Chloe Tablets, box, 84 pcs., 35 mcg + 2 mg, for oral administration, film-coated

Compound

Conditions for dispensing from pharmacies

The drug Chloe is sold in pharmacies only with a doctor's prescription, since we are talking about a general contraceptive, a hormonal drug.

Moreover, you need to take a prescription for each new package of Chloe’s tablets, after undergoing preventive examinations.

If you self-medicate, you may encounter bleeding, side effects, and worsening of the situation, especially in cases of possible pregnancy.

Try to get a full recommendation from a doctor and take all tests to select the most effective remedy.

Remember that any drug, even a natural one, can harm the body or worsen existing problems.

The same applies to Chloe’s tablets, because they can lead to bleeding, spasms, increased lactation, poisoning and vomiting. It is important that the treatment process with tablets is supervised by the attending physician, even after completing the course of therapy three months later.

Pharmacodynamics

Combined low-dose monophasic oral contraceptive drug with antiandrogenic activity. The mechanism of action is due to its constituent antiandrogenic steroid drug - cyproterone acetate - and oral estrogen - ethinyl estradiol.

Cyproterone acetate 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 CHLOE®, 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, this usually leads to the disappearance of the existing rash. 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. It, like other drugs with gestagenic activity, inhibits the pituitary secretion of gonadotropic hormones and inhibits ovulation, which determines its contraceptive effect.

Ethinyl estradiol enhances the central and peripheral effects of cyproterone acetate on ovulation, maintains the high viscosity of cervical mucus, which makes it difficult for sperm to penetrate into the uterine cavity and helps ensure a reliable contraceptive effect.

While taking the drug, the cycle becomes more regular, painful menstruation is observed less frequently, the intensity of bleeding will decrease, resulting in a reduced risk of iron deficiency anemia.

Dosage and overdose

They start taking orange tablets, and then move on to white ones.
Chloe needs to take the tablets according to the instructions, the course that was developed by the doctor, according to the problems and age of the patient.

Usually this is one tablet a day, which it is advisable to take at the same time of day, with plenty of water.

They start taking Chloe's drug with orange tablets, and then move on to white tablets, after which there is no need to take a break.

If you missed taking Chloe's tablets, you need to take it within the first 12 hours , later you can double the dose.

Although it is better to use a barrier method of contraception for the next seven days.

The course of taking the drug can last for different times, this is determined by the doctor, usually about three to five months.

If you take large doses of the drug Chloe, you may encounter some adverse reactions, an overdose:

1. Nausea;
2. Headache;
3. Heat;
4. Vaginal bleeding.

You also need to consult a doctor, start symptomatic treatment and perform gastric lavage. Chloe's course of pills is usually interrupted or stopped completely.

Pharmacokinetics

Cyproterone acetate

Suction. After taking CHLOE® cyproterone acetate, it is completely absorbed from the gastrointestinal tract. After oral administration, 1 tablet. CHLOE®Cmax is 15 ng/ml and is achieved after 1.6 hours. 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. Up to 0.2% of the dose of cyproterone acetate is excreted in breast milk.

Metabolism and excretion. The pharmacokinetics of cyproterone acetate is biphasic, T1/2 is 0.8 hours and 2.3 days, respectively, for the first and second phases.

The total plasma clearance is 3.6 ml/min/kg. Biotransformed by hydroxylation and conjugation, the main metabolite is the 15b-hydroxyl derivative. 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.

T1/2 for cyproterone acetate metabolites is 1.8 days.

Ethinyl estradiol

Suction. After taking CHLOE® ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. During absorption and first passage through the liver, ethinyl estradiol undergoes extensive metabolism, which results in a bioavailability of approximately 45% and its significant individual variability. After oral administration of 1 tablet, film-coated CHLOE® Cmax is approximately 80 pg/ml and is achieved after 1.7 hours.

Distribution. The connection with proteins (albumin) of the blood plasma is high (2% are found in free form in the plasma).

