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MILLINETTE 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: Contraception. The decision to prescribe Millinette should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Millinette 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.
Do not start or continue with Millinette in case of known or suspected pregnancy. Posology How is Millinette taken?
To patients who use a package with 21 active tablets:
The tablets 1-21 contain active substances (active tablets). The tablets must be taken in the order given on the blister pack, every day at approximately the same point. One tablet is 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 usually starts on the 2nd or 3rd day after taking the last tablet has been taken and it may not have stoped, before the next blister pack is started. e. on the first day the woman has a menstrual bleeding). g. condom or spermicide) for the first 7 days is recommended.
Changing from another combined oral pill The woman should start with Millinette on the day following the usual tablet-free or placebo tablet interval of her previous COC. Changing from a progestogen-only method (mini pills, injection, implant) The woman may switch from progestogen-only pills on any day (from an implant on the day the implant is removed or from injection, when the next injection should have been given).
In all these cases the woman should be advised to use a concomitant barrier method for the first 7 days of the tablet intake. 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.
6. The woman should be advised to start on day 21-28 after delivery in non-lactating women or abortion in the 2nd trimester. She should also be advised to use a concomitant contraception 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. Missed tablets The contraceptive effect may be reduced in case of forgotten tablet intake, especially if the forgotten tablets prolong the tablet-free interval- If the woman has forgotten tablet intake for less than 12 hours, the woman should take the tablet as soon as she remembers this, and the remaining tablets should be taken at the usual time.
4. 4. g. focal nodular hyperplasia, hepatic adenomas). - Cervical intraepithelial neoplasia and cervical cancer - Breast cancer. In the beginning of the treatment period a large part (10-13%) of women may expect adverse events such as headache, breast tenderness, malaise and spot bleeding.
These adverse events are usually temporary and disappear after 2-4 months. The following adverse events were reported by users of COCs but the connection with the use of COCs is neither confirmed or ruled out: Infections and Infestations Common (≥1/100 to <1/10) Vaginitis, including candidiasis Neoplasms benign, malignant and unspecified (including cysts and polyps) Very rare (<1/10,000, including isolated cases) Hepatocellular carcinomas Blood and lymphatic system disorders Very rare (<1/10,000, including isolated cases) Exacerbation of varicose veins Immune system disorders Rare (≥1/10,000 to <1/1,000) Rare – very rare (<1/1,000) Not known (frequency cannot be estimated from the available data) Anaphylactic/ anaphylactoid reactions including very rare cases of urticaria, angiooedema and serious reactions with circulatory and respiratory symptoms General disease in the immune system, hypersensitivity.
Exacerbation of systemic lupus erythematosus exacerbation of symptoms of hereditary and acquired angioedema Metabolism and Nutrition disorders Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000, including isolated cases) Fluid retention.
000, including isolated cases) Haemolytic uraemic syndrome Reproductive system and breast disorders Very common (≥1/10) Common (≥1/100 to <1/10) Spot bleeding/ break-through bleeding. Breast tenderness, pain, swelling, secretion. 4. e.
deep leg or pelvic venous thrombosis and pulmonary embolism. - Arterial thromboembolic disorders - Cervical cancer - Liver tumours - Skin and subcutaneous disorders: chloasma; erythema nodosum. The frequency of diagnosis of breast cancer is very slightly increased among COC-users.
Medical Examination/Consultation Prior to the initiation or reinstitution of Millinette a complete medical history (including family history) should be taken and pregnancy must be ruled out. 4). It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of Millinette compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given. The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman.
Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases. Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Millinette 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 Millinette 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, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as Millinette may have up to twice this level of risk. 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 Millinette, 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.
Combined oral contraceptives (COCs) must not be used in the presence of any of the conditions listed below. g. deep venous thrombosis [DVT] or pulmonary embolism [PE]). g. g. 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. 1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the delay exceeds 12 hours, the contraceptive protection may be reduced. 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.
She should use a barrier method concomitantly for the next 7 days. If there are less than 7 days back in the actual package the woman should continue taking the pills in the package until the actual package is empty, there will be no tablet- free interval.
This will prevent a prolonged tablet-free interval, which increases the risk of premature ovulation. 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.
If no bleeding occurs after finishing the second package the possibility of pregnancy must be eliminated before the woman continues with the tablets in the next package. What to do in case of vomiting/diarrhoea If vomiting occurs within 3-4 hours after tablet taking, absorption may not be complete.
In this case the advice concerning missed tablets, described above should be followed. The woman should take the required extra tablet(s) from another blister pack. In case of longer lasting or severe gastrointestinal symptoms, the woman should be advised to use another contraceptive method and/or to contact her physician.
How to delay or shift a withdrawal bleeding In order to delay a withdrawal bleeding, the woman should continue the next blister pack of Millinette without a tablet-free interval. The extension can be carried on for as long as is desired until the end of the second blister pack.
During the extension the woman may experience break through bleeding or spotting. Regular intake of Millinette is resumed after the usual 7 days tablet-free interval. To move menstruation to a weekday other than that on which the woman is used to having it under the current tablet schedule, she can be advised to shorten the next tablet- free period by as many days as she wishes.
The shorter the pause, the higher the risk that she will not get her menstruation and will have withdrawal bleeding or spotting while she is taking the next pack (which is also true when menstruation is being delayed). Special population Elderly Not applicable.
Millinette is not indicated for use after the menopause. 3). Renal impairment There are no data available in patients with renal impairment. Paediatric population Millinette is recommended only after the first period. Method of administration For oral use.
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. 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. uk/yellowcard.
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 gestodene 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.
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. 6 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. 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).
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 method of contraception should be used to avoid unintentional pregnancy.
Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors. Antithrombotic treatment should be considered if Millinette 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 […]