Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, Isando, 1609
Oral contraception.
The first course of FEMODENE ED is started on the first day of the menstrual period (day 1 of the cycle) from the silver section of the pack by selecting the appropriate tablet for that day of the week (e.g. “MO” for Monday). The tablet is swallowed whole with some liquid. Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once the patient has selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 to 3 after starting the hormone-free larger white tablets and may not have finished before the next pack is started. Each subsequent pack is started the day after the last tablet of the current pack. If a patient starts FEMODENE ED during the latter part of the week, the very first cycle may be slightly shortened.
Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). If the woman starts with hormone-free larger white tablet on day 1, she should be advised to additionally use a barrier method for the first 14 days of tablet-taking.
The woman should start with FEMODENE ED preferably on the day after the last hormone-containing tablet of her previous combined oral contraceptive. In case a vaginal ring or transdermal patch has been used, the woman should start using FEMODENE ED preferably on the day of removal of the last ring or patch of a cycle pack.
The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the first 14 days of tablet-taking.
The woman may start immediately. She should be advised to additionally use a barrier method for the first 14 days of tablet-taking.
For breastfeeding women see section 4.6.
Women should be advised to start at day 21 after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 14 days of tablettaking.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of combined oral contraceptive use or the woman has to wait for her first menstrual period.
Missed hormone-free larger white tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the hormone-free tablet phase. The following advice only refers to missed hormone-containing smaller white tablets.
If the user is less than 12 hours late in taking any hormone-containing tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any hormone-containing tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:
Accordingly the following advice can be given in daily practice:
If a hormone-containing tablet has been missed for more than 12 hours, 7 days of additional barrier methods are required.
If the woman missed tablets and subsequently has no withdrawal bleed in the hormone-free larger white tablet phase, the possibility of a pregnancy should be considered.
In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3 to 4 hours after taking a hormone-containing smaller white tablet, absorption may not be complete and the advice concerning missed tablets is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
To delay a period the woman should continue with another pack of FEMODENE ED without taking the remaining hormone-free larger white tablets from her current pack and the hormone-free larger white tablets from the next pack, and starting with the hormone-containing smaller white tablets from the next pack as soon as the hormone-containing smaller white tablets from the current pack are finished. The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of FEMODENE ED is then resumed after the hormone-free larger white tablet phase.
FEMODENE ED is only indicated after menarche.
FEMODENE ED is not indicated after menopause.
FEMODENE ED is contraindicated in women with severe hepatic diseases. See also section 4.3.
FEMODENE ED has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population.
Oral use.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of hormone-containing smaller white tablets are nausea, vomiting and, withdrawal bleeding. The last may even occur in girls before their menarche, if they have accidentally taken the medicine. There are no antidotes and further treatment should be symptomatic.
2 years.
Store at or below 30°C.
Protect from light.
FEMODENE ED is packed in colourless transparent PVC/aluminium blisters containing 21 small, white hormonal tablets plus 7 large white non-hormonal tablets per blister strip.
The blister strip is sealed in a hermetic foil pouch.
The foil pouch is packed into an outer cardboard carton.
Pack sizes: 28 tablets, 84 tablets and 280 tablets.
Not all pack sizes are marketed.
No special requirements.
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