Contraception.

How to take ANTIGONE 0.075 mg film-coated tablet

One tablet per day without interruption at the same time, so that the interval between taking 2 tablets is always 24 hours.
The first tablet should be taken on the first day of the rules.
Thereafter, a tablet should be taken daily, continuously, without considering possible bleeding.





How to start ANTIGONE 0.075 mg, film-coated tablet

No hormonal contraception (previous month)

The first tablet should be taken on the first day of the woman's menstrual cycle (ie the first day of menstruation). Treatment may also be started between the 2 nd and the 5 th day of the cycle if a mechanical contraceptive method (eg, condom) is used during the first seven days of taking ANTIGONE

After an abortion of the first quarter

After an abortion of the first trimester, it is recommended to start treatment immediately. In this case, it is not necessary to use an additional contraceptive method

After a childbirth or after a second trimester abortion

Contraceptive treatment by ANTIGONE after delivery can be started before the return of the rules. If more than 21 days have elapsed since childbirth, the possibility of pregnancy should be ruled out, before starting ANTIGONE and an additional mechanical contraceptive method should be used in the first week Of the contraceptive tablets

For additional information on breast-feeding, see section Pregnancy and lactation

How to start ANTIGONE 0.075 mg tablet, labeled in relay of other methods, contraceptives

Relapse of a combined hormonal contraceptive (oral contraceptive, combined (COC), vaginal ring or patch, transdermal)
The woman should start ANTIGONE preferably on the day after taking the last active tablet (ie, the last tablet containing the active substance), her previous COC or the day of withdrawal from the vaginal ring Or the transdermal patch. In these cases, the use of an additional contraceptive is not necessary.

All contraceptive methods may not be available in all countries of the European Union

The woman may also start ANTIGONE at the latest on the day following the usual period, without taking tablets or without using a patch or ring, or according to the placebo period of the previous COC. However, the use of an additional mechanical contraceptive method is recommended during the first 7 days of taking the tablets.

Relay of a single progestative method (microprogestative pill, injection, implant or intra-uterine device releasing a progestin)

In relay of a microprogestative pill, the woman can relay on any day (in relay of the implant or an intra-uterine device releasing a progestative, the day of their withdrawal, A progestin, injectable, on the day scheduled for the next injection).
Tips for forgetting a tablet

Contraceptive protection may be reduced if more than 36 hours elapse between 2 tablets

If forgotten is found within 12 hours after the usual time of taking, immediately take the forgotten tablet and take the next tablet at the usual time.

If forgetfulness is noticed more than 12 hours after the usual time of taking, the woman should take the last forgotten tablet as soon as it is forgotten and take the next tablet at the usual time If this leads to the taking of 2 tablets at the same time. In addition, a mechanical contraceptive method (eg, condom) should be used for the next 7 days. If this was forgotten during the first week of use and sexual intercourse took place during the 7 days preceding the forgetfulness, there is a risk of pregnancy
< Br>

Tips for gastrointestinal disorders

In the case of severe gastrointestinal disorders, absorption may not be complete and contraceptive measures must be taken.

If vomiting occurs within 3-4 hours after taking a tablet, absorption may not be complete. In this case, the advice given in the section on dosing and administration of tablets should be followed.

Monitoring the processing

Before any prescription, it is necessary to carry out a collection of personal and family history and a gynecological examination is recommended in order to rule out a pregnancy. Disorders of the rules, such as oligomenorrhea or amenorrhoea, should be sought before the prescription.

The interval between examinations depends on the circumstances in each individual case. If the prescribed treatment can affect latent or manifest disease (see Warnings and Precautions for Use), check-ups should be scheduled accordingly.

During regular administration of ANTIGONE, irregular bleeding may occur. If bleeding is very frequent or irregular, another method of contraception should be considered. If the symptoms persist, an organic cause must be discarded.

The management of amenorrhea during treatment depends on whether the tablets have been taken as directed and may include a pregnancy test.


Women should be warned that ANTIGONE does not protect against HIV / AIDS and other sexually transmitted diseases

Pediatric population

The safety and efficacy of desogestrel in adolescents under the age of 18 years have not been established No data is available >
White film-coated tablet, cylindrical, biconvex and approximately 6.00 mm in diameter.

Pharmacotherapeutic group: monocomponent (progestin) hormonal contraceptive

ATC code: G03AC09

ANTIGONE is a contraceptive only, progestin, containing desogestrel.

