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.
Synonyms or related conditions are not listed, but should be taken into account as well. In addition to the above-mentioned adverse reactions, hypersensitivity reactions have been reported in Zoely users (frequency unknown). 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.