See the package insert for Cilest (Ethinylestradiolum, Norgestimatum). Check the composition, use, dosage and description of the preparation. COMPOSITION, DESCRIPTION OF ACTION, INDICATIONS, CONTRAINDICATIONS, RECOMMENDED PRECAUTIONS, INTERACTION WITH OTHER MEDICINES, DOSAGE AND ADMINISTRATION, ADVERSE EFFECTS.
Cilest FLYER
manufacturer: Janssen-Cilag International N.V.
tablets
Active substances: Ethinylestradiol, Norgestimate
ATC code: G 03 A A 11
Synonyms:
Ethinylestradiol Aethinyloestradiolum; Ethinyl Estradiol; Éthinylestradiol; Ethinylestradiolum; Ethinylestradiol; Etinilestradiol; Etinilestradiolis; Etinilöstradiol; Etinilösztradiol; Ethinylestradiol; Etinyyliestradioli; Ethinylestradiol Norgestimate Dexnorgestrel Acetime; Norgestimaatti; Norgestimate; Norgestimato; Norgestimatum
Indications: contraception
ATTENTION! The patient information leaflet is included in the package of the medicine. Contains information for the patient on the correct use of the drug.
Cilest®
tablets
Composition
One tablet contains: 0.250 mg Norgestimatum
0.035 mg Ethinyloestradiolum
Excipients:
Anhydrous lactose, modified starch, magnesium stearate, indigo carmine aluminum lake.
Description of actionCilest® inhibits the secretion of gonadotropins as a result of the estrogenic and progestagenic effects of ethinylestradiol and norgestimate. The primary mechanism of action is inhibition of ovulation. The change in the properties of the cervical mucus and the endometrium may also contribute to the contraceptive effect.
Other activities not related to pregnancy prevention.
Effects on menstruation: increase the regularity of the menstrual cycle, decrease blood loss and decrease the incidence of iron deficiency anemia, decrease the incidence of dysmenorrhea.
Effects related to ovulation inhibition: reduction of the incidence of functional ovarian cysts, reduction of the incidence of ectopic pregnancies.
Other activities: reduction of the incidence of fibroadenomas, mastopathy, reduction of the incidence of acute pelvic inflammatory diseases, reduction of the incidence of endometrial cancer, reduction of the incidence ofovarian cancer.
IndicationsOral contraception.
Contraindications- Thrombophlebitis or other thromboembolic disorders
- Previous deep vein thrombophlebitis or other thromboembolic disorders - Cerebral circulation disorders or coronary artery disease
- Migraine with focal aura
- Known or suspected breast cancer
- Complicated valvular heart disease
- Severe hypertension (constant systolic blood pressure equal to or greater than 160 mm Hg and diastolic blood pressure greater than or equal to 100 mm Hg)
- Diabetes mellitus with vascular complications
- Endometrial cancer or other diagnosed neoplasm estrogenic or suspected estrogen cancer
- Undiagnosed abnormal vaginal bleeding
- Jaundice due to cholestasis (cholestatic) in pregnancy or jaundice with a history of oral contraceptive use
- Acute or chronic hepatocellular disease with hepatic impairment y
- Adenoma or liver cancer
- Pregnancy or presumption of pregnancy
- History of pregnant herpes (diagnosis confirmed by skin biopsy)
- Hypersensitivity to any component of the preparation
Special warnings and recommended precautions
When determining the risk-benefit ratio of OCs, it is important to check for the conditions listed below that may increase the risk of complications related to with the use of oral contraception:- Disorders that may increase the risk of developing venous thromboembolic complications, e.g. prolonged immobilization or major surgery- Risk factors for arterial disease, e.g. smoking, elevated blood levels serum lipids (hyperlipidemia), hypertension or obesity
- Hypertension (constant systolic blood pressure between 140 and 159 mm Hg, and diastolic blood pressure between 90 and 99 mm Hg)
- Diabetes
- Has a history of severe depression or a history of severe depression
- Smoking
General
Oral contraceptives DO NOT protect against human immunodeficiency virus (HIV) infection or any other sexually transmitted disease.
A complete history and physical examination should be performed before prescribing an OC. Medical examinations should be repeated periodically, in accordance with generally applicable rules.
It is recommended to check the medications taken by the woman who presents to prescribe an oral contraceptive. This also applies toherbal preparations (especially St. John's wort Hypericum perforatum). Please refer to the patient information leaflets of any medicines taken with the oral contraceptive (see Interactions with other medicines).
