1st trimester The woman may start the tablet intake immediately. In this case, it is not necessary to take further contraceptive precautions. After delivery or abortion in 2nd trimester The woman should be advised to start on day 21-28 after delivery in non-lactating women or abortion in the 2nd trimester, because there is an increased risk of thromboembolic disorders during the post partum period.
If she starts later than this, she should be advised to use a concomitant barrier method during the first 7 days of tablet intake. However, if she already has had intercourse, pregnancy must be excluded, before she starts the tablets, or she should wait for her first menstrual bleeding.
1 Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (frequency cannot be estimated from the available data) Neoplasms benign, malignant and unspecified (incl. g. focal nodular hyperplasia, hepatic adenoma).
Infections and infestations Vaginitis including vaginal candidiasis Immune system disorders Anaphylactic reactions with very rare cases of urticaria, angioedema, circulatory and severe respiratory disorders Exacerbation of disseminated lupus erythematosus.
g. 4. 4 Special warnings and precautions for use. - Venous thromboembolic disorders - Arterial thromboembolic disorders - Hypertension - Cervical cancer - Liver tumours - Skin and subcutaeous disorders: chloasma; erythema nodosum. - Crohn’s disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice.
The frequency of diagnosis of breast cancer is very slightly increased among COC-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 COC use is unknown.
4. 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. uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Rigevidon 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 Rigevidon should be discontinued.
1. 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, such as Rigevidon, norgestimate or norethisterone are associated with the lowest risk of VTE.
The decision to use Rigevidon should be taken after a discussion with the woman to ensure she understands the risk of VTE with Rigevidon, 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). Epidemiological studies in women who use low dose combined oral contraceptives (<50 μg ethinylestradiol) have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year.
It is estimated that out of 10,000 women who use a CHC that contains levonorgestrel, about 61 will develop a VTE in one year. 6 This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
VTE is fatal in 1% to 2% of the cases. g. hepatic, mesenteric, renal or retinal veins and arteries. Risk factors for VTE The risk for venous thromboembolic complications in COC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
Combined oral contraceptives (COCs) must not be used in the presence of any of the conditions listed below. g. g. g. g. transient ischaemic attack, TIA) - Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and anti-phospholipid 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. - Severe hepatic disease, current or previous, as long as liver function values have not returned to normal.
- Presence or history of liver tumours (benign or malignant). g. genital organ or breast tumours). - Undiagnosed vaginal bleeding. - Concomitant use with St. 5). 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.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
6. Missed tablets Contraceptive efficacy can be reduced in case a forgotten dose, especially if the dose is forgotten for >12 hours. If the woman has forgotten tablet intake for less than 12 hours, the contraceptive protection is not reduced.
The woman should take the tablet as soon as she remembers this, and the remaining tablets should be taken at the usual time. If the delay exceeds 12 hours, the contraceptive protection may be reduced. Handling of missed tablets may be managed by the following two basic rules: 1.
Tablets should never be delayed for longer than 7 days. 2. Seven days of uninterrupted tablet taking is required to maintain adequate suppression of the hypothalamus-pituitary-ovarian-axis.
Thus, the following advice may be given in daily practice:
Week 1: The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time. Hereafter, she continues taking the tablets at the usual time point. g. a condom, for the next 7 days.
If intercourse has taken place during the previous 7 days, the possibility of pregnancy must be considered. The more forgotten tablets, and the closer to the usual tablet-free interval this takes place, the greater the risk of pregnancy.
Week 2:
The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time. Hereafter, she continues taking the tablets at the usual time point. Provided that the tablets have been taken correctly during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive precautions.
However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to additionally use a barrier method (such as a condom) for 7 days.
Week 3:
The risk of reduced reliability is imminent because of the forthcoming tablet-free interval. The reduced contraceptive protection may, however, be prevented by adjusting the tablet intake. Therefore, by following one of the following two alternatives, it is not necessary to take further contraceptive precautions, provided that all tablets have been taken correctly 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. Additionally a barrier method (such as a condom) should be used concomitantly for the next 7 days. 1. The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time.
Thereafter, she should continue to take the tablets at the usual time point. e. there will be no tablet-free interval between the blister packs. A withdrawal bleeding is unlikely until the end of the second blister 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 tablets from the current blister pack. In this case, she should keep a tablet-free interval of up to 7 days, including the days she forgot to take her tablets, and thereafter continue with the next blister pack.
If the woman has missed tablets and does not get a withdrawal bleeding during the first, normal tablet-free interval, the possibility of pregnancy must be considered. Advice in the case of […]
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 Rigevidon has not been discontinued in advance. g. before 50). 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 (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 almost immediately. g. transient ischaemic attack, stroke). Arterial thromboembolic events may be fatal. Risk factors for ATE The risk of arterial […]