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CIMIZT 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 Cimizt should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Cimizt compares with other CHCs (see sections 4.3 and 4.4).
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
Oral use How to take Cimizt Tablets The tablets must be taken every day at about the same time, with a little liquid as needed, in the order shown on the blister pack. 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 bleeding usually 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). If menstruation has already begun, (that is 2, 3, or 4 days previously), tablet taking should commence on day 5 of the menstrual period.
In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking. If menstruation began more than 5 days previously then the patient should be advised to wait until her next menstrual period before starting to take Cimizt.
• Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start taking Cimizt Tablets preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
In case a vaginal ring or a transdermal patch has been used, the woman should start using preferably on the day of removal, but at the latest when the next application would have been due.
Changing from a 21 day pill or another 22 day pill to Cimizt:
All tablets in the old pack should be finished. e. no gap is left between taking tablets nor does the patient need to wait for her period to begin. Tablets should be taken as instructed in ‘How to take Cimizt’. Additional contraceptive precautions are not required.
The patient will not have a period until the end of the first Cimizt pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days. e. after taking 21 or 22 tablets). e. no gap is left between taking tablets nor does the patient need to wait for her period to begin.
One tablet is taken daily at the same time, without interruption for 21 days, followed by a 7 day tablet-free period. Each subsequent pack is started after the 7 day tablet-free period has elapsed. Additional contraceptive precautions are not required.
Description of selected adverse reactions As with all COCs, 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.
4. Possibly related undesirable effects that have been reported in users of Cimizt or CHC users in general are listed in the table below1. All ADRs are listed by system organ class and frequency; common (≥1/100), uncommon (≥1/1,000 to < 1/100) rare (<1/1,000) and not known (cannot be estimated from the available data).
System Organ Class Common Uncomm on Rare Not Known Immune system disorders Hypersensitivity Exacerbation of symptoms of hereditary and acquired angioedema Metabolism and nutrition disorders Fluid retention Psychiatric disorders Depressed mood, mood altered Libido decreased Libido increased Nervous system disorders Headache Migraine Eye disorders Contact lens Intolerance Vascular disorders Venous thromboembolism2, Arterial thromboembolism2 Gastrointestinal disorders Nausea, abdominal pain Vomiting, diarrhoea Hepatobiliary disorders Transaminases increased Skin and subcutaneous Rash, urticaria Erythema Nodosum, tissue disorders Erythema multiforme Reproductive system and breast disorders Breast tenderness, breast pain Breast enlargeme nt Vaginal Discharge, breast discharge Investigations Weight increased Weight decreased 1 The most appropriate MedDRA term (version 11) to describe a certain adverse reaction is listed.
Synonyms or related conditions are not listed, but should be taken into account as well. 2 Incidence in observational cohort studies of ≥1/10000 to 1/1000 women-years.
4 Special warnings and special precautions for use: The Pill and Cancer) • Endometrial hyperplasia. • Undiagnosed vaginal bleeding. • Known or suspected pregnancy. 1. 5). 1 Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Cimizt 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 Cimizt 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, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as Cimizt 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 Cimizt, 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. Number of VTE events per 10,000 women in one year 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 presence of any of the conditions listed below. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
o 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. g. transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
o 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 • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
• 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). • Known or suspected estrogen-dependent tumours (See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Remaining tablets from the Every Day (ED) pack should be discarded. The patient will not have a period until the end of the first Cimizt pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days.
Changing from a Progestogen -only Pill (POP or Mini Pill) to Cimizt:" The first Cimizt tablet should be taken on the first day of the period, even if the patient has already taken a mini pill on that day. One tablet is taken daily at the same time, without interruption for 21 days, followed by a 7 day tablet-free period.
Each subsequent pack is started after the 7 day tablet-free period has elapsed. Additional contraceptive precautions are not then required. All the remaining Progestogen-only pills in the mini pill pack should be discarded. If the patient is taking a (mini) pill, then she may not always have a period, especially when she is breast feeding.
The first Cimizt tablet should be taken on the day after stopping the mini pill. All remaining pills in the mini pill packet must be discarded. Additional contraceptive precautions must be taken for the first seven days. • Changing from a progestogen-only-method (, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from an implant or the IUS on the day of its removal; from an injectable when the next injection would be due but in all of these cases, be advised to additionally use a barrier method for the first 7 days of tablet- taking.
• Following first-trimester abortion The woman may start immediately. When doing so, she need not take additional contraceptive measures. • Following delivery or second-trimester abortion The non-breast feeding woman should be advised to start at day 21 to 28 after delivery or second-trimester abortion.
When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However if intercourse has already occurred, pregnancy should be excluded before the actual start of CHC use or the woman has to wait for her first menstrual period.
If post-delivery administration of Cimizt begins more than 21 days after delivery then additional contraceptive preacautions are required for the first 7 days. For breastfeeding women Also mothers who are breast feeding should be advised not to use the combined pill since this may reduce the amount of breast milk, but may be advised instead to use a Progestogen-only pill (POP).
6.
Additional contraceptive precautions:
When additional contraceptive precautions are required the patient should be advised either not to have sex, or to use a cap plus spermicide, or for her partner to use a condom. g. changes in temperature and cervical mucus.
How to skip a period:
To skip a period, a new pack of Marvelon should be started on the day after finishing the current pack (the patient skips the tablet-free days). Tablet- taking should be continued in the usual way. During the use of the second pack she may experience slight […]
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 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 Cimizt 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; - […]