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Posology: How to take Regulon: The tablets must be taken in the order directed on the package every day at about the same time. 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. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.
How to start Regulon: No preceding hormonal contraceptive use [in the past month]: The tablet intake must be started on the first day of the woman's natural cycle (i.e. on the first day which the woman has a menstrual bleeding). Tablet intake is also allowed to start on day 2-5, but during the first cycle concurrent use of a barrier method for the first 7 days of tablet intake is advisable.
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), combined contraceptive vaginal ring or transdermal patch): The woman should start taking Regulon on the day after the last active tablet (the last tablet containing the active substance) of the previous COC, but at the latest on the day following the usual tablet-free interval or following the last placebo tablet (tablet containing no active substance) of the previous COC.
In case a vaginal ring or a transdermal patch has been used, it is preferable to start using Regulon on the day of its removal. The woman may also start using Regulon on the day the new vaginal ring or a transdermal patch would have been due, but no later than this day.
If the woman has used the previous contraception method regularly and correctly and if the woman is not pregnant, the woman may also change from the previous hormonal contraception on any day during the cycle.
The hormone-free period from the previous contraception method must not be extended for longer than recommended.
Changing from progestogen-only products (progestogen-only-pills, injection, implant, a progestogen-releasing intrauterine system (IUS)): The woman can change from progestogen-only pills on any day (changing from implant or IUS on the day of its removal; changing from injection when the next injection should have been given) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.
After abortion in the 1st trimester: Tablet intake should start immediately. In this case no further contraceptive measures are necessary.
After delivery or abortion in the 2nd trimester: For breast-feeding women - see Use in Pregnancy & Lactation.
The woman should be advised to start the pill on day 21-28 after delivery or abortion in the 2nd trimester. The woman should be advised to use a barrier method concurrently during the first 7 days of tablet intake if starting the pill later. In case the woman already had intercourse, pregnancy should be excluded before starting to take Regulon, or should wait for the first menstrual bleeding.
Missed tablets: If the tablet intake is forgotten for less than 12 hours, contraceptive protection is not reduced. The woman should take the forgotten tablet as soon as remembered, and the remaining tablets are taken as usual.
If the tablet intake is forgotten for more than 12 hours, the contraceptive protection can be reduced.
The following two basic rules should be considered in case of forgotten tablets: 1. Continuous tablet intake must not be interrupted for longer than a period of 7 days.
2. 7 days of uninterrupted tablet intake are required to achieve sufficient suppression of the hypothalamus-pituitary-ovarian-axis.
Thus, the following advice may be given for daily practice: Week 1: The woman should take the last forgotten tablet as soon as remembered, even if this means taking 2 tablets at the same time. Then, continue taking the tablets at the usual time of the day. The woman should concurrently use a barrier method, e.g. a condom, for the next 7 days. If intercourse has taken place during the preceding 7 days, the possibility of pregnancy should be considered. The more tablets are forgotten and the closer they are to the regular tablet-free/placebo tablet period, the higher the risk of pregnancy is.
Week 2: The woman should take the last forgotten tablet as soon as remembered, even if this means taking 2 tablets at the same time. Then, continue taking the tablets at the usual time of the day. Provided that the tablets have been taken in a correct manner during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive measures. However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to use another contraceptive method for 7 days.
Week 3: The risk of reduced contraceptive protection is imminent due to the forthcoming 7-day tablet-free/placebo tablet period. However, this risk may be prevented by adjusting tablet intake. Thus, it is not necessary to take further contraceptive measures if one of the two alternatives as follows is followed, provided that all tablets have been taken in a correct manner during the 7 days preceding the forgotten tablet. If this is not the case, the woman should be advised to follow the first of the two alternatives and concurrently use another contraceptive method for the next 7 days.
1. The woman should take the last forgotten tablet as soon as remembered even if it means taking 2 tablets at the same time. Then continue taking the tablets at the usual time of the day. The next blister pack must be started right away after the last tablet from the present package has been taken, thus there will be no tablet-free period between the two packages. It is not very likely that the user will have menstrual bleeding until the end of the second pack, but may experience spotting or break-through bleeding on the days tablets are taken.
2. The woman may also be advised to stop taking active tablets from the present pack. In that case there should be a tablet-free period for up to 7 days, including those days when tablets are forgotten, and then continue with the next pack.
In case the woman has forgotten tablets and then does not have a menstrual bleeding in the first normal tablet-free period, the possibility of pregnancy should be considered.
Advice in case of gastrointestinal disturbances: In case of severe gastrointestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after taking the active tablets, the advice concerning missed tablets, as given as follows, is applicable. If the woman does not want to change the normal tablet-taking schedule, extra tablet(s) needed should be taken from another pack.
How to induce or postpone a withdrawal bleed: There is no indication for this product to postpone menstruation. However, in extraordinary cases, if postponing menstruation is required the woman should continue with another package of Regulon, without tablet-free interval. 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 Regulon is then resumed after the usual 7-day tablet-free interval.
To shift periods to another day of the week than the woman is used to with the current scheme, the patient can be advised to shorten the forthcoming tablet-free interval by as many days as the patient likes. The shorter the interval, the higher the risk that the patient does not have a withdrawal bleed and will experience breakthrough bleeding and spotting during the subsequent pack (just as when delaying a period).
Paediatric population: The safety and efficacy of desogestrel in adolescents below 18 years has not yet been established. No data are available.
Method of administration: For oral administration.
The tablets should be taken in the order of succession stated on the package every day at about the same time of the day with some liquid as need.
