Charosetta tablets p / o, No. 28

Contraception.

Inside, at the same time, with a small amount of liquid.

Should take 1 table. Once a day, daily for 28 days, in the order indicated on the package. Reception of each subsequent pill from the package begins immediately after the end of the previous one, without any interruption.

How to start taking Charosetta

In the absence of previous use of hormonal contraceptives (for the last month)

The pill should be started on the first day of the menstrual cycle (the first day of menstrual bleeding). It is possible to start taking on the 2-5th day, but then during the initial cycle during the first 7 days of taking the drug, it is recommended to use an additional (barrier) method of contraception.

Switching from a combined oral contraceptive

You should start taking Charosetta the day after taking the last combined oral contraceptive pill containing hormones.

Switching from other drugs containing only progestogen (mini-pills, injections, implants)

A woman taking mini-pills can switch to Charosetta on any day using the implant - on the day of removal, using the drug in the form of injections - on the day when the next injection should be given. In all cases, during the first 7 days of taking Charosetta, it is recommended to additionally use barrier contraception.

After an abortion in the first trimester

A woman can start taking the drug immediately.

After childbirth or abortion in the second trimester

It is recommended to start taking the drug on the 21st or 28th day after childbirth or abortion. When you start taking the drug at a later date, it is recommended to use barrier methods of contraception during the first 7 days of taking the drug Charosetta. However, if a woman has already had sexual intercourse after childbirth or abortion before taking Charosetta, you should first exclude pregnancy before taking the drug or wait until the first menstruation.

What to do if you miss another drug intake

Contraceptive effectiveness may decrease if the interval between taking two tablets is more than 36 hours.

If taking the next pill is delayed by less than 12 hours, you should take the pill as soon as the woman remembers it, and take the next pills at the usual time.

If taking the next pill is delayed for more than 12 hours, you should adhere to the above rules for taking pills. However, over the next 7 days, you should additionally use barrier methods of contraception.

If the pill was missed in the first week of their use, and at the same time there was intercourse in the week preceding the missed pills, the possibility of pregnancy should be discussed.

Recommendations in case of vomiting

If vomiting occurs within 3-4 hours after taking the drug, absorption may be incomplete. In this case, you should use the recommendations regarding skipping the next dose of the drug.

If the woman does not want to change her usual dosage regimen, she needs to take additional pill (s) from a different package.

Film-coated tablets, white, round, biconvex, engraved with 'KV' above the number '2' on one side of the tablet and 'ORGANON' with a five-pointed star on the other side of the tablet; at the break - white.

1 tab.

desogestrel - 75 mcg

Excipients: corn starch - 6.5 mg, povidone - 1.95 mg, ?-tocopherol - 80 ?g, stearic acid - 650 ?g, colloidal silicon dioxide - 650 ?g, lactose monohydrate - up to 65 mg.

The composition of the film shell: opadry OY-S-28833 - 1.2 mg (hypromellose - 750 ?g, macrogol 400 - 150 ?g, titanium dioxide - 110 ?g, talc - 190 ?g).

• Hypersensitivity to desogestrel;

• the presence or history of venous thromboembolism (including deep vein thrombosis of the lower extremities, pulmonary embolism);

• severe liver disease at present or in history (before normalization of liver function indicators);

• liver failure currently or in history;

• established or suspected malignant hormone-dependent tumors (including breast cancer);

• vaginal bleeding of unknown etiology;

• established or suspected pregnancy;

• children and adolescents up to 18 years old.

With care: persistent arterial hypertension; long-term immobilization associated with surgery, disease or injury, liver cancer, chloasma, especially in women with a history of chloasma during pregnancy, diabetes mellitus, porphyria, systemic lupus erythematosus, herpes (with a history of pregnancy).

Clinical and pharmacological group: Gestagen for oral contraception

Pharmaco-therapeutic group: Progestogen

pharmachologic effect

A synthetic progestin, chemically similar to levonorgestrel. Possesses progestogenic activity. It causes the transition of the endometrial epithelium from the proliferative phase to the secretory phase. Increases the viscosity of cervical mucus. Inhibits the secretion of LH by the pituitary gland and thus inhibits ovulation. Possesses weak androgenic activity, which may not manifest itself.

