Instructions:
Clinical and pharmacological group
23.035 (Monophasic oral contraceptive with antiandrogenic properties)
Release form, composition and packaging
Film-coated tablets, two types.
Tablets, film-coated, yellow-orange, round, biconvex (21 pieces in a blister).
| 1 tab. | |
| cyproterone acetate | 2 mg |
| ethinylestradiol | 35 mcg |
Excipients: lactose monohydrate, povidone, sodium carboxymethyl starch (type A), colloidal anhydrous silicon dioxide, colloidal aluminum oxide, magnesium stearate.
Shell composition: dye Opadry II Yellow OY-L-32901 (lactose monohydrate, hypromellose 2910, titanium dioxide, macrogol 4000, yellow iron oxide, black iron oxide, red iron oxide, purified water).
Placebo tablets are white, round, biconvex (7 pieces in a blister).
Excipients: lactose monohydrate, povidone, sodium carboxymethyl starch (type A), colloidal anhydrous silicon dioxide, colloidal aluminum oxide, magnesium stearate.
28 pcs. — contour cell packaging (1) — cardboard packs, 28 pcs. — cellular contour packages (3) — cardboard packs.
pharmachologic effect
Combined low-dose monophasic oral contraceptive drug with antiandrogenic activity. The mechanism of action is due to the antiandrogenic steroid drug it contains - cyproterone acetate and oral estrogen - ethinyl estradiol.
Cyproterone acetate
It has the ability to competitively bind to the receptors of natural androgens (including testosterone, dihydroepiandrosterone, androstenedione), formed in small quantities in the body of women, mainly in the adrenal glands, ovaries and skin. By blocking androgen receptors in target organs, it reduces the phenomenon of androgenization in women (due to disruption of processes mediated by hormone-receptor complexes at the level of basic intracellular mechanisms). Thus, it becomes possible to treat diseases caused by increased production of androgens or specific sensitivity to these hormones.
While taking the drug, the increased activity of the sebaceous glands, which plays an important role in the occurrence of acne and seborrhea, decreases. After 3-4 months of therapy, the existing rash usually disappears. Excessive oiliness in hair and skin disappears even earlier. Hair loss, which often accompanies seborrhea, is also reduced.
Chloe® therapy in women of reproductive age reduces the clinical manifestations of mild forms of hirsutism; however, the effect of treatment should be expected only after several months of use.
Along with antiandrogenic properties, cyproterone acetate has gestagenic activity that imitates the properties of the corpus luteum hormone. Inhibits the secretion of gonadotropic hormones by the pituitary gland and inhibits ovulation, which causes a contraceptive effect.
Ethinyl estradiol
It enhances the central and peripheral effects of cyproterone acetate on ovulation, maintains the high viscosity of cervical mucus, making it difficult for sperm to penetrate into the uterine cavity and helping to ensure a reliable contraceptive effect.
While taking the drug, the cycle becomes more regular, painful menstruation is observed less frequently, the intensity of bleeding decreases, and the risk of iron deficiency anemia decreases.
Pharmacokinetics
Cyproterone acetate
Suction
After taking the drug orally, cyproterone acetate is completely absorbed from the gastrointestinal tract. Cmax in blood plasma is reached after 1.6 hours and is 15 ng/ml. Bioavailability is 88%.
Distribution
Cyproterone acetate is almost completely bound to plasma albumin, approximately 3.5-4% is in the free state. Since protein binding is nonspecific, changes in sex steroid binding globulin (SGBS) levels do not affect the pharmacokinetics of cyproterone acetate.
Metabolism
Biotransformed by hydroxylation and conjugation, the main metabolite is the 15b-hydroxyl derivative.
Removal
The pharmacokinetics of cyproterone acetate is biphasic: T1/2 is 0.8 hours and 2.3 days, respectively, for the first and second phases. Total plasma clearance is 3.6 ml/min/kg. It is excreted mainly in the form of metabolites by the kidneys and through the intestines in a ratio of 1:2, a small part - unchanged through the intestines. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk. T1/2 for cyproterone acetate metabolites is 1.8 days.
Ethinyl estradiol
Suction
After taking the drug, ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. Cmax is approximately 80 pg/ml and is achieved after 1.7 hours. Bioavailability is about 45%, has significant individual variability.
Distribution
Binding to proteins (albumin) of blood plasma is high: only 2% is found in plasma in free form.
Ethinyl estradiol increases the hepatic synthesis of SHBG and corticosteroid binding globulin (CBG) with continuous use. During Chloe® treatment, the serum SHG concentration increases from approximately 100 nmol/l to 300 nmol/l, and the serum concentration of DRG increases from approximately 50 μg/ml to 95 μg/ml.
