Medicinal Products

DESOPOP G 75 micrograms 0.075 mg

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

Coated tablet
Box of 1 Plate of 28
All forms

Indication

Oral contraception.

Dosage DESOPOP Ge 75 micrograms 0.075 mg Film-coated tablet Box of 1 Plate of 28

Route of administration: oral.

How to take DESOPOP 75 micrograms, 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, a tablet should be taken daily without interruption, regardless of possible bleeding.

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

How to start DESOPOP 75 micrograms, 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 may also be started between the 2nd and 5th day of the cycle provided that a mechanical contraceptive method is used for the first 7 days of DESOPOP.

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 contraceptive method.

After a delivery or after a second trimester abortion:

Contraceptive treatment with DESOPOP after delivery 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 DESOPOP and a complementary method of contraception should be used within the first week of taking the contraceptive tablets .

For breastfeeding women, see section Pregnancy and breastfeeding .

How to start DESOPOP in relays of other contraceptive methods

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

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

The woman can also start DESOPOP at the latest the day following the usual period without taking tablets or without use of patch or ring, or after the period of placebo of the previous COC. However, the use of a mechanical contraceptive method is recommended during the first 7 days of taking 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.

Recommendations in case of 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 collect personal and family history and a gynecological examination is recommended to rule out a pregnancy. Rule disorders such as oligomenorrhea or amenorrhea should be sought before prescribing.

The interval between exams depends on each individual case. If it is possible that the prescribed treatment influences a latent or patent disease (see Warnings and Precautions section ), the control tests should be scheduled accordingly.

When taking DESOPOP 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 taking the tablets according to the instructions or not and may include performing a pregnancy test.

Treatment should be stopped if pregnancy occurs.

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

Against indications

· 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.

Side effects Desopop GE 75 micrograms

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 can also be prolonged.

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.

Within each frequency group, adverse effects are presented in order of decreasing severity.

Very common (≥1 / 10)

Frequent (≥1 / 100 to <1/10)

Uncommon (≥1 / 1, 000 to <1/100

Rare (≥1 / 10, 000 to <1/1000)

Very rare (<1 / 10, 000)

Frequency unknown (can not be estimated from the available data.

Class of organ systems

Frequency of adverse effects

Frequent

Rare

Rare

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 the genital tract and breasts

Mastodynia, irregular bleeding, amenorrhea

Dysmenorrhea, ovarian cyst

General disorders and condition related to the site of administration

Asthenia

Examination results

Weight gain

Breast flow may occur during the use of desogestrel. 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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