Zoely

Posology One tablet is to be taken daily for 28 consecutive days. Each pack starts with 24 white active tablets, followed by 4 yellow placebo tablets. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake and irrespective of presence or absence of withdrawal bleeding.

Withdrawal bleeding usually starts on day 2-3 after intake of the last white tablet and may not have finished before the next pack is started. See ‘Cycle control’ in section

Summary of the safety profile 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. 8%). 4) Tabulated list of adverse reactions Possibly related adverse reactions that have been reported in clinical trials or during post-marketing use with Zoely are listed in the table below.

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).

14 Table: List of adverse reactions System organ class Adverse reaction in MedDRA Term1 Very common Common Uncommon Rare Metabolism and nutrition disorders increased appetite, fluid retention decreased appetite Psychiatric disorders decreased libido, depression/ depressed mood, mood altered increased libido Nervous system disorders headache, migraine cerebrovascular accident, transient ischaemic attack, disturbance in attention Eye disorders contact lens intolerance/dry eye Vascular disorders hot flush venous thromboembolism Gastrointestinal disorders nausea abdominal distension dry mouth Hepatobiliary disorders cholelithiasis, cholecystitis Skin and subcutaneous tissue disorders acne hyperhydrosis, alopecia, pruritus, dry skin, seborrhea chloasma, hypertrichosis Musculoskeletal and connective tissue disorders sensation of heaviness Reproductive system and breast disorders abnormal withdrawal bleeding metrorrhagia, menorrhagia, breast pain, pelvic pain hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness vaginal odour, vulvovaginal discomfort General disorders and administration site conditions irritability, oedema hunger Investigations weight increased hepatic enzyme increased 1The most appropriate MedDRA term to describe a certain adverse reaction is listed.

4. Special populations Renal impairment Although data in renal impaired patients are not available, renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol. Hepatic impairment No clinical studies have been performed in patients with hepatic insufficiency.

3). Paediatric population Safety and efficacy have not been established in adolescents under 18 years of age. There is no relevant use of Zoely in children and pre-menarchal adolescents. Method of administration Oral use. How to take Zoely Tablets must be taken every day at about the same time without regard to meals.

Tablets should be taken with some liquid as needed, and in the order as directed on the blister. Stickers marked with the 7 days of the week are provided. The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister.

e. the first day of her menstrual bleeding). When doing so, no additional contraceptive measures are necessary. Changing from a CHC (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start with Zoely preferably on the day after the last active tablet-taking (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.

In case a vaginal ring or transdermal patch has been used, the woman should start using Zoely preferably on the day of removal, but at the latest when the next application would have been due. Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormone-medicated intra uterine system (IUS) The woman may switch any day from the minipill and Zoely should be started on the next day.

An implant or IUS may be removed any day, and Zoely should be started on the day of its removal. When changing from an injectable, Zoely should be started on the day when the next injection would have been due. In all of these cases, the woman should be advised to additionally use a barrier method until she has completed 7 days of uninterrupted white active table-taking.

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. 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. 4). 4). g. g. angina pectoris).

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.

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). , of the genital organs or the breasts). • Meningioma or history of meningioma.

• Undiagnosed vaginal bleeding. 1. 6