Metabolism
During absorption and “first pass” through the liver, ethinyl estradiol undergoes intensive metabolism.
Removal
The pharmacokinetics of ethinyl estradiol is biphasic: T1/2 1-2 hours and approximately 20 hours, respectively. Plasma clearance is about 5 ml/min/kg. Ethinyl estradiol is excreted from the body in the form of metabolites: about 40% by the kidneys, 60% through the intestines. Up to 0.02% of the dose of ethinyl estradiol is excreted in breast milk.
Dosage
The drug should be taken orally, 1 tablet/day. The tablet is taken without chewing and washed down with a small amount of liquid. It is recommended to take the drug at the same time, preferably after breakfast or dinner.
Chloe® is started on the 1st day of the cycle, using the tablet of the corresponding day of the week from the calendar package. Daily administration of the drug is carried out using tablets from the calendar package sequentially in the direction of the arrow marked on the foil until all the tablets have been taken. After finishing taking all the yellow-orange tablets from the calendar pack, you must take the remaining white tablets over the next 7 days.
During the last 7 days of the treatment cycle (28 days), menstrual-like bleeding should occur (as a result of discontinuation of treatment). Menstruation usually begins 2-3 days after the 21st day of the drug treatment cycle.
The next package must be started the day after the tablets from the previous package are completely taken, regardless of whether bleeding continues/cessation.
When switching from combined oral contraceptives, the use of Chloe should begin the day after taking the last tablet with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in use (for drugs containing 21 tablets). Continue according to the scheme described above.
If the patient has taken the previous contraceptive daily for 28 days, Chloe® should be started after taking the last inactive tablet.
When switching from contraceptives containing only gestagens (“mini-pills”), Chloe® can be used without interruption.
When using injectable forms of contraceptives, Chloe® should be used from the day when the next injection is due.
When transitioning from an implant, Chloe should be used on the day of its removal.
In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of using the drug.
After an abortion in the first trimester of pregnancy, a woman can begin using Chloe® immediately. In this case, there is no need for additional methods of contraception.
After childbirth or abortion in the second trimester of pregnancy, use of the drug should begin on days 21-28. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of using the drug.
If a woman was sexually active in the period between childbirth or abortion and the start of using the drug, pregnancy should first be excluded or it is necessary to wait until the first menstruation.
The missed tablet should be taken as soon as possible, the next tablet at the usual time. If the delay is <12 hours, the reliability of contraception does not decrease. If the delay in taking the pill is >12 hours, the reliability of contraception may be reduced.
If the missed tablet is >12 hours late (the interval since the last tablet is >36 hours) during the 1st and 2nd weeks of taking the drug, the woman should take the last missed tablet as soon as possible: even if this means taking two tablets simultaneously. The next tablet should be taken at the usual time. Additionally, it is necessary to use a barrier method of contraception for the next 7 days.
If the missed tablet is >12 hours late (the interval since the last tablet is >36 hours) during the 3rd week of taking the drug, the woman should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. The next tablet should be taken at the usual time. Taking tablets from a new package should be started without interruption at the end of the current package. There will probably be no withdrawal bleeding until the end of the second pack, but spotting or breakthrough uterine bleeding is possible on the days of taking the pills.
If a woman has vomited within 3 to 4 hours after taking the drug, absorption of the active substances may be incomplete. In this case, you need to follow the recommendations when skipping a pill.
To delay the onset of menstruation, a woman should continue taking tablets from a new package of the drug immediately after taking all the tablets from the previous one, without interruption. Tablets from the new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should start taking the tablets from the next pack after you have completed taking all 28 tablets.
To move the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and, in the future, will have spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).
When treating hyperandrogenic conditions, the duration of use of the drug is determined by the severity of the disease. After the symptoms disappear, it is recommended to take the drug for at least 3-4 months. If a relapse occurs several weeks or months after completion of the course, re-therapy with Chloe® can be performed.
Overdose
Symptoms: nausea, vomiting, slight vaginal bleeding.
Treatment: carry out symptomatic therapy. There is no specific antidote.
Drug interactions
With simultaneous use of Chloe® with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and also possibly with oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinyl estradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decreased reliability of contraception.
When used simultaneously with ampicillin, rifampicin and tetracyclines, the contraceptive reliability of Chloe® is reduced.
Use during pregnancy and lactation
The use of the drug is contraindicated during pregnancy, suspected pregnancy and during breastfeeding.
Side effects
From the endocrine system: rarely - engorgement, pain, enlargement and discharge from the mammary glands, weight gain.
