Medicinal Products

DESOGESTREL EG 0.075 mg

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

Compressed
Box of 1 Plate of 28
All forms

Indication

Oral contraception.

Dosage DESOGESTREL EG 0.075 mg Tablet Box of 1 Plate of 28

Administration mode

The tablets should be taken in the order indicated on the blister pack at approximately the same time each day with a little water if necessary, so that the interval between 2 tablets is always 24 hours.

One tablet should be taken daily for 28 consecutive days, regardless of possible bleeding.

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

How to start treatment with DESOGESTREL EG

No previous hormonal contraception (during the previous month)

The first tablet should start on the first day of the woman's natural cycle (ie the first day of menstruation). It is possible to start between the 2nd and 5th day of the cycle, but in this case, during the first cycle, additional mechanical contraception (for example, a condom) should be used for the first 7 days of treatment. tablets.

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

The woman should start DESOGESTREL 0.075 mg tablet 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 patch transdermal. In these cases, it is not necessary to use additional mechanical contraception.

The woman may also start DESOGESTREL EG no later than the next day after the usual period without taking pills or using a patch or ring, or following the period of taking placebo tablets from the previous COC. However, the use of additional contraception is recommended for the first 7 days of taking the tablets.

Relay of a progestogen-only method (microprogestative pill, injection, implant or intrauterine system (IUS) releasing a progestin)

In reliance on a microprogestative pill, the woman can start any day. Relaying an implant or an SIU: the day of removal; in relay of a progestin injectable, the day envisaged for the following injection. There is no need to use additional mechanical contraception.

After a first trimester abortion

After a first trimester abortion, it is recommended to start taking the tablets immediately. In this case, it is not necessary to use additional mechanical contraception.

After a birth or after a second trimester abortion

DESOGESTREL EG can be started 21 to 28 days after second trimester birth or abortion. If taking the tablets starts later, the possibility of pregnancy should be ruled out before starting DESOGESTREL EG and an additional method of mechanical contraception should be used for the first seven days of taking the tablets (see section Pregnancy). and breastfeeding ).

Tips for forgetting a tablet

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

If it is missed within 12 hours of the usual time of taking a tablet, the woman should immediately take the missed tablet and take the next tablet at the usual time.

If forgetfulness is noted more than 12 hours after the usual time of taking a tablet, the woman should immediately take the forgotten tablet and take the next tablet at the usual time, even if it leads to taking two tablets at the same time. In addition, the woman will have to use an additional method of mechanical contraception (for example, a condom) 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

If vomiting or severe diarrhea occurs within 3-4 hours of 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.

In the case where a new tablet is needed, if the woman does not want to change her normal schedule of taking the tablets, she can take the extra tablet (s) in another wafer.

Against indications

Only progestin-only contraceptives should not be used if any of the situations listed below are present. If any of these conditions occur for the first time while using DESOGESTREL EG, this medicine should be discontinued immediately.

· Hypersensitivity to the active substance or to any of the excipients.

· Evolutionary venous thromboembolic accidents.

· Presence or history of severe liver disease, as long as hepatic function parameters are not normalized.

· Malignant tumors sensitive to known or suspected sex steroids.

· Unexplained genital bleeding.

· In combination with St. John's Wort (see section Interactions with other medicinal products and other forms of interaction ).

Adverse effects Desogestrel EG

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

* MedDRA version 9.0

Class of organ systems

(MedDRA *)

Frequency of adverse effects

Frequent

≥ 1/100

Rare

<1/100, ≥ 1/1000

Rare

<1/1000

Infections and infestations

Vaginal infections

Psychiatric disorders

Mood modification, decreased libido, depressed mood

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

Asthenia

investigations

Weight gain

Breast flow may occur during the use of desogestrel. In rare cases, ectopic pregnancies have been reported (see Warnings and Precautions ). Angioedema or worsening of angioedema (hereditary) may also occur (see Warnings and precautions for use ).

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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