Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-123110 · Präparat HOS-095645

CHCs must not be used in the following conditions. Should any of the conditions appear for the first time during Zoely use, the medicinal product should be stopped immediately.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-123111 · Präparat HOS-095645

• Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]). o Known hereditary or acquired predisposition for venous thromboembolism, such as activated protein C (APC)-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency. o Major surgery with prolonged immobilisation (see section 4.4). o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4). • Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism - current ATE, history of ATE (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris). o Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack [TIA]). o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). o History of migraine with focal neurological symptoms. o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: • diabetes mellitus with vascular symptoms; • severe hypertension; • severe dyslipoproteinaemia. • Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia. • Presence or history of severe hepatic disease as long as liver function values have not returned to normal. • Presence or history of liver tumours (benign or malignant). • Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts). • Meningioma or history of meningioma. • Undiagnosed vaginal bleeding. • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): protein S (HOS-110298) protein C (HOS-091603)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-123114 · Präparat HOS-095645

Interactions Note: The prescribing information of concomitant medicinal products should be consulted to identify potential interactions.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-123115 · Präparat HOS-095645

Influence of other medicinal products on Zoely Interactions between oral contraceptives and enzyme-inducing medicinal products may lead to breakthrough bleeding and/or contraceptive failure.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lead (HOS-085592)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-123116 · Präparat HOS-095645

Hepatic metabolism: Interactions can occur with substances that induce CYP450 enzymes, resulting in reduced concentrations of sex hormones and decreased effectiveness of combined oral contraceptives, including Zoely. These substances are represented mostly with anticonvulsants (e.g. carbamazepine, topiramate, phenytoin, phenobarbital, primidone, oxcarbazepine, felbamate); anti-infective drugs (e.g. rifampicin, rifabutin, griseofulvin); St. John’s wort; bosentan and HIV or Hepatitis C virus (HCV) protease inhibitors (e.g. ritonavir, boceprevir, telaprevir) and non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz). Enzyme induction can occur after a few days of treatment. Maximal enzyme induction is generally 11 observed within a few weeks. After drug therapy is discontinued, enzyme induction can last for about 28 days.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): felbamate (HOS-110308) protease (HOS-085623) topiramate (HOS-110310) phenobarbital (HOS-085617) carbamazepine (HOS-085618) rifabutin (HOS-086262) hepatitis C virus (HOS-108813) telaprevir (HOS-090618) boceprevir (HOS-090617) griseofulvin (HOS-091156) efavirenz (HOS-087947) oxcarbazepine (HOS-110224) ritonavir (HOS-084521) bosentan (HOS-086291) phenytoin (HOS-084531) primidone (HOS-090551)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123123 · Präparat HOS-095645

A barrier contraceptive method should also be used during the concomitant use of an enzyme inducer, and for 28 days after its discontinuation. In case of long-term treatment with hepatic enzyme-inducing substances another method of contraception should be considered.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123124 · Präparat HOS-095645

If concomitant drug administration runs beyond the end of the active tablets in the current blister pack, the next blister pack should be started right away without the usual placebo tablet interval.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): placebo (HOS-088378)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123125 · Präparat HOS-095645

Concomitant administration of strong (e.g. ketoconazole, itraconazole, clarithromycin) or moderate (e.g. fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors may increase the serum concentrations of oestrogens or progestogens.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): diltiazem (HOS-086288) ketoconazole (HOS-084513) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123127 · Präparat HOS-095645

Medicinal product interaction studies were not performed with Zoely, but two studies with rifampicin and ketoconazole, respectively, were performed with a higher dosed nomegestrol acetate-estradiol combination (nomegestrol acetate 3.75 mg + 1.5 mg estradiol) in post-menopausal women. Concomitant use of rifampicin decreases the AUC0-∞ of nomegestrol acetate by 95 % and increases the AUC0-tlast of estradiol by 25 %. Concomitant use of ketoconazole (200 mg single dose) does not modify estradiol metabolism whereas increases in the peak concentration (85 %) and AUC0-∞ (115 %) of nomegestrol acetate were observed, which were of no clinical relevance. Similar conclusions are expected in women of childbearing potential.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ketoconazole (HOS-084513)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123128 · Präparat HOS-095645

