Posology: Route of administration: Oral.
How to use Rigevidon: Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary.
One tablet 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. Withdrawal bleeding will usually start on the 2nd or 3rd day after the last tablet has been taken and it may not have stopped, before the next blister pack is started.
How to start the use of Rigevidon: No preceding hormonal contraceptive use in the past month: Tablet-taking is started on day 1 of the woman's natural cycle (= the first day of menstrual bleeding).
Changing from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch): Take the first tablet the day after the dose of the last active tablet of the previous contraceptive or, at the latest, the day after the usual period of stopping the tablets.
In case of vaginal ring or transdermal patch, take the first tablet the day of removal or at the latest the day scheduled for application of the new device or ring.
Changing from a progestogen-only method (progestogen-only or mini-pills, injection, implant or from a progestogen-releasing intrauterine system (IUS)): Switching from the mini-pill can be performed at any time in the cycle and Rigevidon tablet should be commenced the day after stopping.
Switching from an implant or IUS should occur on the day of removal and for an injectable contraceptive on the day scheduled for the new injection. In all cases, using an additional method of contraception for the 7 first days of treatment is recommended.
After abortion in 1st trimester: The woman may start the tablet intake immediately. In this case, it is not necessary to take further contraceptive precautions.
After delivery or abortion in 2nd trimester: The woman should be advised to start on day 21-28 after delivery in non-lactating women or abortion in the 2nd trimester, because there is an increased risk of thromboembolic disorders during the postpartum period. If starting later than this, the woman should be advised to use a concomitant barrier method during the first 7 days of tablet intake. However, if the woman already had intercourse, pregnancy must be excluded, before starting the tablets, or should wait for the first menstrual bleeding.
In case of breast-feeding: See Use in Pregnancy & Lactation.
Missed tablets: If the woman has forgotten tablet intake for less than 12 hours, the contraceptive protection is not reduced. The woman should take the tablet as soon as remembered, and the remaining tablets should be taken at the usual time.
If the delay exceeds 12 hours, the contraceptive protection may be reduced. Handling of missed active tablets may be managed by the following two basic rules: 1. Tablets should never be delayed for longer than 7 days.
2. Seven days of uninterrupted tablet taking is required to maintain adequate suppression of the hypothalamus-pituitary-ovarian-axis.
Thus, the following advice may be given in daily practice: Week 1: The woman should take the last missed tablet as soon as remembered, even if this means taking 2 tablets at the same time. Hereafter, continue taking the tablets at the usual time point. The woman should use a barrier method concomitantly, e.g. a condom, for the next 7 days. If intercourse has taken place during the previous 7 days, the possibility of pregnancy must be considered. The more forgotten tablets, and the closer to the usual hormone-free interval this takes place, the greater the risk of pregnancy.
Week 2: The woman should take the last missed tablet as soon as remembered, even if this means taking 2 tablets at the same time. Hereafter, continue taking the tablets at the usual time point. Provided that the tablets have been taken correctly during the 7 days preceding the first missed tablet, it is not necessary to take further contraceptive precautions. However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to additionally use a barrier method (such as a condom) for 7 days.
Week 3: The risk of contraceptive failure is imminent because of the ensuing hormone-free interval. The reduced contraceptive protection may, however, be prevented by adjusting the tablet intake. Therefore, by following one of the following two alternatives, it is not necessary to take further contraceptive precautions, provided that all tablets have been taken correctly during the 7 days preceding the first missed tablet. If this is not the case, the woman should be advised to follow the first of the two alternatives. Additionally a barrier method (such as a condom) should be used concomitantly for the next 7 days.
1. The woman should take the last missed tablet as soon as remembered, even if this means taking 2 tablets at the same time. Thereafter, continue to take the tablets at the usual time point. The woman should start on the next blister pack immediately after taking the last tablet in the current blister pack, i.e. there will be no hormone-free interval between the blister packs. A withdrawal bleeding is unlikely until the end of the second blister pack, but may experience spotting or break through bleeding on the days tablets are being taken.
2. The woman may also be advised to stop taking tablets from the current blister pack. In this case, the woman should keep a hormone-free interval of up to 7 days, including the days the tablets that were forgotten to take, and thereafter continue with the next blister pack.
If the woman has missed tablets and does not get a withdrawal bleeding during the first, normal hormone-free interval, the possibility of pregnancy must be considered.
Advice in case of gastro-intestinal disturbances: In case of severe gastro-intestinal symptoms (e.g. vomiting or diarrhoea), absorption of the active ingredients may not be complete and additional contraceptive measures should be taken.
If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a tablet, a new tablet should be taken as a replacement as soon as possible. The new tablet should be taken if possible within 12 hours of the usual dose time.
If more than 12 hours elapse, the same instructions as those provided for missed tablets should apply (see "Missed tablets" as previously mentioned).
If the woman does not wish to modify the normal tablet-taking schedule, additional tablets from another blister pack should be taken.
How to delay or shift a withdrawal bleeding:
In order to delay a withdrawal bleeding, the woman should continue the next blister pack of Rigevidon, after taking the last tablet in the current pack, without a hormone-free interval. The extension can be carried on for as long as desired until the end of the second blister pack. During the extension the woman may experience break through bleeding or spotting. Regular intake of Rigevidon is resumed after the usual 7 days hormone-free interval.
To shift withdrawal bleeding to another day of the week, rather than the one the woman is used to with the present tablet intake, the woman may be advised to shorten the forthcoming hormone-free interval by as many days as desired. The shorter the interval, the greater the risk that the woman will not have a withdrawal bleeding and will not have breakthrough bleeding or spotting during the second blister pack (which is also the case when delaying a period). It is important to emphasise that the hormone-free interval should not be extended.