Up to 0.02% of the dose of ethinyl estradiol is excreted in breast milk. Ethinyl estradiol increases the hepatic synthesis of SHBG and corticosteroid binding globulin (CBG) during continuous use. During treatment with CHLOE®, the serum SHG concentration increases from approximately 100 to 300 nmol/l, and the serum concentration of DRG increases from approximately 50 to 95 μg/ml.

Metabolism and excretion. The pharmacokinetics of ethinyl estradiol is biphasic, with T1/2 1–2 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.

Price for the drug

The price of Chloe may vary depending on the pharmacy, region, manufacturer, and number of packages.

Usually the cost is at the level of 700-1800 rubles, although if necessary, you can choose a substitute with a similar effect, but at a more affordable price.

Contraindications

hypersensitivity to the components of the drug;

simultaneous use with another hormonal contraceptive;

thrombosis (venous and arterial) or thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders, such as stroke);

conditions preceding thrombosis (including angina pectoris, transient ischemic attacks);

multiple or severe risk factors for venous or arterial thrombosis (including complicated heart valve defects, atrial fibrillation, cerebral or coronary artery disease; uncontrolled arterial hypertension, severe dyslipoproteinemia, subacute bacterial endocarditis, prolonged immobilization, surgical interventions on the lower limbs, neurosurgical operations, extensive trauma, smoking over the age of 35, obesity with a body mass index of more than 30 kg/m2);

identified hereditary or acquired predisposition to venous or arterial thrombosis, for example, resistance to activated protein C (APC), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);

diabetes mellitus with diabetic angiopathy;

severe liver disease currently or in history or severe liver dysfunction - no earlier than 6 months after normalization of liver function indicators;

liver tumors (benign and malignant);

hormone-dependent malignant tumors or suspicion of them, incl. tumors of the breast or genital organs (including in history);

bleeding from the vagina of unknown etiology;

pancreatitis with severe hypertriglyceridemia (including a history);

a history of migraine, which was accompanied by focal neurological symptoms;

breastfeeding period;

congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);

age over 40 years;

hyperprolactinemia;

lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

pregnancy or suspicion of it.

If any of these conditions develop for the first time while taking CHLOE®, the drug should be discontinued immediately.

CHLOE® is not intended for use in men.

With caution: 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), dyslipoproteinemia, sickle cell anemia, idiopathic jaundice or pruritus during a previous pregnancy, otosclerosis with hearing impairment during a previous pregnancy.

Storage conditions and periods

Chloe tablets can only be stored in a dry place, protected from sunlight, where the temperature is 15-20 degrees Celsius .

It is important to avoid contact with other drugs and liquids. Don't let children or mentally ill people use Chloe's pills.

The maximum shelf life of the product is no more than two years in the original packaging.

If it has expired, then Chloe must discard the drug and not take the pills.

Otherwise, it can cause a number of side effects, allergies and even poisoning. But even in this case, go to the hospital for help and gastric lavage.

Side effects

The side effects listed below are presented in accordance with the following gradations of frequency of their occurrence: very often (≥1/10); often (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); frequency unknown (frequency cannot be estimated from available data).

From the nervous system: often - headache; uncommon - migraine: frequency unknown - worsening of epilepsy.

On the part of the organ of vision: rarely - intolerance to contact lenses.

From the gastrointestinal tract: often - nausea, abdominal pain; infrequently - vomiting, diarrhea.

From the skin and subcutaneous tissues: infrequently - rash, urticaria; frequency unknown - erythema nodosum, erythema multiforme.

Metabolism and nutrition: often - weight gain; uncommon - fluid retention; rarely - weight loss.

From the immune system: rarely - hypersensitivity reactions.

From the genital organs and mammary gland: often - pain/tenderness in the mammary glands, engorgement of the mammary glands; infrequently - enlargement of the mammary glands; rarely - vaginal discharge, discharge from the mammary glands*; frequency unknown - acyclic spotting/bleeding (metrorrhagia).

Mental disorders: often - decreased mood, mood swings; infrequently - decreased libido; rarely - increased libido; frequency unknown - worsening of endogenous depression.