From the reproductive system: rarely - intermenstrual bleeding, changes in vaginal secretion, changes in libido.
From the central nervous system: rarely - headache, migraine, decreased mood.
From the digestive system: rarely - nausea, vomiting, gastralgia.
Other: very rarely - poor tolerance to contact lenses, swelling of the eyelids, blurred vision, conjunctivitis, hearing loss, allergic reactions, thrombophlebitis, thromboembolism, generalized itching, jaundice, the appearance of age spots on the face (chloasma).
These side effects may develop in the first few months of using the drug and usually decrease over time.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years.
Indications
- contraception in women with androgenization phenomena.
Androgen-dependent diseases in women:
— acne (especially its pronounced forms, accompanied by seborrhea, inflammation with the formation of nodules / papular-pustular acne, nodular-cystic acne/);
- androgenic alopecia;
- mild forms of hirsutism.
Contraindications
- thrombosis and thromboembolism, incl. history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
- arterial hypertension;
— diabetes mellitus complicated by microangiopathies;
- the presence of severe or multiple risk factors for venous or arterial thrombosis;
- diseases or severe liver dysfunction;
- liver tumors (including in history);
- hormone-dependent malignant tumors, incl. tumors of the breast or genital organs (including in history);
- congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes);
- pancreatitis (including a history), if it was accompanied by severe hypertriglyceridemia;
- uterine bleeding of unknown etiology;
— migraine, accompanied by focal neurological symptoms (including a history);
- sickle cell anemia;
- idiopathic jaundice or itching during the last pregnancy;
- otosclerosis worsening during pregnancy;
- hyperprolactinemia;
- period of breastfeeding;
— pregnancy or suspicion of it;
- age over 40 years;
- hypersensitivity to the components of the drug.
If any of these conditions develop for the first time while taking Chloe®, the drug should be discontinued immediately.
The drug should be used with caution in case of epilepsy, depression, ulcerative colitis, liver and gallbladder diseases, uterine fibroids, mastopathy, chorea, tetany, porphyria, multiple sclerosis, varicose veins, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles) .
special instructions
Before starting to use Chloe®, it is necessary to conduct a general medical examination (including mammary glands and cytological examination of cervical mucus), exclude pregnancy and disorders of the blood coagulation system. With long-term use of the drug, preventive control examinations must be carried out every 6 months.
If there are risk factors, the potential risk and expected benefit of therapy should be carefully assessed and discussed with the woman before starting the drug.
The estimated incidence of venous thromboembolism (VTE) with low-dose estrogen oral contraceptives (<50 mcg ethinyl estradiol) is up to 4/10,000 women per year compared with 0.5-3/10,000 women not taking oral contraceptives. However, the incidence of VTE when taking combined oral contraceptives is less than the incidence of VTE associated with pregnancy (6/10,000 pregnant women per year).
The patient should be warned that if symptoms of venous or arterial thrombosis develop, she should immediately consult a doctor. These symptoms include unilateral leg pain and/or swelling, sudden severe chest pain with or without radiation to the left arm, sudden shortness of breath, sudden coughing fit, any unusual, severe, prolonged headache, increased frequency and severity of migraines, sudden partial or complete loss of vision, diplopia, slurred speech or aphasia, dizziness, collapse with or without a partial seizure, weakness or very significant loss of sensation suddenly appearing on one side or in one part of the body, movement disorders, acute abdomen symptom complex.
The relationship between the use of combined oral contraceptives and arterial hypertension has not been established. If persistent arterial hypertension occurs, the drug should be discontinued and appropriate antihypertensive therapy should be prescribed. Taking the contraceptive can be continued if blood pressure normalizes.
If liver dysfunction occurs, temporary discontinuation of the drug may be required until laboratory parameters normalize.
Recurrent cholestatic jaundice, which develops for the first time during pregnancy or during previous use of sex hormones, requires discontinuation of combined oral contraceptives.
Although combined oral contraceptives have an effect on tissue resistance to insulin and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus. However, this category of patients should be closely monitored.
Women prone to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking combined oral contraceptives.
If symptoms have recently developed or become significantly worse in women with hirsutism, other causes, such as androgen-producing tumor, congenital adrenal dysfunction, should be considered in the differential diagnosis.
When using Chloe®, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of therapy. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.
If irregular bleeding recurs or develops after previous regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures (including diagnostic curettage) should be carried out to exclude malignancy or pregnancy.
In some cases, withdrawal bleeding may not develop during a break in drug use. If you do not take the pills regularly or in the absence of two menstrual-like bleeding in a row, pregnancy should be excluded before continuing to use the drug.
