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ELLAONE * 1CPR RIV 30MG

  • Laboratoire HRA Pharma
  • 039366036
Ellaone is a drug based on the active ingredient ulipristal (acetate) - belonging to the category of emergency contraceptives and specifically emergency contraceptives. Ellaone can be prescribed with SOP Recipe - non-prescription medicine. Emergency contraceptive to be taken within 120 hours (5 days) of unprotected sexual intercourse or failure of another contraceptive method.
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ELLAONE * 1CPR RIV 30MG

Therapeutic indications

Emergency contraceptive to be taken within 120 hours (5 days) of unprotected sexual intercourse or failure of another contraceptive method.

Dosage and method of use

DosageThe treatment consists of one tablet to be taken orally as soon as possible and in any case no later than 120 hours (5 days) from unprotected sexual intercourse or the failure of another contraceptive method. The tablet can be taken at any time during the menstrual cycle. If vomiting occurs within 3 hours of taking the tablet, a second tablet should be taken. In case of delayed menstruation or in the presence of symptoms of pregnancy, pregnancy must be ruled out prior to administration of the tablet. Special populations Kidney failureNo dose adjustment is necessary.Hepatic insufficiencyIn the absence of specific studies, it is not possible to make alternative recommendations regarding the dose of ulipristal acetate.Severe hepatic insufficiencyIn the absence of specific studies, the use of ulipristal acetate is not recommended.Pediatric populationThere is no indication for a specific use of ulipristal acetate in prepubertal children in the indication of emergency contraception. Adolescents: Ulipristal acetate for emergency contraception is suitable for any woman of childbearing age, including adolescents. No differences in safety or efficacy were observed compared to adult women at least 18 years of age (see section 5.1).Method of administrationOral use. The tablet can be taken with or without food.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Summary of the safety profileThe most frequently 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.Table of adverse reactionsThe table below shows the adverse reactions recorded in the phase III program in 2,637 women. Adverse reactions listed below are ranked by frequency and by system organ class according to the following convention: very common (≥1 / 10), common (≥ 1/100 to

MedDRA Adverse reactions (frequency)
System and organ classification Common Uncommon Rare
Infections and infestations   Influence  
Disorders of the immune system     hypersensitivity reactions including rash, urticaria, angioedema **
Metabolism and nutrition disorders   Disorders of appetite  
Psychiatric disorders Mood disturbances Emotional disturbances, Anxiety, Insomnia, Hyperactivity disorders, Changes in libido Disorientation
Nervous system disorders Headache, Dizziness Somnolence, Migraine Tremors, Disturbances in attention, Dysgeusia, Syncope
Eye disorders   Visual disturbances Abnormal ocular sensation, Ocular hyperaemia, Photophobia
Ear and labyrinth disorders     Dizziness
Respiratory, thoracic and mediastinal disorders     Dry throat
Gastrointestinal disorders Nausea *, Abdominal pain *, Discomfort, abdominal, Vomiting * Diarrhea, dry mouth, dyspepsia, flatulence  
Skin and subcutaneous tissue disorders   Acne, Skin lesions, Itching  
Musculoskeletal and connective tissue disorders Myalgia, Back pain    
Reproductive system and breast disorders Dysmenorrhea, Pelvic pain, Breast tenderness Menorrhagia, Vaginal discharge, Menstrual disorders, Metrorrhagia, Vaginitis, Hot flashes, Premenstrual syndrome Genital itching, Dyspareunia, Ruptured ovarian cyst, Vulvo-vaginal pain, Hypomenorrhea *
General disorders and administration site conditions Fatigue Chills, Malaise, Pyrexia Thirst

