FAYE Cyproterone Acetate / Ethinyl Estradiol 2mg / 35mcg Film-Coated Tablet 21's

For the treatment of androgen-dependent diseases in women, such as acne, especially pronounced forms and those which are accompanied by seborrhea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenetic alopecia and mild forms of hirsutism.

 

Dosage regimen: How to take Cyproterone acetate + Ethinylestradiol (Faye): Cyproterone acetate + Ethinylestradiol (Faye) is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of Cyproterone acetate + Ethinylestradiol (Faye) is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Cyproterone acetate + Ethinylestradiol (Faye) can lead to intermenstrual bleedings and could deteriorate the therapeutic and contraceptive reliability.
Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. 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 usually occurs. This usually starts on day 2-3 after the last coated tablet and may not have finished before the next pack is started.
How to start Cyproterone acetate + Ethinylestradiol (Faye): No preceding hormonal contraceptive use (in the past month): Tablet-taking has to start on the day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.
Changing from a combined hormonal contraceptive (combined oral contraceptive/COC), vaginal ring, or transdermal patch: The woman should start with Cyproterone acetate + Ethinylestradiol (Faye) preferably on the day after the last hormone-containing tablet of her previous COC, but at the latest on the day following the usual tablet-free or hormone free tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Cyproterone acetate + Ethinylestradiol (Faye) preferably on the day of removal, but at the latest when the next application would have been due.
Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.
Following the first-trimester abortion: The woman may start immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion: For breastfeeding women see Pregnancy & Lactation.
Women 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 of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Cyproterone acetate + Ethinylestradiol (Faye) use or the woman has to wait for her first menstrual period.
Management of missed tablets: If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules: 1. Tablet-taking must never be discontinued for longer than 7 days.
2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis. Accordingly 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 taking two tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.
Week 2: The user 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 correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for7 days.
Week 3: The risk of reduced reliability is imminent because of the forthcoming tablet-free interval. However, by adjusting the tablet intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well.
1. The user 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. The next pack must be started as soon as the current pack is finished, i.e., no gap should be left between packs. 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.
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.
Advice in case of gastro-intestinal disturbances: In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, the advice concerning missed tablets, as given in section 'Management of missed tablet', is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
Length of use: The length of use depends on the severity of the symptoms of androgenization and their response to treatment. In general, treatment should be carried out several months. Acne and seborrhea usually respond sooner than hirsutism or alopecia.
It is recommended to take Cyproterone acetate + Ethinylestradiol (Faye) for at least another 3 to 4 cycles after the signs have subsided. Should there be a recurrence, weeks or months after discontinuation of tablet-taking, treatment with Cyproterone acetate + Ethinylestradiol (Faye) may be resumed. In case of a restart of Cyproterone acetate + Ethinylestradiol (Faye) (following a 4 week or greater pill free interval), the increased risk of VTE should be considered (see Precautions).
Additional information on special populations: Children and adolescents: Cyproterone acetate + Ethinylestradiol (Faye) is only indicated after menarche.
Geriatric patients: Not applicable. Cyproterone acetate+ Ethinylestradiol (Faye) is not indicated after menopause.
Patients with hepatic impairment: Cyproterone acetate + Ethinylestradiol (Faye) is contraindicated in women with severe hepatic diseases as long as liver function values have not returned to normal. See also Contraindications.
Patients with renal impairment: Cyproterone acetate + Ethinylestradiol (Faye) has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population.
Mode of administration: Oral use.

 

Overdosage

May be taken with or without food.

Preparations containing estrogen/progesterone combinations should not be used on the presence of any conditions listed as follows. Should any of the conditions appear for the first time during their use, the product should be stopped immediately. Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
Presence or history of prodomi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication (see Precautions).
History of migraine with focal neurological symptoms.
Diabetes mellitus with vascular involvement.
Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
Severe hepatic disease as long as liver function values not returned to normal.
Presence or history of liver tumors (benign or malignant).
Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breast).
Undiagnosed vaginal bleeding.
Known or suspected pregnancy.
Lactation.
Hypersensitivity to the active substances or to any of the excipients.
Cyproterone acetate + Ethinylestradiol (Faye) is not for use in men.