It is possible that the results of skin allergy tests may change and the concentrations of LH and FSH may decrease with the use of the drug.
Due to the fact that the contraceptive effect is fully manifested by the 7th day from the start of taking the drug, additional non-hormonal methods of contraception are recommended in the first week.
The use of the drug after childbirth is recommended no earlier than the first normal menstrual cycle.
Treatment should be stopped immediately 3 months before the planned pregnancy and approximately 6 weeks before the planned surgical intervention, with prolonged immobilization.
With diarrhea and vomiting, the contraceptive effect is reduced (without stopping the drug, additional non-hormonal methods of contraception should be used).
Women who smoke and take hormonal contraceptive drugs have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 30 years of age).
Use for renal impairment
The drug should be used with caution in case of kidney disease.
Use for liver dysfunction
The use of the drug is contraindicated for diseases or severe liver dysfunction, liver tumors (including a history), congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes), idiopathic jaundice or itching during the last pregnancy.
The drug should be used with caution for diseases of the liver and gallbladder.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Contraceptives Zentiva CHLOE - reviews
Mary
https://www.babyblog.ru/user/id1739735/313203
I took OK Chloe for 4 months. And everything would have been fine if the doctor had not prescribed clostilbegit, which I am well familiar with, from her friend. She didn’t prescribe any ultrasound, just drink and that’s it. As a result, I abandoned this doctor and changed gynecologist in January 2016. I switched to a paid doctor, but verified by 4 friends and acquaintances. I stopped taking Ok according to her prescription. I learned from her that if I would continue...
Anonymous
https://v_dguk.ukr/ru/contraceptives_zentiva_khloe-r975290.html
I'm happy with the tablets. The skin is already 2 blisters and has improved significantly. Almost cleaned up.
If we compare the antiandrogenic effect of Chloe and others - Zhanine or Novinet - then it is much stronger.
My appetite has not increased. In 2 months I haven’t gained a single extra kg. There is no cellulite or stretch marks, as you can sometimes read in someone’s reviews. - Don’t blame your appetite and laziness on pills.
Libido increased in the first month. Then it returned to its previous normal. No depression or psychosis.)
Lately, small titmouses have begun to appear on the veins (- But the legs themselves do not hurt.
Headache - headaches become more frequent and blood pressure rises more often - which also affects the headache. Not very strong. I manage without pills, but still(
Menstruation is painless. started already on the 5th day of withdrawal. The doctor said it was normal.
Price-380-450 rub. Dzhierik Diana 35. - Absolutely similar and much cheaper.
Breasts have not increased.
I would like to say that if your doctor prescribed them to you, do not be afraid to take them. And your weight will not increase if you take care of yourself and your diet. and it no longer depends on the pills.
It's been a year since I started drinking them:
The weight has not increased. With my 170cm - 53kg.
The breasts have increased by only 3 cm..- And it has stayed that way all this year
My veins stopped hurting after I started taking more vitamin C.
The headaches have gone away and have not bothered me for a long time.
The acne has gone away, but the skin and hair are still oily.
Sex: libido has not decreased, but the problem is that a feeling of dryness has appeared;) well, you know what I mean….
Stretch marks:
There was a period when they suddenly appeared on the lower back after I started stretching and in the background there were just such adjustments and getting used to Chloe. Perhaps even my husband doesn’t notice them, but there are a couple and I know it.
Mood:
Perhaps the only change is tearfulness.. Once I burst into tears in the supermarket because the last jar of yogurt was taken away in front of me. -mmm yes, that’s already a diagnosis)))
However, my condition is not depressed at all, and even everything is fine, it’s just that at times my reaction is now too emotional
Due to the facts that have emerged, I am reducing the rating to 4! but no less)
Thinglision
https://otzyv.expert/podoshli-otlichno-i-bez-pobochek-983984
Advantages:
no side effects
Flaws:
a little expensive
Details:
Hello! I decided to start with a review about Chloe. Why? Yes, I’ve just been using it for a long time, I’ve studied this drug inside and out on myself.)) They were recommended to me by a regular gynecologist from our free clinic. She simply advised based on age, examination and I don’t know what yet, apparently it was an open secret.)) I bought these pills and started taking them in October 2012. Looking ahead, I will say that I have been taking them for 2 years, and everything is fine. There are only 28 tablets, of which 21 are active (yellow) and 7 are white (placebo). The whole trick here is to take them correctly and not miss the time of taking them, this is undesirable, you are setting up the body to work artificially, try to be more careful, strong pills. I take them at 21:00, after eating (an important point), with a small amount of water. During all this long time of taking it, I had no spotting, no nausea, no unwanted pregnancy. After a year of taking it I took a break and everything was fine, the cycle did not stop. When I started taking it in the second year, I was pleased with my breasts - my breasts grew for 2 months, then everything returned to normal. Objectively, I will say that these tablets turned out to be ideal for me; for those who are interested, in our city they cost 430 rubles.
uhtiiii
https://kupi-slona.com/catalog/kontraceptivy-zentiva-hloe/1299416
Chloe bought contraceptives as a generic version of the more expensive Diane-35 (twice as expensive). At first I started taking Lindinet-20, but it didn’t suit me. I felt very bad with it, and when I started taking Diane-35 I immediately realized that it was for me. Feeling...