If there is undiagnosed, persistent, or recurrent vaginal bleeding, appropriate testing should be performed to exclude the presence of a malignancy.
The oral contraceptive can be used not earlier than three months after the liver function parameters have returned to normal after hepatitis. This period must be at least six months in the event of severe hepatitis.
Thromboembolic and other vascular disorders
There is evidence of an increased risk of thromboembolic and other vascular disorders with the use of oral contraceptives. The relative risk in women using oral contraceptives is higher compared to the relative risk in women not taking oral contraceptives, respectively: 3 times the incidence of superficial vein thrombosis for the first time, 4 to 11 times the incidence of deep vein thrombosis, or pulmonary embolism and 1.5 to 6 times in women with factors predisposing to the development of venous thromboembolism. The risk of thromboembolism associated with the use of oral contraceptives does not depend on the duration of their use and disappears after the end of taking the preparations.
There was a 2 to 4-fold increase in the relative risk of thromboembolic complications after surgery in women taking oral contraceptives. The relative risk of developing a venous thrombosis is twice as high in women with predisposing factors for their development compared with women without such factors.
Where possible, in the case of elective surgeries that are associated with the risk of thromboembolic disorders, the use of oral contraceptives should be discontinued at least four weeks before and two weeks after surgery, as well as during prolonged postoperative the period of immovable property. Moreover, in the period immediately after delivery, there is an increased risk of developing thromboembolic disorders, therefore, in women not planning to breastfeed, oral contraceptives should be taken no earlier than 3 weeks after the day of delivery. After a miscarriage that occurs at or after 20 weeks of pregnancyOral contraceptives can be used 21 days after a miscarriage or on the first day of the first spontaneous menstrual bleeding, whichever comes first.
The relative risk of arterial thrombosis (e.g. stroke, myocardial infarction) is greater in the presence of predisposing factors such as smoking, hypertension, elevated serum lipids (hyperlipidaemia), obesity, diabetes, pre-eclampsia in an interview and older age. These serious vascular complications have occurred with the use of oral contraceptives containing 50 micrograms or more of estrogen. The risk of vascular disorders may be lower with lower doses of oral contraceptives of oestrogens and progestogens.
The risk of serious cardiovascular side effects increases with age and with heavy smoking. The risk is significant in women over the age of 35 who smoke. Women using oral contraceptives should be advised to stop smoking.
Increased blood pressure has been reported in women taking oral contraceptives. The increase in blood pressure is more common in older women and in users of long-term contraception. Many women had their blood pressure returned to normal after stopping oral contraceptives. There was no difference in the incidence of hypertension between the group of women who have ever used oral contraceptives in the past and the group of women who have never used oral contraceptives.
In women with arterial hypertension (systolic blood pressure from 140 to 159 mm Hg / diastolic blood pressure from 90 to 99 mm Hg), lower to normal values and monitor blood pressure before starting the use of oral contraceptives. . In the event of a significant increase in blood pressure, oral contraceptives should be discontinued.
Cases of retinal thrombosis have been reported with the use of oral contraceptives. Oral contraceptives should be discontinued in the event of unexplained transient partial or complete loss of vision, blurred or double vision, macular edema or retinal vascular changes. In such situations, the cause of the disorders should be diagnosed immediately andapply appropriate treatment.
Liver tumors
The incidence of benign and malignant liver tumors (liver adenomas and hepatocellular carcinomas) is low. The risk of these tumors may increase due to the fact and the length of time that oral contraceptives have been used. Rupture of hepatic adenomas can be fatal due to intra-abdominal haemorrhage.
Cancer of the reproductive organs and the breast
Women who are currently taking oral contraceptives or have taken them in the last 10 years have a slightly higher risk of having breast cancer diagnosed, but when diagnosed with cancer, the risk is usually limited to the mammary gland. The age at which a woman stops taking oral contraceptives is an important risk factor for developing breast cancer. The later the age at discontinuation of OCs, the greater the likelihood of a diagnosis of breast cancer. The duration of oral contraceptive use was of less importance in this respect.
Women should consider the possibility of increasing the risk of developing breast cancer in relation to the benefits of using oral contraceptives.