From the side of blood vessels: rarely - thromboembolism.

*In post-marketing studies, painful menstrual-like bleeding and absence of menstrual-like bleeding were reported, the frequency of which could not be assessed.

The following serious adverse events have been reported in women using COCs (which include CHLOE®):

- venous thromboembolic disorders;

- arterial thromboembolic disorders;

- stroke;

- increased blood pressure;

- hypertriglyceridemia;

- impaired glucose tolerance or effect on peripheral insulin resistance;

- liver tumors (benign and malignant);

- violation of liver functional parameters;

- chloasma;

- in women with hereditary angioedema, exogenous estrogens can cause or intensify the symptoms of angioedema;

- the onset or worsening of conditions for which the connection with the use of COCs (which includes the drug CHLOE®) is not indisputable: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during a previous pregnancy; hearing loss associated with otosclerosis; Crohn's disease; ulcerative colitis; cervical cancer;

- visual impairment;

- dizziness;

- pancreatitis;

- cholecystitis;

— the frequency of diagnosis of breast cancer in women using COCs (which includes the drug CHLOE®) is increased very slightly. Breast cancer is rarely observed in women under 40 years of age, the excess incidence is insignificant in relation to the overall risk of breast cancer. The cause-and-effect relationship between the occurrence of breast cancer and the use of COCs has not been established. For additional information, see the “Contraindications” and “Special Instructions” sections.

Analogue substitutes

There are also analogs and substitutes for Chloe tablets, which have the same contraceptive group, pharmacological action, indications and contraindications.

Although the composition may differ, as well as the price, because it is at the level of 400-2500 rubles.

We are talking about the following substitutes for Chloe:

1. Diana;
2. Erika;
3. Bellun;
4. Modell Pure.

Photo gallery:

Modell Pure

Erika

Diana

They also consist of ethinestradiol and cyproterone, and are produced in Germany and India.

But before starting a course with other tablets, you need to get permission, undergo diagnostics and understand compatibility with the components of the tablets. It is not allowed to interrupt the course of treatment.

Interaction

With simultaneous use of CHLOE® with inducers of microsomal liver enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin; and possibly oxcarbazepine, topiramate, felbamate and griseofulvin), the clearance of ethinyl estradiol and cyproterone increases, which can lead to breakthrough uterine bleeding or decreased reliability contraception.

When used simultaneously with ampicillin, rifampicin and tetracyclines, the contraceptive reliability of CHLOE® is reduced.

Instructions for use

Chloe needs to take one tablet per day, preferably at the same time of day, with water.

Start therapy with orange tablets, and then switch to white ones.

When the package runs out, start taking the orange ones again, without breaks for a week. White pills occur during the menstrual cycle.

In case of abortion, Chloe should start taking the drug on the same day.

If you need to delay menstruation, you need to take not a white, but an orange pill from a new pack.

If you do not take the drug on time, you may experience bleeding, vomiting and unwanted pregnancy.

Directions for use and doses

Orally, 1 tablet/day. The tablet is taken without chewing and washed down with a small amount of liquid. The time of taking the drug does not matter, however, subsequent doses should be taken at the same selected hour, preferably after breakfast or dinner.

If you have not taken any hormonal contraceptives in the previous month. Taking the drug CHLOE® begins on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding), using a tablet of the corresponding day of the week from the calendar package. It is possible to start taking it on the 2nd–5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first 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 21 tablets. yellow-orange color from the calendar package, 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 (bleeding as a result of discontinuation of treatment) should occur. Menstrual-like bleeding usually begins 2-3 days after the 21st day of the CHLOE® treatment cycle. The next package must be started the next day after taking the tablets from the previous package, regardless of whether bleeding continues or not.

When switching from combined contraceptive drugs (COCs, vaginal ring or contraceptive patch). Taking CHLOE® should be started the day after taking the last active tablet of the previous drug, but in no case later than the next day after the usual 7-day break in taking it (for drugs containing 21 tablets). Next - according to the scheme described above. If the patient took the previous contraceptive daily for 28 days, taking CHLOE® should be started after taking the last inactive tablet. Taking CHLOE® should be started on the day the vaginal ring or contraceptive patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.

