FEANOLLA

Posology To achieve contraceptive effectiveness, Feanolla must be used as directed (see 'How to take Feanolla' and 'How to start Feanolla'). Special populations Renal impairment No clinical studies have been performed in patients with renal impairment.

Hepatic impairment No clinical studies have been performed in patients with hepatic insufficiency. 3). Paediatric population The safety and efficacy of desogestrel in adolescents below 18 years has not been established. No data are available.

Method of administration Oral use. How to take Feanolla Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding.

Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. How to start Feanolla No preceding hormonal contraceptive use [in the past month] Tablet-taking has to start on day 1 of the woman’s natural cycle (day 1 is the first day of her menstrual bleeding).

Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following first-trimester abortion:

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.

Following delivery or second-trimester abortion:

The woman should be advised to start any day between day 21 to 28 after delivery or second-trimester abortion. When starting later, she should be advised to additionally use a barrier method until completion of the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Feanolla use or the woman has to wait for her first menstrual period. 6. How to start Feanolla when changing from other contraceptive methods Changing from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) The woman should start with Feanolla preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch.

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Feanolla. Since Feanolla causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills.

In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent.

Information, counselling and a bleeding diary can improve the woman’s acceptance of the bleeding pattern. 5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.

0 Breast discharge may occur during use of Feanolla. 4). 4). In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. g. 4. 5). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

If any of the conditions/risk factors mentioned below is present the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start Feanolla.

In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Feanolla should be discontinued. The risk for breast cancer increases in general with increasing age.

During the use of combined oral contraceptives (COCs) the risk for having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC.

The expected number of cases diagnosed per 10,000 women who use combined COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

7 44 30-34 years 110 100 35-39 years 180 160 40-44 years 260 230 The risk in users of progestogen-only contraceptives (POC), such as Feanolla, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive.

Compared to the risk of getting breast cancer even in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer. When acute or chronic disturbances of liver function occur, the woman should be referred to a specialist for examination and advice.

Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Known or suspected sex-steroid sensitive malignancies. Undiagnosed vaginal bleeding. 1.