Effect on metabolism
Oral contraceptives may cause glucose tolerance disturbances. This effect is directly related to the dose of estrogen. The steroidal female sex hormones produced and secreted by the corpus luteum of the ovary in the luteal phase (progestogens) may increase insulin secretion and make tissues resistant to insulin, the severity of which depends on the type of progestogen used. In he althy (nondiabetic) women, oral contraceptives have no effect on fasting serum glucose. Due to the effect of oral contraceptives, women with prediabetes or diabetes who are taking oral contraceptives should be closely monitored.
A small percentage of women taking oral contraceptives have persistently elevated levels of serum triglycerides (hypertriglyceridaemia).
Headache
If migraine begins or worsens, or if an unusual, recurrent, persistent, or severe headache occurs, stop using the oral contraceptive pill and investigate the cause of the headache.
Irregular bleeding
Women may experience breakthrough bleeding, spotting and / or no bleeding in women taking COCs, especially during the first three months of use.bleeding. It should be determined whether there is another cause of these disorders and, if necessary, additional tests should be performed to exclude cancer or pregnancy.
Some women may experience amenorrhea or infrequent menstruation after discontinuing oral contraceptive use, especially if the abnormalities occurred prior to commencing oral contraceptive use.
Spotty discoloration of the skin, mostly on the face (chloasma)
Chloasma may rarely occur in women taking oral contraceptives, especially in women who have had chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking the preparation. Chloasma often does not resolve completely after discontinuation of the preparation.
Use during pregnancy and breastfeeding
Cilest® should not be used during pregnancy.Effects on the ability to drive motor vehicles, use of machines and psychophysical fitness
Cilest® has no influence on the ability to drive vehicles and operate moving mechanisms.Interactions with other drugs (interactions).
The metabolism of oral contraceptives can be influenced by various medications and herbal preparations, including St. John's wort. The effectiveness of the preparation is significantly reduced by factors that increase the metabolism and excretion of active substances. These include factors that stimulate estrogen metabolising enzymes, and factors that influence the enterohepatic circulation of estrogens. The reduced efficacy of the estrogen component of the oral contraceptive may cause spotting, breakthrough bleeding or contraceptive failure. It is possible that the stimulation of the same isoenzymes may also lead to a decrease in the concentration of the progestogen component of Cilest® in the blood. Medicines and herbal preparations known to have a stimulating effect on the enzymes responsible for the breakdown of steroid hormones in oral contraceptives (e.g. St. John's wort, barbiturates, phenytoin sodium, and especially rifampicin) are of clinical significance. Certain protease inhibitors and certain antiretroviral agents increase (e.g. indinavir) or decrease (e.g. ritonavir) the blood levels of the active substances of combined hormonal contraceptives.Another type of interaction is the disturbance of the enterohepatic circulation of oestrogens, which may lead to an acceleration ofexcretion of active substances and reduced effectiveness of oral contraceptives. Such an interaction is observed, for example, when a drug (e.g. cholestyramine) is combined with conjugated estrogens from bile or when the degradation of conjugates by intestinal bacteria is impaired (e.g. after the use of some antibiotics - ampicillin or tetracycline).A reduction in the effectiveness of the contraceptive effect was found with the simultaneous use of Cilest®, rifampicin and St. John's wort preparations. Interactions with topiramate, barbiturates, phenylbutazone, phenytoin sodium, carbamazepine have been reported. Interactions with griseofulvin, ampicillin, (troglitazone) and tetracyclines are possible.
The effect of Cilest® on laboratory test results
Oral contraceptives may affect the results of some endocrine and liver function tests and blood tests:
- Increase in prothrombin levels and factors II, VII, VIII, IX, X, XII and XIII; decrease in the concentration of antithrombin 3; enhancement of noradrenaline-induced platelet aggregation.
- Increase in thyroid hormone binding globulin (TBG), which leads to an increase in total blood thyroid hormone levels as measured by protein-bound iodine (PBI), and thyroxine as measured by column chromatography or by radioimmunoassay. Reduction of free triiodothyronine resin uptake corresponding to an increase in TBG. The concentration of free thyroxine remains unchanged.
- There may be an increase in the concentration of other binding proteins in the blood serum.
- The concentration of sex hormone binding globulin increases, which leads to an increase in the levels of total sex hormones in the blood. However, free or biologically active hormone levels either decrease or remain unchanged.
- There may be an increase in high-density lipoprotein (HDL) cholesterol and total cholesterol. There may be an increase or a decrease in low density lipoprotein (LDL) cholesterol with a decrease in LDL-C / HDL-C ratio and unchanged triglycerides. The effects mentioned above depend on the dose of estrogen and progestogen and the type of progestogen.
