ellaOne · 4.4 Special warnings and precautions for use · 1

HOS-095356 · has-adverse-reaction-information · PDF-Seite 17

Summary of the safety profile The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea. Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program. Tabulated list of adverse reactions The adverse reactions reported in the phase III program of 2,637 women are provided in the table below. Adverse reactions listed below are classified according to frequency and system organ class using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 17 MedDRA Adverse reactions (frequency) System organ class Common Uncommon Rare Infections and Influenza infestations Immune system hypersensitivity reactions disorders including rash, urticaria, angioedema** Metabolism and Appetite disorders nutrition disorders Psychiatric disorders Mood disorders Emotional disorder Disorientation Anxiety Insomnia Hyperactivity disorder Libido changes Nervous system Headache Somnolence Tremor disorders Dizziness Migraine Disturbance in attention Dysgueusia Syncope Eye disorders Visual disturbance Abnormal sensation in eye Ocular hyperaemia Photophobia Ear and labyrinth Vertigo disorders Respiratory, thoracic

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HOS-095350 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea. Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program. Tabulated list of adverse reactions The adverse reactions reported in the phase III program of 2,637 women are provided in the table below. Adverse reactions listed below are classified according to frequency and system organ class using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 6 MedDRA Adverse reactions (frequency) System organ class Common Uncommon Rare Infections and Influenza infestations Immune system hypersensitivity reactions disorders including rash, urticaria, angioedema** Metabolism and Appetite disorders nutrition disorders Psychiatric disorders Mood disorders Emotional disorder Disorientation Anxiety Insomnia Hyperactivity disorder Libido changes Nervous system Headache Somnolence Tremor disorders Dizziness Migraine Disturbance in attention Dysgueusia Syncope Eye disorders Visual disturbance Abnormal sensation in eye Ocular hyperaemia Photophobia Ear and labyrinth Vertigo disorders Respiratory, thoracic

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HOS-095352 · has-contraindication-information · PDF-Seite 14

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

HOS-095346 · has-contraindication-information · PDF-Seite 3

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

HOS-095351 · has-indication-information · PDF-Seite 13

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

HOS-095345 · has-indication-information · PDF-Seite 2

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

HOS-095348 · has-interaction-information · PDF-Seite 4

Potential for other medicinal products to affect ulipristal acetate Ulipristal acetate is metabolised by CYP3A4 in vitro. - CYP3A4 inducers In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure. Concomitant use of ellaOne with CYP3A4 inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne. For women who have used enzyme-inducing drugs in the past 4 weeks, ellaOne is not recommended (see section 4.4) and non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered. - CYP3A4 inhibitors In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences. The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal acetate. Concomitant use is therefore not recommended (see section 4.4). Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks. Medicinal products affecting gastric pH Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax 4 (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of this interaction for single dose administration of ulipristal acetate as emergency contraception is not known. Potential for ulipristal acetate to

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HOS-095354 · has-interaction-information · PDF-Seite 15

Potential for other medicinal products to affect ulipristal acetate Ulipristal acetate is metabolised by CYP3A4 in vitro. - CYP3A4 inducers In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure. Concomitant use of ellaOne with CYP3A4 inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne. For women who have used enzyme-inducing drugs in the past 4 weeks, ellaOne is not recommended (see section 4.4) and non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered. - CYP3A4 inhibitors In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences. The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal acetate. Concomitant use is therefore not recommended (see section 4.4). Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks. Medicinal products affecting gastric pH Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax 15 (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of this interaction for single dose administration of ulipristal acetate as emergency contraception is not known. Potential for ulipristal acetate t

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HOS-095355 · has-pregnancy-information · PDF-Seite 16

Pregnancy ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see section 4.2). Ulipristal acetate does not interrupt an existing pregnancy. Pregnancy may occasionally occur after ulipristal acetate intake. Although no teratogenic potential has been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3). Limited human data regarding pregnancy exposure to ellaOne do not suggest any safety concern. Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported to www.hra-pregnancy-registry.com. The purpose of this web-based registry is to collect safety information from women who have taken ellaOne during pregnancy or who become pregnant after ellaOne intake. All patient data collected will remain anonymous. Breast-feeding Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for emergency contraception, breast-feeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation. Fertility A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception. Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period. 16

HOS-095349 · has-pregnancy-information · PDF-Seite 5

Pregnancy ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see section 4.2). Ulipristal acetate does not interrupt an existing pregnancy. Pregnancy may occasionally occur after ulipristal acetate intake. Although no teratogenic potential has been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3). Limited human data regarding pregnancy exposure to ellaOne do not suggest any safety concern. Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported to www.hra-pregnancy-registry.com. The purpose of this web-based registry is to collect safety information from women who have taken ellaOne during pregnancy or who become pregnant after ellaOne intake. All patient data collected will remain anonymous. Breast-feeding Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for emergency contraception, breast-feeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation. Fertility A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception. Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period. 5

HOS-095353 · has-warning-information · PDF-Seite 14

ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception. Ulipristal acetate is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, it does not interrupt an existing pregnancy (see section 4.6). ellaOne does not prevent pregnancy in every case In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor (see section 4.6). Ulipristal acetate inhibits or postpones ovulation (see section 5.1). If ovulation has already occurred, it is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse. No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days) after unprotected intercourse. Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne 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 the woman’s body weight or BMI. After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days. Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.5). Contraception after ellaOne intake Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, 14 after using emergency contraception, women should be advised to use a reliable barrier method until her ne

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HOS-095347 · has-warning-information · PDF-Seite 3

ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception. Ulipristal acetate is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, it does not interrupt an existing pregnancy (see section 4.6). ellaOne does not prevent pregnancy in every case In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ulipristal acetate should contact their doctor (see section 4.6). ulipristal acetate inhibits or postpones ovulation (see section 5.1). If ovulation has already occurred, it is no longer effective. The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse. No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days) after unprotected intercourse. Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne 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 the woman’s body weight or BMI. After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days. Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.5). Contraception after ellaOne intake Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, 3 after using emergency contraception, women should be advised to use a reliable barrier method until her ne

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