Like other progestin-only contraceptives, ANTIGONE is best suited for breastfeeding women and for those who can not or do not want to use estrogens. Unlike other contraceptives, only traditional progestins, the contraceptive effect of ANTIGONE is mainly related to inhibition of ovulation. Other effects include an increase in the viscosity of the cervical mucus.
In a two-cycle study where ovulation was defined as progesterone levels greater than 16 mmol / l for 5 consecutive days, the frequency of ovulation was 1% (1/103) with a confidence interval 95% 0.02% -5.29% in the intent-to-treat (ITT) group (taking into account user errors, and Method).

Inhibition of ovulation was obtained from the first cycle of use. In this study, after discontinuation of desogestrel after 2 cycles (56 consecutive days), the return of ovulation occurred on average after 17 days (between 7 and 30 days). >

In a comparative efficacy trial (with a cure time, a forgotten tablet at 3 hours maximum), the Pearl index of desogestrel calculated on the ITT population was 0.4 (confidence interval 95% confidence interval from 0.42 to 3.96) for 30 μg of levonorgestrel
< Br>

The Pearl index of desogestrel is comparable to that found historically for COCs in the general population using them.

Treatment with ANTIGONE leads to a decrease in estradiol levels at a level corresponding to that observed at the beginning of the follicular phase. No clinical effect on the metabolism of carbohydrates, lipids and hemostasis was observed.
Population, pediatric

None: Clinical efficacy and safety data is not available for adolescents under 18 years of age

ANTIGONE has no or negligible influence on the ability to drive and use machines.

· Known or suspected pregnancy.

· Evolving venous thromboembolic events.

· Presence or history of pathology, severe liver disease, as long as the parameters of liver function are not returned to normal

· Known or Suspected Tumors Sensitive to Sexual Steroids.

· Unexplained vaginal haemorrhage

Hypersensitivity to the active substance or to any of the excipients listed in the section Composition.
In the presence of any of the conditions or risk factors mentioned below, the benefits of using a progestin should be measured, in relation to the possible risks for each patient and discussed With her before she decides to start ANTIGONE. In case of aggravation, exacerbation or first appearance of any of these conditions, the patient should contact her doctor. The doctor will then have to decide whether to stop using ANTIGONE.

Breast cancer

The risk of breast cancer increases, usually with age. During the use of combined oral contraceptives (COCs), the risk of diagnosis of breast cancer is slightly increased. The increase in this risk disappears gradually within 10 years after cessation of treatment and is not related to the duration of use but to the age of the woman at the time of use. The number of diagnosed cases expected, for every 10,000 women using COCs (up to 10 years after discontinuation), compared to women who did not take COCs during the same period, was calculated for each Class and is presented in the table below

Age class

Number of cases expected in women using COCs

Number of cases expected in women, not using COCs

16-19 years old

4.5

4

20-24 years

17,5

16

25-29 years

48,7

44

30-34 years

110

100

35-39 years

180

160

40-44 years old

260

230

The risk in users of only progestin-only contraceptives, such as ANTIGONE, is potentially similar to that associated with taking COCs. However, for only progestational contraception, the evidence is less conclusive. Compared to the risk of developing breast cancer over the course of life, the increased risk associated with COCs is low. Cases of breast cancer diagnosed among COC users tend to be less advanced than women who have not. The increased risk for users of COCs may be due to a more early diagnosis, to the biological effects of the pill or to the combination of the two.
< Br>
Hepatic disorders

As a biological effect of progestins on liver cancer can not be ruled out, the benefit / risk ratio should be evaluated individually in women with liver cancer

In case of acute or chronic liver problems the patient should be referred to a specialist for examination and advice

Thromboses

Epidemiological studies have associated the use of COCs with an increased incidence of venous thrombosis (venous thromboembolic events, deep vein thrombosis, and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an estrogen is not known, ANTIGONE should be discontinued in the event of thrombosis. Long-term immobilization related to surgery or illness. Women with a history of venous thrombo-embolic disorders should be advised of the possibility of recurrence.
Patients with diabetes

Although progestins may have an effect on insulin peripheral resistance and on glucose tolerance there is no evidence of the need to modify the dosage regimen in women with diabetes using pills Containing only progestins. However, diabetic patients should be carefully monitored during the first months of use of ANTIGONE.
Hypertensive patients

If persistent hypertension develops during use, ANTIGONE, or if a significant increase in arterial pressure does not respond adequately to antihypertensive therapy, discontinuation of ANTIGONE should be considered.

