Medicinal Products

ANTIGONE Ge 75 micrograms Tablet box of 1 plate 28

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

Coated tablet
All forms

Indication

Contraception.

Dosage ANTIGONE Ge 75 micrograms Tablet box of 1 plate 28

Contraception.

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.

Side effects Antigone 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 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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