Regulon Adverse Reactions

In the first part of the treatment period a large part (10-30%) of the women may expect to get side effects such as breast tenderness, malaise and spot bleeding. However, these side effects are usually temporary and disappear after 2-4 months.
Description of selected adverse reactions: An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in Precautions.
Other side effects have been reported in women using combined hormonal contraceptives. These are described in Precautions.
As with all CHCs, changes in vaginal bleeding patterns may occur, especially during the first months of use. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration.
Possibly related undesirable effects that have been reported in users of Regulon or CHC users in general are listed in the table as follows. (See Table 3.)

Click on icon to see table/diagram/image

Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).
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.