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MICROGYNON 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 and the recognised gynaecological indications for such oestrogen- progesterone combinations. The decision to prescribe Microgynon 30 should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with…
Verbatim from this product's MHRA label. Tap a section to expand.
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. First treatment cycle: 1 tablet daily for 21 days, starting on the first day of the menstrual cycle.
Contraceptive protection begins immediately.
Subsequent cycles:
Tablet-taking from the next pack of Microgynon 30 is continued after a 7-day tablet-free interval, beginning on the same day of the week as the first pack. A withdrawal bleed usually occurs during the tablet-free interval.
Changing from 21-day combined oral contraceptives:
The first tablet of Microgynon 30 should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required.
Changing from a combined Every Day pill (28 -day tablets):
Microgynon 30 should be started after taking the last active tablet from the Every Day Pill pack. The first Microgynon 30 tablet is taken the next day. Additional contraceptive precautions are not then required.
Changing from a progestogen-only pill (POP):
The first tablet of Microgynon 30 should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.
Post-partum and post-abortum use:
After pregnancy, oral contraception can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of tablet taking.
Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. After a first-trimester abortion, oral contraception may be started immediately in which case no additional contraceptive precautions are required.
Summary of the safety profile The most commonly reported adverse reactions with Microgynon 30 are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥1% of users.
Serious adverse reactions are arterial and venous thromboembolism. 4. g. transient ischemic attack, ischemic stroke, haemorrhagic stroke) • Hypertension • Liver tumours (benign and malignant) 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 ‘Special warnings and precautions for use’. Conditions reported to deteriorate with pregnancy or previous COC use Jaundice and/or pruritus related to cholestasis; gallstone formation; systemic lupus erythematosus; herpes gestationis; otosclerosis-related hearing loss; sickle cell anaemia; renal dysfunction; hereditary angioedema; porphyria; cervical cancer.
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.
5 Overdose There have been no reports of serious effects from overdose. Overdosage may cause nausea, vomiting and, in females, withdrawal bleeding. Withdrawal bleeding may even occur in girls before their menarche, if they accidentally take the medicinal product.
There are no specific antidotes and treatment should be symptomatic. 1 Pharmacodynamic properties Pharmacotherapeutic group: Sex hormones and modulators of the genital system, Progestogens and oestrogens, fixed combinations ATC Code: G03AA07 Microgynon 30 is an oestrogen-progestogen combination which acts by inhibiting ovulation by suppression of the mid-cycle surge of luteinising hormone, the inspissation of cervical mucus producing a barrier to sperm, and the rendering of the endometrium unreceptive to implantation.
Warnings • If any of the conditions or risk factors mentioned below is present, the suitability of Microgynon 30 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 Microgynon 30 should be discontinued.
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 Microgynon 30, norgestimate or norethisterone are associated with the lowest risk of VTE.
The decision to use Microgynon 30 should be taken after a discussion with the woman to ensure she understands the risk of VTE with Microgynon 30, 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 estimated that out of 10,000 women who use a CHC that contains levonorgestrel, about 61 will develop a VTE in a year.
This number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period. VTE may be fatal in 1-2% of cases. 6. g. hepatic, mesenteric, renal, cerebral 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).
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. g. g. g. g. g. active viral hepatitis and severe cirrhosis, as long as liver function values have not returned to normal.
• Presence or history of liver tumours (benign or malignant). • Current or history of breast cancer. • Hypersensitivity to the active substance(s) or to any of the excipients. Relevant UK clinical guidance should also be consulted. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Special circumstances requiring additional contraception Incorrect administration:
A single delayed tablet should be taken as soon as possible, and if this can be done within 12 hours of the correct time, contraceptive protection is maintained. With longer delays, additional contraception is needed. Only the most recently delayed tablet should be taken, earlier missed tablets being omitted, and additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used for the next 7 days, while the next 7 tablets are being taken.
Additionally, therefore, if tablet(s) have been missed during the last 7 days of a pack, there should be no break before the next pack is started. In this situation, a withdrawal bleed should not be expected until the end of the second pack.
Some breakthrough bleeding may occur on tablet taking days but this is not clinically significant. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.
Gastro-intestinal upset:
Vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption. If vomiting or diarrhoea occurs within 4 hours of taking Microgynon tablet-taking from the current pack should be continued. Additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used during the gastro-intestinal upset and for 7 days following the upset.
If these 7 days overrun the end of a pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.
Other methods of contraception should be considered if the gastro-intestinal disorder is likely to be prolonged.
Children:
Not applicable.
Elderly:
Not applicable.
2. Pharmacokinetic properties Levonorgestrel Levonorgestrel is absorbed quickly and completely. Maximum active substance levels of approx 3 ng/ml were reached in serum just one hour after ingestion of Microgynon 30. 5 hours and 20 hours.
The metabolic clearance rate from plasma is approx. 5 ml/min/kg. Levonorgestrel is eliminated not in unchanged form, but in the form of metabolites with a half-life of around one day and in almost equal proportions via the kidney and bile.
Levonorgestrel is extensively metabolised. The major metabolites in plasma are the unconjugated and conjugated forms of 3α, 5β-tetrahydrolevonorgestrel. Based on in vitro and in vivo studies, CYP3A4 is the main enzyme involved in the metabolism of levonorgestrel.
Levonorgestrel is bound to serum albumin and SHBG. 5% of the respective total concentration is present in unbound form, while approx. 65% is bound to SHBG. The relative proportions (free, albumin-bound, SHBG-bound) depend on the concentration of SHBG.
After induction of the binding protein, the portion bound to SHBG increases, while the free portion and that bound to albumin decreases. After daily repeated ingestion, levonorgestrel accumulates by about the factor 2. A steady state is reached during the second half of the treatment cycle.
The pharmacokinetics of levonorgestrel are dependent on the concentration of SHBG in plasma. Under treatment with Microgynon, an increase in the levels of SHBG effect a concomitant increase in the specific binding capacity and therefore also an increase in levonorgestrel serum levels.
The […]
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 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 Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors. method of contraception should be used to avoid unintentional pregnancy. Antithrombotic treatment should be considered if Microgynon 30 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.
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 thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table).
Microgynon 30 is contraindicated if […]