The clinical and epidemiological experience with estrogen/ progestogen combinations like Cyproterone acetate + Ethinylestradiol (Faye) is predominantly based on combined oral contraceptives (COC). Therefore, the following warnings related to the use of COC apply also for Cyproterone acetate + Ethinylestradiol (Faye).
Warnings: If any of the conditions/risk factors mentioned as follows is present, the benefits of use of Cyproterone acetate + Ethinylestradiol (Faye) should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether use of Cyproterone acetate + Ethinylestradiol (Faye) should be discontinued.
Circulatory Disorders: Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboemolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and cerebrovascular accidents. These events occur rarely.
The risk of VTE is highest during the first year of use. This increased risk is present after initially starting a COC or restarting (following a 4 week or greater pill free interval) the same or a different COC. Data from a large, prospective 3-armed cohort study suggest that this increased risk is mainly present during the first 3 months.
Overall the risk for venous thromboembolism (VTE) in users of low estrogen dose (< 50 μg ethinylestradiol) COC is two to threefold higher than for non-users of COCs who are not pregnant and remains lower than the risk associated with pregnancy and delivery.
VTE may be fatal (in 1-2 % of the cases).
Venous thromboembolism (VTE), manifesting as deep venous thrombosis and/or pulmonary embolism, may occur during the use of all COCs.
Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in COC users. There is no consensus as to whether the occurrence of these events is associated with the use of COCs.
Symptoms of deep venous thrombosis (OVT) can include: unilateral swelling of the leg 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 discolored 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 bring up blood; sharp chest pain which may increase with deep breathing; sense of anxiety; severe light headedness or dizziness; rapid or irregular heartbeat. Some of these symptoms (e.g. "shortness of breath", "coughing") are-non specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).
An arterial thromboembolic event can include cerebrovascular accident, vascular occlusion or myocardial Infarction (MI). Symptoms of a cerebrovascular accident can include: sudden numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure. Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity; acute abdomen.
Symptoms of MI can include: pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeats.
Arterial thromboembolic events may be fatal.
The risk of venous or arterial thrombotic/thromboembolic events or of a cerebrovascular accident increases with: age; obesity (body mass index over 30 kg/m²); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age). If a hereditary predisposition is known or suspected, the woman should be referred to a specialist for advice before deciding about any COC use; prolonged immobilization, major surgery, any surgery to the legs, or major trauma. In these situations it is advisable to discontinue COC use (in the case of elective surgery at least four weeks in advance) and not to resume until two weeks after complete remobilization.
Smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); dyslipoproteinemia; hypertension; migraine; valvular heart disease; atrial fibrillation.
There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
The increased risk of thromboembolism in the puerperium must be considered (for information on pregnancy and lactation see 'Pregnancy & Lactation').
Other medical conditions which have been associated with adverse circulatory events include diabetes mellitus, polycystic ovary syndrome, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative collitis) and sickle cell disease.
An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.
Biochemical factors that may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis include Activated Protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When considering risk/benefit, the physician should take into account that adequate treatment of a condition may reduce the associated risk of thrombosis and that the risk associated with pregnancy is higher than that associated with low-dose COCs (<0.05 mg ethinylestradiol).
Tumors: The most important risk factor for cervical cancer is persistent HPV infection. Some epidemiological studies have indicated that long-term use of COCs may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable to confounding effects, e.g., cervical screening and sexual behaviour including use of barrier contraceptives.
A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR=1.24) of having breast cancer diagnosed in women who are currently using COCs. The excess risk gradually disappears during the course of the 10 years after cessation of COC use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically that the cancers diagnosed in never-users.
In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of COCs. In isolated cases, these tumors have led to life-threatening intra-abdominal hemorrhages. A liver tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur in women taking COCs.
Other conditions: Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare. However, if a sustained clinically significant hypertension develops during the use of a COC then it is prudent for the physician to withdraw the COC and treat the hypertension. Where considered appropriate, COC use may be resumed if normotensive values can be achieved with antihypertensive therapy.
The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive; jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss.
In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal. Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of COCs.
Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using low-dose COCs (containing<0.05 mg ethinylestradiol). However, diabetic women should be carefully observed while taking COCs.
Crohn's disease and ulcerative colitis have been associated with COC use.
Choalasma may occasionally occur, especially in women with a history of choalasma gravidarum. Women with a tendency to choalasma should avoid exposure to the sun or ultraviolet radiation whilst taking COCs.
If in women suffering from hirsutism, symptoms have recently developed or increased substantially, the causes (androgen-producing tumor, adrenal enzyme defect) must be clarified by differential diagnosis.
Each coated tablet of this medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should take this amount into consideration.
Medical examination/consultation: A complete medical history and physical examination should be taken prior to the initiation or reinstitution of Cyproterone acetate + Ethinylestradiol (Faye), guided by the contraindications (see Contraindications) and warnings (see Precautions), and should be repeated periodically. Periodic medical assessment is also of importance because contraindications (e.g. a transient ischaemic attack, etc.) or risk factors (e.g. a family history of venous or arterial thrombosis) may appear for the first time during the use of a Cyproterone acetate + Ethinylestradiol (Faye). The frequency and nature of these assessments should be based on established practice guidelines and be adapted to the individual woman but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology.
Women should be advised that preparations like Cyproterone acetate + Ethinylestradiol (Faye) do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Reduced efficacy: The contraceptive effect of Cyproterone acetate + Ethinylestradiol (Faye) may be reduced in the event of e.g. missed tablets (see Management of missed tablets under Dosage & Administration), gastro-intestinal disturbances (see Advice in case of gastro-intestinal disturbances under Dosage & Administration) during tablet taking or concomitant medication (see Interactions). Reduced cycle control: With estrogen/progestogen combinations, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first month of use. Therefore, the evaluation of any irregular bleeding is only meaningful after adaptation interval of about three cycles.
If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy, these may include curettage.
In some women withdrawal bleeding may not occur during the tablet-free interval. If the COC has been taken according to the directions described in section 'Dosage & Administration', it is unlikely that the woman is pregnant. However, if the COC has not been taken according to these directions prior to the first missed withdrawal bleed or if two withdrawal bleeds are missed, pregnancy must be ruled out before COC use is continued.
Effects on ability to drive or use machines: No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of Cyproterone acetate + Ethinylestradiol (Faye).

