Meliane/Meliane ED

Meliane/Meliane ED Dosage/Direction for Use

ethinylestradiol + gestodene

Manufacturer:

Bayer HealthCare Pharma

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Tablets must be taken in the order directed on the package everyday at about the same time with some liquid as needed.
Meliane: One tab is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on days 2-3 after the last tablet and may not have finished before the next pack is started.
Starting on Meliane: No preceding hormonal contraceptive use (in the past month): Tablet-taking has to start on day 1 of the woman's natural cycle (ie, the 1st day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the 1st cycle, a barrier method is recommended in addition for the first 7 days of tablet-taking.
Meliane ED: Follow the direction of the arrows until all 28 tablets have been taken. Usually a period will starts on day 2-3 after the last active Meliane ED tablet (ie, while taking tablets from the last row of the pack). Do not leave a gap between packs, ie, start taking the next pack on the day after finishing the current one, even if the period continues. This means that new packs will always be started on the same day of the week, and withdrawal bleed occurs on about the same days, each month.
Starting on Meliane ED: No preceding hormonal contraceptive use (in the past month): Tablet-taking has to start on day 1 of the woman's natural cycle (ie, the 1st day of her menstrual bleeding). Follow the days in order. Meliane ED will work immediately, it is not necessary to use an additional contraceptive method. Starting on days 2-5 is allowed, but during the 1st cycle, additional contraceptive method (barrier method) is recommended for the first 7 days of tablet-taking.
Preparing the Meliane ED Pack: The Meliane ED pack holds 3 memo-packs, each containing 21 active hormonal tablets and 7 inactive non-hormonal tablets (in the last row). In addition to the memo-packs, the outer carton contains 3 self-adhesive stickers. Each of these hold 7 self-adhesive strips showing the days of the week. Choose the strip that starts with the day when tablet-taking starts. For example, if tablet-taking starts on a Wednesday, the strip that starts with "Wed" should be used. Stick the strip along the top of the memo-pack on the clear side, where the tablets are visible, so that the first day is above the tablet to which the arrow marked "Start" is pointing.
Changing from Another COC, Vaginal Ring or Transdermal (Contraceptive) Patch: The woman should start with Meliane/Meliane ED preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case of women using vaginal ring or transdermal patch, Meliane/Meliane ED should be started preferably on the day of removal, but at the latest when the next application would have been due. If these instructions are followed, it is not necessary to use an additional contraceptive method.
Changing from a Progestogen-Only Pill: The woman may switch any day from the minipill but should, in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking when having intercourse.
Changing from an Injectable, an Implant, or a Progestogen-Releasing Intrauterine Device (IUD): Meliane/Meliane ED may be started when the next injection is due or on the day the implant or IUD is removed. An additional contraceptive method (barrier method) should be used for the first 7 days of tablet-taking when having intercourse.
Following 1st Trimester Abortion: The woman may start immediately. When doing so, she need not take additional contraceptive measures.
Following Delivery or 2nd Trimester Abortion: For breastfeeding women, see Use in pregnancy & lactation under Precautions.
Women should be advised to start at days 21-28 after delivery or 2nd trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her 1st menstrual period.
Management of Missed Tablets: If the user is <12 hrs late in taking any 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 >12 hrs late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following 2 basic rules: Tablet-taking must never be discontinued for >7 days; 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian axis.
Accordingly, the following advice can be given in daily practice:
Week 1: The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tabs at the same time. She then continues to take tablets at her usual time. In addition, a barrier method eg, condom, should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.
Week 2: The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tabs at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the 1st missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she missed >1 tab, the woman should be advised to use extra precautions for 7 days.
Week 3: The risk of reduced reliability is imminent because of the forthcoming tablet-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following 2 options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the 1st missed tablet, the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the 1st of these 2 options and to use extra precautions for the next 7 days as well.
The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tabs at the same time. She then continues to take tablets at her usual time. The next pack must be started as soon as the current pack is finished ie, no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the 2nd pack, but she may experience spotting or breakthrough bleeding on tablet-taking days.
The woman may also be advised to discontinue tablet-taking from the current pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets and subsequently continue with the next pack.
If the woman missed tablets and subsequently, has no withdrawal bleed in the 1st normal tablet-free interval, the possibility of a pregnancy should be considered.
Advice in Case of Vomiting: If vomiting occurs within 3-4 hrs after tablet-taking, absorption may not be complete. In such an event, the advice concerning missed tablets, as given under Management of 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.
How to Shift Periods or How to Delay a Period: To delay a period, the woman should continue with another pack of Meliane without a tablet-free interval. The extension can be carried on for as long as wished until the end of the 2nd pack. During the extension, the woman may experience breakthrough bleeding or spotting. Regular intake of Meliane is then resumed after the usual 7-day tablet-free interval.
To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming tablet-free interval by as many days as she likes. The shorter the interval, the higher the risk that she will not have a withdrawal bleed, and will experience breakthrough bleeding and spotting during the 2nd pack (just as when delaying a period).
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