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SOPHELLE 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 Treatment of endometriosis Treatment of spasmodic dysmenorrhoea and premenstrual tension Treatment of functional uterine bleeding (menorrhagia, metrorrhagia, metropathia haemorrhatica) Emergency treatment of acute uterine bleeding
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Oral contraception How to take Sophelle 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. Regular daily intake of tablets for 21 consecutive days is important for the preservation of contraceptive efficacy.
One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval during which time a withdrawal bleed occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.
e. the first day of her menstrual bleeding). Additional contraception (barriers and spermicides) is not required. Changing from another combined oral contraceptive (COC) Changing from another 21 day combined oral contraceptive: The first tablet of Sophelle should be taken on the first day immediately after the end of the previous oral contraceptive course.
Additional precautions are not required. A withdrawal bleed should not be expected until the end of the first pack.
Changing from an every day 28 day combined oral contraceptive:
The first tablet of Sophelle should be taken on the day immediately after the day on which the last active pill in the every day pack has been taken. The remaining tablets in the every day pack should be discarded. Additional precautions are not required.
A withdrawal bleed should not be expected until the end of the first pack. Changing from a progestogen-only-pill (POP) The first tablet of Sophelle should be taken on the first day of menstruation even if the POP for that day has already been taken.
The remaining tablets in the POP pack should be discarded. Additional precautions are not required. 4). If the pill is started later than 21 days after delivery, then alternative contraception (barriers and spermicides) should be used until oral contraception is started and for the first 7 days of pill-taking.
If unprotected intercourse has taken place after 21 days post partum, then oral contraception should not be started until the first menstrual bleed after childbirth. 6). After miscarriage or abortion oral contraception may be started immediately.
Other indications Endometriosis:
g. 4 for more information. 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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Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. 4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination, including cervical cytology.
Before starting treatment, pregnancy must be excluded. In cases of undiagnosed abnormal genital bleeding, adequate diagnostic measures are indicated. Warnings Patients should be counselled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
The suitability of a combined oral contraceptive should be judged according to the severity of such conditions in the individual case, and should be discussed with the patient before she decides to take it. Minimising exposure to estrogens and progestogens is in keeping with good principles of therapeutics.
For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one that contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the patient.
Conditions requiring supervision:
Sophelle can be used in women with a condition that falls into WHO category 3, but as the theoretical or proven risks usually outweigh the advantages of using the COC, the decision to prescribe the COC must be made using clinical judgment and in consultation with the woman.
If any of these conditions appear for the first time during Sophelle use, consideration should be given to stopping COC use. • Breastfeeding - ≥6 weeks to <6 months postpartum (primarily breastfeeding) • Postpartum (in non-breastfeeding women) - <21 days • Smoking – aged ≥35 years and smoking <15 cigarettes/day • Cardiovascular disease – Multiple risk factors for arterial cardiovascular disease (such as older age, smoking, diabetes and hypertension) • Hypertension – adequately controlled hypertension: elevated blood pressure levels systolic 140-159 mmHg or diastolic 90-94 mmHg • Known hyperlipidaemias • Migraine headaches – past history of migraine with aura; new onset migraine (see below) • Breast cancer – past and no evidence of current disease for 5 years • Diabetes - with mild vascular disease or mild nephropathy, retinopathy, or neuropathy • Gallbladder disease – current or medically treated symptomatic gallbladder disease • History of cholestasis – past COC-related • Viral hepatitis – acute or flare.
Sophelle should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during Sophelle use, the product should be stopped immediately. • Breastfeeding: <6 weeks postpartum • History of confirmed venous thromboembolism (VTE).
Known risk factors for VTE. g. 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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Continuous treatment with two tablets daily.
Spasmodic dysmenorrhoea, premenstrual tension:
Dosage as for oral contraception.
Functional uterine bleeding:
Two tablets are taken daily on a cyclic basis as for oral contraception. In the first one or two cycles it may be necessary to give four tablets, or in exceptional cases, five.
Emergency treatment of acute uterine bleeding:
Four tablets are given initially and, if necessary, 4-8 tablets daily. Special circumstances requiring additional contraception. Management of missed tablets Contraceptive reliability may be reduced if tablets are missed and particularly if the missed tablets extend the tablet-free interval.
If tablets were missed in the first week of the cycle and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered. • Provided that the user is less than 12 hours late in taking any tablet, she should take it as soon as she remembers and further tablets should be taken at the usual time.
• If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. • The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets in one day. She then continues to take tablets at her usual time.
In addition, a back-up method such as the condom should be used for the next 7 days. • If these 7 days run beyond the last tablet in the current pack, the next pack must be started as soon as the current pack is finished; no gap should be left between packs.
This prevents an extended break in tablet taking which may increase the risk of escape ovulation. The user is unlikely to have a withdrawal bleed until the end of the second pack but she may experience spotting or breakthrough bleeding on tablet taking days.
• If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be ruled out before resuming tablet taking from the next pack. Gastrointestinal upset If vomiting or severe diarrhoea occurs within 4 hours after tablet taking, tablet absorption may be incomplete.
Repeat the missed dose as soon as possible. The general advice for women using COCs who have persistent vomiting or severe diarrhoea for more than 24 hours is to follow the instructions for missed pills. How to delay a period To delay a period the woman should continue with another pack of Sophelle without a tablet-free interval.
The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of Sophelle is then resumed after the usual 7 day tablet-free interval.
Elderly Not applicable. Paediatric population Not applicable. Method of administration For oral administration.
Reasons for stopping Sophelle immediately: • Occurrence of migraine in patients who have never previously suffered from it. Exacerbation of pre-existing migraine. Any unusually frequent or unusually severe headaches. 4). If oral contraception is stopped for any reason and pregnancy is not desired, it is recommended that alternative non-hormonal methods of contraception (such as barriers or spermicides) are used to ensure contraceptive protection is maintained.
Circulatory disorders Use of COCs is associated with an increased risk of venous and arterial thrombotic and thromboembolic events. 3). Venous thrombosis and thromboembolism Use of COCs increases the risk of venous thrombotic and thromboembolic events.
Reported events include deep venous thrombosis and pulmonary embolism. The use of any COC carries an increased risk of venous thrombotic and thromboembolic events compared with no use. The excess risk is highest during the first year a woman ever uses a combined oral contraceptive.
This increased risk is less than the risk of venous thrombotic and thromboembolic events associated with pregnancy which is estimated as 60 cases per 100,000 woman-years. Venous thromboembolism is fatal in 1-2% of cases. Some epidemiological studies have reported a greater risk of VTE for women using combined oral contraceptives containing ethinylestradiol, mostly at a dose of 30 micrograms, and desogestrel or gestodene (the so-called third generation pills) than for women using pills containing levonorgestrel (the so-called second generation pills).
The spontaneous incidence of VTE in healthy non-pregnant women (not taking any oral contraceptive) is about 5 cases per 100,000 women per year. The incidence in users of the second generation pills (such as Sophelle) is about 15 per 100,000 women per year of use.
The incidence in users of third generation pills is about 25 cases per 100,000 women per year of use: this excess incidence has not been satisfactorily explained by bias or confounding. The level of all these risks of VTE increases with age and is likely to be further increased in women with other known risk factors for VTE.
Caution must be exercised when prescribing COCs for such women. The risk for venous thromboembolic complications in COCs users increases with: • A personal or family history of venous thrombotic/thromboembolic events; certain inherited and acquired thrombophilias (see below) • Obesity (body mass index of 30 kg/m2 or over) • Recent delivery or second-trimester abortion • Prolonged immobilisation, major surgery or trauma with increased risk of […]