Medicinal Products

ANTIGONE Ge 75 micrograms

Generic drug of Cerazette
Therapeutic class: Contraception and termination of pregnancy
active ingredients: Desogestrel
laboratory: Besins Healthcare

Coated tablet
Box of 3 Pads of 28
All forms

Indication

Contraception.

Dosage ANTIGONE Geu 75 micrograms Film-coated tablet Box of 3 Wafers of 28

How to take ANTIGONE 0.075 mg, film-coated tablet

One tablet a 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 menstruation.

Thereafter, one tablet should be taken every day continuously, regardless of possible bleeding.

A new plate must be started immediately the day after the previous plate has been completed.

How to start ANTIGONE 0.075 mg film-coated tablets

No previous hormonal contraception (during the previous month):

The first pill should start on the first day of the woman's menstrual cycle (ie, the first day of menstruation). Treatment can also be started between the 2nd and 5th day of the cycle provided that a mechanical contraceptive method (eg condom) is used for the first 7 days of taking ANTIGONE.

After a first trimester abortion:

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

After a delivery or after a second trimester abortion:

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

For additional information on breastfeeding, see section Pregnancy and breastfeeding .

How to get started ANTIGONE 0.075 mg film-coated tablet relays other contraceptive methods

Relay of combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch):

The woman should start ANTIGONE preferably the day after taking the last active tablet (ie the last tablet containing the active substance) of its previous COC or the day of withdrawal of the vaginal ring or the transdermal patch. In these cases, the use of additional mechanical contraception is not necessary.

Not all contraceptive methods may be available in all countries of the European Union.

The woman can also start ANTIGONE at the latest the day following the usual period without taking of tablets or without use of patch or ring, or then following 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 progestogen-only method (microprogestative pill, injection, implant or intrauterine device releasing a progestin):

In relays of a microprogestative pill, the woman will be able to relay any day (in relay of the implant or of a device intrauterine releasing a progestative, the day of their withdrawal, in relay of a progestative injectable, 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 you forget to take 12 hours after the usual time, take the missed tablet immediately and take the next tablet at the usual time.

If the forgetfulness is observed more than 12 hours after the normal time of the catch, the woman will have to take the last forgotten tablet as soon as the oblivion is observed and to take the next tablet at the usual time, even if that leads to taking 2 tablets at the same time. In addition, a method of mechanical contraception (eg condom) should be used for the next 7 days. If this forgetfulness occurred during the first week of use and sexual intercourse took place during the 7 days preceding this forgetfulness, there is a risk of pregnancy.

Tips for gastrointestinal disorders

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

If vomiting occurs within 3-4 hours after taking a tablet, absorption may not be complete. In such a case, the advice given in the section Dosage and method of administration concerning the omission of a tablet should be followed.

Treatment monitoring

Before any prescription, it is necessary to carry out a collection of the personal and family antecedents and a gynecological examination is recommended in order to avoid a pregnancy. Rule disorders such as oligomenorrhea or amenorrhea should be sought before prescribing.

The interval between exams depends on the circumstances in each individual case. If the prescribed treatment may influence latent or manifest disease (see Warnings and Precautions section ), the control tests should be scheduled accordingly.

When taking ANTIGONE regularly, irregular bleeding may occur. If bleeding is very common or irregular, another method of contraception should be considered. If symptoms persist, an organic cause must be ruled out.

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

Treatment should be stopped if pregnancy occurs.

Women should be warned that ANTIGONE does not protect against HIV (AIDS) or other sexually transmitted diseases.

Pediatric population

The safety and effectiveness of desogestrel in adolescents under the age of 18 have not been established. No data is available.

Against indications

· Pregnancy known or suspected.

· Evolutionary venous thromboembolic accidents.

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

· Known or suspected tumors sensitive to sex steroids.

· Unexplained vaginal haemorrhage.

Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.

Antigonal effects GE

The most frequently reported adverse reaction in clinical trials is the irregularity of bleeding. Up to 50% of women using desogestrel reported irregular bleeding. As desogestrel causes ovulation inhibition close to 100%, unlike other progestin-only pills, irregular bleeding is more common than with these other pills. In 20% to 30% of women, bleeding may occur more frequently, whereas in 20% of women bleeding may be less frequent or absent altogether. Vaginal bleeding may also be longer. After a few months of treatment, bleeding tends to be less frequent. Information, tips and a bleeding tracker can help women better accept them.

The other most commonly reported adverse reactions (> 2.5% frequency) in clinical trials with desogestrel are: acne, mood changes, mastodynia, nausea, and weight gain. The undesirable effects listed in the table below were considered by the investigators to be causally certain, probable or possible with the treatment.

System Organ Class (MedDRA) version 12.0

Frequency of adverse effects

Frequent

(≥1 / 100 to <1/10)

Rare

(≥1 / 1000 to <1/100)

Rare

(≥1 / 10, 000 to <1/1000)

Infections and infestations

Vaginal infections

Psychiatric disorders

Mood modification, decreased libido

Nervous system disorders

headaches

Eye disorders

Contact lens intolerance

Gastrointestinal disorders

nausea

vomiting

Skin and subcutaneous tissue disorders

Acne

Alopecia

Rash, hives, erythema nodosum

Disorders of reproductive organs and breast

Mastodynia, irregular bleeding, amenorrhea

Dysmenorrhea, ovarian cyst

General disorders and administration site conditions

Tired

investigations

Weight gain

Breast discharge may occur during the use of ANTIGONE. In rare cases, ectopic pregnancies have been reported (see Warnings and Precautions ).

In women using oral contraceptives (combined) a number of (serious) side effects have been reported. They include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumors (eg liver tumors, breast cancer) and chloasma, some of which are detailed in the Warnings and Precautions for Use section .

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