- Worsening of glucose tolerance may occur.
- The level of folic acid in the blood serum may decrease with the use of oral contraceptives. This may be of clinical relevance if a woman becomes pregnant shortly after discontinuing oral treatment
Dosage and administration
Efficacy of oral contraceptive preparationsWhen used exactly as prescribed without skipping any tablets, the probability of pregnancy is less than 1% (i.e. less than 1 in 100 women using the preparation for one year). The average failure rate is 5% during the first year of use. The likelihood of becoming pregnant increases with each missed tablet in that cycle.Use in adults
To achieve maximum contraceptive effectiveness, Cilest® tablets should be taken exactly as prescribed and in the right order, every day at the same time, e.g. at bedtime. Take the tablets each day without a break as follows: Take one tablet once a day with water, at the same time of the day for 21 days. After taking the last tablet, no tablets should be taken for 7 days. During the period when you are not taking your medicine, you can expect some bleeding, usually 2 to 4 days after taking the last tablet. At the end of this 7-day period, a new cycle of taking Cilest® tablets should be started, even in the event that bleeding has not occurred or has not been completed.
In the first cycle of application, the preparation should be started on the first day of menstrual bleeding ( as described above). The drug should be taken with water at the same time of the day for 21 days. When taken as recommended, Cilest® has a contraceptive effect starting from the first day of taking, and during the 7-day period of not taking tablets (between consecutive packages of the preparation).
Children
Safety and efficacy of Cilest® have been established in women of childbearing age. The drug should not be used in girls before the onset of menstruation.
Elderly people
The preparation is not recommended for postmenopausal women.
Starting Cilest® use in women previously taking another combined oral (estrogen-progestogen) contraceptive.
When switching from another combined oral contraceptive, Cilest® should be started between 1 to 7 days after taking the last pill used in the previous cycle of contraceptive pill. The interval between taking the last tablet of the previously used preparation and taking the first tablet of Cilest® should not be longer than 7 days. In the case of a break longer than 7 days between admissions in the previous cycle, the last onecontraceptive pill and taking the first Cilest® pill is necessary to use an effective, additional, non-hormonal method of contraception. It should be used for a week, i.e. until you have taken seven tablets of Cilest®.
Starting treatment with Cilest® in women previously taking another oral (progestogen-only) contraceptive.
When switching from a progestin-only contraceptive, you should start taking Cilest® on the first day after taking the last tablet of the previously used preparation. An additional non-hormonal method of contraception should be used during the first 7 days.
Use of Cilest® after childbirth
Women who have decided not to breastfeed may start using an oral contraceptive, including Cilest®, not earlier than 3 weeks after delivery (see Thromboembolic and other vascular disorders and Pregnancy and breast-feeding). If you decide to start using Cilest® later than 21 days after giving birth, your doctor may decide whether it is necessary to use an additional, non-hormonal method of contraception together with Cilest® for the first 7 days, or whether you should wait until Cilest® is administered. your first menstrual bleeding.
Use after a miscarriage
After a miscarriage that occurs before 20 weeks gestation, you can start taking oral contraceptives immediately. No additional contraceptive measures are required.
After or after abortion in the 20th week of pregnancy, hormonal contraceptive use can be started on day 21 after the miscarriage or on the first day of the first spontaneous menstrual bleeding, depending on what will come sooner. A non-hormonal method of contraception should be used concomitantly during the first 7 days of the first cycle. In exceptional cases, when there are indications to start an effective method of contraception immediately after a miscarriage, Cilest® should be started within the first week after the miscarriage. One should take into account the increased risk of thromboembolic disorders in the period immediately after the miscarriage.
What to do if you miss tablets on timethis fact. Take the next tablet at the scheduled time. This means that two tablets can be taken in one day.
If you forget to take two tablets during the first or second week of the cycle, take two tablets on the day you remember to take the preparation and two tablets on the next day. Then take one tablet a day as directed, until all tablets in the pack have been used. In addition, an additional, effective, non-hormonal method of contraception should be used every day until the seventh tablet is taken consecutively.
If you have not taken two tablets in the third week of using the preparation, do not take more tablets from this package, throw them away and start taking tablets from the next package on the same day. In addition, an additional, effective non-hormonal method of contraception should be used every day until the seventh tablet is taken consecutively.
