Product Details

Product Information

Contraindications

Combined oral contraceptives (COCs) must not be used in the presence of any of the following conditions. If any of these conditions occurs for the first time during COC use, the medicinal product must be discontinued immediately. – Presence or risk of venous thromboembolism (VTE) – venous thromboembolism – existing VTE (including during therapy with anticoagulants) or history of VTE (e.g. deep vein thrombosis [DVT] or pulmonary embolism [PE]) – known hereditary or acquired predisposition for venous thromboembolism, e.g. APC resistance (including Factor V Leiden), antithrombin III deficiency, protein C deficiency or protein S deficiency – major surgery with prolonged immobilisation (see section 4.4) – high risk of venous thromboembolism due to several risk factors (see section 4.4) – Presence or risk of arterial thromboembolism (VTE) – arterial thromboembolism – existing ATE, history of ATE (e.g. myocardial infarction) or disease at the prodromal stage (e.g. angina pectoris) – cerebrovascular disease – existing stroke, history of stroke or prodromal disease (e.g. history of transient ischaemic attack [TIA]) – known hereditary or acquired predisposition for arterial thromboembolism, e.g. hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) – history of migraine with focal neurological symptoms – high risk of arterial thromboembolism due to several risk factors (see section 4.4) or a serious risk factor, such as: – diabetes mellitus with vascular damage – severe hypertension – severe dyslipoproteinaemia – Existing or previous pancreatitis, if accompanied by severe hypertriglyceridaemia – Existing or previous severe hepatic disease, until liver function values have returned to normal – Existing or previous liver tumours (benign or malignant) – Known or suspected sex hormone-dependent malignant tumours (e.g. of the genital organs or breast) – Undiagnosed vaginal bleeding – Amenorrhoea of unknown cause – Hypersensitivity to the active substances levonorgestrel and ethinylestradiol or to any of the excipients listed in section 6.1. The simultaneous use of Microgynon Fe together with medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir is contraindicated

Special warnings and precautions for use

Warnings

The suitability of Microgynon Fe should be discussed with the woman if any of the following disorders or risk factors is present. If any of these disorders or risk factors deteriorates or appears for the first time, the user should be advised to contact her doctor to decide whether the use of Microgynon Fe should be terminated. 5 Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with non-use. The decision to use Microgynon Fe should be taken only after discussion with the woman, during which it should be ensured that she understands the following: – the risk of VTE with Microgynon Fe use, – how her existing, individual risk factors influence this risk, – and that her risk of VTE is highest during her very first year of use. There are also indications that the risk is increased when CHC use is resumed after an interval of 4 weeks or more. Approximately 2 out of 10,000 women not using a CHC and who are not pregnant will suffer a VTE during the course of a year. However, the risk may be significantly higher in individual women, depending on their underlying risk factors (see below). Approximately 61 out of 10,000 women using a levonorgestrel-containing CHC will suffer a VTE during the course of a year. The number of VTEs per year with low-dose CHCs is lower than the expected number during pregnancy or in the postpartum period. VTEs are fatal in 1-2% of cases.

Fertility, pregnancy and lactation

Pregnancy

Microgynon Fe is not indicated during pregnancy. If pregnancy occurs during use of Microgynon 28, the product must be withdrawn immediately. In most of the epidemiological studies, no increased risk of malformations was found in children whose mothers had taken combined oral contraceptives before pregnancy, or any teratogenic effect when combined oral contraceptives were inadvertently taken during early pregnancy.

Breastfeeding

COCs can affect lactation, as they can reduce the quantity of breast milk and alter its composition. COC use is therefore not recommended until the mother has completely weaned her infant. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk. These amounts might adversely affect the infant. The increased VTE risk in the postpartum period should be considered prior to reuse after a break in administration