When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implants, gestagen-releasing intrauterine contraceptive). When switching from a mini-pill, you can start taking CHLOE® without interruption.

When using injectable forms of contraceptives, taking CHLOE® begins on the day when the next injection is due. When switching from an implant - 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 taking the drug.

After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth, in the absence of breastfeeding or abortion in the second trimester of pregnancy, taking the drug should begin on the 21st–28th day. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the drug.

If a woman was sexually active in the period between childbirth or abortion and the start of taking CHLOE®, then pregnancy should first be excluded or you should wait until your first menstruation.

Taking missed pills

A woman should take the missed pill as soon as possible, and the next pill should be taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking pills is more than 12 hours, the reliability of contraception may be reduced. The more pills are missed and the closer the missed pill is to the 7-day break in taking pills, the greater the likelihood of pregnancy. In this case, you can be guided by the following two basic rules:

- taking the drug should never be interrupted for more than 7 days;

— to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous use of the drug are required.

Accordingly, the following recommendations can be given if the delay in taking the pills is more than 12 hours (the interval since the last pill was taken is more than 36 hours).

The first week of taking the drug. A woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days. If sexual intercourse took place during the week before missing the pill, the possibility of pregnancy must be taken into account.

Second week of taking the drug. A woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet is taken at the usual time.

Provided that the woman has taken the pills correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss 2 or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug. The risk of pregnancy increases due to the upcoming pill break, but if all pills have been taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods.

1. A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablets are taken at the usual time until the tablets in the current pack are gone. The next pack should be started immediately. Withdrawal bleeding is unlikely until the second pack of tablets is gone, but spotting and breakthrough bleeding may occur while taking the tablets.

2. A woman can also stop taking pills from the current package. She should then take a break of 7 days, including the day she missed the pill, and then start taking the pills from a new pack.

If a woman misses a pill and then does not have withdrawal bleeding during the break, pregnancy must be ruled out.

Recommendations for gastrointestinal disorders. 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.

Changing the day of menstrual bleeding. In order to delay the onset of menstrual bleeding, a woman should continue taking tablets from a new package of the drug immediately after taking all the tablets from the previous package, without interruption. The tablets from this new pack can be taken for as long as the woman wishes (until the pack runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking CHLOE® from a new pack after the usual 7-day break.

In order to move the day of the onset of menstrual-like bleeding 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 will continue to 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 menstrual-like bleeding).

When treating hyperandrogenic conditions, the duration of use is determined by the severity of the disease. After the symptoms disappear, it is recommended to take the drug for at least another 3-4 months. If a relapse occurs several weeks or months after completion of the course, repeated therapy with CHLOE® can be performed. If you resume taking the drug (after a 4-week break or more), the increased risk of VTE should be taken into account (see also “Special Instructions” and Precautions).

Children and teenagers. The drug CHLOE® is indicated only after the onset of menarche.

Postmenopausal patients. Not applicable. CHLOE® is not indicated after menopause.

Patients with liver disorders. CHLOE® is contraindicated in women with severe liver disease until liver function tests return to normal (see also Contraindications).

Patients with kidney disorders. CHLOE® has not been specifically studied in patients with renal impairment. Available data do not suggest changes in treatment in these patients.

Indications for use

There are a number of indications for which doctors recommend that patients take Chloe, usually these are:

• Androgen-dependent diseases;
• Acne, acne;
• Increased activity of the sebaceous glands;
• Contraception;
• Inhibition of the ovulation period;
• Normalization of the menstrual cycle.

You can also take Chloe tablets to normalize hormonal levels and eliminate PMS syndrome. But it is recommended to do this after diagnosis by a doctor, and even then the course may have adjustments.

