1CPR RIV 30MG

ELLAONE 30 MG COMPRESSA RIVES WITH FILM

active ingredients

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

Excellent

Compressed core: Lactose monohydrate Povidone Croscarmellosio sodico Magnesio stearato Coating with film: Polyvinyl alcohol (E1203) Macrogol (E1521) Talco (E553b) Titanium oxide (E171) Polysorbed 80 (E433) Yellow iron oxide (E172) Aluminium and potassium silicate (E555)

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population The treatment consists of an oral tablet as soon as possible and not more than 120 hours (5 days) from an unprotected sexual relationship or failure of another contraceptive method. The tablet can be taken at any time during the menstrual cycle. In case of vomiting within 3 hours of taking the tablet, a second tablet must be taken. In case of delay of menstruation or in the presence of symptoms of pregnancy, before administration of the tablet, the existence of a pregnancy must be excluded. Special popularity Renal insufficiency No dose adjustment is required. Epathetic insufficiency In the absence of specific studies, it is not possible to give alternative recommendations regarding the acetate ulipristal dose. Severe liver failure In the absence of specific studies, the use of acetate ulipristal is not recommended. Pediatric population There is no indication for specific use of acetate ulipristal in prepuberal children in the indication of emergency contraception. Teenagers: Ulipristal acetate for emergency contraception is suitable for any woman in fertile age, including teenagers. Differences have not been observed in terms of safety or effectiveness compared to adult women of at least 18 years of age (see paragraph 5.1). Method of administration Oral use. The tablet can be taken with or without food.

Conservation

This medicine does not require any special condition of conservation.

Warnings

ellaOne is intended exclusively for occasional use. ellaOne must never replace the use of a regular anti-inflammatory method. In any case, women should be advised to use a regular contraceptive method. Ulipristal Acetate is not intended for use in pregnancy and should not be taken by women in actual or suspect pregnancy. In any case, ellaOne does not interrupt an existing pregnancy (see paragraph 4.6). ellaOne does not prevent pregnancy in all cases In case of delay of more than 7 days in the appearance of subsequent menstruation, if the bleeding of expected menstruation is abnormal or if there are symptoms that indicate a pregnancy or in case of doubt, a pregnancy test must be performed. As in every pregnancy, the possibility of extrauterine pregnancy must be considered. It is important to know that the presence of uterine bleeding does not exclude the possibility of an extrauterine pregnancy. Women beginning a pregnancy after taking acetate ulipristal should contact your doctor (see paragraph 4.6). Ulipristal acetate inhibits or delays ovulation (see paragraph 5.1). If ovulation has already occurred, it is no longer effective. Since it is not possible to predict the moment of ovulation, the tablet must be taken as soon as possible after an unprotected sexual intercourse. There are no data available on the effectiveness of acetate ulipristal assumed more than 120 hours (5 days) after an unprotected relationship. Limited and non-conclusive data suggest that ellaOne may be less effective with the increase in body weight or body mass index (BMI) (see paragraph 5.1). In all women, emergency contraception must be taken as soon as possible after an unprotected relationship, regardless of body weight or BMI. After taking the tablet, menstruation may occur in advance or a few days later than expected. In about 7% of women, menstruation showed up over 7 days ahead of the expected date. In 18.5% of women were delayed more than 7 days, while in 4% of patients the delay exceeded 20 days. Intake of acetate ulipristal in conjunction with an emergency contraceptive containing levonorgestrel is not recommended (see paragraph 4.5). Contraception after taking ellaOne Ulipristal Acetate is an emergency contraceptive that reduces the risk of pregnancy after an unprotected relationship, but does not give contraceptive protection to subsequent relationships, so after the use of emergency contraception it is necessary to recommend to women the use of a reliable barrier method up to subsequent menstruation. Although the continuous use of a regular hormonal contraceptive is not contraindicated in case of taking ulipristal acetate for emergency contraception, ellaOne can reduce its contraceptive effectiveness (see paragraph 4.5). Therefore, if a patient wishes to start or continue the use of a hormonal contraceptive, he can do so after taking ellaOne, however it is necessary to recommend to women the use of a reliable barrier contraceptive method until the appearance of successive menstruations. Special popularity Concurrent use of ellaOne with CYP3A4 inductive drugs is not recommended due to their interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, phosfenitoin, carbamazepine, oxcarbazepine, vegetable-based medicines Hypericum perforatum (Erba di San Giovanni), rifamp, rifabutina, griseofulvina, efavirenz, nevirapina and long-term use of ritonavir). The use of ellaOne in women with severe asthma in treatment with oral glucocorticoids is not recommended. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption should not take this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘without sodium’.

