Dienille Dosage/Direction for Use

Application of Dienille: Film-coated tablets are taken daily at the same time (if necessary with some fluid), according to the sequence printed on the blister pack. One film-coated tablet a day is taken for 21 consequent days. Each subsequent pack is started after 7 tablet-free days; usually a break-through bleeding occurs in this period. Typically, it starts 2-3 days after the last pill and may still be present when the first film-coated tablet from the next blister pack is taken.
How to start Dienille: No previous application of hormonal contraception (in the last month).
One film-coated tablet should be taken starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).
Changing from a combined contraceptive (combined oral contraceptive, vaginal ring, transdermal patch) to oral contraception: The woman should start with Dienille on the day following the usual tablet-free or placebo tablet interval of her previous COC or on the day after the last active tablet of her previous COC. In case a vaginal ring or transdermal patch has been used the woman should start using Dienille preferably on the day of removal, but at the latest when the next application would have been due.
Changing from a monocomponent progestogen-only product (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): Women taking progestogen-only minipills can change at any time to combined oral contraceptives. Those using implants or IUS can start on the day when the implant or IUS is removed. Women receiving injections can start taking film-coated tablets when the next injection is due. But in all of these cases an additional contraceptive precautions must be taken for the first 7 days.
Application after an abortion in the first trimester: The product can be taken immediately; no additional contraceptive precautions are required.
Post-partum application and usage after an abortion in the second trimester: The product can be started 21-28 days after delivery or an abortion in the second trimester. If the start of the product is delayed additional contraceptive precautions (e. g. barrier methods) will be required for the first 7 days of pill-taking. However, if sexual intercourse has already preceded, existence of a pregnancy should be excluded, or the start of the film-coated tablet should be delayed to the next menstrual cycle.
Advice in case of missed pills: If the forgotten film-coated tablet is taken within 12 hours, no further precautions are necessary; the product should be taken as soon as possible and further film-coated tablets should be taken at the usual time.
If the film-coated tablet is forgotten for more than 12 hours, contraceptive protection may be reduced. In this case the following rules have to be applied: Taking the film-coated tablet should not be stopped for more than 7 days.
For the proper inhibition of the hypothalamus-hypophysis-ovary system film-coated tablets have to be taken for 7 days without interruption.
Based on these, the following advice can be given for the everyday practice: First week: The patient should take the last forgotten film-coated tablet, even if this means taking two film-coated tablets in one day and then continue to take film-coated tablets at the normal time. Additional contraceptive precautions (e.g. condom) should be taken for the next 7 days. However, if sexual intercourse has already preceded in the previous 7 days, pregnancy cannot be excluded. Risk of getting pregnant is proportional to the number of film-coated tablets missed and is increasing as the "missed-period" gets closer to the tablet free period.
Second week: The patient should take the last forgotten film-coated tablet, even if this means taking two film-coated tablets in one day and then continue to take film-coated tablets at the normal time. If she has taken the film-coated tablets regularly on the preceding 7 days, there is no need to take additional contraceptive precautions. However, if there was more than one film-coated tablet missed or she has not taken the film-coated tablets regularly, additional contraceptive precautions must be taken for the next 7 days.
Third week: In this period the risk for incomplete contraception is extremely high because of the advancing tablet-free period. However, some sort of contraception can be ensured by modifying the schedule of the film-coated tablets. By using the next protocols, there is no need to take additional contraceptive precautions, given that the woman has taken the film-coated tablets regularly on the preceding 7 days. If not, the first protocol should be selected and additional contraceptive precautions must be taken for the next 7 days.
The patient should take the last forgotten film-coated tablet, even if this means taking two film-coated tablets in one day and then continue to take film-coated tablets at the normal time. The next pack must be started as soon as the current one is finished, i.e. no gap should be left between the packs. The patient is not likely to have a withdrawal bleeding until the end of the second pack and she might experience some spotting or break-through bleeding on film-coated tablet taking days.
The second possibility is that she does not continue the pack already in use, but she observes a seven-day-long tablet free period (days when the film-coated tablet was missed should be counted), then she carries on with a new pack.
If several film-coated tablets were missed from the current package and there is no withdrawal bleeding in the tablet-free period the existence of a pregnancy cannot be excluded.
Gastro-intestinal upset: If vomiting or diarrhea occurs within 3-4 hours after film-coated tablet intake, a film-coated tablet may not be absorbed properly by the body. In this case a film-coated tablet should be taken as soon as possible.
After more than 12 hours, directions in Advice in case of missed pills as previously mentioned should be followed to take missed film-coated tablets. If the patient does not want to disturb the order of film-coated tablets in the current package, she has to take an extra film-coated tablet (or more) from a spare pack.
Delaying or modifying the time of menstrual bleeding: To delay bleeding after finishing the previous package, application of Dienille should be continued without a drug-free interval. During the application of the second pack the patient might experience some spotting or break-through bleeding on tablet taking days. After finishing the second pack 7 tablet-free days have to elapse, then application of Dienille can commence.
If she wants to have the start of the menstrual cycle on a different day of the week, length of the tablet-free interval can be decreased as necessary. However, the shorter is the tablet-free interval, the higher raises the probability of spotting or break- through bleeding during the application of the second pack. (It is similar to the case when the time of menstrual cycle is delayed).