Chloe tablets No. 28

Compound

Active ingredients: ethinyl estradiol - 35 mcg, cyproterone acetate - 2 mg. Excipients: lactose monohydrate, povidone, sodium carboxymethyl starch (type A), colloidal anhydrous silicon dioxide, colloidal aluminum oxide, magnesium stearate.

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.

Indications for use

• contraception in women with androgenization phenomena.

Androgen-dependent diseases in women:

• acne, especially its severe forms, accompanied by seborrhea, inflammation with the formation of nodes (papular-pustular acne, nodular-cystic acne);
• androgenetic alopecia;
• mild forms of hirsutism.

Contraindications

• simultaneous use with other hormonal contraceptives;
• thrombosis and thromboembolism, incl. history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders, such as stroke);
• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
• multiple or severe risk factors for venous or arterial thrombosis (including complicated heart valve defects, atrial fibrillation, cerebral or coronary artery disease; uncontrolled arterial hypertension, severe dyslipoproteinemia, subacute bacterial endocarditis, prolonged immobilization, surgical interventions on the lower limbs, neurosurgical operations, extensive trauma, smoking over the age of 35, obesity with a BMI of more than 30 kg/m2);
• identified hereditary or acquired predisposition to venous or arterial thrombosis, for example, resistance to activated protein C (APC), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
• diabetes mellitus with diabetic angiopathy;
• severe liver disease currently or in history or severe liver dysfunction no earlier than 6 months after normalization of liver function indicators;
• liver tumors (benign and malignant);
• hormone-dependent malignant tumors or suspicion of them, incl. tumors of the breast or genital organs (including in history);
• bleeding from the vagina of unknown etiology;
• pancreatitis with severe hypertriglyceridemia (including a history);
• a history of migraine, which was accompanied by focal neurological symptoms;
• pregnancy or suspicion of it;
• breastfeeding period;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
• age over 40 years;
• hyperprolactinemia;
• lactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome;
• 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.

Chloe® is not intended for use in men.

Chloe® should be used with caution in case of epilepsy, depression, ulcerative colitis, liver and gall bladder diseases, uterine fibroids, mastopathy, chorea, tetany, porphyria, multiple sclerosis, varicose veins, tuberculosis, kidney disease, in adolescence (without regular ovulatory periods). cycles), dyslipoproteinemia, sickle cell anemia, idiopathic jaundice or pruritus during a previous pregnancy, otosclerosis with hearing impairment during a previous pregnancy.

Directions for use and doses

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.

If you have not taken any hormonal contraceptives in the previous month

Chloe® is started on the 1st day of the cycle (i.e. on the first day of menstrual bleeding), using the tablet of the corresponding day of the week from the calendar package. It is allowed to start taking it on days 2-5 of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first 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 21 yellow-orange tablets from the calendar package, 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). Menstrual-like bleeding usually begins 2-3 days after the 21st day of the drug treatment cycle. The next pack must be started the day after the tablets from the previous pack are completely taken, regardless of whether bleeding continues or not.

When switching from combined contraceptives (oral contraceptives (COCs), vaginal ring, or contraceptive patch)

Taking Chloe® should be started the day after taking the last active tablet of the previous drug, but in no case later than the next day after the usual 7-day break in taking it (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. Taking Chloe® should be started on the day the vaginal ring or contraceptive patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.

When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implants, gestagen-releasing intrauterine contraceptive)

When switching from the mini-pill, Chloe® can be taken without interruption.

When using injectable forms of contraceptives, Chloe® should be taken from the day the next injection is due.

When switching 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 taking 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, in the absence of breastfeeding or abortion in the second trimester of pregnancy, taking 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 between childbirth or an abortion, then before starting to take Chloe®, pregnancy should first be excluded or you should wait until your first menstruation.

Taking missed pills

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. The more pills are missed and the closer the missed pill is to the 7-day break in taking pills, the greater the likelihood of pregnancy. In this case, you can be guided by the following two basic rules:

• taking the drug should never be interrupted for more than 7 days;
• To achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous use of the drug are required.

Accordingly, the following recommendations can be given if the delay in taking the pills is more than 12 hours (the interval since the last pill was taken is more than 36 hours).