Interactions

Potential ability by other drugs to interfere with acetate ulipristal Ulipristal Acetate is metabolized by CYP3A4 in vitro. - CYP3A4 Inductors The results in live show that the administration of acetate ulipristal with a strong inducer of CYP3A4 as the rifamp significantly reduces C_max and AUC of ulipristal acetate of at least 90% and decreases the half-life of acetate ulipristal 2.2 times, with a corresponding reduction of exposure to acetate ulipristal about 10 times. For this reason the concomitant use of ellaOne with inductors of CYP3A4 (e.g. barbituric (including primidone and phenobarbital), phenytoin, phosfenitoin, carbamazepine, oxcarbazepine, medicinal products of plant origin containing Hypericum perforatum (Herba di San Giovanni), rifamp, rifabutina, griseofulvina, efavirenz and nevirapine) reduces the plasma concentrations of acetate ulipristal, resulting in a possible reduction of ellaOne effectiveness. For women who have used in the last 4 weeks medicines as enzymatic inductors, ellaOne is not recommended (see paragraph 4.4) and should be considered the use of a non-hormonal emergency contraception (i.e. intrauterine copper spiral, Cu-IUD). - CYP3A4 inhibitors Results in live have shown that concurrent administration of acetate ulipristal with a powerful inhibitor and a moderate inhibitor of CYP3A4 increases C_max and AUC of ulipristal acetate up to a maximum of 2 and 5,9 times, respectively. It is unlikely that the effects of CYP3A4 inhibitors have clinical consequences. The CYP3A4 ritonavir inhibitor may also have an induction effect on CYP3A4 if it is used for a prolonged period. In such cases, ritonavir could reduce plasma concentrations of acetate ulipristal. The concomitant use of these medicines is therefore not recommended (see paragraph 4.4). The induction of the enzyme slowly exhausts and the effects on the plasma concentration of acetate ulipristal can occur even if the woman has stopped taking an enzyme inducer in the last 4 weeks. Medicines that affect gastric pH Concurrent administration of acetate ulipristal (compressed by 10 mg) with esomeprazole protonic pump inhibitor (20 mg per day for 6 days) resulted in an average reduction of C_max of about 65%, a delay of T_max (from an average of 0.75 hours to 1.0 hours) and an increase in the area under the curve (AUC) average of 13%. The clinical relevance of this interaction for the administration of a single dose of acetate ulipristal as an emergency contraception is not known. Potential ability by acetate ulipristal to interfere with other medicines Hormonal contraceptives Since ulipristal acetate binds with great affinity to the progesterone receptor, it can interfere with the action of medicines containing progestine. - The contraceptive action of combined hormonal contraceptives and contraceptives based on progestine alone may be reduced. - Concurrent use of acetate ulipristal and an emergency contraceptive method containing levonorgestrel is not recommended (see paragraph 4.4). Data in vitro indicate that acetate ulipristal and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4 at clinically relevant concentrations. After administering a single dose, it is unlikely that the induction of CYP1A2 and CYP3A4 by acetate ulipristal or its active metabolite occurs. It is therefore unlikely that the administration of ulipristal acetate alters the clearance of medicinal products metabolized by these enzymes. P-glycoprotein substrates (P-gp) The data in vitro indicate that acetate ulipristal could be a P-gp inhibitor at clinically relevant concentrations. The results in live with the substrate of the fexofenadine P-gp did not provide definitive results. It is unlikely that the effects of P-gp substrates may have clinical consequences.