* Symptom that may also be related to an undiagnosed pregnancy (or related complications) ** Adverse reaction from spontaneous reporting Adolescents: the safety profile observed in women under 18 years of age in studies and post-marketing experience is similar to that observed in adult women during the phase III program (see section 4.2). Post-marketing: Adverse reactions reported spontaneously in the post-marketing phase were similar in nature and frequency to the safety profile described during the phase III program.Description of some adverse reactionsThe majority of women (74.6%) in the phase III studies had menses after the expected date or within ± 7 days, while in 6.8% of them, menses appeared more than 7 days earlier than expected and on 18 , 5% experienced a delay of more than 7 days on the expected date of the start of menstruation. The delay was greater than 20 days in 4% of the women. A minority (8.7%) of women reported intermenstrual bleeding for an average duration of 2.4 days. In the majority of cases (88.2%) the bleeding was described as spotting. Of the women who took ellaOne in phase III studies, only 0.4% reported profuse intermenstrual bleeding. In the phase III studies, 82 women were enrolled more than once and therefore received more than one dose of ellaOne (73 women were enrolled twice and 9 women were enrolled three times). No differences were observed in the safety of these subjects in terms of the incidence and severity of adverse reactions, changes in the duration or volume of menstruation, or the incidence of intermenstrual bleeding.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Italian Medicines Agency. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

ellaOne is intended for occasional use only. ellaOne should never replace the use of a regular method of birth control. In any case, women should be advised to use a regular method of contraception. Ulipristal acetate is not intended for use in pregnancy and should not be taken by women who are actually or suspected to be pregnant. However, ellaOne does not terminate an existing pregnancy (see section 4.6).ellaOne does not prevent pregnancy in all casesIf your next period is more than 7 days late, if your expected period bleeding is abnormal or if there are symptoms that indicate pregnancy or if you are in doubt, a pregnancy test should be performed. As in any pregnancy, the possibility of an ectopic pregnancy must be considered. It is important to know that the presence of uterine bleeding does not exclude the possibility of an ectopic pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor (see section 4.6). Ulipristal acetate inhibits or delays ovulation (see section 5.1). If ovulation has already occurred, it is no longer effective. As it is not possible to predict the time of ovulation, the tablet should be taken as soon as possible after unprotected intercourse. There are no data available on the efficacy of ulipristal acetate taken more than 120 hours (5 days) after unprotected intercourse. Limited and inconclusive data suggest that ellaOne may be less effective with increasing body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of body weight or BMI. After taking the tablet, your period may occur a few days earlier or later than expected. In about 7% of women, menstruation occurred more than 7 days earlier than the expected date. In 18.5% of women there was a delay of more than 7 days, while in 4% of patients the delay exceeded 20 days. Taking ulipristal acetate concomitantly with an emergency contraceptive containing levonorgestrel is not recommended (see section 4.5).Contraception after taking ellaOneUlipristal acetate is an emergency contraceptive that reduces the risk of pregnancy after unprotected intercourse, but does not confer contraceptive protection in subsequent intercourse, therefore women should be advised to use a method of reliable barrier until the next menstruation. Although the continued use of a regular hormonal contraceptive is not contraindicated when taking ulipristal acetate for emergency contraception, ellaOne may reduce its contraceptive efficacy (see section 4.5). Consequently, if a patient wishes to initiate or continue using a hormonal contraceptive, she may do so after taking ellaOne, however women should be advised to use a reliable barrier method of contraception until menstruation begins. following.Special populationsThe concomitant use of ellaOne with CYP3A4 inducer drugs is not recommended due to their interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containingHypericum perforatum(St. John's wort), rifampin, rifabutin, griseofulvin, efavirenz, nevirapine and long-term use of ritonavir). The use of ellaOne in women with severe asthma being treated with oral glucocorticoids is not recommended. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

