|Manufacturer:||Bayer NZ Ltd manufactures Femodene.|
|Uses:||The uses of Femodene include:|
FEMODENE 28: The memo-pack holds 21 white tablets, diameter 5.7 mm, containing 0.075 mg gestodene and 0.030 mg ethinylestradiol and in addition, 7 larger white non-hormonal tablets diameter 6.8 mm.
Dosage and Administration:
Combined oral contraceptives, such as FEMODENE 28, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.
How to Take FEMODENE 28:
Tablets must be taken in the order directed on the package every day at about the same time with some water as needed. Tablet-taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack following the directional arrows. Withdrawal bleeding usually occurs while taking the 7 non-hormonal tablets. This usually starts on day 2 - 3 after starting the non-hormonal tablets and may not have finished before the next pack is started.
How to Start FEMODENE 28:
START WITH THE FIRST TABLET FROM THE GREEN SECTION MARKED WITH THAT DAY OF THE WEEK, in accordance with one of the following:
No preceding hormonal contraceptive use (in the past month)
Tablet taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2 - 3 is allowed, but during the first cycle an additional barrier contraceptive method is recommended for the first 7 days of tablet taking.
Changing from another combined oral contraceptive (COC), vaginal ring or transdermal patch
The woman should start with FEMODENE 28 preferably on the day after the last hormonal tablet of her previous COC, but at the latest on the day following the usual tablet-free or non-hormonal tablet interval of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using FEMODENE 28 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, injection, implant) or progestogen-releasing intrauterine system (IUS)
The woman may switch any day from the minipill, from an implant or IUS on the day of its removal, or from an injectable when the next injection would be due. In all of these cases, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking.
Following first-trimester abortion
The woman may start immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion
The woman should be advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later than this, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before starting FEMODENE 28 or the woman has to wait for her first menstrual period.
Management of Missed Tablets
Errors in taking the non-hormonal tablets contained in FEMODENE 28 can be ignored. However, they should be discarded to avoid unintentionally prolonging the placebo tablet phase. The following advice only refers to missed non-hormonal tablets:
If the user is less than 12 hours late in taking any hormonal tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take subsequent tablets at the usual time.
If she is more than 12 hours late in taking any hormonal tablet, contraceptive protection may be reduced.
There is a particularly high risk of pregnancy if tablets are missed just before or immediately after taking the non-hormonal tablets. If tablets are missed in the first week of taking hormonal tablets following the non-hormonal tablets and intercourse took place in the preceding 7 days, the possibility of pregnancy should be considered.
The management of missed tablets can be guided by the following two basic rules:
Tablet taking must never be discontinued for longer than 7 days.
Seven days of uninterrupted tablet taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian axis.
These rules form the basis of the instructions to patients provided in the package insert.