Medicinal Products

ELLAONE 30 mg

Generic drug of the therapeutic class: Contraception and termination of pregnancy
Active ingredients: Ulipristal
laboratory: Hra Pharma

Compressed
box of 1 plate of 1
All forms

Indication

Emergency contraception within 120 hours (5 days) of unprotected intercourse or failure of a contraceptive method.

Dosage ELLAONE 30 mg tablet box of 1 plate of 1

Emergency contraception within 120 hours (5 days) of unprotected intercourse or failure of a contraceptive method.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Ellaone side effects

Summary of the security profile

The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.

The safety of ulipristal acetate was evaluated in 4, 718 women during the clinical development program.

Summary table of adverse effects

Adverse events reported during the Phase III program involving 2, 637 women are presented in the table below.

The side effects listed below are classified by frequency and organ system classes. Within each frequency group, adverse effects are presented in order of decreasing frequency.

The following adverse reactions are listed by organ system and frequency order: very common ≥1 / 10), common (≥ 1/100 to <1/10), uncommon (≥1 / 1000 to <1) / 100) and rare (≥ 1/10 000 to <1/1000).

MedDRA

Side effects (frequency)

Class of organ systems

Very common

Frequent

Rare

Rare

Infections and infestations

Influenza

Metabolism and nutrition disorders

Appetite disorders

Psychiatric disorders

Mood disorders

Emotional disorders

Anxiety

Insomnia

Hyperactivity Disorders

Changes in libido

disorientation

Nervous system disorders

Headache Dizziness

Drowsiness

Migraine

tremors

Attention disorders

dysgeusia

Syncope

Eye disorders

Vision disorders

Abnormal sensation in the eye

Ocular hyperemia

Photophobia

Affections of the ear and

of the labyrinth

Dizziness

Respiratory, thoracic and mediastinal disorders

Dry throat

Gastrointestinal disorders

intestinal

Nausea * Abdominal pain * Abdominal discomfort Vomiting *

diarrhea

Dry mouth

Dyspepsia

flatulence

Skin and subcutaneous tissue disorders

Acne

Skin lesions

itching

Urticaria

Musculoskeletal disorders

skeletal and systemic

myalgia
Back pain

Disorders of reproductive organs and breast

Dysmenorrhea Pain

pelvic

Sensitivity of the breasts

menorrhagia

Vaginal discharge

Menstrual disorders

bleeding

vaginitis

Hot flashes

Premenstrual syndrome

Genital Pruritus

dyspareunia

Broken ovarian cyst Vulvovaginal pains Hypomenorrhea *

General disorders and administration site conditions

Tired

Chills

Discomfort

Fever

Thirst

* Symptom that could also be related to an undiagnosed pregnancy (or related complications).

Adolescent: The safety profile observed in women under 18 in studies and post-marketing is similar to that of adults in the Phase III program (see section 4.2 ).

Postmarketing Experience: Spontaneous adverse reactions reported in postmarketing experience are similar in nature and frequency to the safety profile described in the Phase III program ( Dosage and Method of Administration ).

Description of selected adverse reactions

In the majority of women (74.6%) in the Phase III studies, the following rules occurred on the scheduled date, or within 7 days before or after, whereas in 6.8% of women they occurred more than 7 days before the scheduled date and at 18.5% with a delay of more than 7 days compared to the planned date. This delay was more than 20 days for 4% of women.

A minority (8.7%) of women reported intermenstrual bleeding with an average duration of 2.4 days. In most cases (88.2%), this bleeding was spotting. Of the women who received ellaOne in the Phase III studies, only 4% reported significant intermenstrual bleeding.

In phase III studies, 82 women were included in one study more than once and therefore received more than one dose of ellaOne (73 women were included twice and 9 times). No differences were observed in these subjects in terms of frequency and severity of adverse events, changes in duration or volume of the menstrual period, or frequency of occurrence of intermenstrual bleeding.

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 reporting system - see Annex V.

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