Pharmacokinetics

After oral administration, desogestrel is rapidly absorbed. The average Cmax in serum is reached within 1.8 hours (Tmax) after administration. The bioavailability of etonogestrel is about 70%.

Etonogestrel is 95.5-99% bound to plasma proteins, mainly to albumin and to a lesser extent to sex hormone binding globulin (SHBG).

Css in blood plasma is established in 4-5 days.

Desogestrel is metabolized by hydroxylation and dehydrogenation to the active metabolite etonogestrel. Etonogestrel is metabolized by the formation of sulfate and glucuronide conjugates.

The average T1 / 2 of etonogestrel is about 30 hours, both with a single and multiple doses. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines (in a ratio of 1.5: 1) in the form of free steroids and conjugates.

Etonogestrel is excreted in breast milk.

Indications

Contraception.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside. The average daily dose is 150 mcg.

Side effect

From the side of the psyche: often - mood changes, decreased libido, depressive disorder.

From the nervous system: often - headache.

From the side of the organ of vision: infrequently - intolerance to contact lenses.

From the digestive system: often - nausea; infrequently - vomiting.

On the part of the skin and subcutaneous tissues: often - acne; infrequently - alopecia; rarely - skin rash, urticaria, erythema nodosum.

Reproductive system disorders: often - breast tenderness, irregular menstrual bleeding, amenorrhea; infrequently - dysmenorrhea, ovarian cyst, vaginitis; rarely - discharge from the mammary glands, ectopic pregnancy.

Others: often - an increase in body weight; infrequently - fatigue.

In women who received (combined) oral contraceptives, various serious undesirable effects were rarely observed: venous and arterial thrombosis and thromboembolism, hormone-dependent tumors (for example, breast cancer) and chloasma.

Contraindications for use

• Hypersensitivity to desogestrel;

• the presence or history of venous thromboembolism (including deep vein thrombosis of the lower extremities, pulmonary embolism);

• severe liver disease at present or in history (before normalization of liver function indicators);

• liver failure currently or in history;

• established or suspected malignant hormone-dependent tumors (including breast cancer);

• vaginal bleeding of unknown etiology;

• established or suspected pregnancy;

• children and adolescents up to 18 years old.

With care: persistent arterial hypertension; long-term immobilization associated with surgery, disease or injury, liver cancer, chloasma, especially in women with a history of chloasma during pregnancy, diabetes mellitus, porphyria, systemic lupus erythematosus, herpes (with a history of pregnancy).

Application during pregnancy and lactation

Use during pregnancy is contraindicated.

It can be used during breastfeeding according to indications.

Application for violations of liver function

Contraindicated for use in severe liver diseases, incl. history (before normalization of liver function indicators), as well as with liver failure, incl. history.

Application in children

Contraindicated for use in children and adolescents under the age of 18 years.

special instructions

Before using desogestrel, a thorough history should be taken and a gynecological examination should be performed to exclude pregnancy.

Despite the regular intake of desogestrel, irregular spotting is possible. If bleeding is frequent and irregular enough, it is necessary to decide on the appointment of another contraceptive. If the above symptoms continue to occur even after discontinuation of desogestrel, organic pathology should be excluded.

In patients with large body weight, the contraceptive effect of desogestrel is less effective.

Desogestrel can be used in combination with ethinyl estradiol.

Drug interactions

Possible drug interaction of desogestrel with drugs that induce microsomal enzymes, which leads to an increase in the clearance of sex hormones, for example, hydantoins (phenytoin), barbiturates (phenobarbital), primidone, carbamazepine, rifampicin; and probably also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin, and preparations containing St. John's wort . Women using any of these drugs should use a different method of contraception while using desogestrel.

When using activated carbon, the absorption of desogestrel may decrease and, therefore, contraceptive efficacy may decrease.