First week of taking the drug

A woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet should be taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days. If sexual intercourse took place during the week before missing the pill, the possibility of pregnancy must be taken into account.

Second week of taking the drug

A woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet should be taken at the usual time.

Provided that the woman has taken the pills correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of pregnancy increases due to the upcoming pill break, however, if all pills have been taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods.

1. A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablets are taken at the usual time until the tablets in the current pack are gone. The next pack should be started immediately. Bleeding “breakthrough” bleeding while taking pills.

2. A woman can also stop taking pills from the current package. She should then take a break of 7 days, including the day she missed the pill, and then start taking the pills from a new pack. If a woman misses a pill and then does not bleed during the break, she will experience breakthrough uterine bleeding. You should resume taking Chloe® from a new pack after the usual 7-day break.

In order to move the day of the onset of menstrual-like bleeding 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 breakthrough bleeding while taking the second pack (just as if she wanted to delay the onset of menstrual bleeding).

In the treatment of hyperandrogenic conditions

The duration of treatment is determined by the severity of the disease. After the symptoms disappear, it is recommended to take the drug for at least another 3-4 months. If a relapse occurs several weeks or months after completion of the course, re-therapy with Chloe® can be performed. If you resume taking the drug (after a 4-week break or more), the increased risk of VTE should be taken into account.

Children and teenagers

Chloe® is indicated only after menarche.

Postmenopausal patients

Chloe® is not indicated after menopause.

Liver dysfunction

Chloe® is contraindicated in women with severe liver disease until liver function tests return to normal.

Renal dysfunction

Chloe® has not been specifically studied in patients with renal impairment. Available data do not suggest dose adjustment in such cases.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Best before date

3 years. Do not use after the expiration date.

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.

If the severity, intensification, or first manifestation of any of the following conditions or risk factors increases, discontinuation of the drug may be necessary.

The use of Chloe® leads to an increased risk of developing venous thromboembolism (VTE) compared with the risk in women not taking the drug. The additional risk of VTE is greatest during the first year of use of Chloe® or when use is resumed after a break of 4 weeks or more. VTE can be fatal in 1-2% of cases. The estimated incidence of VTE when taking oral contraceptives with low doses of estrogens (less than 50 mcg ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5-1 per 10,000 women not taking COCs. However, the incidence of VTE when taking COCs is lower than the incidence of VTE associated with pregnancy (6 per 10,000 pregnant women per year).

Epidemiological studies have shown that the incidence of VTE is 1.5 to 2 times higher in women taking Chloe® compared to COCs containing levonorgestrel, and similar for COCs containing desogestrel/gestodene/drospirenone. Patients with polycystic ovary syndrome have an increased risk of developing cardiovascular disease. Epidemiological studies have also shown an association between the use of hormonal contraceptives and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic attacks).

Thrombosis of other vessels, namely the veins and arteries of the liver, mesentery, kidney, brain or retina, has been extremely rarely reported in persons taking hormonal contraceptives.

The patient should be warned that if symptoms of venous or arterial thrombosis develop, she should immediately consult a doctor. These symptoms include unilateral lower extremity pain and/or swelling; sudden severe chest pain radiating to the left arm or without radiating; sudden shortness of breath; sudden attack of coughing; 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 partial seizure; weakness or significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; symptom complex “acute abdomen”.

The risk of VTE increases:

• with increasing age;
• when smoking (with heavy smoking and with increasing age, the risk further increases, especially in women over 35 years of age. Women over 35 years of age should be strongly advised to stop smoking if they want to take Chloe®);
• with a burdened family history (i.e., if there is a history of cases of venous thromboembolism at a relatively young age in parents or close relatives). If a hereditary predisposition is suspected, a woman should consult a specialist before deciding on any hormonal contraception;
• with prolonged immobilization, surgical interventions on the lower extremities, neurosurgical operations or extensive trauma. In these situations, it is necessary to discontinue use (in the case of planned surgery, at least 4 weeks in advance), and not resume it until 2 weeks have passed after complete restoration of motor activity. If Chloe® has not been discontinued in advance, antithrombotic therapy should be considered;
• for obesity (BMI more than 30 kg/m2).

