Medicinal Products

DESOGESTREL EG 0075 mg

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

Compressed
box of 3 pads of 28
All forms

Indication

Oral contraception.

Dosage DESOGESTREL EG 0075 mg tablet box of 3 platelets of 28

Oral contraception.

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 ).

Undesirable 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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