If you have not taken three tablets in the first three weeks of using the preparation, do not take more tablets from this package, throw them away and start taking tablets from the next package on the same day. In addition, an additional, effective non-hormonal method of contraception should be used every day until the seventh tablet is taken consecutively.
Breakthrough bleeding or spotting
If breakthrough bleeding or spotting occurs, continue using contraception. Breakthrough bleeding is more likely to occur with the use of low-estrogen inhibitory preparations (ovulation inhibitors). This type of bleeding often stops after a few cycles. In the event of persistent intermenstrual bleeding, consult a gynecologist.
If there is no bleeding during the tablet-free period (withdrawal bleeding), continue to take the contraceptive pill. If the oral contraceptive has been taken correctly, the absence of bleeding during the tablet-free period does not necessarily indicate pregnancy. Nevertheless, pregnancy must be ruled out.
Management of vomiting
If vomiting occurs within 3 hours of taking the tablet, or if severe diarrhea persists for more than 24 hours, the contraceptive efficacy of the preparation may be reduced. If vomiting or diarrhea stops quickly, effective contraception will be maintained, provided that the same dayyou will take a second tablet of Cilest®. In the event of vomiting or diarrhea lasting 24 hours or more, contraceptive effect may be reduced and an additional, non-hormonal method of contraception should be used until the day of taking seven tablets consecutively (daily).
Overdose
Life-threatening symptoms caused by OC overdose have not been described. Overdose may cause nausea and vomiting, and in girls - vaginal bleeding. There are no antidotes and treatment should be symptomatic.
Side effects
The following side effects have been reported with the use of oral contraceptives (see Special warnings and precautions for use).
- Cardiovascular system: hypertension, myocardial infarction, cerebral circulation disorders, deep vein thrombosis, arterial thromboembolism, pulmonary embolism and other embolisms.
- Tumors: benign liver tumors, malignant liver tumors, cervical cancer, breast cancer.
- Liver and biliary tract: intrahepatic cholestasis, gallstones.
- Miscellaneous: severe headache, migraine, optic nerve damage.
Other side effects
- Cardiovascular system: slight increase in blood pressure, edema.
- Reproductive system: breakthrough bleeding, spotting, amenorrhea, no withdrawal bleeding, changes in severity menstrual bleeding, increased size of uterine fibroids, vaginal candidiasis, intensification of cervical erosion and cervical gland secretion.
- Breast: tenderness, galactorrhoea, pain, enlargement, decreased milk secretion when used immediately after delivery.
- Digestive tract: nausea, vomiting, abdominal cramps, gas, colitis. Skin: erythema nodosum, rash, chloasma, erythema multiforme, acne, seborrhea, alopecia, hirsutism (hirsutism, hypertrichosis), pemphigoid (gestational herpes), discoloration that may not go away after withdrawal, bleeding eruptions.
- Liver and bile ducts: cholestatic jaundice, Budd-Chiari syndrome.
- Eyes: corneal curvature changes (maceration), contact lens intolerance, cataracts. Central nervous system: headache, mood changes, depression, irritability, chorea. Metabolic disorders: fluid retention, weight changes (increase or decrease), impaired glucose tolerance, changes in appetite.
- Other: changes in sex drive (libido), tension syndromepremenstrual, temporary, transient infertility after discontinuation of the preparation.
- Urinary system: renal dysfunction, hemolytic uremic syndrome.
Inform your doctor about the occurrence of these or other side effects.
Do not use the preparation after the expiry date.
Storage
Store in the original package.
Store at a temperature below 25 ° C.
Keep out of reach of children.
Available packages
Immediate packaging
Blister containing 21 tablets
Multipack
Blisters are packed in cardboard boxes
One carton contains 1 or 3 blisters of Cilest® tablets.
Marketing authorization holder
Janssen - Cilag International NV
Turnhoutseweg 30
B - 2340 Beerse
Belgium
Manufacturer to whom the batch of the medicinal product is released
Janssen Pharmaceutica NV
Turnhoutseweg 30
B - 2340 Beerse Belgium
For more information, please contact the representative of the responsible entity:
Janssen-Cilag Polska Sp. z o.o.
ul. Iłżecka 24
02-135 Warszawa
Date of the leaflet: October 3, 2007
ATTENTION! The patient information leaflet is included in the package of the medicine. Contains information for the patient on the correct use of the drug.