The risk of arterial thromboembolic complications or cerebrovascular accident increases:

• with increasing age;
• when smoking (with heavy smoking and with increasing age, the risk further increases, especially in women over 35 years of age. Women over 35 years of age should be strongly advised to stop smoking if they want to take Chloe®);
• with dyslipoproteinemia;
• with arterial hypertension;
• for migraines;
• for diseases of the heart valves;
• with atrial fibrillation;
• with a burdened family history (i.e., if there is a history of cases of arterial thrombosis at a relatively young age in parents or close relatives). If a hereditary predisposition is suspected, a woman should consult a specialist before deciding on any hormonal contraception.

Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (namely Crohn's disease or ulcerative colitis) and sickle cell anemia.

The increased risk of thromboembolism in the postpartum period must be taken into account.

An increase in the frequency or severity of migraine attacks while using Chloe® (which may be a harbinger of cerebrovascular accident) is grounds for immediate discontinuation of the drug.

There is no consensus regarding the potential role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.

Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) .

When assessing the risk/benefit ratio, the physician should take into account that appropriate treatment of the underlying pathology may reduce the risk of thrombosis. Women taking Chloe® should be advised of the need to promptly report to their doctor if possible symptoms of thrombosis develop. In case of thrombosis or suspicion of its occurrence, treatment with Chloe® should be discontinued. Considering the teratogenicity of coagulants (coumarins), the use of adequate methods of contraception should be started.

Other states

In women with hypertriglyceridemia, while taking COCs (if there is a family history of this condition), there may be an increased risk of developing pancreatitis.

The relationship between taking COCs and arterial hypertension has not been established. If persistent arterial hypertension occurs, Chloe® 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 Chloe® may be necessary until laboratory parameters normalize. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COC use.

Although COCs have an effect on insulin resistance 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 under close medical supervision.

Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.

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.

While taking Chloe®, irregular bleeding (spotting or breakthrough bleeding) may sometimes 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 should be taken to exclude malignancy (including diagnostic curettage of the uterine cavity) or pregnancy. In some cases, withdrawal bleeding may not develop during a break from taking the pills. 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 take the drug.

It is possible that the results of skin allergy tests may change and the concentrations of LH and FSH may decrease. 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.

It is recommended to prescribe the drug after childbirth in the absence of breastfeeding only after the completion of the first normal menstrual cycle.

Treatment must be stopped 3 months before the planned pregnancy.

With diarrhea and vomiting, the contraceptive effect is reduced (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).

Tumors

There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. The connection with taking COCs has not been proven. It remains controversial to what extent these findings are related to cervical pathology or to characteristics of sexual behavior (less frequent use of barrier methods of contraception). The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in current or recent COC users is small relative to the overall risk of breast cancer. Its connection with COC use has not been proven. The observed increased risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.

In rare cases, the development of liver tumors has been observed during the use of COCs, which in some cases led to life-threatening intra-abdominal bleeding. This should be taken into account when making a differential diagnosis in the event of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Laboratory tests

The use of COCs may affect the results of laboratory tests, including biochemical indicators of the efficiency of the liver, thyroid gland, adrenal glands and kidneys, the concentration of plasma proteins, for example, corticosteroid binding globulin, as well as the lipid/lipoprotein composition of the blood, indicators of carbohydrate metabolism and indicators of the blood coagulation system. However, deviations usually remain within the range of normal laboratory values.

Description

Monophasic oral contraceptive with antiandrogenic properties.

Dosage form

Tablets, film-coated, yellow-orange, round, biconvex (21 pieces in a blister).
Tablets (placebo) are white, round, biconvex (7 pieces in a blister).

Pharmacodynamics

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.

Side effects

Determination of the frequency of adverse reactions: very often (≥1/10); often (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥ 1/10,000 to < 1/1000); very rare (<1/10,000); frequency unknown (frequency cannot be estimated from available data).

