Medicinal Products

DESOGESTREL MYLAN 75 μg 0.075 mg

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

Coated tablet
Box of 1 Plate of 28
All forms

Indication

Oral contraception.

Dosage DESOGESTREL MYLAN 75 μg 0.075 mg Film-coated tablet Box of 1 Pack of 28

Administration mode

One tablet a day every day without interruption at the same time with a small amount of drink, 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 per day should be taken every day continuously, regardless of bleeding.

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

How to start a treatment with DESOGESTREL MYLAN

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). The treatment can also be started between the 2nd and the 5th day of the cycle, provided you use a mechanical contraceptive method known as barrier during the first seven days of taking contraceptive tablets.

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 childbirth, premature labor or after a second trimester abortion:

Contraceptive treatment by DESOGESTREL MYLAN 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 DESOGESTREL MYLAN and an additional method of contraception should be used within the first week of taking the tablets. contraceptives (see section on Pregnancy and lactation ).

How to start treatment with DESOGESTREL MYLAN in reliance on other contraceptive methods

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

The woman should start DESOGESTREL MYLAN preferably the day after taking the last active tablet (ie the last tablet containing active ingredients) 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.

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

The woman can also start DESOGESTREL MYLAN at the latest the day following the usual period without taking tablets or without use of patch or ring, or after the period of taking placebo of 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 device releasing a progestin):

In relay of a microprogestative pill, the woman will be able to relay any day. In relay of the implant or of an intrauterine device releasing a progestin, the day of their withdrawal; Relay of a progestin-only 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 it is noted more than 12 hours after the normal time of taking, the woman will have to use an additional method of contraception during 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 this section about forgetting 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 DESOGESTREL MYLAN regularly, irregular bleeding may occur. If bleeding is very common or irregular, another method of contraception should be considered. If the syptomas persist, an organic cause must be discarded.

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 DESOGESTREL MYLAN does not protect against HIV (AIDS) and other sexually transmitted diseases.

Pediatric population

The safety and effectiveness of desogestrel for adolescent girls under the age of 18 have not been measured yet. No data available.

Against indications

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

· Pregnancy known or suspected.

· Evolutionary venous thromboembolic accidents.

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

· Known or suspected tumors sensitive to sex steroids.

· Unexplained genital hemorrhage.

Side effects Desogestrel Mylan 75 μG

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.

Very common (≥1 / 10)

Frequent (≥1 / 100 to <1/10)

Uncommon (≥1 / 1, 000 to <1/100)

Rare (≥1 / 10, 000 to <1 / 1, 000)

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 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 ).

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 .

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions

via the national declaration system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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