Anastasia
https://lekotzyvy.com/review.php?id=4052
I've been on Chloe for three years now. The reason for such loyalty is simple - among all the OCs I tried, only this remedy did not cause problems with libido and weight. From other pills, even those that cost more than Chloe, my desire disappeared after a maximum of 3-4 months of taking it. And if there is no attraction, and there is no need to accept OK, the logic is simple. In terms of weight, I am even more pleased - during this time it fluctuated slightly, I added only 1.4 kg, while from other OCs I sometimes gained 9-10 kg in a year. I’m generally silent about the cosmetic effect, Chloe means healthy skin, thick hair, mandatory breast growth (due to the presence of an artificial analogue of female hormones) and the complete destruction of all unsightly protruding hairs on the body. I also undoubtedly like the fact that Chloe does not have such a strong side effect - it has not caused me any problems with veins or liver over the years. The most interesting thing is that the longer you take the drug, the fewer side effects there are, not vice versa. If in the first two months I had severe cycle interruptions, my mood alternately changed from excellent to disgusting and sometimes vomited without stopping, then by the middle of the third there was no trace of all this.
Advantages: Does not cause a decrease in libido or weight gain, effective, good cosmetic effect, does not harm the liver and veins
Disadvantages: At the beginning of use it caused cycle interruptions, mood changes, vomiting
Inna
https://www.piluli.ru/product/Khloe/review
Chloe drank for two years between pregnancies, she did not gain any excess weight, and she felt normal. There were pimples on my face and they still remained, but they didn’t help) After the cancellation, pregnancy occurred three months later, but for the last year of taking it, I took Lavita, special vitamins, along with contraceptives, so that there were no consequences and to increase the chances of conception.
Margarita
https://med-otzyv.ru/lekarstva/164-h/36123-hloe
Between my first and second births, Chloe drank for three years. Then she became pregnant without any problems. So I don't believe the horror stories about oral contraceptives. Is abortion better?!
Miller1995
https://otzovik.com/review_3125094.html
Advantages:
Release form, quality, convenience.
Flaws:
Not detected.
In fact, contraception is a delicate matter. What suits me won't suit everyone. Of course, you need to consult a doctor. It so happened that my mother is a doctor. Dermatologist-venereologist. And she has every right to write prescriptions. You can't buy Chloe without a prescription, although it makes no sense. But that’s not about that now. Tablets in convenient packaging. Twenty-one tablets with the necessary hormones, and another seven placebos with a sweetener. The tablets are very small, easy to swallow, smooth-coated, biconvex. I have never had any particular problems with acne, so I can’t say that it helps in the fight against acne. But the skin itself becomes better, looks healthier, and the tone evens out. They work great. It's not a big deal even if you missed one day of your appointment. The next day, just take two tablets and you will be happy. It alleviates pain during menstruation, but that’s for me personally. I don’t gain weight from these hormonal pills, but then again, that’s me. A friend of mine who also takes the same pills, quite the opposite - she gets plump. I know for sure that “Chloe” performs its function with “Hurray!” I have been using this drug for five years and have no plans to replace it. Didn't cause an allergic reaction.
Anonymous170627
https://otzovik.com/review_519341.html
Advantages:
Good contraception, slightly enlarged breasts, skin, hair in good condition, stable cycle, price
Flaws:
decreased libido, astringent discharge in the first month.
I've been taking it for about a year. In general, the drug is good, I didn’t notice anything terrible. I started taking it after Yarina as a cheaper drug and the doctor prescribed it. But at the moment I want to try Midiana, my gynecologist also advised me. I haven’t gained any weight, quite the opposite.
Nadi 01
https://irecommend.ru/content/ono-togo-stoilo-5
Of course, before starting this review, I must warn you that the choice of OCs is individual, and the doctor should select them based on your hormonal tests.
A year ago I thought about starting to take OK. The first reason was, of course, the need for contraception, and of course it was not without the wonderful cosmetological properties I had heard, which I also needed because... my face, covered with acne, looked very much like a field after a bombing
