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CILIQUE 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: Hormonal contraception. The decision to prescribe Cilique should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Cilique 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.
For oral administration.
Adults:
How to use Cilique: One tablet is to be taken at around the same time of day on each of 21 consecutive days followed by a tablet-free interval of 7 days. Each subsequent pack is started after keeping a tablet-free interval. Withdrawal bleed occurs usually 2-3 days after the last tablet and may not finish before the next pack is started.
e. the first day of menstrual bleeding. If menstruation has already begun, Cilique may be commenced up to day 5 of the menstrual period, provided additional contraceptive precautions are taken for the first 7 days of tablet taking. - Changing from a combined contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) to Cilique: The woman should start taking Cilique the next day after having taken the last active tablet of her previous pack of contraceptive pills – but no later than the day after the usual tablet-free or placebo-tablet period of her previous contraceptive pill.
In case a vaginal ring or transdermal patch has been used the woman should start using Cilique preferably on the day of removal, but at the latest when the next application would have been due. - Changing from a progestin-only method (progestin-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may change from progestogen-only pills (POPs) any day.
The first tablet should be taken the day after any tablet of the POP pack. When changing from an implant or the IUS, Cilique should be started the day when the implant is removed. When changing from injections, Cilique should be started when the next injection is to be given.
In all these cases the woman is advised to use also a barrier method for the first 7 days of taking the Pills.
Following a first trimester abortion:
Cilique can be used immediately, while another additional contraceptive method is not needed. Following delivery or a second-trimester abortion Women should be advised to start at day 21 to 28 day 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 COC use or the woman has to wait for her first menstrual period.
Description of selected adverse reactions An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs.
4. The safety of Cilique was evaluated in 1,891 healthy women of child bearing potential who participated in 5 clinical trials (2 randomized active-controlled trials and 3 uncontrolled open-label trials) and received at least 1 dose of Cilique for contraception.
In 3 trials, subjects were followed for up to 24 cycles and in the other 2 trials, subjects were followed for up to 12 cycles. In these studies the following ADRs were solicited or determined from bleeding pattern or cycle characteristics data and the incidence could only be determined by treatment cycle (by cycle) and not overall: nausea, gastrointestinal disorder (reported as nausea or vomiting), vomiting, dysmenorrhoea, metrorrhagia, abnormal withdrawal bleeding, amenorrhoea, and diarrhoea (diarrhoea was identified as an ADR during post-marketing review).
An additional uncontrolled study (N=8,331) reported ADRs by cycle only and was only included in the incidence calculation for the by-cycle ADRs. For these by cycle ADRs, the pooled incidences for cycles 1, 3, 6, 12 and 24 were calculated and the highest cycle incidence (cycle 1 for all except vomiting and diarrhoea) presented and used to assign the ADR to a frequency category.
7%). 0%). With the exception of vomiting and dysmenorrhoea, the incidence of these ADRs was highest in cycle 1 and decreased over time with further treatment cycles (based on incidence data from cycles 1, 3, 6, 12 and 24). Vomiting increased in some later cycles, whereas dysmenorrhoea remained relatively stable, with a slight decrease over time.
4%) *This calculated incidence value may be slightly higher than the actual incidence, as more than 1 event term reported in the same trial coded to the MedDRA preferred term of ‘Back pain’. It is possible that the same subject(s) may have reported more than 1 of the event terms and may therefore be counted more than once for the Preferred Term of ‘Back pain’.
Adults:
If any of the conditions/risk factors mentioned below is present, the suitability of Cilique should be discussed with the woman. In the event of aggravation, or first appearance of any of the conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Cilique should be discontinued.
Exclude likelihood of pregnancy before starting treatment. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Conditions requiring supervision - The theoretical or proven risks usually outweigh the advantages of using Combined oral contraceptives (COCs) in the conditions listed below.
Consequently the decision to prescribe the COC must be made with specialist clinical judgement. 6). 3 and “Circulatory disorders” below). - Adequately controlled hypertension (persistently elevated baseline systolic values 140-159 mm Hg or diastolic values 90-94 mm Hg).
- Obesity (BMI ≥ 35 kg/m2). - History of cholestasis (related to COCs), current or medically treated gall bladder disease, porphyria. - History of breast cancer, 5 years disease-free. Circulatory disorders Risk of Venous Thromboembolism (VTE) The use of any CHCs increases the risk of venous thromboembolism (VTE) compared with no use.
Products that contain levonorgestrel, norgestimate (including Cilique) or norethisterone are associated with the lowest risk of VTE. The decision to use Cilique should be taken after a discussion with the woman to ensure she understands the risk of VTE with Cilique, 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.
g. g. g. g. 4) or to the presence of one serious risk factor such as: • diabetes mellitus with vascular symptoms • severe hypertension • severe dyslipoproteinaemia - Acute or chronic liver disease, including hepatitis (viral or non-viral) or severe cirrhosis, or a history of these conditions until at least 3 months after abnormal liver function tests have returned to normal; hepatic adenomas or carcinomas.
g. 5). Should any of the conditions appear during CHC use, the product should be stopped immediately.
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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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.
NB: When oral contraceptives are administered in the immediate postpartum/post miscarriage period, the increased risk of thromboembolic disease must be considered.
Missed tablets:
Missing a tablet for less than 12 hours does not diminish the, contraceptive protection. The woman should take the tablet as soon as she remembers and proceed taking the rest of the tablets as usual. Missing a tablet for more than 12 hours can diminish the contraceptive protection.