PregnancyellaOne is not intended for use during pregnancy and must not be taken by women who are pregnant or suspected (see section 4.2). Ulipristal acetate does not terminate an existing pregnancy. Pregnancy may occasionally develop after taking ulipristal acetate. Although no teratogenic potential was found, the results obtained in animal species are insufficient for an assessment of reproductive toxicity (see section 5.3). Limited data on pregnancy exposure to ellaOne in humans do not suggest safety concerns, but it is important that any pregnancies of women who have taken ellaOne are reported on www.hra-pregnancy-registry.com. The purpose of this web log is to collect safety information from women who have taken ellaOne during pregnancy or who have become pregnant after taking ellaOne. All collected patient data will remain anonymous.Feeding timeUlipristal acetate is excreted in breast milk (see section 5.2). The effect on newborns / infants has not been studied. A risk to the breast-fed infant cannot be excluded. After taking ulipristal acetate for emergency contraception, breastfeeding is not recommended for one week. During this period, the mother is recommended to take the milk from the breast and discard it to keep its production active.FertilityA rapid return to fertility is expected after treatment with ulipristal acetate as an emergency contraceptive. Women should therefore be advised to use a reliable barrier method for all subsequent sexual intercourse up to the next menstruation.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Potential for other drugs to interfere with ulipristal acetateUlipristal acetate is metabolised by CYP3A4in vitro. -CYP3A4 inducersThe resultsin vivoshow that administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin significantly reduces Cmaxand AUC of ulipristal acetate by at least 90% and decreases the half-life of ulipristal acetate by 2.2-fold, with a corresponding reduction in exposure to ulipristal acetate by approximately 10-fold. For this the concomitant use of ellaOne with inducers of CYP3A4 (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containingHypericum perforatum(St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) reduces the plasma concentrations of ulipristal acetate, resulting in a possible reduction in the efficacy of ellaOne. For women who have used enzyme-inducing medicinal products within the past 4 weeks, ellaOne is not recommended (see section 4.4) and the use of non-hormonal emergency contraception (i.e. copper intrauterine coil, Cu- IUD). -CYP3A4 inhibitorsResultsin vivodemonstrated that concomitant administration of ulipristal acetate with a strong inhibitor and a moderate inhibitor of CYP3A4 increases Cmaxand AUC of ulipristal acetate up to a maximum of 2 and 5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have clinical consequences. The CYP3A4 inhibitor ritonavir may also have an inducing effect on CYP3A4 if used for a prolonged period. In such cases, ritonavir may reduce the plasma concentrations of ulipristal acetate. Concomitant use of these medicinal products is therefore not recommended (see section 4.4). The induction of the enzyme wears off slowly and the effects on the plasma concentration of ulipristal acetate may occur even if the woman has stopped taking an inducer of the enzyme within the last 4 weeks.Medicines affecting gastric pHConcomitant administration of ulipristal acetate (10 mg tablet) with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in a mean decrease in Cmaxof about 65%, a delay of the T.max(from a median of 0.75 hours to 1.0 hours) and an increase in the mean area under the curve (AUC) of 13%. The clinical relevance of this interaction for the administration of a single dose of ulipristal acetate as emergency contraception is unknown.Potential for ulipristal acetate to interfere with other medicinal products Hormonal contraceptivesSince ulipristal acetate binds with great affinity to the progesterone receptor, it may interfere with the action of progestogen-containing medicines. - The contraceptive action of combined hormonal contraceptives and progestogen-only contraceptives may be reduced. - The concomitant use of ulipristal acetate and an emergency contraceptive method containing levonorgestrel is not recommended (see section 4.4). The datain vitroindicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4 at clinically relevant concentrations. After single dose administration, induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is unlikely. Therefore, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products metabolised by these enzymes.P-glycoprotein (P-gp) substratesThe datain vitroindicate that ulipristal acetate may be a P-gp inhibitor at clinically relevant concentrations. The resultsin vivowith the P-gp substrate fexofenadine did not provide definitive results. The effects of P-gp substrates are unlikely to have clinical consequences.

Overdose

Experience with ulipristal acetate overdose is poor. Single doses of the drug up to 200 mg have been administered to women without safety concerns. Such high doses were well tolerated, but the women had a shorter menstrual cycle (uterine bleeding occurred 2-3 days earlier than expected) and in some of them the bleeding duration was prolonged, although in quantities not excessive (spotting). There is no antidote and subsequent treatment should be symptomatic.

Active principles

Each tablet contains 30 mg of ulipristal acetate. Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1.

Excipients

Tablet core: Lactose monohydrate Povidone Croscarmellose sodium Magnesium stearate Film coating: Polyvinyl alcohol (E1203) Macrogol (E1521) Talc (E553b) Titanium dioxide (E171) Polysorbate 80 (E433) Yellow iron oxide (E172) Potassium aluminum silicate (E555)

039366036

Data sheet

Packaging
30 mg 1 film-coated tablet
Product Type
HUMAN DRUG
ATC code
G03AD02
ATC description
Ulipristal
Therapeutic Group
Emergency contraceptives
Active principle
ulipristal (acetate)
Class
C.
Pharmaceutical form
coated tablet
coated tablets
Type of Administration
oral
Container
blister
Quantity
1 tablet
Quantity of the Active Ingredient
30MG
Recipe required
SOP - non-prescription medicine
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