Effects

Summary of security profile The most frequently reported adverse reactions were headaches, nausea, abdominal pain and dysmenorrhea. The safety of acetate ulipristal was assessed in 4,718 women during the clinical development program. Table of adverse reactions The following table shows the adverse reactions recorded in Phase III on 2,637 women. The following adverse reactions are classified by frequency and according to the classification for systems and organs according to the following convention: very common (≥1/10), common (from ≥ 1/100 to MedDRA Adverse reactions (frequency) Classification for systems and organs Town Not common Rare Infections and infestations   Influence   Immune system disorders     hypersensitivity reactions including rash, hives, angioedema** Disorders of metabolism and nutrition   Disorders of appetite   Psychiatric disorders Mood disorders Emotional disorders, Anxiety, Insomnia, Hyperactivity disorders, Alterations of libido Disorientation Diseases of the nervous system Cephalea, Capogiri Sonnolence, migraine Tremors, Disorders of attention, Disgeusia, Sincope Pathologies of the eye   Visual disturbances Anomalous eye sensation, Eye hyperemia, Fotofobia Ear and labyrinth pathologies     Vertigo Respiratory, chest and mediastinic pathologies     Dry gorge Gastrointestinal diseases Nausea*, Abdominal Pain*, Fastidium, Abdominal, Vomite* Diarrhea, Dry mouth, Dispepsia, Flatulenza   Pathologies of skin and subcutaneous tissue   Acne, Skin injuries, Prurito   Diseases of musculoskeletal system and connective tissue Myalgia, dorsal pain     Pathologies of the reproductive apparatus and of the breast Dismenorrea, Pelvic Pain, Mummy Dolorability Menorragia, Vaginal Secretion, Menstrual Disorders, Metrorragia, Vaginitis, Heat Veils, Premenstrual Syndrome Genital prrite, Dispareunia, broken ovarian cyst, vulvo-vaginal pain, Hypomenorrea* Systemic pathologies and conditions for administration Fatigue Brivi, Malessere, Piressia Seasons *We feel that it may also be related to an undiagnosed pregnancy (or related complications) **Averse reaction from spontanee reports Teenagers: 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 phase III (see paragraph 4.2). Post-marketing: negative reactions spontaneously reported in the post-marketing phase were similar in nature and frequency to the security profile described during phase III. Description of some adverse reactions The majority of women (74.6%) in Phase III studies had menstruation following the expected date or within ± 7 days, while in 6.8% of them the menstruation appeared more than 7 days before the planned date and 18.5% recorded a delay of more than 7 days on the expected date for the beginning of the menstruation. The delay was greater than 20 days in 4% of women. A minority (8.7%) of women reported intermenstrual bleeding for an average duration of 2.4 days. In most cases (88.2%) bleeding was described as spotting. Among women who have taken ellaOne in Phase III studies, only 0.4% reported a plentiful intermenstrual bleeding. In Phase III studies, 82 women were enrolled more than once and received more than one dose of ellaOne (73 women were enrolled twice and 9 women were enrolled three times). There were no differences in the safety of these subjects in terms of the incidence and severity of adverse reactions, variations in duration or volume of menstruation or incidence of intermenstrual bleeding. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system: Italian Pharmaco Agency. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The experience of overdose with acetate ulipristal is poor. They were given to women of the individual doses of the drug up to 200 mg without security problems. Such high doses were well tolerated, but women had a shorter menstrual cycle (the uterine bleeding occurred 2-3 days prior to the planned) and in some of them the duration of bleeding was prolonged, although in non-excessive quantities (spotting). There are no antidotes and the subsequent treatment must be symptomatic.

Pregnancy

ellaOne is not intended for use during pregnancy and should not be taken by actual or suspect pregnant women (see paragraph 4.2). Ulipristal acetate does not interrupt an existing pregnancy. After taking acetate ulipristal, you can occasionally get pregnant. Although there is no teratogenic potential, the results obtained on animal species are insufficient for a reproductive toxicity assessment (see paragraph 5.3). The limited data related to pregnancy exposure to ellaOne in the human species do not suggest security issues, but it is important that any pregnancy of women who have taken ellaOne be reported on www.hra-pregnancy-registry.com. The purpose of this register on Web is to collect security information from women who took ellaOne during pregnancy or who started a pregnancy after taking ellaOne. All data collected by patients will remain anonymous.

Food

Ulipristal acetate is excreted in breast milk (see paragraph 5.2). The effect on infants/ infants has not been studied. You cannot exclude risks for breast milk breast-feeding baby. After taking acetate ulipristal for emergency contraception, breastfeeding is not recommended for a week. During this period it is recommended that the mother take milk from the breast and eliminate it to keep the production active.

Fertility

After treatment with acetate hydropristal as an emergency contraceptive, a rapid return to fertility is expected. It is therefore necessary to advise women to use a reliable barrier method for all subsequent sexual intercourse until subsequent menstruation.

Source: Farmadati