From the nervous system: often - headache; infrequently - migraine; frequency unknown - worsening of epilepsy.

On the part of the organ of vision: rarely - intolerance to contact lenses.

From the digestive system: often - nausea, abdominal pain; infrequently - vomiting, diarrhea.

From the skin and subcutaneous tissues: infrequently - rash, urticaria; frequency unknown - erythema nodosum, erythema multiforme.

Metabolism and nutrition: often - weight gain; uncommon - fluid retention; rarely - weight loss.

From the immune system: rarely - hypersensitivity reactions.

From the genital organs and mammary gland: often - pain/tenderness in the mammary glands, engorgement of the mammary glands; infrequently - enlargement of the mammary glands; rarely - vaginal discharge, discharge from the mammary glands*; frequency unknown - acyclic spotting/bleeding (metrorrhagia).

Mental disorders: often - decreased mood, mood swings; infrequently - decreased libido; rarely - increased libido; frequency unknown - worsening of endogenous depression.

From the cardiovascular system: rarely - thromboembolism.

*In post-marketing studies, painful menstrual-like bleeding and absence of menstrual-like bleeding were reported, the frequency of which could not be assessed.

Serious adverse events reported in women using COCs (including Chloe®)

From the cardiovascular system: venous thromboembolic disorders, arterial thromboembolic disorders, stroke, increased blood pressure.

Metabolic: hypertriglyceridemia, impaired glucose tolerance or effect on peripheral insulin resistance.

From the digestive system: liver tumors (benign and malignant), impaired liver function, pancreatitis, cholecystitis.

From the skin and subcutaneous tissues: chloasma.

Allergic reactions: In women with hereditary angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

From the nervous system and sensory organs: blurred vision, dizziness.

The occurrence or worsening of conditions, the connection of which with the use of COCs (which includes the drug Chloe®) is not indisputable: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham's chorea; herpes during a previous pregnancy; hearing loss associated with otosclerosis; Crohn's disease; ulcerative colitis; cervical cancer.

The incidence of breast cancer diagnosis in women using COCs (which include Chloe®) is increased very slightly. Breast cancer is rarely observed in women under 40 years of age, the excess incidence is insignificant in relation to the overall risk of breast cancer. The cause-and-effect relationship between the occurrence of breast cancer and the use of COCs has not been established.

Use during pregnancy and breastfeeding

The use of the drug is contraindicated during pregnancy, suspected pregnancy and during breastfeeding.

Interaction

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.

Overdose

Symptoms: nausea, vomiting, slight vaginal bleeding.

Treatment: carry out symptomatic therapy. There is no specific antidote.

Impact on the ability to drive vehicles and operate machinery

The drug Chloe® does not affect the ability to drive vehicles and machines.

Reviews

Victoria, 31 years old : “For a long time, my boyfriend and I were choosing a method of contraception, since condoms did not suit us, and I did not want to install a diaphragm. After consulting a doctor, a bunch of tests and reading reviews on the Internet, we settled on a drug like Chloe. It is especially suitable for young girls, it can heal the skin, restore the monthly cycle and even reduce the amount of bleeding. The first time the course lasted about three months, then I underwent an examination, everything turned out to be fine in the body and we continued further. Regarding adverse reactions, the most I had was a rash and a slight headache, and my breasts may swell before my period. But it passes quickly, literally in two days. Thanks to Chloe’s wonderful pills for a carefree life.”

Natalya, 26 years old : “Before taking the pills, Chloe managed to try a lot of things, even Diana and Eric. But they were not suitable for me due to adverse reactions and incompatibility with my renal failure. Therefore, the doctor advised Chloe to try the tablets, as they are suitable for girls under 40 years old and almost do not harm the body. The first course lasted two months, and I was satisfied. At the same time, I was able to treat PMS syndrome and no longer experience severe pain during menstruation. Regarding the menstrual cycle, it became as accurate as a clock. And it’s all thanks to Chloe’s pills!”