 

Use In Pregnancy & Lactation

Side effects that have been reported in users of COCs but for which the association has been neither confirmed nor refuted are*:

*The most appropriate MedDRA term (version 12.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
The following serious adverse events have been reported in women using COCs, which are discussed in section 'Precautions'; Venous thromboembolic disorders; Arterial thromboembolic disorders; Cerebrovascular accidents; Hypertension; Hypertriglyceridemia; Changes in glucose tolerance or effect on peripheral insulin resistance; Liver tumours (benign and malignant); Liver function disturbances; Chloasma.
In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
Occurrence or deterioration of conditions for which association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Syndenham's chorea; herpes gestationis; otosclerosis-related hearing loss, Crohn's disease, ulcerative colitis, cervical cancer.
The frequency of diagnosis of breast cancer is very slightly increased among OC 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 see sections 'Contraindications' and 'Precautions'.

 

Effects of other medicaments on Cyproterone acetate + Ethinylestradiol (Faye): Interactions of other drugs (enzyme inducers, some antibiotics) with estrogen/progestogen combinations like Cyproterone acetate + Ethinylestradiol (Faye) may lead to breakthrough bleeding and/or contraceptive failure. Women on treatment with any of these drugs should be temporarily use a barrier method in addition to Cyproterone acetate + Ethinylestradiol (Faye) or choose another method of contraception. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation.
Women on treatment with antibiotics (except rifampicin and griseofulvin) should be use the barrier method until 7 days after discontinuation. If the period during which the barrier method is used runs beyond the end of the tablets in the Cyproteroneacetate + Ethinylestradiol (Faye) pack, the next pack should be started without the usual tablet-free interval.
Substances diminishing the efficacy of Cyproterone acetate + Ethinylestradiol (Faye) (enzyme-inducers and antibiotics): Enzyme induction (increase of hepatic metabolism): Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of sex hormones (e.g. phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort).
Also HIV protease (e.g. ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine), and combinations of them, have been reported to potentially increase hepatic metabolism.
Antibiotics (interference with enterohepatic circulation): Some clinical reports suggest that enterohepatic circulation of estrogens may decrease when certain antibiotic agents are given, which may reduce ethinylestradiol concentrations (e.g. penicillins, tetracyclines).
Effects of estrogen/progestogen combinations on other medicaments: Estrogen/progestogen combinations like Cyproterone acetate + Ethinylestradiol (Faye) may affect the metabolism of certain other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin) or decrease (e.g. lamotrigine).
Other forms of interactions: Laboratory tests: The use of preparations like Cyproterone acetate + Ethinylestradiol (Faye) may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

 

Caution For Usage

Storage

Action

Oral Contraceptives / Acne Treatment Preparations