The two following rules may be helpful in dealing with missed tablets: 1. Taking tablets should never be delayed by a period discontinued for longer than 7 days. 2. It takes 7 days of uninterrupted ingestion of the tablets to achieve suppression of the hypothalamus-pituitary- ovarian-axis.
Thus, the following advice can be given in daily practice: • Week 1 The user should take the last missed tablet as soon as she remembers, even if this means that she needs to take 2 tablets at the same time. From then on she should continue to take the tablets at the usual time.
e. condom, for the next 7 days. If she had intercourse during the previous 7 days, she should consider the possibility that she might be pregnant. The more tablets have been missed, and the closer this happened to the monthly tablet-free period, the higher the risk of pregnancy is.
• Week 2 The user should take the last missed tablet as soon as she remembers, even if it means that she has to take 2 tablets at the same time. From then on, she should go ahead with taking the tablets at the usual time. If the tablets have been taken correctly for the 7 days prior to the missed tablet, it is not necessary to take any additional contraceptive precautions.
If this is not the case, however, or if more than 1 tablet has been missed, the woman should be advised to use another birth-control method for 7 days. • Week 3 The risk of reduced protection is imminent because of the approaching tablet- free period.
The reduced contraceptive protection can be prevented, however, by adjusting the intake of the tablets. It is, therefore, not necessary to take any additional contraceptive precautions, provided that the tablets have been taken correctly for the 7 days prior to the missed tablet, if one follows any of the following choices.
If this is not the case, the woman should be advised to go ahead according to the first of the two opportunities, and at the same time use another birth-control method for 7 days. The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
She then continues to take tablets at her usual time. e. no gap should be left between packs. The patient 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.
2. The woman may also be advised to discontinue tablet-taking from the current pack. She should then have a tablet- free interval of up to 7 days, including the days she missed tablets, and subsequently continue with the next pack. If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, the possibility of a pregnancy should be considered.
- Postpartum Women who choose not to breast-feed their newborn infant may start a new Cilique treatment on the first day of the first […]
The clinical trial incidence of diarrhoea was reported by cycle, therefore assignment of frequency category was based on the highest cycle incidence (cycle 12). Including the above-mentioned ADRs, Table A displays all ADRs that have been reported with the use of Cilique in clinical trials or from post marketing experiences with norgestimate and ethinyl estradiol tablets.
The displayed frequency categories use the following convention:
Very common (≥1/10); 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); and not known (cannot be estimated from the available data).
Table:
Adverse Drug Reactions Infections and infestations Common Urinary tract infection, vaginal infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon Cervical dysplasia Rare Breast cyst Frequency not known Breast cancer, Hepatic adenomas, Benign breast neoplasm, Focal nodular hyperplasia, Fibroadenoma of breast, Hepatic tumours Immune system disorders Common Hypersensitivity Frequency not known Exacerbation of symptoms of hereditary and acquired angioedema.
Metabolism and nutrition disorders Common Fluid retention, Weight increased Uncommon Weight fluctuation, Weight decreased, Increased appetite, Decreased appetite Rare Appetite disorder Frequency not known Dyslipidaemia Psychiatric disorders Common Mood altered, depression, nervousness, insomnia Uncommon Anxiety, libido disorder Nervous system disorders Very common Headache Common Migraine, dizziness Uncommon Syncope, paraesthesia Frequency not known Cerebrovascular accident, convulsion Eye disorders Uncommon Visual impairment, dry eye Frequency not known Contact lenses intolerance, retinal vascular thrombosis* Ear and labyrinth disorders Rare Vertigo Cardiac disorders Uncommon Palpitations Rare Tachycardia Frequency not known Myocardial infarction Vascular disorders Uncommon Thrombosis, hypertension, hot flush Rare Venous thromboembolism, Arterial thromboembolism Frequency not known Deep venous thrombosis*, Venous thrombosis** Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea Frequency not known Pulmonary embolism* Gastrointestinal disorders Very common Gastrointestinal disorder, Vomiting, Diarrhoea, Nausea Common Gastrointestinal pain, Abdominal pain, Abdominal distension, Constipation, Flatulence Rare Pancreatitis Hepato-biliary disorders Rare Hepatitis Frequency not known Cholestatic jaundice Skin and subcutaneous tissue disorders Common Acne, rash Uncommon Alopecia, Hirsutism, Urticaria, Pruritus, Erythema, Skin discolouration Rare Hyperhidrosis, Photosensitivity reaction Frequency not known Angioedema, Erythema nodosum, Night sweats Musculoskeletal and connective tissue disorders Common Muscle spasms, Pain in extremity, Back pain Uncommon Myalgia Reproductive system and breast disorders Very common Dysmenorrhoea, Metrorrhagia, Abnormal withdrawal bleeding Common Amenorrhoea, Genital discharge, Breast pain Uncommon Breast discharge, Galactorrhea, Breast enlargement, Ovarian […]
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 6 will develop a VTE in a year.
Current evidence suggests that the risk of VTE with use of norgestimate-containing CHCs is similar to the risk with levonorgestrel-containing CHCs. 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. 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 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 Cilique 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 old.
There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis. 6; see also graph on VTE risk). 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. shortness of breath, coughing) are non-specific and might be misinterpreted as more common or less […]