Other conditions

Treatment with ANTIGONE leads to a decrease in the serum level of estradiol at a level corresponding to that observed at the beginning of the follicular phase. To date, it is not known whether this decrease has a clinically relevant effect on bone mineral density.

With traditional, progestin-only pills, protection from ectopic pregnancies is not as good as with COCs because of the frequent occurrence of ovulations in the use of pills Only progestins. Although ANTIGONE inhibits ovulation consistently, ectopic pregnancy should be considered for differential diagnosis if the woman has amenorrhea or abdominal pain.
< Br>
A chloasma may occasionally occur, especially in women with an antecedent of pregnancy chloasma. Women with a tendency to have chloasmas should avoid exposure to sunlight or UV rays when taking ANTIGONE

The following conditions have been reported both during pregnancy and during the use of steroids, but a correlation with progestogen intake has not been established: jaundice and / or cholestasis-related pruritus , Formation, gallstones, porphyria, lupus erythematosus, disseminated, haemolytic syndrome, uremic, Sydenham's chorea, herpes, gestational, hearing loss related to otosclerosis, hereditary angioedema. >

ANTIGONE contains 67.25 mg of lactose. This drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or malabsorption syndrome, glucose or galactose (hereditary diseases, rare).

Interactions between contraceptives, hormones and other drugs may lead to bleeding and / or contraceptive failure. The following interactions have been reported in the literature (mainly with combined oral contraceptives but occasionally, also with only progestin-only contraceptives).
Hepatic Metabolism: Interactions may occur with drugs that induce microsomal enzymes, which may lead to increased clearance of sex hormones, such as hydantoins (eg phenytoin), barbiturates (eg, Phenobarbital), primidone, carbamazepine, rifampicin, and also optionally oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum Perforatum)].

Maximum enzymatic induction is usually only observed after 2 to 3 weeks but may persist for at least 4 weeks or longer after discontinuation of therapy. Women treated with either of these medications should use a contraceptive method temporarily in addition to ANTIGONE. This mechanical contraceptive method should be used throughout the duration of the concomitant administration of the inducing treatment of microsomal enzymes and for 28 days after discontinuation thereof. >

In women treated with long-term liver enzymatic inducers, the use of a non-hormonal method should be considered.

During treatment with activated charcoal, the absorption of the steroids contained in the tablets may be reduced and therefore the contraceptive efficacy can be reduced as well. In these circumstances, advice regarding the forgetfulness of a tablet is applicable (see Dosage and Administration).

Hormonal contraceptives can alter the metabolism of other drugs. Therefore, plasma and tissue concentrations may be increased (eg ciclosporin) or decreased.
Examinations, biological s

The data obtained with the COCs have shown that contraceptive steroids may affect the results of certain biological tests including biochemical parameters, hepatic tests, thyroid tests, adrenal and renal function tests, serum protein levels (Carriers) such as corticosteroid binding globulin (CBG) and lipid / lipoprotein fractions, carbohydrate metabolism parameters as well as coagulation and fibrinolysis parameters. The modifications remain, usually within normal limits. It is not clear to what extent they apply equally to progestin-only contraceptives.

Not applicable.

There were no serious adverse reactions reported as a result of overdose. Symptoms of overdose include nausea, vomiting, and vaginal bleeding in young girls. There are no antidotes and treatment should be symptomatic.

Studies in animals have shown that very high doses of progestogenic substances can lead to masculinization of female fetuses.

Large-scale epidemiological studies have not shown an increased risk of malformations in children born of women who used COCs before pregnancy or teratogenicity when COCs were inadvertently used at the beginning of ;pregnancy. The pharmacovigilance data collected from the various COCs containing desogestrel also do not indicate an increase in risk.


Long-term, limited data are available in children whose mothers started taking desogestrel between the 4 th and 8 th week postpartum. They were breastfed for 7 months and followed up to the age of one and a half years (n = 32) or two years and half (n = 14). Assessment of growth, physical and psychomotor development showed no difference compared to breast-fed infants whose mothers had used an intrauterine device (IUD) with copper. Based on available data, ANTIGONE may be used during breastfeeding. Nevertheless, the development and growth of breast-fed infants whose mothers use ANTIGONE should be carefully monitored.
Other commonly reported adverse reactions (frequency> 2.5%) in clinical trials with desogestrel include acne, mood changes, mastodynia, nausea and weight gain. The adverse reactions mentioned in the table below have been considered by the investigators as having a certain, probable or possible causal relationship with the treatment.
Class of organ systems (MedDRA) version 12.0

Frequency of undesirable effects

Common

(≥1 / 100 to;