Influence of Zoely on other medicinal products Contraceptives containing ethinylestradiol may decrease the concentrations of lamotrigine by approximately 50%. Attention should be paid, notably when introducing a combined contraceptive, even with estradiol, in a well-equilibrated woman given lamotrigine.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lamotrigine (HOS-086242)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123130 · Präparat HOS-095645

Other interactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123131 · Präparat HOS-095645

Direct acting antiviral agents (DAAs) and ethinylestradiol-containing medicinal products such as CHCs During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medicinal products such as CHCs. Additionally, also in patients treated with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, ALT elevations were observed in women using ethinylestradiol- containing medications such as CHCs.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) ribavirin (HOS-088127) dasabuvir (HOS-110302) voxilaprevir (HOS-108930) ombitasvir (HOS-110300) velpatasvir (HOS-108929) ritonavir (HOS-084521) paritaprevir (HOS-110301)

Wechselwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-123141 · Präparat HOS-095645

Direct acting antiviral agents (DAAs) and medicinal products containing oestrogens other than ethinylestradiol, such as estradiol Women using medicinal products containing oestrogens other than ethinylestradiol, such as estradiol, and ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin had a rate of ALT elevation similar to those not receiving any oestrogens; however, due to the limited number of women taking these other oestrogens, caution is warranted for co-administration with the following combination drug regimens: ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) ribavirin (HOS-088127) dasabuvir (HOS-110302) voxilaprevir (HOS-108930) ombitasvir (HOS-110300) velpatasvir (HOS-108929) ritonavir (HOS-084521) paritaprevir (HOS-110301)

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-123142 · Präparat HOS-095645

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-123143 · Präparat HOS-095645

Six multi-centre clinical trials of up to one-year duration were used to evaluate safety of Zoely. In total 3,434 women, aged 18-50, were enrolled and completed 33,828 cycles. Most commonly reported adverse reactions in these clinical trials were acne (15.4%) and withdrawal bleeding irregular (9.8%). An increased risk for venous and arterial thromboembolism, causative of serious adverse events has been observed with the use of CHCs (see section 4.4)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-123144 · Präparat HOS-095645

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-123145 · Präparat HOS-095645

Possibly related adverse reactions that have been reported in clinical trials or during post-marketing use with Zoely are listed in the table below.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-123146 · Präparat HOS-095645

Adverse reactions are listed according to the MedDRA system organ class and ranked under frequency groupings using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14

HOS-123147 · Präparat HOS-095645

13 Table: List of adverse reactions Adverse reaction in MedDRA Term1 System organ class Very common Common Uncommon Rare Metabolism and increased decreased nutrition disorders appetite, fluid appetite retention Psychiatric disorders decreased increased libido libido, depression/ depressed mood, mood altered Nervous system headache, cerebrovascular disorders migraine accident, transient ischaemic attack, disturbance in attention Eye disorders contact lens intolerance/dry eye Vascular disorders hot flush venous thromboembolism Gastrointestinal nausea abdominal dry mouth disorders distension Hepatobiliary cholelithiasis, disorders cholecystitis Skin and acne hyperhydrosis, chloasma, subcutaneous tissue alopecia, hypertrichosis disorders pruritus, dry skin, seborrhea Musculoskeletal and sensation of connective tissue heaviness disorders Reproductive system abnormal metrorrhagia, hypomenorrhoea, vaginal odour, and breast disorders withdrawal menorrhagia, breast swelling, vulvovaginal bleeding breast pain, galactorrhoea, discomfort pelvic pain uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness General disorders and irritability, hunger administration site oedema conditions Investigations weight hepatic enzyme increased increased 1 The most appropriate MedDRA term to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Zoely

Zoely 2.5 mg/1.5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-123148 · Präparat HOS-095645

In addition to the above-mentioned adverse reactions, hypersensitivity reactions have been reported in Zoely users (frequency unknown).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.